# Sermorelin: full monograph (Sermorelin Co)
> Source page: https://sermorelinco.com/monograph

Status: Compounded, not FDA-approved
Disclosure: Sermorelin was once FDA-approved as Geref, which was discontinued for commercial reasons. FDA determined it was not withdrawn for safety or effectiveness. No FDA-approved sermorelin product is on the market today; current versions are compounded and not FDA-reviewed.
Updated: 2026-08-14

## Key facts
- Status: Compounded, not FDA-approved
- Parent half life: 6.8 minutes (GHRH 1-44 by HPLC) min (source: https://pubmed.ncbi.nlm.nih.gov/3093533/)
- Clearance: 39.7 mL/kg per min (GHRH 1-29) (source: https://pubmed.ncbi.nlm.nih.gov/7962295/)
- Onset: GH release within 10 minutes of SC injection (source: https://pubmed.ncbi.nlm.nih.gov/9141536/)
- Duration: single GH pulse lasting about 2 hours (source: https://pubmed.ncbi.nlm.nih.gov/9141536/)
- Degradation: cleaved by DPP-IV at the 2-3 bond to an inactive metabolite (source: https://pubmed.ncbi.nlm.nih.gov/2565342/)
- Class: GHRH analog (GRF 1-29) (source: https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams)
- Half-life: about 4 minutes min (source: https://pubmed.ncbi.nlm.nih.gov/7962295/)
- Route: Subcutaneous injection; bedtime in trials (source: https://pubmed.ncbi.nlm.nih.gov/8772599/)
- Molecule: 29-amino-acid fragment of human GHRH (source: https://pubmed.ncbi.nlm.nih.gov/18031173/)
- First approved: Dec 28, 1990 (Geref, diagnostic use) (source: https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams)
- Discontinued: 2008, for commercial reasons (source: https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams)
- GH response onset: within 10 min, lasting about 2 h (source: https://pubmed.ncbi.nlm.nih.gov/9141536/)

## Overview
Sermorelin is a synthetic 29-amino-acid fragment of human growth hormone-releasing hormone (GHRH) that carries the full GH-releasing activity of the parent hormone 1 . Injected subcutaneously, it prompts the pituitary to release the body's own growth hormone in a short pulse rather than supplying growth hormone from outside 2 . Two facts frame everything else on this page. First, sermorelin is not an FDA-approved product today: it is sold through compounding pharmacies, and compounded drugs are not FDA-reviewed for safety, effectiveness, or quality before marketing 3 . Second, sermorelin once was approved: FDA cleared Geref (sermorelin acetate) for diagnostic use on December 28, 1990 and for pediatric therapy on September 26, 1997, and after the maker discontinued both products in 2008 FDA formally determined they were not withdrawn from sale for reasons of safety or effectiveness 4 . This monograph lays out what the human trials actually measured, where the animal and mechanistic work stops, and which popular claims have no outcome evidence behind them. Every numbered citation resolves to a primary source.
Sources: https://pubmed.ncbi.nlm.nih.gov/1379256/ ; https://pubmed.ncbi.nlm.nih.gov/18031173/ ; https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers ; https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams

## About sermorelin (GRF 1-29)
Native human GHRH circulates mainly as a 44-amino-acid peptide. Structure-activity work in the 1980s showed the first 29 residues are the shortest fragment with full biological activity, and that fragment, GRF(1-29) amide, became the drug substance sermorelin acetate 1 . FDA chemistry records for Geref describe the product as lyophilized sermorelin acetate powder for injection 5 . The first therapeutic use in humans was reported in 1985, when two GH-deficient children received GRF by portable pump every 3 hours for 6 months and accelerated their growth from 4.6 to 7.1 cm/yr and from 2.1 to 13.7 cm/yr respectively 6 . Serono later developed sermorelin as Geref in two forms: a 0.05 mg ampoule for diagnostic testing of pituitary GH secretion (NDA 19-863, approved December 28, 1990) and 0.5 mg and 1.0 mg vials for pediatric growth hormone deficiency (NDA 20-443, approved September 26, 1997) 4 . Today the molecule is prescribed off the approved-drug system entirely, through compounding pharmacies, most often marketed to adults interested in GH-axis support. That population was never the subject of the approval, and the adult evidence base is far thinner than the marketing suggests; the sections below quantify it 7 .
Sources: https://pmc.ncbi.nlm.nih.gov/articles/PMC7108996/ ; https://pubmed.ncbi.nlm.nih.gov/18031173/ ; https://pubmed.ncbi.nlm.nih.gov/3917299/ ; https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S001_GEREF.pdf ; https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams

## Regulatory history: what actually happened to Geref
Sermorelin has the most unusual regulatory story of any compound in this site family, and it is worth telling precisely, because both its promoters and its critics tend to get it wrong. Approved. Geref (sermorelin acetate) injection 0.05 mg base/amp was approved December 28, 1990 under NDA 19-863, indicated, in FDA's words, "for evaluating the ability of the somatotroph of the pituitary gland to secrete growth hormone." Geref 0.5 mg and 1.0 mg base/vial followed on September 26, 1997 under NDA 20-443, indicated, again quoting FDA, "for the treatment of idiopathic growth hormone deficiency (GHD) in children with growth failure." 4 Discontinued. In letters dated July 11, 2008 and December 2, 2008, EMD Serono told FDA it was discontinuing the diagnostic ampoule and the therapeutic vials, and FDA moved both to the Discontinued Drug Product List section of the Orange Book 4 . Drugs@FDA still lists both applications with marketing status Discontinued 8 9 . Not a safety withdrawal. On March 4, 2013, responding to the question every generic maker must ask, FDA published a formal determination that the Geref products "were not withdrawn from sale for reasons of safety or effectiveness," a finding that legally opens the door to generic (ANDA) versions 4 . No company has brought one to market: Drugs@FDA shows no active sermorelin application, so no FDA-approved sermorelin product exists today 9 . What fills the gap. Compounding pharmacies. FDA is explicit about what that means: "Compounded drugs are not FDA-approved. This means that FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed." 3 Unlike CJC-1295, ipamorelin, and most research peptides, sermorelin does not appear on FDA's list of bulk substances flagged for significant compounding safety risks; its history as an approved drug substance is the reason it occupies a gray zone rather than a red one 10 . So the honest one-sentence version is: a formerly approved drug, dropped for business reasons, never pulled for safety, and never brought back through any FDA pathway.
Sources: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863 ; https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443 ; https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ; https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers ; https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams

## Dosage: what was labeled and what was studied
There is no current FDA-approved dose of sermorelin for anyone, because there is no current FDA-approved product 9 . The figures below are the historical label dose and the doses used in published trials; they are reported for education, not as recommendations. Pediatric label era. The approved Geref regimen studied in the pivotal trial was 30 mcg/kg subcutaneously once daily at bedtime in prepubertal GH-deficient children 11 . A review of the program notes the growth effect was maintained through 36 months of continued dosing in the data available, and that height-velocity gains were smaller than those seen with daily somatropin at the same weight-based dose 1 . Diagnostic use. The diagnostic test used a single 1 mcg/kg intravenous dose to provoke a measurable GH response 1 . Adult research doses. Published adult protocols used 0.5 mg or 1.0 mg SC twice daily for 14 days, 2 2 mg SC nightly for 6 weeks, 12 and 10 mcg/kg of a stabilized GHRH(1-29) analog nightly for 16 weeks 13 . Notably, the once-nightly 2 mg regimen raised overnight GH but did not move IGF-I at all over 6 weeks, while twice-daily dosing did; frequency mattered more than size 12 . Compounded products are dispensed in pharmacy-specific vial sizes and concentrations that FDA has not reviewed 3 . If a licensed clinician has prescribed sermorelin, the dose on that prescription label, not this page, governs; our reconstitution calculator only converts a prescribed dose into injection volume.
Sources: https://pubmed.ncbi.nlm.nih.gov/1379256/ ; https://pubmed.ncbi.nlm.nih.gov/18031173/ ; https://pubmed.ncbi.nlm.nih.gov/8772599/ ; https://pubmed.ncbi.nlm.nih.gov/9005976/ ; https://pubmed.ncbi.nlm.nih.gov/9141536/ ; https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443 ; https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

## Mechanism of action
Sermorelin binds the GHRH receptor, a G-protein-coupled receptor on pituitary somatotroph cells, and stimulates both synthesis and pulsatile secretion of growth hormone. The receptor requirement is not hypothetical: mice carrying a single disabling mutation in this receptor secrete little GH and grow to dwarf proportions 14 . Because sermorelin works upstream of the pituitary, the downstream control loops stay connected: GH output remains episodic rather than flat, as shown by frequent overnight sampling in treated older men, where injections amplified natural GH peaks instead of producing a continuous elevation 2 . Even continuous GHRH infusion preserved pulsatile GH release in older men 15 . The GHRH-somatostatin-GH-IGF-I feedback system that regulates all of this is reviewed in detail elsewhere 16 . The signal is deliberately brief. Plasma dipeptidylpeptidase IV (DPP-IV) removes the first two residues of GHRH peptides, including GRF(1-29), in a single cleavage that leaves a metabolite with under one thousandth of the original activity, 17 18 and the measured disappearance half-time of GHRH(1-29) in men is 4.3 minutes 19 . A nightly injection therefore delivers a transient prompt: in treated adults, GH rises within about 10 minutes and the induced pulse runs its course in roughly 2 hours 13 . This is the core mechanical difference from injected growth hormone, which enters the circulation as the end hormone itself and does not depend on, or preserve, the pituitary's own release pattern; comparisons are drawn out in the dedicated section below 20 .
Sources: https://pubmed.ncbi.nlm.nih.gov/1379256/ ; https://pubmed.ncbi.nlm.nih.gov/2565342/ ; https://pubmed.ncbi.nlm.nih.gov/3093533/ ; https://pubmed.ncbi.nlm.nih.gov/7962295/ ; https://pubmed.ncbi.nlm.nih.gov/8395283/ ; https://pubmed.ncbi.nlm.nih.gov/8421077/ ; https://pubmed.ncbi.nlm.nih.gov/8491152/ ; https://pubmed.ncbi.nlm.nih.gov/9141536/ ; https://pubmed.ncbi.nlm.nih.gov/9861545/

## Evidence in adults: what the trials measured
The adult literature is real but small, and it measures hormones far more often than outcomes. The complete study table with species labels appears below this monograph; the highlights: Hormone levels. In healthy men in their sixties and seventies, GHRH(1-29) 1.0 mg twice daily for 14 days raised 24-hour GH and IGF-I to ranges seen in untreated young men 2 . A 16-week nightly regimen of a GHRH(1-29) analog raised nocturnal GH in both sexes, and raised IGF-I within 2 weeks, but IGF-I then drifted back toward baseline by week 16 despite continued injections 13 . A single nightly 2 mg dose for 6 weeks raised overnight GH yet changed neither IGF-I nor body composition 12 . Function and body composition. Across these trials the functional signals were modest and inconsistent: 2 of 6 strength measures improved in one uncontrolled 6-week study, 12 skin thickness increased in both sexes and lean mass in men only over 16 weeks, 13 and no trial demonstrated fat-loss, fitness, or appearance outcomes that a buyer could bank on. Sleep. GHRH participates in sleep regulation: bolus IV GHRH given late in the night produced a near 10-fold rise in slow-wave sleep in young men, 21 and animal work shows GRF promotes non-REM sleep 22 . But timing dominates the effect, morning administration did nothing for slow-wave sleep, 23 and in the one long adult trial that asked, self-reported sleep quality did not improve over 16 weeks of nightly use 13 . Reviews. Modern reviews of GH secretagogues in adults, sermorelin included, reach the same verdict we do: mechanistically coherent, clinically under-evidenced, with efficacy data that "largely remain lacking." 7 A 2026 review of GH-axis peptides sold online classes the sector's recomposition and performance claims as unproven and flags the added uncertainty of unregulated supply chains 24 .
Sources: https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/ ; https://pmc.ncbi.nlm.nih.gov/articles/PMC7108996/ ; https://pubmed.ncbi.nlm.nih.gov/1379256/ ; https://pubmed.ncbi.nlm.nih.gov/3136672/ ; https://pubmed.ncbi.nlm.nih.gov/8476038/ ; https://pubmed.ncbi.nlm.nih.gov/9005976/ ; https://pubmed.ncbi.nlm.nih.gov/9089471/ ; https://pubmed.ncbi.nlm.nih.gov/9141536/

## Evidence in children (the Geref era)
The strongest sermorelin data were generated in the population it was approved for: prepubertal children with idiopathic growth hormone deficiency. In the multicenter registration-era trial, 110 previously untreated children received 30 mcg/kg SC at bedtime for up to a year; mean height velocity rose from 4.1 cm/yr to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months, 74% were judged good responders at 6 months, and bone age advanced in step with height age rather than ahead of it 11 . The candid footnotes: catch-up growth occurred in the majority but not all children; the effect was documented out to 36 months without final-adult-height data; and the height-velocity gains were smaller than those achieved with once-daily somatropin at the same weight-based dose, a comparison never run head-to-head at the recommended regimens 1 . The diagnostic product had its own evidence track: a 1 mcg/kg IV dose provokes GH release rapidly and relatively specifically, with fewer false positives than conventional stimulation tests, though a normal response cannot exclude hypothalamic GH deficiency 1 . In adults, combining GHRH with arginine became a standard provocative test, with a validated cut-off of 16.5 mcg/L versus 5 mcg/L for insulin-induced hypoglycemia 25 . None of this transfers automatically to the healthy adults who buy compounded sermorelin today; the pediatric data establish that the mechanism can produce a clinically meaningful outcome when the axis is genuinely deficient and the endpoint is growth.
Sources: https://pubmed.ncbi.nlm.nih.gov/18031173/ ; https://pubmed.ncbi.nlm.nih.gov/8772599/ ; https://pubmed.ncbi.nlm.nih.gov/9589665/

## Contraindications
No current FDA label exists for sermorelin, so there is no authoritative contraindication list for the compounded products sold today 9 . What follows is the closest honest substitute, drawn from the labeled GHRH analog still on the market and from the pharmacology. Who should not consider sermorelin? The FDA-approved GHRH analog tesamorelin (Egrifta SV) is contraindicated in active malignancy, in disruption of the hypothalamic-pituitary axis from surgery, irradiation, or head trauma, in pregnancy, and in known hypersensitivity; because sermorelin drives the same receptor and the same downstream axis, those exclusions are the rational starting point for any conversation about sermorelin 26 . Growth factors are mitogens: reviews of GH-axis peptides flag biologically plausible, unproven mitogenic concerns as a standing reason for oncologic caution 24 . Anyone considering sermorelin without a prescriber has a simpler contraindication: FDA does not review compounded drugs for safety, effectiveness, or quality before marketing, so a licensed clinician and a licensed pharmacy are the only quality controls available at all 3 .
Sources: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224 ; https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/ ; https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443 ; https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

## Drug interactions
Formal interaction studies for compounded sermorelin do not exist, and the Geref-era label is out of distribution; reviews of this drug class note that interaction and safety data in modern self-administration contexts are simply not collected 24 . What is known to change the GH response? Timing and physiology. The GH response to GHRH depends on when it is given: identical IV doses that raised slow-wave sleep and GH at night did not raise slow-wave sleep in the early morning, when cortisol activity is high 23 . Dosing frequency. Twice-daily dosing moved IGF-I where once-nightly dosing did not, an interaction of schedule rather than substance, but one with more measured impact than any drug pair on record for this molecule 12 2 . Stacking. Online protocols commonly combine sermorelin with other GH-axis peptides; the 2026 peptide-landscape review emphasizes that the safety of such combinations is unstudied and that product composition in unregulated supply chains is itself uncertain 24 . Tell every prescriber and pharmacist about all hormones and peptides in use; that is the entire reliable interaction guidance that exists.
Sources: https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/ ; https://pubmed.ncbi.nlm.nih.gov/1379256/ ; https://pubmed.ncbi.nlm.nih.gov/9005976/ ; https://pubmed.ncbi.nlm.nih.gov/9089471/

## Adverse reactions and side effects
What side effects were reported in trials? Across the development program, single IV doses and repeated daily SC doses were described as well tolerated; the most commonly reported adverse events were transient facial flushing and pain at the injection site 1 . In the 1-year pediatric trial no adverse changes in general biochemical profiles were reported 11 . In adults, the 16-week nightly trial recorded transient hyperlipidemia that resolved by study end as its only adverse effect, 13 and the 6-week nightly trial observed no significant adverse effects 12 . What has not been measured? Long-term safety surveillance ended when the approved product left the market in 2008; no post-marketing safety system covers today's compounded use 4 . Class reviews of GH-axis peptides bought online report injection-site reactions, fluid retention syndromes, glucose disturbances, and hormonal imbalance across the category, and stress the uncertainty added by unverified product composition 24 . For calibration, the adverse-event profile of raising the axis pharmacologically is best documented for injected growth hormone itself: in pooled randomized trials in healthy older adults, GH caused significantly more soft-tissue edema, arthralgia, carpal tunnel syndrome, and gynecomastia, with a trend toward new diabetes and impaired fasting glucose 27 . Sermorelin's gentler, pulse-preserving mechanism is often argued to lower those risks, 28 but no trial has demonstrated it.
Sources: https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/ ; https://pmc.ncbi.nlm.nih.gov/articles/PMC2699646/ ; https://pubmed.ncbi.nlm.nih.gov/17227934/ ; https://pubmed.ncbi.nlm.nih.gov/18031173/ ; https://pubmed.ncbi.nlm.nih.gov/8772599/ ; https://pubmed.ncbi.nlm.nih.gov/9005976/ ; https://pubmed.ncbi.nlm.nih.gov/9141536/ ; https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams

## Pregnancy and breastfeeding
Can sermorelin be used in pregnancy? No published human data support sermorelin use in pregnancy or while breastfeeding, and no FDA-reviewed labeling exists to define the risk 9 . The one FDA-labeled drug in the same class, tesamorelin, is expressly contraindicated in pregnancy 26 . Compounded sermorelin adds a second layer of unknowns because FDA does not verify the safety, effectiveness, or quality of compounded drugs before marketing 3 . The education-grade bottom line: this is a category where the absence of evidence should be treated as a stop sign, not a blank check. Anyone pregnant, planning pregnancy, or breastfeeding should not use sermorelin outside a clinician-supervised setting, and should raise the topic with that clinician directly.
Sources: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224 ; https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443 ; https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

## Storage and handling
How should compounded sermorelin be stored? Sermorelin acetate was supplied as a lyophilized (freeze-dried) powder for reconstitution, and FDA's 1991 supplement approval for Geref documents a shelf life of 24 months when stored refrigerated at 7 degrees C 5 . Peptide stability is temperature-sensitive; refrigeration of both the sealed vial and any reconstituted solution, protection from light, and prompt use after reconstitution are the standard handling pattern for this class. Because every compounding pharmacy sets its own formulation, beyond-use date, and storage instructions, and FDA reviews none of them, the dispensing label from the pharmacy is the controlling document; when it conflicts with anything on this page, follow the label and ask the pharmacist 3 .
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S001_GEREF.pdf ; https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

## Administration: how sermorelin was given
Every approved-era and trial regimen used small-volume subcutaneous injection: at bedtime in children, 11 and nightly or twice daily in the adult studies 12 2 . The diagnostic test used a single IV bolus in a supervised setting 1 . Why was dosing at bedtime? The largest natural GH pulse of the day occurs shortly after sleep onset, in association with the first slow-wave sleep episode; in men roughly 70% of sleep GH pulses coincide with slow-wave sleep 29 . Bedtime injection places the pharmacologic prompt where the physiologic one already lives, and the timing studies show that the same dose given in the early morning loses part of its effect profile 23 . Injection technique basics The technique literature for subcutaneous therapies recommends short needles into the abdomen or thigh, and systematic rotation of injection sites so lipohypertrophy, the fat-pad thickening that distorts absorption, does not develop at overused sites 30 . Our injection timing and rotation planner turns those recommendations into a printable schedule; it teaches technique concepts and never sets doses.
Sources: https://pubmed.ncbi.nlm.nih.gov/1379256/ ; https://pubmed.ncbi.nlm.nih.gov/18031173/ ; https://pubmed.ncbi.nlm.nih.gov/27594187/ ; https://pubmed.ncbi.nlm.nih.gov/8627466/ ; https://pubmed.ncbi.nlm.nih.gov/8772599/ ; https://pubmed.ncbi.nlm.nih.gov/9005976/ ; https://pubmed.ncbi.nlm.nih.gov/9089471/

## References
Every claim on this page carries a numbered citation that resolves to a primary source: peer-reviewed journals, FDA records, the Federal Register, and National Library of Medicine labeling. The full numbered list is below, and the same data ships as a machine-readable manifest at /evidence.json .

## Frequently asked questions
Direct answers to the questions readers actually bring to sermorelin, each with its sources; the first paragraph of every answer is the short version.

## Related compounds and comparisons
Sermorelin sits in a family of GH-axis molecules that are easy to conflate and importantly different. Tesamorelin is the only GHRH analog with a current FDA approval 26 . CJC-1295 is a GHRH analog engineered for a days-long half-life, studied in healthy adults but never approved 31 . Ipamorelin works on a different receptor entirely, the ghrelin (GH secretagogue) receptor 32 . Both CJC-1295 and ipamorelin appear on FDA's compounding safety-risk list; sermorelin does not 10 . Detailed cited comparisons: sermorelin vs HGH (somatropin) , sermorelin vs CJC-1295 plus ipamorelin , and sermorelin vs tesamorelin .
Sources: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224 ; https://pubmed.ncbi.nlm.nih.gov/16352683/ ; https://pubmed.ncbi.nlm.nih.gov/9849822/ ; https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks

## Study results
| Study | Species/model | n | Duration | Outcome | Effect size |
| --- | --- | --- | --- | --- | --- |
| Geref multicenter pediatric trial (open label) (https://pubmed.ncbi.nlm.nih.gov/8772599/) | human | 110 | 12 months | Height velocity in GH-deficient children rose from 4.1 cm/yr at baseline to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months on 30 mcg/kg SC at bedtime; 74% classed as good responders at 6 months; no adverse biochemical changes reported | +3.1 cm/yr at 12 months vs baseline |
| GHRH(1-29) twice daily in healthy old men (https://pubmed.ncbi.nlm.nih.gov/1379256/) | human | 10 | 14 days per dose | 0.5 mg and 1.0 mg SC twice daily; the 1.0 mg dose raised 24-h GH and IGF-I with no significant difference remaining vs young men; fasting glucose and blood pressure unchanged | IGF-I increase P<0.005 at 1.0 mg; dose-related |
| Nightly GHRH(1-29) analog in ages 55-71 (randomized, placebo lead-in, single blind) (https://pubmed.ncbi.nlm.nih.gov/9141536/) | human | 19 | 16 weeks | 10 mcg/kg nightly raised nocturnal GH (P<0.01 women, P<0.05 men); IGF-I and IGFBP-3 rose within 2 weeks but returned toward baseline by week 16; skin thickness up in both sexes; lean mass up in men only; sleep quality unaffected; transient hyperlipidemia was the only adverse effect | IGF-I P<0.05 at week 2; not sustained at week 16 |
| Single nightly 2 mg GHRH(1-29) in healthy elderly men (https://pubmed.ncbi.nlm.nih.gov/9005976/) | human | 11 | 6 weeks | Nocturnal GH release increased (P<0.02) but IGF-I, IGFBP-3, weight, and body composition did not change; 2 of 6 strength measures improved; no significant adverse effects | GH up, IGF-I unchanged |
| First therapeutic use, GRF by pump in 2 GH-deficient children (https://pubmed.ncbi.nlm.nih.gov/3917299/) | human | 2 | 6 months | Subcutaneous GRF pulses every 3 hours accelerated growth: 4.6 to 7.1 cm/yr in one child and 2.1 to 13.7 cm/yr in the other, with increased somatomedin C in the second | +2.5 and +11.6 cm/yr |
| IV GHRH and sleep architecture (https://pubmed.ncbi.nlm.nih.gov/8476038/) | human | healthy young men (n not stated in abstract) | single-night sessions | GHRH 0.3 mcg/kg IV during the third REM period produced a near 10-fold increase in slow-wave sleep and reduced wake; early-sleep injection increased REM sleep | about 10-fold SWS increase (late-sleep dosing) |
| Early-morning GHRH timing test (https://pubmed.ncbi.nlm.nih.gov/9089471/) | human | 7 | 2 nights | 4 x 50 mcg IV GHRH between 04.00 and 07.00 h stimulated GH but did not increase slow-wave sleep; only REM density fell; Sleep effects of GHRH depend on time of administration | GH up; no SWS change in the morning |
| GHRH(1-29) clearance in normal men (https://pubmed.ncbi.nlm.nih.gov/7962295/) | human | 10 | 90-min infusion | Disappearance half-time of GHRH-(1-29)-NH2 was 4.3 +/- 1.4 minutes with metabolic clearance 39.7 mL/kg per min; a D-Ala2 substitution slowed clearance | t1/2 4.3 min |
| GHRH(1-44) degradation in vivo (https://pubmed.ncbi.nlm.nih.gov/3093533/) | human | normal subjects (n not stated in abstract) | single IV dose | Half-life of intact GHRH(1-44) was 6.8 minutes by HPLC; the circulating metabolite GRH(3-44) retained under one thousandth of the biologic activity | t1/2 6.8 min; metabolite inactive |
| DPP-IV cleavage mechanism (https://pubmed.ncbi.nlm.nih.gov/2565342/) | in vitro | plasma assays | in vitro kinetics | Dipeptidylpeptidase IV cleaves GHRH, including the (1-29) fragment, at the 2-3 bond in a single step to an inactive metabolite; blocking DPP-IV stopped the cleavage | primary inactivation route identified |
| GRF metabolic clearance in man (https://pubmed.ncbi.nlm.nih.gov/6425363/) | human | normal adult men (n not stated in abstract) | single doses and infusions | Metabolic clearance rate of GRF(1-40) was about 194-202 L/m2 per day; immunoreactive disappearance showed a 7.6-minute equilibration phase and an elimination phase near 52 minutes | MCR about 200 L/m2/day |
| GHRH + arginine vs insulin tolerance test (https://pubmed.ncbi.nlm.nih.gov/9589665/) | human | 40 | single-visit tests | In 40 hypopituitary adults the GHRH + arginine test separated GH deficiency from normal with a 16.5 mcg/L cut-off, vs 5 mcg/L for insulin-induced hypoglycemia; the two tests agreed on classification | diagnostic cut-offs established |
| Continuous SC GHRH(1-44) infusion in old men (https://pubmed.ncbi.nlm.nih.gov/8421077/) | human | healthy old men (n not stated in abstract) | 14 days per dose | 1 and 2 mg/day continuous infusions increased 24-h GH, GH peak number, and IGF-I (P<0.001) while preserving pulsatile release; nocturnal peak amplitude fell | IGF-I P<0.001; pulsatility preserved |
| GRF and sleep in animals (https://pubmed.ncbi.nlm.nih.gov/3136672/) | rat and rabbit | not stated in abstract | 6-24 h recordings | Intracerebroventricular GRF promoted non-REM and REM sleep and increased EEG slow-wave activity in both species | NREM sleep increased postinjection |
| GHRH receptor loss-of-function model (https://pubmed.ncbi.nlm.nih.gov/8395283/) | mouse | little (lit) mutant line | genetic model | A missense mutation disrupting the GHRH receptor causes reduced GH secretion and dwarfism in little mice, demonstrating the receptor requirement for GHRH action | receptor necessity shown |

## What we do not know yet
What we do not know yet, as of this writing. No study has tested whether sermorelin improves body composition, fat loss, strength, skin, sleep, recovery, or longevity as a primary outcome in healthy adults; the adult literature measures hormones, and its functional findings are small, mixed, and mostly uncontrolled. IGF-I responses are inconsistent across dosing schedules, and in the longest study the early rise faded back toward baseline before the trial ended; durable elevation has never been demonstrated, nor has benefit from one. Self-reported sleep quality did not improve in the one long trial that measured it. Final adult height was never established even in the approved pediatric use, and sermorelin was never compared head-to-head with somatropin at the recommended regimens. Long-term safety is unmeasured: surveillance ended with the discontinuation of Geref, today's compounded products are not FDA-reviewed, and class-level questions, including mitogenic risk with sustained GH-axis stimulation, remain open. Claims that sermorelin is an established anti-aging therapy are not supported by any outcome trial we can cite; where sermorelin marketing borrows numbers, they usually trace to studies of growth hormone itself, whose pooled trials in healthy elderly adults showed small body-composition changes and more adverse events.

## Questions and answers
### Is sermorelin FDA approved?
Not today. Sermorelin was FDA-approved as Geref (diagnostic 1990, pediatric therapy 1997), discontinued in 2008 for commercial reasons, and FDA determined it was not withdrawn for safety or effectiveness. Everything sold now is compounded and not FDA-reviewed.

Not today, and the details matter. FDA approved Geref (sermorelin acetate) for diagnostic use in 1990 and for pediatric growth hormone deficiency in 1997; EMD Serono discontinued both products in 2008, and in 2013 FDA published a formal determination that Geref was not withdrawn from sale for reasons of safety or effectiveness, the finding that permits generic versions.No generic ever came: Drugs@FDA still lists both Geref applications as Discontinued. Every sermorelin product sold today comes from a compounding pharmacy, and FDA states that compounded drugs are not FDA-approved and are not reviewed for safety, effectiveness, or quality before marketing.

### Why was Geref discontinued?
For commercial reasons, not safety. EMD Serono discontinued Geref by letters to FDA in 2008 and it moved to the Orange Book discontinued list; in 2013 FDA formally determined Geref was not withdrawn from sale for reasons of safety or effectiveness.

For commercial reasons, not for safety. In letters dated July 11 and December 2, 2008, EMD Serono told FDA it was discontinuing the Geref diagnostic ampoule and the therapeutic vials, and FDA moved both presentations to the Discontinued Drug Product List of the Orange Book.Because generic applications legally require it, FDA then examined its records and published the determination in the Federal Register on March 4, 2013: the Geref products were not withdrawn from sale for reasons of safety or effectiveness. The commercial context is not mysterious: recombinant growth hormone had taken the pediatric market, and sermorelin's height-velocity gains were smaller than somatropin's at the same weight-based dose.

### How is sermorelin different from HGH?
HGH (somatropin) is the hormone itself, injected from outside. Sermorelin is a signal peptide that asks the pituitary to release your own GH in pulses, with the feedback loops intact. HGH is FDA-approved with deep evidence; sermorelin is compounded today, with a thin adult evidence base.

Somatropin (recombinant human growth hormone) is the end hormone, delivered from outside; the body responds to the injected exposure and the pituitary's own output is bypassed. Sermorelin acts one step upstream: it stimulates the pituitary's GHRH receptor so the gland releases its own GH in short pulses, and the somatostatin and IGF-I feedback that normally caps exposure stays connected, a pattern documented by overnight sampling in treated older men.The practical differences follow. Somatropin is FDA-approved and label-titrated against serum IGF-I. Its trade-offs are also the best measured: in pooled randomized trials in healthy elderly adults it produced about 2 kg of lean-mass gain and 2 kg of fat loss alongside significantly more edema, joint pain, and carpal tunnel syndrome. Sermorelin has no current approval, needs a functional pituitary, and its adult trials measured hormone levels far more often than outcomes. The full row-by-row comparison, including where sermorelin loses, is on our comparison page.

### Sermorelin vs CJC-1295 vs ipamorelin: what is the difference?
All three raise GH, differently. Sermorelin: GHRH analog, minutes-long half-life, formerly FDA-approved. CJC-1295: GHRH analog built to last 5.8 to 8.1 days, never approved. Ipamorelin: ghrelin-receptor agonist, mostly animal data. Both stack peptides sit on FDA's compounding risk list.

All three stimulate growth hormone release, by two different receptors and three different exposure patterns. Sermorelin is the GHRH fragment with a minutes-long half-life and one GH pulse per injection; it alone in this trio was once FDA-approved, in 1990 and 1997, before its commercial discontinuation in 2008. CJC-1295 stretches the same GHRH signal to a half-life of 5.8 to 8.1 days, raising GH 2- to 10-fold for 6 days or more and IGF-I 1.5- to 3-fold for up to 11 days after single doses in healthy adults, a fundamentally non-pulsatile exposure. Ipamorelin is not a GHRH analog at all: it is a pentapeptide agonist of the ghrelin receptor, characterized as a selective GH secretagogue in animal and in vitro work.Regulatory status separates them further: CJC-1295 and ipamorelin have never been approved for anything and both appear on FDA's list of bulk substances whose compounding may present significant safety risks, while sermorelin does not. Combining them in stacks is common online and unstudied for safety, with product composition itself uncertain in unregulated supply chains. Our sister sites cover each compound in this same depth.

### Does sermorelin raise IGF-1, and by how much?
Schedule decides. Twice-daily dosing for 14 days restored older men's IGF-1 to young-adult ranges. Nightly analog dosing raised IGF-1 by week 2, fading toward baseline by week 16. A single 2 mg nightly dose for 6 weeks did not move IGF-1.

The honest answer is: sometimes, modestly, and the schedule matters more than vendors admit. In healthy men in their sixties and seventies, GHRH(1-29) at 1.0 mg twice daily for 14 days raised IGF-I until no significant difference remained versus young men. A 16-week trial of a nightly GHRH(1-29) analog raised IGF-I within 2 weeks, after which levels drifted back toward baseline by week 16 despite continued injections. A single nightly 2 mg dose for 6 weeks raised overnight GH yet left IGF-I, IGFBP-3, and body composition unchanged.Marketing pages that promise a specific percentage rarely name the study, the schedule, or the fade-out. If IGF-1 is the goal, the measured record says: dosing density moved it, single nightly doses moved it weakly or not at all, and durable elevation has never been demonstrated.

### Why is sermorelin taken at bedtime?
Because GH physiology is nocturnal: the largest natural GH pulse follows sleep onset with slow-wave sleep. The approved pediatric regimen was 30 mcg/kg at bedtime, and morning administration loses part of the effect.

Because that is where the physiology already is. The largest and most reproducible GH pulse of the day occurs shortly after sleep onset, in association with the first slow-wave sleep episode, and in men about 70% of nocturnal GH pulses coincide with slow-wave sleep. The approved Geref regimen was explicitly 30 mcg/kg at bedtime, and the adult trials injected at night.Timing is not cosmetic. Late-night IV GHRH produced a near 10-fold increase in slow-wave sleep in young men, while the same peptide given between four and seven in the morning raised GH without touching slow-wave sleep. A bedtime injection rides the natural rhythm; an off-schedule one fights it.

### Does sermorelin improve sleep?
Not shown. Acute IV GHRH increased slow-wave sleep in young men, and GHRH promotes non-REM sleep in animals. But in the 16-week nightly trial that measured it, self-reported sleep quality did not improve.

The mechanism is real; the consumer claim is not proven by trials. Acute intravenous GHRH increased slow-wave sleep markedly in young men when given late in the night, and GHRH-family peptides promote non-REM sleep in rats and rabbits. That is why sleep appears in every sermorelin ad.What is missing is evidence that injected sermorelin improves sleep as people actually use it: in the 16-week nightly trial in older adults, the only long trial to assess it, self-reported sleep quality was unaffected in both sexes. Morning administration did not increase slow-wave sleep at all. If better sleep is the goal, behavioral sleep medicine holds the outcome evidence this category lacks, and any sermorelin sleep benefit should be treated as a hypothesis.

### Who should not use sermorelin?
Start from the labeled GHRH analog: tesamorelin is contraindicated in active malignancy, pituitary axis disruption, pregnancy, and known hypersensitivity. Add anyone without a licensed prescriber and pharmacy, since compounded drugs get no FDA review before sale.

Sermorelin has no current FDA label, so the honest contraindication list borrows from the closest labeled relative and from common sense. Tesamorelin, the FDA-approved GHRH analog, is contraindicated with active malignancy, disruption of the hypothalamic-pituitary axis, pregnancy, and known hypersensitivity; each of those cautions transfers rationally to sermorelin, which drives the same receptor. Reviews of GH-axis peptides add unresolved mitogenic concerns as a standing reason for oncologic caution.Beyond that: anyone unwilling to involve a licensed prescriber and a licensed pharmacy should not use it, because FDA does not verify the safety, effectiveness, or quality of compounded drugs before marketing, which makes the prescriber and the pharmacy the only quality controls in the chain.

### What are sermorelin's side effects?
In trials: transient facial flushing and injection-site pain most commonly; one adult trial saw transient hyperlipidemia; the 1-year pediatric trial reported no adverse biochemical changes. Long-term safety since discontinuation is unmonitored.

In the published trials sermorelin was well tolerated: transient facial flushing and pain at the injection site were the most commonly reported adverse events. The 1-year pediatric trial reported no adverse changes in general biochemical profiles. In adults, the 16-week nightly trial recorded transient hyperlipidemia that resolved by study end as its only adverse effect, and the 6-week nightly trial observed no significant adverse effects.Two caveats belong next to that clean record. First, formal safety surveillance ended when the approved product left the market in 2008; nobody systematically tracks today's compounded use. Second, class reviews of GH-axis peptides report injection-site reactions, fluid retention syndromes, and glucose disturbances across the category, with product composition itself uncertain in unregulated supply chains. A clean short-trial record is not demonstrated long-term safety.

### Does sermorelin work for anti-aging, fat loss, or muscle gain?
No outcome trial shows it. Adult sermorelin studies show hormone shifts plus small mixed signals: skin thickness, lean mass in men only, and 2 of 6 strength tests in an uncontrolled study. Pooled GH trials in healthy elderly found more adverse events, no anti-aging case.

This is where our answer diverges most from the marketing. No published trial shows sermorelin producing fat-loss, muscle-gain, longevity, or appearance outcomes in healthy adults; the measured findings are hormone-level changes plus scattered small signals, notably increased skin thickness in both sexes with lean mass in men only over 16 weeks and 2 of 6 strength measures in a 6-week uncontrolled study.The cautionary tale comes from growth hormone itself. The famous trial in men over sixty reported an 8.8% lean-mass increase and 14.4% adipose decrease over six months. But pooled randomized trials afterward found only small body-composition changes, no meaningful functional gains, and significantly more edema, joint pain, carpal tunnel syndrome, and glucose problems, concluding GH cannot be recommended as an anti-aging therapy, a caution the New England Journal repeated editorially. Sermorelin's pulse-preserving mechanism is a reasonable hypothesis for a better risk profile, and it remains exactly that: a hypothesis.

### How was sermorelin used as a diagnostic test?
Geref's original 1990 approval was diagnostic: a 1 mcg/kg IV dose provokes GH release to test pituitary secretory capacity, with fewer false positives than conventional tests. Its adult descendant, GHRH plus arginine, separates GH deficiency at a 16.5 mcg/L cut-off.

Sermorelin's first approval, in 1990, was as a diagnostic agent: a single 1 mcg/kg intravenous dose that provokes the pituitary so clinicians can measure its secretory capacity directly, with fewer false positives in children than conventional provocative tests, though a normal response cannot exclude hypothalamic GH deficiency.The descendant of that idea is the GHRH plus arginine test used in adults: in hypopituitary patients it separates GH deficiency from normal secretion at a validated 16.5 mcg/L cut-off, versus 5 mcg/L for insulin-induced hypoglycemia. If you are pursuing a genuine GH-deficiency diagnosis, that endocrinologist-run testing pathway is the evidence-based route, and it is how the approved GH therapies become available.

### Is compounded sermorelin the same as Geref was?
Same molecule on paper, different oversight entirely. FDA does not verify the safety, effectiveness, or quality of compounded drugs before marketing. Strengths and dating vary by pharmacy; sermorelin is at least absent from FDA's compounding risk list.

The molecule is the same on paper: sermorelin acetate, the GRF(1-29) amide fragment. What differs is everything approval used to guarantee. Geref's manufacturing, stability, potency, and labeling were FDA-reviewed, down to a documented 24-month refrigerated shelf life. A compounded vial's are not: FDA states that compounded drugs are not FDA-approved and that it does not verify their safety, effectiveness, or quality before they are marketed.In practice, compounded sermorelin varies by pharmacy in vial size, concentration, diluent, and beyond-use date, which is why our dosing content defers to the dispensing label. One genuine point in sermorelin's favor: unlike most peptides sold this way, it does not appear on FDA's list of bulk substances flagged for significant compounding safety risks.

### What is sermorelin's half-life?
Minutes: GHRH(1-29) shows a 4.3-minute disappearance half-time in men and the parent GHRH(1-44) clears at 6.8 minutes. The GH pulse it triggers runs about 2 hours: signal briefly, let the axis answer.

Minutes, by design of the biology. The measured disappearance half-time of GHRH(1-29) in normal men is 4.3 minutes, the parent GHRH(1-44) clears at 6.8 minutes by HPLC, and the enzyme DPP-IV removes two amino acids in one cleavage, leaving a metabolite with under one thousandth of the activity. Older immunoassay methods that could not distinguish that inactive metabolite reported apparent elimination phases near 52 minutes, which explains the inconsistent numbers on vendor pages.The brevity is functional. Sermorelin is a prompt, not an infusion: after a bedtime injection GH rises within about 10 minutes and the induced pulse completes in roughly 2 hours, preserving the pulsatile pattern the axis is built around. Compare CJC-1295, engineered for a half-life of 5.8 to 8.1 days and days of continuous elevation: same receptor, opposite philosophy.

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