{"format":"citation-manifest/v1","page":"https://sermorelinco.com/monograph","claim_count":47,"claims":[{"id":"SRM-001","text":"Sermorelin is a synthetic 29-amino-acid analogue of human GHRH, the shortest fragment with the full biological activity of the parent hormone.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18031173/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-002","text":"Geref (sermorelin acetate) injection 0.05 mg base/amp was approved by FDA on December 28, 1990 under NDA 19-863 for evaluating the pituitary's ability to secrete growth hormone.","source_url":"https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SRM-003","text":"Geref (sermorelin acetate) injection 0.5 mg and 1.0 mg base/vial was approved by FDA on September 26, 1997 under NDA 20-443, indicated for idiopathic growth hormone deficiency in children with growth failure (FDA's indication wording).","source_url":"https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SRM-004","text":"EMD Serono notified FDA by letters dated July 11, 2008 and December 2, 2008 that the Geref products were being discontinued, and FDA moved them to the Orange Book Discontinued Drug Product List.","source_url":"https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SRM-005","text":"On March 4, 2013 FDA published a determination that the Geref sermorelin products were not withdrawn from sale for reasons of safety or effectiveness, permitting ANDA approvals.","source_url":"https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SRM-006","text":"Drugs@FDA lists both Geref applications (NDA 019863 and NDA 020443) with marketing status Discontinued, and no approved sermorelin application is active today.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SRM-007","text":"FDA states that compounded drugs are not FDA-approved and that FDA does not verify their safety, effectiveness, or quality before they are marketed.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SRM-008","text":"Sermorelin does not appear on FDA's list of bulk drug substances flagged for significant safety risks in compounding; CJC-1295 and ipamorelin both do.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SRM-009","text":"In the multicenter pediatric trial, 110 GH-deficient children received sermorelin 30 mcg/kg SC once daily at bedtime; mean height velocity rose from 4.1 cm/yr at baseline to 8.0 cm/yr at 6 months and 7.2 cm/yr at 12 months.","source_url":"https://pubmed.ncbi.nlm.nih.gov/8772599/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-010","text":"At 6 months, 74% of children in the pediatric sermorelin trial were considered good responders, and no adverse changes in general biochemical profiles were reported.","source_url":"https://pubmed.ncbi.nlm.nih.gov/8772599/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-011","text":"In the first therapeutic use (1985), two GH-deficient children treated 6 months with pump-delivered GRF accelerated growth from 4.6 to 7.1 cm/yr and from 2.1 to 13.7 cm/yr.","source_url":"https://pubmed.ncbi.nlm.nih.gov/3917299/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-012","text":"In healthy old men, GHRH(1-29) 1.0 mg SC twice daily for 14 days raised 24-hour GH and IGF-I so that no significant difference remained versus young men (IGF-I P<0.005).","source_url":"https://pubmed.ncbi.nlm.nih.gov/1379256/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-013","text":"In a 16-week randomized single-blind trial (n=19, ages 55-71), nightly GHRH(1-29) analog 10 mcg/kg raised nocturnal GH and raised IGF-I within 2 weeks, but IGF-I returned toward baseline by week 16 despite continued injections.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9141536/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SRM-014","text":"In the 16-week nightly GHRH analog trial, skin thickness increased in both sexes, lean body mass increased in men only, self-reported sleep quality was unaffected, and transient hyperlipidemia was the only adverse effect.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9141536/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SRM-015","text":"GH release after the nightly GHRH analog began within 10 minutes of injection and the induced pulse lasted about 2 hours.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9141536/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SRM-016","text":"In healthy elderly men, a single nightly 2 mg dose of GHRH(1-29) for 6 weeks increased nocturnal GH (P<0.02) but did not change IGF-I, IGFBP-3, weight, or body composition; 2 of 6 muscle strength measures improved; no significant adverse effects were observed.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9005976/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-017","text":"Continuous subcutaneous GHRH(1-44) infusion (1 or 2 mg/day for 14 days) in old men increased 24-h GH, GH peak number, and IGF-I (P<0.001) while GH release remained pulsatile.","source_url":"https://pubmed.ncbi.nlm.nih.gov/8421077/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-018","text":"The disappearance half-time of GHRH(1-29)-NH2 in normal men is 4.3 +/- 1.4 minutes, with metabolic clearance of 39.7 mL/kg per minute.","source_url":"https://pubmed.ncbi.nlm.nih.gov/7962295/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-019","text":"Intact GHRH(1-44) disappears from human plasma with a 6.8-minute half-life by HPLC, leaving a metabolite with less than one thousandth of the biological activity.","source_url":"https://pubmed.ncbi.nlm.nih.gov/3093533/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-020","text":"Dipeptidylpeptidase IV cleaves GHRH peptides, including the (1-29) fragment, at the 2-3 bond in a single step to a biologically inactive metabolite.","source_url":"https://pubmed.ncbi.nlm.nih.gov/2565342/","grade":"in-vitro","grade_label":"In vitro"},{"id":"SRM-021","text":"By immunoassay, GRF disappearance in man shows a 7.6-minute equilibration phase and an elimination phase near 52 minutes, with metabolic clearance about 194-202 L/m2 per day; immunoreactive methods overstate persistence because they detect the inactive metabolite.","source_url":"https://pubmed.ncbi.nlm.nih.gov/6425363/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-022","text":"Mice with a missense mutation disrupting the GHRH receptor (little mice) have reduced GH secretion and a dwarf phenotype, demonstrating that GHRH action requires this receptor.","source_url":"https://pubmed.ncbi.nlm.nih.gov/8395283/","grade":"animal","grade_label":"Animal"},{"id":"SRM-023","text":"GHRH given intravenously during the third REM period produced a near 10-fold increase in slow-wave sleep in normal young men.","source_url":"https://pubmed.ncbi.nlm.nih.gov/8476038/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-024","text":"GHRH given between 04.00 and 07.00 h stimulated GH but did not increase slow-wave sleep; sleep-endocrine effects of GHRH depend on time of administration.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9089471/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-025","text":"In adults, the most reproducible GH pulse occurs shortly after sleep onset in association with the first slow-wave sleep phase, and in men about 70% of sleep GH pulses coincide with slow-wave sleep.","source_url":"https://pubmed.ncbi.nlm.nih.gov/8627466/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-026","text":"Intracerebroventricular GRF promoted non-REM and REM sleep and increased EEG slow-wave activity in rats and rabbits.","source_url":"https://pubmed.ncbi.nlm.nih.gov/3136672/","grade":"animal","grade_label":"Animal"},{"id":"SRM-027","text":"Single IV doses and repeated subcutaneous doses of sermorelin were well tolerated; transient facial flushing and pain at the injection site were the most commonly reported adverse events.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18031173/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-028","text":"Height-velocity increases with sermorelin 30 mcg/kg/day were smaller than those in children receiving once-daily subcutaneous somatropin 30 mcg/kg/day, and the recommended regimens were never compared directly; the growth effect was maintained through 36 months in available data, and the effect on final adult height is undetermined.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18031173/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-029","text":"A single 1 mcg/kg IV dose of sermorelin is a rapid and relatively specific provocative test of GH secretion, with fewer false positives than other provocative tests in children, though a normal response cannot exclude hypothalamic GH deficiency.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18031173/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-030","text":"In hypopituitary adults the GHRH + arginine test distinguishes GH deficiency with a 16.5 mcg/L cut-off, versus 5 mcg/L for insulin-induced hypoglycemia.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9589665/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-031","text":"The Endocrine Society guideline on adult GH deficiency requires biochemical confirmation by stimulation testing in most cases before GH therapy.","source_url":"https://pubmed.ncbi.nlm.nih.gov/21602453/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-032","text":"In pooled randomized trials in healthy elderly adults, growth hormone therapy changed fat mass by about -2.1 kg and lean mass by about +2.1 kg, with significantly higher rates of soft tissue edema, arthralgia, carpal tunnel syndrome, and gynecomastia, and GH could not be recommended as an anti-aging therapy.","source_url":"https://pubmed.ncbi.nlm.nih.gov/17227934/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-033","text":"In men over 60, six months of growth hormone increased lean body mass 8.8% and decreased adipose mass 14.4%; this 1990 study seeded the anti-aging GH narrative.","source_url":"https://pubmed.ncbi.nlm.nih.gov/2355952/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-034","text":"A 2003 New England Journal of Medicine perspective answered its own title question about growth hormone as an aging therapy with caution against use outside trials.","source_url":"https://pubmed.ncbi.nlm.nih.gov/12606731/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-035","text":"GHRH administration has been proposed as a more physiological alternative to GH in aging because it preserves pulsatile secretion, a hypothesis articulated in reviews rather than proven in outcome trials.","source_url":"https://pubmed.ncbi.nlm.nih.gov/8491152/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-036","text":"The claim that sermorelin is preferable to recombinant GH for adult-onset GH insufficiency traces to opinion literature, which itself frames the position as a proposal needing study.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC2699646/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-037","text":"Reviews of growth hormone secretagogues conclude that clinical efficacy data in adults largely remain lacking.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7108996/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-038","text":"A 2026 review of GH-axis peptides sold online stratifies them into evidence tiers, reports class adverse effects including injection-site reactions, fluid retention, and dysglycemia, and emphasizes unverified product composition and unstudied stacking in unregulated supply chains.","source_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13322892/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-039","text":"CJC-1295 is a long-acting GHRH analog with an estimated half-life of 5.8 to 8.1 days; single doses raised GH 2- to 10-fold for 6 or more days and IGF-I 1.5- to 3-fold for 9 to 11 days in healthy adults.","source_url":"https://pubmed.ncbi.nlm.nih.gov/16352683/","grade":"human-rct","grade_label":"Human RCT"},{"id":"SRM-040","text":"Ipamorelin is a selective growth hormone secretagogue acting through the GHRP (ghrelin) receptor, characterized in vitro and in animal models.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9849822/","grade":"animal","grade_label":"Animal"},{"id":"SRM-041","text":"Tesamorelin (Egrifta SV) is an FDA-approved GHRH analog indicated to reduce excess abdominal fat in adults with HIV-associated lipodystrophy; its label contraindicates use in active malignancy, pituitary axis disruption, pregnancy, and known hypersensitivity, and directs IGF-1 monitoring during therapy.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3d783378-b02d-4f19-99dd-0fc91a042224","grade":"fda-label","grade_label":"FDA label"},{"id":"SRM-042","text":"Somatropin labeling directs individualized dosing with serum IGF-1 concentrations used to guide titration.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1058e17c-9261-459c-a3e6-fae38d196c14","grade":"fda-label","grade_label":"FDA label"},{"id":"SRM-043","text":"Injection-technique recommendations for subcutaneous therapy call for short needles and systematic rotation of injection sites so that lipohypertrophy does not develop.","source_url":"https://pubmed.ncbi.nlm.nih.gov/27594187/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-044","text":"FDA's 1991 supplement approval for Geref documents lyophilized sermorelin acetate powder, 50 mcg per vial, with a 24-month shelf life stored at 7 degrees C.","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019863_S001_GEREF.pdf","grade":"regulatory","grade_label":"Regulatory record"},{"id":"SRM-045","text":"Published adult research regimens used 0.5 or 1.0 mg SC twice daily (14 days), 2 mg SC nightly (6 weeks), and 10 mcg/kg of a GHRH(1-29) analog nightly (16 weeks); the historic pediatric label regimen was 30 mcg/kg SC nightly at bedtime.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9005976/","grade":"human-trial","grade_label":"Human trial"},{"id":"SRM-046","text":"The GHRH-somatostatin-GH-IGF-I axis operates as a multivalent feedback system in which somatostatin and IGF-I restrain GH secretion, the physiological basis for expecting different exposure patterns from secretagogues versus exogenous GH.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9861545/","grade":"review","grade_label":"Review or guideline"},{"id":"SRM-047","text":"Drugs@FDA lists NDA 019863 (Geref injection, the diagnostic presentation first approved December 28, 1990) with marketing status Discontinued.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019863","grade":"regulatory","grade_label":"Regulatory record"}]}