Sermorelin

What it is

Sermorelin is a synthetic 29-amino-acid peptide matching the biologically active fragment of human growth-hormone-releasing hormone (GHRH). Rather than supplying growth hormone directly, it signals the pituitary to release its own GH in short pulses, which only works if the pituitary is otherwise intact. It has a genuine regulatory history: as Geref, it was FDA-approved, first in 1990 as an intravenous diagnostic test of GH reserve, then in 1997 as a nightly subcutaneous treatment for confirmed GH deficiency in children. Its manufacturer, EMD Serono, discontinued Geref in 2008, and the FDA explicitly determined this was for business reasons unrelated to safety or effectiveness. No FDA-approved sermorelin product exists today, DailyMed carries no current label, and the GHRH-arginine diagnostic test built around it has been commercially unavailable in the United States ever since. Everything sold now is compounded by 503A or 503B pharmacies, a different and less rigorous pathway than an approved drug. Human pharmacokinetic studies consistently show it clears from plasma within minutes. The 200-300 mcg nightly regimen widely marketed for adult 'growth hormone optimization' or anti-aging use is a compounding-clinic and community convention, not a dose tested in the small, decades-old published adult GHRH trials, and no major endocrine society currently endorses GHRH therapy for anti-aging in healthy adults.

Dose ranges

Study-backed ranges carry a source you can open. Community ranges are widely reported but not clinically established - treat them as what people do, not as advice.

Reconstitution & storage

Compounded sermorelin is dispensed as a lyophilized powder in multi-dose vials, commonly 6-15 mg, and reconstituted with bacteriostatic water for injection, commonly at roughly a 2 mg/mL ratio (for example 6 mg plus 3 mL, 9 mg plus 4.5 mL, 15 mg plus 7.5 mL), though some compounders instead formulate at about 1 mg/mL. Exact vial size, diluent volume, and final concentration vary by compounding pharmacy, so the pharmacy's own label and instructions govern. Add diluent gently against the vial wall and swirl (do not shake); the reconstituted solution should be clear and colorless, and should not be used if cloudy or if particles are visible. Note that the original FDA-approved Geref label specified reconstitution with Sodium Chloride Injection, USP (saline), not bacteriostatic water; bacteriostatic water is the diluent used in current compounded practice, which allows the multi-dose vial to be used over multiple days.

Common stacks

Interactions & cautions

Sermorelin's own historical FDA labeling, preserved in secondary drug references because DailyMed no longer carries a current sermorelin or Geref label, states that concomitant glucocorticoid (corticosteroid) therapy may blunt the GH response to sermorelin, and that patients with GH deficiency caused by an intracranial lesion were not studied in the original clinical trials, so treatment is 'not recommended' in that population. The same labeling recommends baseline and on-therapy thyroid function testing, since hypothyroidism occurred in about 6.5 percent of clinical-study patients, and lists it as Pregnancy Category C with no data on excretion into breast milk. Because sermorelin works upstream of growth hormone and requires an intact pituitary, it has not been independently confirmed to carry the same formal active-malignancy contraindication that appears on recombinant growth hormone (somatropin) labeling. Reviewers nonetheless commonly flag a theoretical, class-level concern: any therapy that raises GH and IGF-1 signaling could in principle support the growth of an existing tumor, so many prescribers extend the same caution used for GH therapy generally, even though this has not been specifically trial-tested for sermorelin. No controlled drug-drug interaction studies for compounded sermorelin were found in the modern literature. Combining sermorelin with other growth-hormone secretagogues or with recombinant GH itself ('stacking') is common in community and compounding-clinic practice but has not been evaluated in controlled trials.

Questions people ask

Sources

1. [1]Determination That GEREF (Sermorelin Acetate) Injection Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (Federal Register, via GovInfo)regulatoryConfirms Geref (sermorelin acetate) NDA approval dates (December 1990 and September 1997), EMD Serono's 2008 discontinuation letters, and FDA's determination that withdrawal was not for reasons of safety or effectiveness.
2. [2]DailyMed search results for 'sermorelin' and 'geref' (0 results)regulatoryConfirms no current FDA drug label is listed on DailyMed for sermorelin or Geref, corroborating that no FDA-approved sermorelin product is currently marketed.
3. [3]Growth hormone-releasing factor analogue (hGRF1-29NH2): immunoreactive-GRF plasma levels after intravenous and subcutaneous administration (Rafferty et al., J Endocrinol, 1985) PMID 2866222studyRat pharmacokinetic study (not human) reporting an initial distribution-phase half-life of 1.9 min and an elimination-phase half-life of 10.4 min for GRF(1-29)-NH2 after IV dosing, plus only about 4% relative bioavailability after subcutaneous dosing.
4. [4]Incorporation of D-Ala2 in growth hormone-releasing hormone-(1-29)-NH2 increases the half-life and decreases metabolic clearance in normal men (Soule et al., J Clin Endocrinol Metab, 1994) PMID 7962295studyHuman constant-IV-infusion study in 10 healthy men reporting a disappearance half-time of 4.3 +/- 1.4 minutes for unmodified GHRH-(1-29)-NH2, the active sequence in sermorelin.
5. [5]PEGylation of growth hormone-releasing hormone (GRF) analogues (Esposito et al., Adv Drug Deliv Rev, 2003) PMID 14499707reviewStates that native GRF(1-29) (sermorelin) has 'a short half-life in plasma, about 10-20 min in humans.'
6. [6]Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency (Prakash and Goa, BioDrugs, 1999) PMID 18031173reviewReports the FDA-approval-era diagnostic dose (intravenous sermorelin 1 mcg/kg bodyweight) and the pediatric treatment dose (subcutaneous sermorelin 30 mcg/kg bodyweight once daily at bedtime) for idiopathic growth hormone deficiency.
7. [7]Pharmacokinetics of growth hormone-releasing hormone(1-29)-NH2 and stimulation of growth hormone secretion in healthy subjects after intravenous or intranasal administration (Wilton et al., Acta Paediatr Suppl, 1993) PMID 8329825studyHuman dose-response study in 30 healthy men showing IV doses from 0.25 to 2 mcg/kg stimulate GH release (maximal response around 1-2 mcg/kg) and that GHRH(1-29)-NH2 is rapidly eliminated after IV injection.
8. [8]Sermorelin: a better approach to management of adult-onset growth hormone insufficiency? (Walker, Clin Interv Aging, 2006) PMID 18046908reviewConfirms, via title and indexed bibliographic metadata, that management of adult-onset growth hormone insufficiency with sermorelin has been discussed as an editorial position in the peer-reviewed literature; full text/abstract could not be independently retrieved beyond title and metadata.
9. [9]Effects of single nightly injections of growth hormone-releasing hormone (GHRH 1-29) in healthy elderly men (Vittone et al., Metabolism, 1997) PMID 9005976studyRCT giving healthy elderly men 2 mg GHRH(1-29) subcutaneously nightly for 6 weeks; increased nocturnal GH release and peak amplitude but did not significantly change IGF-I, IGFBP-3, or DEXA body composition measures.
10. [10]Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men (Corpas et al., J Clin Endocrinol Metab, 1992) PMID 1379256studyRCT in old men (mean age 68) using 0.5 mg and 1 mg GHRH(1-29) subcutaneously twice daily for 14 days; the 1 mg dose normalized 24-hour GH and IGF-I levels toward young-adult values, with no significant effect on fasting glucose, blood pressure, or hematology.
11. [11]Sermorelin Acetate drug monograph (RxList)referenceSecondary compilation that mirrors the original Geref/sermorelin FDA label (dated 10/2/2001): elimination half-life 11-12 minutes after IV or subcutaneous dosing, clearance 2.4-2.8 L/min, about 6% subcutaneous bioavailability, glucocorticoids may blunt the GH response, hypothyroidism occurred in 6.5% of clinical-study patients, Pregnancy Category C, and treatment 'not recommended' in growth hormone deficiency secondary to an intracranial lesion.
12. [12]Hormones and Aging: An Endocrine Society Scientific Statement (Cappola et al., J Clin Endocrinol Metab, 2023;108(8):1835-1874)reviewEndocrine Society consensus statement concluding that 'no therapy to increase GH secretion or action is approved as an anti-aging intervention' and that 'there are no approved therapies for reversing the age-associated decline of GH secretion.'
13. [13]Growth Hormone Stimulation Tests in Assessing Adult Growth Hormone Deficiency (Yuen, in Endotext, NCBI Bookshelf NBK395585, updated 2023)reviewStates that EMD Serono discontinued manufacturing the GHRH analog (Geref) in November 2008, and that the GHRH-arginine stimulation test has consequently not been commercially available in the United States since then.
14. [14]Sermorelin Acetate Injection (compounding pharmacy product page, Empower Pharmacy)communityCompounding-pharmacy source describing typical compounded vial sizes (6, 9, and 15 mg), bacteriostatic water as the reconstitution diluent, and commonly cited adult (0.2-0.3 mg nightly) and pediatric (about 30 mcg/kg) dosing conventions.
15. [15]Medication and Injection Instructions for Sermorelin (Defy Medical)communityPatient-instruction source giving specific bacteriostatic-water reconstitution ratios (6 mg/3 mL, 9 mg/4.5 mL, 15 mg/7.5 mL) and a commonly cited post-reconstitution refrigerated storage window of up to 90 days, with short room-temperature excursions under about 72 hours described as tolerated.
16. [16]Compounded Sermorelin for Clinical Practice: A Practitioner's Guide (Strive Pharmacy)communityCompounding-pharmacy provider guide citing a 1 mg/mL formulation and an adult dosing convention of 0.15-0.3 mL (150-300 mcg) subcutaneously nightly, 5 of 7 days per week.
17. [17]Sermorelin (Wikipedia)communityTertiary cross-check for aliases (GHRH(1-29), GRF 1-29, sermorelin acetate) and the general regulatory-history summary; used only to corroborate facts independently verified in the primary and secondary sources above, not as a standalone source for any numeric claim.