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Sermorelin

Compounded Rx

Checked · 18 sources · 13 corrections on this page · No vendors · No affiliates · No one buys a word of it

110-child study: growth sped up

children with GH deficiency · year-long · open-label · Thorner 1996

Compounded Rx · Once an approved drug (Geref, 1990–2008); compounded legally today.

Bottom line

A once-approved molecule, well tolerated in its trials (Prakash & Goa, 1999), whose adult use rests on small, short studies.

Also called
  • GRF(1-29)
  • GHRH(1-29)
  • Sermorelin acetate
  • Geref® (formerly)
  • Geref Diagnostic (formerly)
Category
Peptide — GHRH Analog, Growth Hormone Secretagogue
Molecular Weight
3,358 Da
Sequence
29 aa (N-terminal GHRH)
Half-life
~10–12 min (plasma)
Route (studied)
SubQ, IV (people)
Route (sold)
SubQ vials (compounded Rx); Geref brand discontinued
FDA Status
Approved 1990 (Geref diagnostic) and 1997 (Geref treatment), withdrawn 2009 at the sponsor’s request; compounded as a component of an approved drug
Receptor
GHRH-R (GHRHR)
Original Indication
Pediatric GHD (treatment + diagnosis)
Availability
503A compounding
WADA Status
Banned (S2)
Cost & Access
Compounded Rx

Also for muscle & strength

The other four questions

What does it do? It stimulates the pituitary to release growth hormone, as the body’s own GH-releasing hormone does (Prakash & Goa, 1999). In 10 healthy older men, 1 mg injected twice a day for two weeks raised 24-hour GH and IGF-1 to the levels of young men (Corpas et al., 1992).
Who uses it? Adults given it off-label by men’s-health and longevity clinics, filled by compounding pharmacies.
Does the evidence hold up? In children with GH deficiency, partly: growth sped up in a year-long open-label study of 110 children (Thorner et al., 1996), and the approved dose was never compared head to head with somatropin (Prakash & Goa, 1999). In adults, only short studies: 10 older men for two weeks (Corpas et al., 1992) and, with a close analog, 19 older adults for four months (Khorram et al., 1997). FDA found that Geref was not withdrawn from sale for safety or effectiveness (FDA, 2013).
Bottom line? A once-approved molecule, well tolerated in its trials (Prakash & Goa, 1999), whose adult use rests on small, short studies.

Dosing from the Literature

Published for growth hormone: 30 μg/kg nightly, the original label's dose for children. Not published: an approved adult dose; adult use is off-label.

The rows give the doses used in the children’s and diagnostic studies, a two-week trial in older men, and what compounding-pharmacy protocols describe for adult off-label use.

ProtocolDoseFrequencyNotes
Pediatric GHD (the Geref studies)30 μg/kgSubQ nightly at bedtimeGiven for up to a year to 110 prepubertal children with GH deficiency in an open-label multicenter study (Thorner et al., 1996).
Provocative GH test (Geref Diagnostic)1 μg/kgSingle IV doseReviewed as a test for GH deficiency in children, given alongside conventional tests (Prakash & Goa, 1999).
Older men (trial)0.5 or 1 mgSubQ twice daily, 14 days10 healthy men about 68 years old; only the 1 mg dose raised GH and IGF-1 significantly (Corpas et al., 1992).
Adult off-label (compounded)200–500 μgSubQ nightly at bedtimeWhat compounding-pharmacy protocols describe, given at bedtime on an empty stomach; not an FDA-labeled dose.
Adult split dose100–250 μg ×2Morning + bedtimeWhat some clinic protocols describe, with the morning dose for training and recovery.
Dosing Disclaimer

The adult figures are what compounding-pharmacy protocols describe, not an FDA-labeled dose. Consult a licensed healthcare provider.

→ Calculator — vial-to-syringe math

What It Is

Sermorelin is a synthetic 29-amino-acid peptide corresponding to the N-terminal 29 residues of endogenous human growth hormone-releasing hormone (GHRH) — the shortest fragment that retains full biological activity of the 44-amino-acid native molecule (Prakash & Goa, 1999). It was developed by Serono Laboratories (later EMD Serono) under the brand name Geref, which the US FDA approved as a diagnostic test of pituitary GH reserve (a single IV dose) in 1990 and for treating growth hormone deficiency in children (a daily SubQ injection) in 1997 (Drugs@FDA).

In 2008 EMD Serono stopped marketing both formulations of Geref, and FDA withdrew the approvals in June 2009 at the company’s request because the products were no longer marketed. FDA’s 2013 Federal Register notice confirmed that the withdrawal was not for safety or effectiveness reasons — the usual explanation is that the pediatric GHD market had shifted decisively to recombinant human growth hormone (somatropin) and the commercial case for continuing to manufacture a GHRH (the signal that tells the pituitary to release GH) analog no longer closed. That distinction matters: sermorelin has a clean regulatory safety record.

Because sermorelin acetate was the active ingredient of an FDA-approved drug and the withdrawal wasn’t for safety, it can still be compounded: by state-licensed 503A pharmacies as a component of an approved drug (FDA’s lists are consistent with this, though FDA hasn’t said so outright), and by outsourcing facilities (503B) under FDA’s interim policy for its Category 1 list, which is enforcement discretion, not the final 503B bulks list. This is the single reason sermorelin has remained a mainstay of US physician-prescribed "anti-aging" and wellness-clinic growth-hormone-axis protocols despite not being an approved pharmaceutical product. It is currently prescribed off-label for adult GH insufficiency, age-related decline in GH/IGF-1, and as part of body-composition and sleep-quality protocols in functional-medicine contexts. Unlike BPC-157 or MK-677, sermorelin sits in a unique regulatory space as a formerly-approved, now-compounded peptide drug.

Mechanistically, sermorelin is the archetypal GHRH analog — it binds the GHRH receptor on anterior pituitary somatotrophs and stimulates physiologic, pulsatile GH release. It does not elevate GH to supraphysiologic levels the way exogenous recombinant hGH does. The effect is to restore youthful GH pulse amplitude while preserving the natural pulsatile architecture, including the nocturnal GH surge during slow-wave sleep. That mechanism — "restoring function rather than overriding it" — is the core selling point for sermorelin versus recombinant hGH.

Mechanism of Action

Sermorelin is the first 29 amino acids of human GH-releasing hormone, the shortest synthetic piece with the hormone’s full activity; given into a vein or under the skin, it stimulates growth-hormone release from the anterior pituitary (Prakash & Goa, 1999).

  • Pulsatility — In six young men, a 24-hour infusion of the full-length hormone, GHRH(1-40), raised total GH while GH kept coming in pulses (Vance et al., 1985); in older men, twice-daily sermorelin enlarged the GH peaks (Corpas et al., 1992).
  • Somatostatin — The same infusion study read the continuing pulses as evidence that somatostatin, the body’s brake on GH, is still released intermittently (Vance et al., 1985).
  • IGF-1 — The 1 mg twice-daily dose raised older men’s IGF-1 to the level of young men (Corpas et al., 1992); a review of GHRH studies in aging found that repeated doses keep IGF-1 within the young-adult range (Merriam et al., 2003).
  • Sleep — Not improved: chronic treatment with a short-acting GHRH did not improve sleep in a review of studies in aging (Merriam et al., 2003), and sleep quality did not change in 19 older adults on a close analog, [Nle27]GHRH(1-29) (Khorram et al., 1997).
  • Over 16 weeks — With that analog, nightly GH release held up for 16 weeks, while IGF-1 and IGFBP-3 drifted back toward baseline by week 16 (Khorram et al., 1997).
  • Timing of the response — With the analog injected at 9 pm, GH rose within 10 minutes and the release lasted 2 hours (Khorram et al., 1997).

What the Research Shows

Sermorelin’s trials are mostly pediatric: it was approved for children with GH deficiency, and the adult studies are small and short (Prakash & Goa, 1999; Merriam et al., 2003).

  • Pediatric growth (Thorner et al., JCEM 1996; PMID 8772599) — Geref International Study Group; once-daily SubQ sermorelin accelerated growth velocity in prepubertal children with idiopathic GHD. Growth effects smaller than with recombinant hGH but meaningful in a subset of responders.
  • Pediatric GHD first-year therapy (Duck et al., JCEM 1992; PMID 1400880) — Documented safety and growth-velocity improvement in SC GHRH therapy for GH-deficient children.
  • Foundational GHRH pulsatile physiology (Vance et al., J Clin Invest 1985; PMID 2860126) — Continuous GHRH infusion confirmed intermittent somatostatin secretion architecture, providing the pulsatility rationale for short-half-life GHRH analogs.
  • Elderly GH restoration (Corpas et al., JCEM 1992; PMID 1379256) — GHRH(1-29) twice daily reversed decreased GH and IGF-1 levels in old men.
  • Elderly physiologic GHRH administration (Khorram et al., JCEM 1997; PMID 9141536) — Endocrine and metabolic effects of long-term GHRH-(1-29)-NH2 in older men and women.
  • GHRH cognition trial (Baker et al., Arch Neurol 2012; PMID 22869065) — 20-week GHRH administration in adults with mild cognitive impairment and healthy older adults showed improvements in executive function and working memory.
  • GHRH defect in GH deficiency (Grossman et al., Lancet 1983; PMID 6134983) — Foundational work demonstrating that GH deficiency reflects a hypothalamic (brain's hormonal control center) defect in GHRH release.
  • Adult review (Walker, Clin Interv Aging 2006; PMC2699646) — Review article positioning sermorelin as an alternative approach to adult-onset GH insufficiency. Framework widely adopted in functional-medicine prescribing.
  • Diagnostic provocative testing (Ghigo et al., Eur J Endocrinol 1996; PMID 8616534) — Sermorelin 1 μg/kg IV as a provocative agent for pituitary GH reserve.
  • Modern functional-medicine data — Post-2008 compounded sermorelin has accumulated a large clinical-experience base in US wellness-clinic prescribing. Formal controlled-trial evidence for adult anti-aging indications remains limited.
Honest Evidence Framing

Sermorelin’s pediatric evidence led to its approval. Its adult use rests on small, short studies: in older adults on sermorelin or a close analog, GH and IGF-1 rose, lean mass rose in men only, and sleep did not improve (Corpas et al., 1992; Khorram et al., 1997; Merriam et al., 2003).

Human Data

Sermorelin has more human data than nearly any other peptide in the community space because it reached FDA approval.

  • Pediatric GHD — registrational dataset — Randomized and open-label trials in children with idiopathic GHD supporting 1997 FDA approval.
  • Geref Diagnostic (0.05 mg ampoule) — IV provocative testing for adult and pediatric GH reserve.
  • Adult open-label case series — Smaller observational data on adult body composition, sleep quality, and IGF-1 normalization.
  • Elderly GH restoration studies (Corpas 1992, Khorram 1997) — Short-duration physiologic studies confirming restoration of youthful GH pulse patterns.
  • Cognitive function (Baker 2012) — 20-week GHRH in older adults showed executive function improvements.
  • Wellness-clinic cohorts (post-2008) — Large aggregated experience of compounded sermorelin prescribing in adult anti-aging/functional-medicine practice.

Absent from the human dataset: a large Phase 3 trial specifically for adult anti-aging or age-related body-composition endpoints. This is the gap between the adult-use case and the formal regulatory-grade evidence.

Reconstitution & Storage

Compounding pharmacies supply sermorelin acetate as a lyophilized powder, in vials of 2 to 15 mg.

Vial SizeBAC WaterConcentration200 μg Dose500 μg Dose
2 mg1 mL2 mg/mL10 units (0.10 mL)25 units (0.25 mL)
5 mg2 mL2.5 mg/mL8 units (0.08 mL)20 units (0.20 mL)
5 mg1 mL5 mg/mL4 units (0.04 mL)10 units (0.10 mL)
15 mg3 mL5 mg/mL4 units (0.04 mL)10 units (0.10 mL)
  • Reconstitution — Reconstitution guides describe adding the water slowly down the vial wall and swirling rather than shaking.
  • Injection site — Practitioner reports describe injecting under the skin of the abdomen, thigh or upper arm, rotating sites.
  • Timing — The children’s study gave it at bedtime (Thorner et al., 1996); compounding protocols describe bedtime doses on an empty stomach.

→ Calculator — vial-to-syringe math

Side Effects & Risks

Important

Published safety data come from the children’s and diagnostic studies of the 1990s and from small adult studies lasting weeks to months (Prakash & Goa, 1999; Merriam et al., 2003). Consult a licensed healthcare provider.

In those studies, single IV doses and daily injections were well tolerated; transient facial flushing and injection-site pain were reported most often (Prakash & Goa, 1999).

  • Injection-site pain — One of the two most commonly reported adverse events (Prakash & Goa, 1999).
  • Flushing — Transient facial flushing, the other (Prakash & Goa, 1999).
  • Blood pressure — Unchanged in older men on sermorelin (Corpas et al., 1992) and in older adults on a close analog (Khorram et al., 1997).
  • Glucose — Fasting glucose did not change in older men (Corpas et al., 1992) or in children treated for a year (Thorner et al., 1996); with the analog, insulin sensitivity rose in men (Khorram et al., 1997).
  • Lipids — With the analog, the only adverse effect in 19 older adults was a transient rise in blood lipids (Khorram et al., 1997).
  • Cancer — Raising GH and IGF-1 is a theoretical cancer concern; the studies on this page did not measure cancer outcomes.
  • WADA banned — As a named GHRH analog, sermorelin is banned under S2.

Bloodwork & Monitoring

No trial or guideline sets monitoring for adult off-label sermorelin. The studies in older adults measured GH and IGF-1, IGFBP-3, fasting glucose, blood pressure, lipids, and blood chemistry and counts (Corpas et al., 1992; Khorram et al., 1997).

Commonly Stacked With

Ipamorelin

Wellness clinics pair it with sermorelin, often injected together at bedtime. No published study has tested the pair.

Tested together in people: none published · Read the receipt →

BPC-157

No published study has tested the pair.

Tested together in people: none published · Read the receipt →

Testosterone (TRT)

Men’s-health clinics add it to testosterone therapy, sometimes with ipamorelin. In a chart review of men on testosterone prescribed sermorelin with GHRP-2 and GHRP-6 (100 mcg of each, three times a day), IGF-1 rose from 160 to 239 ng/mL in the 14 who kept to the schedule (Sigalos et al., 2017).

Tested together in people: 1 record review, 14 men (2017) (Sigalos et al., 2017) · Read the receipt →

Stacking this? Read the receipt →

→ Calculator — vial-to-syringe math

Legal Status

Current Status — April 2026

Sermorelin acetate was FDA-approved under the brand Geref as a diagnostic test of pituitary GH reserve in 1990 and for treating pediatric growth hormone deficiency in 1997 (Drugs@FDA). In 2008, EMD Serono stopped marketing it, and FDA withdrew the approvals in 2009 at the company’s request. The FDA confirmed in its 2013 Federal Register notice that the withdrawal was not for reasons of safety or effectiveness.

Because the withdrawal wasn’t for safety or effectiveness, sermorelin can be compounded under a valid prescription: by 503A pharmacies as a component of an FDA-approved drug, and by outsourcing facilities (503B) only under FDA’s Category 1 interim policy; it is not on the final 503B bulks list. It is the most-prescribed GHRH-analog peptide in US wellness-clinic practice as a result. This is a meaningful distinction from BPC-157, TB-500, or MK-677, none of which can be legally compounded today: MK-677 is on FDA's 503A Category 2 list, and BPC-157 and TB-500 were removed from Category 2 on April 22, 2026, with rulemaking pending after the July 2026 PCAC recommendation.

Sermorelin is banned by the World Anti-Doping Agency under S2 (peptide hormones, growth factors, related substances and mimetics) of the Prohibited List as a named GHRH analog.

FDA’s April 2026 removals from Category 2 did not concern sermorelin, which was never on the Category 2 list.

Cost & Access

Sermorelin acetate is available through licensed compounding pharmacies where legally permitted for clinician-prescribed off-label use through 503A pharmacies. It is widely dispensed via the men's health, TRT/HRT, and longevity clinic ecosystem, often as part of growth hormone secretagogue protocols (frequently combined with ipamorelin or GHRP-2).

Sermorelin acetate was previously FDA-approved as Geref (Serono / EMD Serono) for the diagnosis (1990) and treatment (1997) of growth hormone deficiency; Geref was discontinued by the manufacturer in 2008 and its approvals withdrawn at the company’s request in 2009, not for safety or effectiveness (FDA, 2013). Sermorelin has remained available through the licensed compounding pharmacy pathway since.

Sermorelin was never on the Category 2 list, so FDA’s April 2026 removals did not change its status — it is already eligible for compounding pharmacy use under the standard 503A pathway as a previously-FDA-approved active ingredient. The HHS secretary’s February 2026 podcast remarks about peptides were public remarks, not a rule, and did not concern sermorelin (NPR, March 31, 2026).

Estimated pricing as of April 2026. Actual costs vary by provider, location, and prescription status. Kalios does not sell compounds.

References

  1. Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 1999;12(2):139-157. PMID: 18031173.
  2. Walker RF. Sermorelin: A better approach to management of adult-onset growth hormone insufficiency? Clin Interv Aging. 2006;1(4):307-308. PMID: 18046908. PMC2699646.
  3. Vance ML, Kaiser DL, Evans WS, et al. Pulsatile growth hormone secretion in normal man during a continuous 24-hour infusion of human growth hormone releasing factor. Evidence for intermittent somatostatin secretion. J Clin Invest. 1985;75(5):1584-1590. PMID: 2860126.
  4. Khorram O, Laughlin GA, Yen SS. Endocrine and metabolic effects of long-term administration of [Nle27]growth hormone-releasing hormone-(1-29)-NH2 in older men and women. J Clin Endocrinol Metab. 1997;82(5):1472-1479. PMID: 9141536.
  5. Baker LD, Barsness SM, Borson S, Merriam GR, Friedman SD, Craft S, Vitiello MV. Effects of growth hormone-releasing hormone on cognitive function in adults with mild cognitive impairment and healthy older adults: results of a controlled trial. Arch Neurol. 2012;69(11):1420-1429. PMID: 22869065.
  6. Ghigo E, Aimaretti G, Gianotti L, Bellone J, Arvat E, Camanni F. New approach to the diagnosis of growth hormone deficiency in adults. Eur J Endocrinol. 1996;134(3):352-356. PMID: 8616534.
  7. Corpas E, Harman SM, Piñeyro MA, Roberson R, Blackman MR. Growth hormone (GH)-releasing hormone-(1-29) twice daily reverses the decreased GH and insulin-like growth factor-I levels in old men. J Clin Endocrinol Metab. 1992;75(2):530-535. PMID: 1379256.
  8. Thorner M, Rochiccioli P, Colle M, et al. Once daily subcutaneous growth hormone-releasing hormone therapy accelerates growth in growth hormone-deficient children during the first year of therapy. Geref International Study Group. J Clin Endocrinol Metab. 1996;81(3):1189-1196. PMID: 8772599.
  9. Duck SC, Schwarz HP, Costin G, et al. Subcutaneous growth hormone-releasing hormone therapy in growth hormone-deficient children: first year of therapy. J Clin Endocrinol Metab. 1992;75(4):1115-1120. PMID: 1400880.
  10. Grossman A, Savage MO, Wass JA, Lytras N, Sueiras-Diaz J, Coy DH, Besser GM. Growth-hormone-releasing factor in growth hormone deficiency: demonstration of a hypothalamic defect in growth hormone release. Lancet. 1983;2(8343):137-138. PMID: 6134983.
  11. Merriam GR, Schwartz RS, Vitiello MV. Growth hormone-releasing hormone and growth hormone secretagogues in normal aging. Endocrine. 2003;22(1):41-48. PMID: 14610297.
  12. US Food and Drug Administration. Determination That GEREF (Sermorelin Acetate) Injection ... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. Fed Regist. 2013;78(43):14124.
  13. Ishida J, Saitoh M, Ebner N, Springer J, Anker SD, von Haehling S. Growth hormone secretagogues: history, mechanism of action, and clinical development. JCSM Rapid Commun. 2020;3(1):25-37. DOI: 10.1002/rco2.9.
  14. WADA. 2026 Prohibited List. Section S2 — Peptide hormones, growth factors, related substances and mimetics. World Anti-Doping Agency.
  15. American Association of Clinical Endocrinologists. Clinical Practice Guidelines for Growth Hormone Use in Growth Hormone-Deficient Adults and Transition Patients — 2019 Update.
  16. Stone W. The wellness world is eager for RFK Jr.’s promised move on peptides. NPR, March 31, 2026. npr.org/2026/03/31/nx-s1-5768206/peptides-rfk-fda-compounding-pharmacies. Read October 3, 2026. (The HHS secretary’s late-February podcast remarks, “about 14” peptides; reported, not a rule.)
  17. Sigalos JT, Pastuszak AW, Allison A, Ohlander SJ, Herati A, Lindgren MC, et al. Growth Hormone Secretagogue Treatment in Hypogonadal Men Raises Serum Insulin-Like Growth Factor-1 Levels. Am J Mens Health. 2017;11(6):1752-1757. doi:10.1177/1557988317718662. PMID: 28830317.
  18. US Food and Drug Administration. Drugs@FDA: GEREF (sermorelin acetate). NDA 019863, injection 0.05 mg per ampoule (approved December 28, 1990), and NDA 020443, injection 0.5 mg and 1 mg per vial (approved September 26, 1997); both discontinued. Read through openFDA, October 4, 2026.

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Tested together in people

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Checked 18 Oct 2026