Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-15. ← Back to Evidence Library
Sermorelin: what the evidence says
At a glance
What it is: a lab-made copy of the first 29 building blocks of GHRH, the brain's growth-hormone "on" signal. It makes the pituitary (a gland at the base of the brain) release more of the body's own growth hormone. It was once an FDA-approved drug, Geref, for children with growth hormone deficiency and for a pituitary test. Today it is sold online and by "anti-aging" clinics for energy, body composition, sleep and aging. R1, R2, R3
What the evidence says: it helped growth hormone–deficient children grow faster in an open-label trial (no placebo group). For healthy adults and aging, we found no placebo-controlled trial of sermorelin itself. The closest study used a slightly different molecule, raised growth-factor blood levels, and gave mixed results. R4, R6, R7
Biggest risks: flushing and injection-site pain were the most common problems in children. Long-term effects of raising growth hormone in healthy adults are unknown. Gray-market vials have no quality guarantees. R5
| Claim | Rating |
|---|---|
| Human Growth hormone deficiency in children (former approved use) | Limited: one multicenter open-label trial (110 children, 86 analyzed) with no placebo group; growth sped up, but final adult height wasn't reported R4, R5 |
| Human Testing pituitary function (former approved use) | Moderate: supported by FDA's former approval of Geref as a diagnostic test (1990); Caution [UNVERIFIED: diagnostic accuracy studies not individually reviewed] R1, R2, R5 |
| Human Anti-aging, body composition, energy in healthy adults | Very limited: no placebo-controlled trial of sermorelin itself; one small 19-person study of a close analog, and one 14-man chart review of a sermorelin combination; both report blood-test changes, not health benefits R6, R7 |
| Animal Animal evidence | Unknown Not reviewed for this page (human data take precedence) |
| Regulatory | No current FDA approval (Geref discontinued 2008; approvals withdrawn 2009; not for safety or effectiveness reasons) · not on the 503A bulks list or in any 503A nomination category; under evaluation (Category 1) on FDA's 503B list · WADA 2026: banned at all times (S2.2.4, named) R1, R2, R8, R9 |
| Established human dose | Unknown None current. Geref's old label applied to children with GH deficiency only; no dose has been reviewed for adults or aging |
Evidence verdict: Childhood GH deficiency (former approved use): Limited · Pituitary testing (former approved use): Moderate · Anti-aging, body composition and energy in adults: Very limited Why these ratings: Childhood GH deficiency is Limited because it rests on one open-label trial with no placebo group. Pituitary testing stays Moderate because FDA approved Geref for that use in 1990, and that approval was never withdrawn for safety or effectiveness reasons.
Card verdict: Moderate (pituitary diagnostic test, former FDA approval) · Childhood GH deficiency: Limited · Adult anti-aging, body composition, energy: Very limited Card note: Varies by use, see page
This page reports what studies and the former approved label used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
What is it?
Sermorelin (GHRH 1-29) is the shortest piece of natural GHRH that still works fully. It tells the pituitary to release growth hormone in pulses, and the liver then makes more IGF-1 (a growth factor). It is related to tesamorelin and CJC-1295, which have their own pages. R5
The former approved medicine: what the approval-era trials showed
This section covers Geref, used under its old label, in the people it was tested in. Geref is no longer made.
Human Children with growth hormone deficiency: in a multicenter open-label trial (the Geref International Study Group), 110 untreated prepubertal children were treated with injections under the skin for up to a year. Of the 86 eligible for the efficacy analysis, growth speed rose from about 4.1 cm a year to 8.0 cm at 6 months and 7.2 cm at 12 months. Bone age didn't race ahead. Glucose and IGF-1 stayed in range. R4 - There was no placebo group, so we can't compare dropouts with placebo. 24 of 110 children weren't in the efficacy analysis; the abstract does not say why. Caution [UNVERIFIED: full text not checked] - A review found growth gains were smaller than with growth hormone itself, and final adult height had not been reported. R5 - Who paid: the trial was run by the Geref International Study Group; Caution [UNVERIFIED: sponsorship by Serono and any employee authors not confirmed from the full text]. R4
Human Pituitary test: an IV injection was used to check whether the pituitary can release growth hormone. A normal result can't rule out deficiency caused by the hypothalamus. R5
Does it work for anti-aging, body composition or energy?
- Human Older adults, close analog: 19 people aged 55–71 got a placebo for 4 weeks, then a GHRH(1-29) analog ([Nle27], one building block different from sermorelin) for 16 weeks. The person running the study knew which was which (single-blind), and there was no separate placebo (dummy treatment) group. IGF-1 rose, skin got thicker, and men gained some lean mass and reported better well-being and libido, though the study also reported temporary high blood fats (see "Is it safe?"). Women didn't. Sleep didn't change. R6
- Human Men on testosterone, combination: a chart review of 14 men taking sermorelin together with GHRP-2 and GHRP-6 found IGF-1 rose. There was no comparison group, and the effect of sermorelin alone can't be separated. R7
- A rise in IGF-1 or growth hormone is a lab change, not a health benefit. Neither study showed that people lived longer, felt better over time, or avoided disease.
Is it safe?
- Human Children (Geref): facial flushing and injection-site pain were the most common problems. There were no adverse changes in blood tests in the 1-year trial. R4, R5
- Human Older adults (analog study): temporary high blood fats (hyperlipidemia) that resolved. R6
- Caution Raising growth hormone and IGF-1 long-term in healthy adults has unknown effects. For the related approved drug tesamorelin, the FDA label warns about fluid retention, high blood sugar and growth of existing cancers (see the tesamorelin page). We have no equivalent label data for sermorelin in adults. Unknown
What we don't know
- Unknown Whether sermorelin improves any health outcome in healthy adults
- Unknown Long-term safety of raised IGF-1 in adults
- Unknown Final adult height in treated children
Is it legal?
- FDA: Geref injection for diagnostic use (NDA 19-863) was approved Dec 28, 1990; Geref for treatment of idiopathic GH deficiency in children with growth failure (NDA 20-443) was approved Sept 26, 1997. EMD Serono notified FDA in 2008 (letters dated July 11 and Dec 2, 2008) that it was discontinuing both. FDA withdrew both approvals effective June 18, 2009 (74 FR 23407). On March 4, 2013, after a citizen petition, FDA determined that Geref "were not withdrawn from sale for reasons of safety or effectiveness," which would let generic versions be approved. The Federal Register notice does not give the company's business reason. A 2009 review reports the manufacturer "announced the discontinuation." No generic has been approved that we found, and it is not in the EMA's list of centrally authorised medicines (checked Oct 15, 2026; Caution [UNVERIFIED: national approvals in other countries not checked]). R1, R2, R3
- Compounding: sermorelin is not on the 503A bulks list (21 CFR 216.23) and does not appear in any category of FDA's 503A nominations list (updated May 14, 2026). On FDA's 503B nominations list (updated Mar 21, 2025), "Sermorelin Acetate" is in Category 1 (under evaluation), marked as a component of an FDA-approved drug. Caution [UNVERIFIED: whether 503A pharmacies may legally use it; we found no FDA statement specific to sermorelin]. R8
- Athletes: WADA's 2026 list names sermorelin under S2.2.4 (growth hormone releasing factors), banned at all times. R9
What's in the vial?
No approved sermorelin product exists today. A gray-market or clinic vial is not Geref. It has no FDA quality control and no guarantee of identity. It could hold the wrong compound or amount, impurities, bacterial toxins, or be fake (counterfeit). The Geref trial results above don't transfer to it. We test retail vials blind under the Open Peptide Standard. See results at /tests/. A passing test covers one batch, tested on one date. It does not mean the compound itself is safe.
What do users report?
Self-report, not evidence.
Unknown TBD. We'll only list this once we can cite a public source.
Study details
R4–R7 Human Human studies
| Study | People | Route | Dose used (study arm, not a recommendation) | Follow-up | Reported | Limitations | Citation |
|---|---|---|---|---|---|---|---|
| Thorner 1996, Geref International Study Group (human) | 110 prepubertal GH-deficient children (86 in efficacy analysis) | Subcutaneous, at bedtime | 30 µg/kg daily | 12 mo | Height velocity 4.1 → 8.0 (6 mo) → 7.2 cm/yr (12 mo); no excess IGF-1; no glucose change | Open-label, no placebo; sponsor UNVERIFIED | PMID 8772599 |
| Prakash 1999, review | Review of Geref data | IV (test); subcutaneous (treatment) | 1 µg/kg IV (test); 30 µg/kg/day SC | n/a | Flushing and injection-site pain most common; final height unknown | Review by a publisher's drug-review unit (Adis) | PMID 18031173 |
| Khorram 1997, older adults ([Nle27]GHRH(1-29), an analog) | 19 (10 women, 9 men), aged 55–71 | Subcutaneous, nightly | 10 µg/kg | 4 wk placebo, then 16 wk | IGF-1 up; skin thickness up; lean mass and insulin sensitivity up in men only; temporary high blood fats | Single-blind; placebo run-in, not a parallel group; analog not sermorelin; funding UNVERIFIED | PMID 9141536 |
| Sigalos 2017, chart review | 14 men on testosterone (from 105 reviewed) | Subcutaneous | 100 µg each of sermorelin, GHRP-2, GHRP-6, three times daily | Mean 134 days | IGF-1 159.5 → 239.0 ng/mL | Retrospective; combination; no control; authors declared no conflicts | PMID 28830317 |
R1, R2, R3, R8, R9 Regulatory (as of Oct 15, 2026)
- R1 Drugs@FDA (openFDA query, Oct 15, 2026): NDA 019863 GEREF (diagnostic), original approval Dec 28, 1990, Discontinued; NDA 020443 GEREF (treatment), original approval Sept 26, 1997, Discontinued; both flagged "Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons." https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020443
- R2 Federal Register, March 4, 2013 (78 FR 14095), doc 2013-04827: "Determination That GEREF (Sermorelin Acetate) Injection ... Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness." Gives approval dates, indications, discontinuation letters and withdrawal effective June 18, 2009 (74 FR 23407). https://www.federalregister.gov/documents/2013/03/04/2013-04827/determination-that-geref-sermorelin-acetate-injection-05-milligrams-basevial-and-10-milligrams
- R3 Yuen KC, et al. J Clin Endocrinol Metab. 2009;94(8):2702-7. PMID 19509104: "In July 2008, the only manufacturer of recombinant GHRH in the United States, EMD Serono, Inc., announced the discontinuation of Geref."
- R8 FDA compounding: 503A bulks list, 21 CFR 216.23; 503A nominations list (updated May 14, 2026; no entry for sermorelin): https://www.fda.gov/media/94155/download ; 503B nominations list (updated Mar 21, 2025; "Sermorelin Acetate**" in Category 1): https://www.fda.gov/media/94164/download
- R9 WADA 2026 Prohibited List, S2.2.4: "growth hormone-releasing hormone (GHRH) and its analogues (e.g. CJC-1293, CJC-1295, sermorelin and tesamorelin)"; prohibited at all times (official PDF text, saved copy). https://www.wada-ama.org/en/resources/world-anti-doping-code-and-international-standards/prohibited-list
Full reference list (PMIDs verified on PubMed, Oct 15, 2026)
- R4 Thorner M, et al. J Clin Endocrinol Metab. 1996;81(3):1189-96. doi:10.1210/jcem.81.3.8772599. PMID 8772599
- R5 Prakash A, Goa KL. BioDrugs. 1999;12(2):139-57. doi:10.2165/00063030-199912020-00007. PMID 18031173
- R6 Khorram O, Laughlin GA, Yen SS. J Clin Endocrinol Metab. 1997;82(5):1472-9. doi:10.1210/jcem.82.5.3943. PMID 9141536
- R7 Sigalos JT, et al. Am J Mens Health. 2017;11(6):1752-1757. doi:10.1177/1557988317718662. PMID 28830317
- R3 Yuen KC, et al. J Clin Endocrinol Metab. 2009;94(8):2702-7. doi:10.1210/jc.2009-0299. PMID 19509104
Disclaimer
This page is for education and harm reduction. It is not medical advice and not a recommendation to use sermorelin. Please talk to a clinician you trust, especially if you have or have had cancer, have diabetes, are pregnant, or are a tested athlete. Seek care right away for a serious reaction, and report it to FDA MedWatch (https://www.fda.gov/safety/medwatch).