Independent directory · not a healthcare provider, pharmacy or seller Directory last updated 2026-07-28
PeptideCare Finder
Clinician-supervised care · not a healthcare provider

Clinician-supervised care · not a healthcare provider

Medical care
Find ClinicsPeptide TherapyFDA StatusCostsMedical Guides
Research suppliers — separate section
Supplier ReviewsCompare SuppliersCOA GuideTesting StandardsRegulatory Actions
Growth hormone secretagogues · Formerly approved; no current approved product

Sermorelin: Once FDA-Approved, for Something Nobody Sells It For

The only peptide here that FDA once approved and then let disappear for purely commercial reasons — and the approval was for growth failure in children, not for anything it is sold for in adults.

Compiled by the PeptideCare Finder editorial team · Published 2026-08-05 · Updated 2026-07-28 · Not independently reviewed by a clinician
Regulatory and anti-doping status
FDA-approved use
Formerly. Two Geref products, held by EMD Serono, were approved in 1990 and 1997 — one to evaluate pituitary growth hormone secretion, one for idiopathic growth hormone deficiency in children with growth failure. Both approvals were withdrawn in June 2009 at the manufacturer’s request. FDA formally determined in 2013 that they were not withdrawn for reasons of safety or effectiveness.
Classification here
Formerly approved; no current approved product
Compounding status
Sermorelin appears on neither of FDA’s compounding risk tables — not in category 2, and not among the withdrawn nominations. Its prior approval gives it a compounding route as a component of a previously approved drug product. That is an absence of a restriction rather than an affirmative FDA endorsement.
Anti-doping status
Prohibited at all times — WADA 2026 Prohibited List, section S2.2.4, named explicitly among growth hormone releasing factors. S2 substances are non-Specified Substances.

Every line above is re-verified against the primary agency source before each update. What the July 2026 FDA vote did and did not do →

What sermorelin is

Sermorelin is a synthetic fragment of growth-hormone-releasing hormone — the first 29 amino acids, the shortest piece that retains activity. It acts on the pituitary to stimulate the body’s own growth hormone release rather than supplying growth hormone directly, which means its effect depends on the pituitary still being able to respond.

The regulatory contradiction worth understanding

Sermorelin sits in an unusual position. It is essentially untouched by the FDA compounding restrictions that capture CJC-1295, ipamorelin, BPC-157 and injectable GHK-Cu — because it was once an approved drug, which gives it a different lawful route. At the same time WADA names it explicitly and bans it at all times. The same molecule is comparatively unencumbered in US compounding and a permanent doping violation in sport. FDA compoundability and sporting legality are independent axes.

What the human evidence covers

Real, but old, small and almost entirely paediatric. The study behind the growth indication enrolled 110 previously untreated prepubertal children with growth hormone deficiency, open-label with no placebo arm, and reported height velocity rising from 4.1 to 7.2 cm per year at twelve months. A separate study in children with radiation-induced deficiency found sermorelin worked, but less well than growth hormone itself in the same children the following year.

What the adult evidence covers

For the uses it is actually sold for today — anti-ageing, body composition, muscle gain, sleep, recovery — there is no adequate randomised controlled trial evidence. A 2020 review of growth hormone secretagogues concluded that clinical efficacy data largely remain lacking. One registered trial of GHRH in older adults was terminated with five participants enrolled. Raising growth hormone and IGF-1 is a measurable effect; it is not by itself a demonstrated benefit.

How far up the evidence hierarchy this reaches

A former FDA approval and genuine registered trials — but the trials were in children with growth hormone deficiency, and for every adult use it is marketed for the evidence drops to nothing.

FDA-approved label
Adverse reactions observed in trials of known size, in a defined population.
Registered human trials This substance reaches here
Useful — but read the size. A few dozen participants cannot detect an uncommon harm.
Animal and in-vitro work
Where the literature for most marketed peptides actually sits. Not evidence of human benefit.
Testimonials and forums
Not evidence. Systematically under-reports harm.
Where a substance's best available evidence sits matters more than any claim made about it.

Where it sits on the compounding pathway

01
Nominated
Someone proposes the substance for compounding use.
02
Category 2
FDA flags significant safety risks pending evaluation.
03
Nomination withdrawn
The nominator pulls it. FDA still publishes its risk language.
04
Advisory committee
A non-binding recommendation. Not a decision.
05 Here
On the 503A Bulks List
The only stage that confers authority. Reached by rulemaking.
As of August 2026 no peptide has reached stage 05. Coverage routinely reports stage 04 as though it were stage 05.

What it is sold for, against what the evidence shows

Marketing claims on the left, in the terms sellers use. What the human literature actually supports on the right.

Marketed forWhat the evidence showsVerdict
Increasing the body’s own growth hormone output Well established — this was the basis of the approved pituitary-function diagnostic product. Supported
Growth in children with growth hormone deficiency Formerly approved indication, on an open-label study of 110 children. It underperformed growth hormone itself in a head-to-head-in-time comparison. Supported
Anti-ageing, restoring youthful hormone levels No randomised trial demonstrating any ageing-related clinical outcome. A hormone level rising is a biomarker, not a benefit. Partly supported
Fat loss and lean-mass gain in healthy adults No adequate randomised trial. A 2020 review found clinical efficacy data largely lacking. No human evidence
Better sleep, recovery, energy, injury healing No controlled human trials for any of these endpoints. No human evidence
"Not a banned substance" WADA names sermorelin explicitly. Prohibited at all times, in and out of competition. Contradicted

Where to go next

Growth hormone secretagogues
CJC-1295
The long-acting GHRH analogue built to replace it. Never approved, and its one efficacy trial was terminated without results.
Growth hormone secretagogues
Ipamorelin
The other half of the pairing clinics most often sell — a secretagogue that reaches the pituitary by a different receptor.
What this guide deliberately omits

No dosing, cycling, stacking, reconstitution or administration instructions appear anywhere on this site, and this page links to no page selling an unapproved injectable. Questions about how a substance would be used belong with a licensed clinician who has evaluated you.

Sources

  1. Federal Register — Determination that GEREF (sermorelin acetate) injection was not withdrawn for reasons of safety or effectiveness, 78 FR 14095, 2013
  2. Thorner M et al. Once daily subcutaneous GHRH therapy accelerates growth in GH-deficient children during the first year. J Clin Endocrinol Metab, 1996
  3. Sinha DK et al. Beyond the androgen receptor: growth hormone secretagogues in body composition management. Transl Androl Urol, 2020
  4. WADA — 2026 Prohibited List, section S2.2.4