Sermorelin
Sermorelin — evidence, FDA history & status

Class: peptide
Synonyms: sermorelin acetate
GHRH(1-29)
GRF(1-29)
GHRH(1-29)-NH₂
brand names Geref (also Gerel). INCI: none
Function tags: GH secretagogue / GHRH analog
(approved historically: pediatric GHD + diagnostics)
adult GH optimization (off-label)
Overall evidence grade: B
WADA prohibited: yes
WADA note: Sport: WADA-prohibited — GHRH and its analogs / GH-releasing factors fall under Section S2.2. Banned even though it is a legal medicine.
Last updated: 2026-07-04

In brief: Sermorelin is GHRH(1-29), the shortest fully active fragment of GHRH, and the only GH secretagogue with a genuine FDA-approval history (as Geref, for pediatric GH deficiency and diagnostics, 1990–2008). It was withdrawn for commercial, not safety reasons and is now legally compounded. Its approved uses have real RCT support; its popular adult anti-aging use is off-label with thinner evidence. It is banned in sport.

## Identity a synthetic **29-amino-acid** peptide (< 40 aa → peptide) representing the **1–29 fragment of the 44-amino-acid GHRH** — the **shortest fully functional fragment**, retaining complete activity at the GHRH receptor. Developed in the 1980s. (CJC-1295 is a longer-acting, substituted version of this same 1-29 sequence.) ## Development & history - **FDA-approved twice:** NDA 19-863 (**Dec 1990**) for **diagnostic** use — assessing pituitary GH reserve (the sermorelin stimulation test); then **Geref** under NDA 20-443 (**Sept 1997**) for **treatment of idiopathic GH deficiency / growth failure in children**.
- **Withdrawn in 2008:** the sole manufacturer (EMD Serono) **voluntarily discontinued** it for **commercial, not safety or efficacy, reasons** — recombinant human GH (rhGH) had come to dominate the pediatric-GHD market. No adverse-event or toxicity action was involved.
- **Today:** no FDA-approved *branded* product exists (the approval lapsed with the withdrawal), but sermorelin is **legally compounded via 503A/503B pharmacies** with a prescription — giving it **the most defensible legal position of any GH secretagogue** (prior FDA approval, no safety-related withdrawal). It sits *outside* the Category-2 / July-2026-PCAC uncertainty that surrounds CJC-1295/Ipamorelin. ## Mechanism (as proposed) a **GHRH-receptor agonist** on pituitary somatotrophs that stimulates GH release **while preserving the normal hypothalamic–pituitary feedback loop** — when GH/IGF-1 rise, somatostatin brakes the response, preventing the supraphysiologic levels seen with direct rhGH. The result is a **pulsatile, self-limiting, more "physiological"** GH signal (and a shorter half-life than CJC-1295-DAC).

Evidence grades by outcome:
outcome: Pediatric GH deficiency / growth failure (former approved indication)
grade: B
base: FDA-approved (NDA 20-443); published pediatric RCTs
effect: Increased height velocity in GHRH-responders
caveat: Effect smaller than direct rhGH; historical approval
outcome: GH-stimulation diagnostic testing (approved use)
grade: B
base: FDA-approved (NDA 19-863); long clinical use
effect: Reliable assessment of pituitary GH reserve
caveat: Established diagnostic role
outcome: Raises GH / IGF-1 (physiologically)
grade: B
base: Well-characterised mechanism + studies
effect: Yes, in a pulsatile, feedback-preserving way
caveat: Works via the pituitary; self-limiting (see mechanism)
outcome: Adult anti-aging / body composition / sleep (the popular off-label use)
grade: C
base: Limited RCTs; "mid-tier" evidence
effect: Suggestive
caveat: Thinner data than its pharmaceutical history implies; off-label
outcome: Safety
base: Approved-drug safety record; self-regulating feedback
effect: Favourable vs direct rhGH
caveat: Considered among the safer GH-directed therapies; WADA-banned

Legal status:
region: US
status: Compounded (Rx) where lawful
note: The contrast case: previously FDA-approved (Geref, 1990/1997), withdrawn 2008 for commercial reasons; no current approved product, but legally compounded (503A/503B) with a prescription. Not part of the gray-market Category-2 situation.
region: EU
status: No current marketing authorisation
note: No current marketing authorisation; not a general OTC/cosmetic ingredient; compounding rules are member-state-specific.
region: INT
status: Status varies
note: Varies.

Cosmetic claims:

Note: Reference entry — not sold here. Note: unlike the gray-market GH peptides, sermorelin is a prescription compound with a real FDA-approval history — this is the "control" case in the register. No dosing/administration is published here; neutral reference only.

Sources:
FDA NDA 19-863 (1990, sermorelin diagnostic) and NDA 20-443 (1997, Geref, pediatric GHD).
Pediatric GH-deficiency treatment trials supporting the original approval (peer-reviewed, 1990s).
Sermorelin monograph / regulatory summaries (approval and 2008 commercial withdrawal).