GH axis FDA Approved (Compounding)

Sermorelin

A synthetic analog of the first 29 residues of growth hormone-releasing hormone, approved as Geref in 1990 for diagnostic use and in 1997 for pediatric growth hormone deficiency, withdrawn in 2009 for reasons unrelated to safety, and now supplied in the United States through compounding.

GHRHGrowth HormoneCompounding

Also referenced as: Sermorelin Acetate, Geref, GRF(1-29), GHRH(1-29)

Also appears in: Performance

Vial price compare
184 tracked offers across 184 vendors · 15 dosages
Best trust-adjusted value: Peptuvia · Strong trust · $1.60/mg
From
$1.60/mg
Tracked market history

What has the price actually done?

Daily, exact-comparability offers. Discounts use the terms known on each historical date.

Flat vs. Oct 11
Current low$1.60/mg
Market median$7.08/mg
Current coverage88 vendors
Observed window90 daily points
How this history is calculated

Effective price per mg uses an active dated override first, then the row-level historical discount, then the latest vendor-default policy recorded for that UTC day. Aggregate chart points include exact-comparability offers only. Missing observations remain gaps; the series does not interpolate across unavailable offers or absent snapshots.

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Public product evidence 198 certificate records for Sermorelin products, from 73 vendors 116 reference a report on the testing laboratory's own system · 86 have a laboratory lookup that answered when last checked · 188 match a vendor product page at the same address
Status
FDA Approved (Compounding)

This compound is not an approved drug product, but it is an FDA-recognized ingredient that licensed pharmacies may compound in the United States.

Research area
GH axis / secretagogue research

Primary research area: GH axis. Also surfaces under Performance for browsing and discovery.

Body systems
Hormones · Muscle & bone

Where the compound acts, as a browse axis. It is an editorial grouping for discovery, not a claim about labeled indications.

Aliases
4

Sermorelin Acetate, Geref, GRF(1-29), GHRH(1-29)

Signal depth
Medium

No FDA label signal · 42 trials · 35 PubMed results

Preclinical

Current evidence for Sermorelin is limited to laboratory or animal studies — there are no name-matched human trials with reported results. Any claims about effects in people are not yet backed by clinical data.

Sermorelin has no clinical trials that name it and 35 PubMed-indexed publications and is not FDA-approved. Current evidence is preclinical or mechanistic.

Human data
Lab / animal only
Trial quality
No human trials
Outcomes
No human trials
Replication
Multiple papers
Literature
High-impact
  1. 2026-11-04 Established → Preclinical Band Established → Preclinical
  2. 2026-11-01 Preclinical → Established Band Preclinical → Established
  3. 2026-07-09 Preclinical First graded

Grades evidence strength, not efficacy or safety. Research-use context; not medical advice. Graded 2026-11-07 from PubMed, ClinicalTrials.gov, ISRCTN, openFDA, Health Canada, and OpenAlex — computed deterministically and refreshed nightly, with a retraction check. How we grade →


What sermorelin is

Sermorelin is a synthetic analog of the first 29 amino acids of growth hormone-releasing hormone, the fragment that carries the hormone’s full activity, and it sits closer to the clinical side of the GH category than many generic secretagogues. It is still common in vendor listings and wellness-adjacent peptide conversations.

Why it matters

It helps bridge the gap between older hormone-therapy language and today’s research-market catalog culture.

Regulatory context

Sermorelin acetate was the active ingredient of an approved US drug. Geref was approved on December 28, 1990 as a 0.05 mg diagnostic ampule for assessing pituitary growth hormone secretion (NDA 019863) and on September 26, 1997 as 0.5 mg and 1 mg vials for treating growth hormone deficiency in children (NDA 020443, with orphan designation). EMD Serono stopped marketing both, and the FDA withdrew the approvals effective June 18, 2009 at the holder’s request (74 FR 23407). On March 4, 2013 the agency determined that Geref had not been withdrawn from sale for reasons of safety or effectiveness (78 FR 14095), which keeps the former product available as a reference for future applications and keeps sermorelin acetate eligible as a bulk substance for compounding under section 503A as a component of a previously approved drug.

The FDA Approved (Compounding) status reflects that no approved sermorelin product is currently marketed and that US supply comes from compounding pharmacies working from an ingredient the FDA once approved. Sermorelin sold through research vendors is a different matter from either the former Geref product or a compounded prescription, and the three should not be treated as interchangeable.

Practical reading note

Sermorelin is a good reminder that a compound can have a more serious historical footing than the average peptide listing while still being marketed in ways that go far beyond that footing.