Bones & muscles GHRH analog (secretagogue)
Sermorelin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- On the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Sermorelin is a synthetic fragment of growth-hormone-releasing hormone (GHRH) that was once an approved medicine (Geref) for growth hormone testing and pediatric growth problems, later discontinued. Today it is supplied mainly as a compounded preparation to raise the body's own growth hormone, but there are no controlled trials establishing the marketed adult anti-aging or body-composition benefits. As of 2026 no approved sermorelin product is marketed, and it is banned in sport.
At a glance
- What it is
- GHRH analog, formerly FDA-approved as Geref, which was discontinued
- FDA status
- No FDA-approved sermorelin product currently marketed; supplied via compounding
- Historical approval
- Pediatric growth hormone deficiency and diagnostic testing, not adult anti-aging
- Sport
- Prohibited by WADA at all times
- Evidence strength
- Low research
Summary
Sermorelin is a synthetic GHRH fragment once sold as Geref and now discontinued. See how it works, its FDA status, and what the research shows.
What is sermorelin?
Sermorelin is the shortest fully active fragment of human GHRH, the hypothalamic hormone that signals the pituitary to release growth hormone. Unlike most peptides in the wellness market, it has a prior approval history: It was marketed as Geref for assessing growth hormone secretion and for treating growth failure in children. That product was discontinued, and sermorelin is now supplied mainly as a compounded preparation and promoted for anti-aging and body composition in adults.
How does it work?
Sermorelin is a GHRH-receptor agonist. It binds the same pituitary receptor as natural GHRH and stimulates pulsatile growth hormone release, which in turn raises IGF-1. It is shorter-acting than CJC-1295 but works through the same pathway. The adult wellness claims rest on this growth-hormone-raising pharmacology rather than on demonstrated outcomes. This describes the proposed mechanism, separate from whether it produces the marketed results.
Is it FDA-approved?
Safety note
Status: No FDA-approved sermorelin product currently marketed; supplied via compounding
Category: Wellness and performance · Primary body area: Bones & muscles
Not currently. The table below sets out sermorelin's regulatory status.
| Area | Status |
|---|---|
| FDA approval | FDA-approved as Geref and then discontinued, reportedly for business reasons rather than a safety withdrawal; no FDA-approved sermorelin product is now on the market |
| Compounding | Available through compounding, and because it was a previously approved ingredient, its compounding footing differs somewhat from never-approved peptides, though its status remains under ongoing FDA review |
| Anti-aging and performance | Not approved for either use |
| Sport | GHRH analogs including sermorelin are prohibited at all times under the WADA list |
What does the research show?
Editor’s note
Evidence strength: Low research
Although it has a genuine prior approval history for pediatric growth hormone deficiency and diagnostics, there is no sound human evidence that it delivers the marketed adult anti-aging or body-composition benefits.
The historical human data relate to its original approved uses, not the adult wellness market. Sermorelin's role in diagnosing growth hormone capacity and treating pediatric growth hormone deficiency was established, and physiology studies confirm that GHRH signaling augments nocturnal growth hormone release (here). There are no controlled trials showing that sermorelin improves muscle, fat, recovery, or aging in healthy adults; those uses are extrapolated from its effect on hormone levels.
Sources: a GHRH physiology study (Jessup et al., European Journal of Endocrinology, 2004, DOI: 10.1530/eje.0.1510561), indexed on PubMed; FDA records on the discontinued Geref product; and the WADA Prohibited List. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
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- [3]
- [4]
- [5]
- [6]
- [7]
- [8]
- [9]
- [10]
- [11]
- [12]
- [13]
- [14]
- [15]
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