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.

Status recorded · FDA source document

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This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information.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.

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Status as of

Key takeaway

Hexarelin is a potent synthetic ghrelin-mimic peptide that prompts the body to release growth hormone, sold in the wellness market for recovery and body composition. Human data are limited to short studies of growth hormone release, with no controlled trials supporting the marketed benefits, and repeated use appears to blunt its own effect. As of 2026 it is not FDA-approved and is banned in sport.

At a glance

FDA status
Non-FDA-approved peptide (also known as examorelin) sold in the wellness/gray market
What it is
Potent ghrelin-receptor agonist / growth hormone-releasing peptide
Research
Human data are limited to short pharmacology studies; the marketed benefits are unproven
Sport
Prohibited by WADA at all times
Evidence strength
Low research

Summary

Hexarelin is a synthetic peptide that triggers growth hormone release. Learn how it works, what human data exist, and why it is not FDA-approved.

What is hexarelin?

Hexarelin, with the generic name examorelin, is a synthetic six-amino acid peptide, structurally a methylated relative of GHRP-6. It is among the more potent growth hormone-releasing peptides for triggering growth hormone release. It is sold through wellness and "research peptide" channels and promoted for recovery and body composition, and it was never marketed as an approved drug.

How does it work?

Three features of its proposed mechanism stand out:

  • It activates the growth hormone secretagogue (ghrelin) receptor on the pituitary to drive growth hormone pulses.
  • It also binds a receptor called CD36 in cardiovascular tissue, which underlies preclinical interest in effects on the heart that may be separate from growth hormone.
  • Studies report partial desensitization, in which the growth hormone response can diminish with repeated exposure.

The marketed benefits are extrapolated from the growth hormone rise. This describes the proposed mechanism, separate from proven outcomes.

Is it FDA-approved?

Safety note

Status: Non-FDA-approved peptide (also known as examorelin) sold in the wellness/gray market

Category: Wellness and performance · Primary body area: Bones & muscles

No. Hexarelin is not approved by the FDA and never reached market as a drug. It has been treated as not eligible for routine 503A compounding in the U.S. and is not approved for performance or anti-aging. In sport, growth hormone-releasing peptides including hexarelin (examorelin) are prohibited at all times under the WADA list.

What does the research show?

Editor’s note

Evidence strength: Low research

Human data are limited to short studies of growth hormone release, with the marketed wellness benefits resting on animal and laboratory work.

The human evidence is short pharmacology. According to PubMed, a study in healthy men found hexarelin produced a larger growth hormone rise than GHRH and acted in synergy with it, a hormone-level result rather than a clinical outcome. Its cardiovascular effects are described mainly in experimental models and reviews. No controlled human trials support the marketed muscle, recovery, or anti-aging uses.

Sources: a growth hormone pharmacology study (Arvat et al., Neuroendocrinology, 1995, DOI: 10.1159/000126827) and a review of growth hormone secretagogues (Cao et al., Trends in Endocrinology & Metabolism, 2005, DOI: 10.1016/j.tem.2005.11.004), both indexed on PubMed; 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

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