Regulatory status

Status at a glance

503A compounding status

Removed from Category 2 (review pending)

FDA has moved this substance out of Category 2 while it is reviewed further. Removal from Category 2 does not authorize compounding. Its status remains unsettled until FDA completes its evaluation.

Listed by FDA · FDA source document

FDA approval
Not FDA-approved for any use
503B outsourcing
Excluded
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.

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Status as of

Key takeaway

Ipamorelin is a synthetic peptide that mimics ghrelin to prompt the body to release more of its own growth hormone, and it is sold on the wellness and "research peptide" market. In a phase 2 trial of 114 bowel-resection patients (Beck, 2014), intravenous ipamorelin brought a median first tolerated meal at 25.3 hours versus 32.6 hours on placebo, a difference that was not significant (p = 0.15). Other human data show only that it raises growth hormone. As of 2026 it is not FDA-approved, it is not eligible for routine pharmacy compounding, and it is banned in sport.

At a glance

FDA status
Non-FDA-approved peptide sold in the wellness/gray market
What it is
Selective ghrelin-receptor agonist ("growth hormone secretagogue")
Research
Human data are limited to short pharmacology studies; benefit for recovery or body composition is unproven
Sport
Prohibited by WADA at all times
Evidence strength
Low research

Summary

Ipamorelin is a ghrelin-mimicking peptide that raises growth hormone. Human data are limited to short studies, it is not FDA-approved, and sport bans it.

What is ipamorelin?

Ipamorelin is an experimental five-amino acid peptide that acts as a ghrelin mimic, developed years ago under the code NNC 26-0161 but never marketed as a drug. It is sold through wellness and "research peptide" channels and promoted for recovery, body composition, and sleep, often paired with a GHRH analog such as CJC-1295 or sermorelin.

How does it work?

Ipamorelin activates the growth hormone secretagogue receptor, the same receptor the hunger hormone ghrelin uses, which triggers the pituitary to release growth hormone in pulses. In laboratory work it is described as relatively "selective," raising growth hormone with comparatively little effect on other hormones such as cortisol and prolactin. In conscious swine, it released GH without raising ACTH or cortisol, while GHRP-6 and GHRP-2 raised both.

Because growth hormone and GHRH signaling act together, ghrelin-mimic peptides are often combined with GHRH analogs. No published human randomized controlled trial tests ipamorelin with CJC-1295 as of September 2026. The marketed benefits are extrapolated from this growth-hormone effect. This describes the proposed mechanism, separate from proven outcomes.

Is it FDA-approved?

Safety note

Status: Non-FDA-approved peptide sold in the wellness/gray market

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

No. Ipamorelin is not approved by the FDA and never reached market as a drug. Its compounding and sport status:

  • Not eligible for routine 503A compounding, because its 503A nomination was withdrawn
  • Still on FDA's 503B Category 2 list
  • Prohibited at all times in sport under the WADA list, which covers growth hormone secretagogues including ipamorelin

What does the research show?

Editor’s note

Evidence strength: Low research (2 human · 2 animal/cell studies)

Human data are limited to short studies of growth hormone release and one phase 2 ileus trial that missed its endpoint, and the marketed recovery and body-composition claims rest on animal and laboratory work.

The human evidence is short pharmacology, not outcomes, and the supporting bone and gut data come from animal models:

Study findings for Ipamorelin
Study Subjects Finding
Dose-ranging study, according to PubMedHealthy menIpamorelin induced growth hormone release, a hormone-level finding rather than a clinical result; the study estimated a terminal half-life of 2 hours
Bone studyRats with glucocorticoid-related bone changesSupporting data on bone effects
Gut transit modelRodent model of post-operative gut transitSupporting data on gut effects
The one published phase 2 efficacy trial (Beck, 2014)114 patients analyzed, adults after bowel resection, given intravenous ipamorelin or placeboMedian time to first tolerated meal was 25.3 versus 32.6 hours, p = 0.15, so it missed its primary endpoint; its secondary efficacy analyses showed no significant differences either

Clinical development for post-operative ileus did not produce an approved product, and there are no controlled human trials supporting the marketed recovery or body-composition uses.

Sources: a pharmacodynamic study of ipamorelin (Gobburu et al., Pharmaceutical Research, 1999, DOI: 10.1023/a:1018955126402); animal studies on bone (Andersen et al., Growth Hormone & IGF Research, 2001, DOI: 10.1054/ghir.2001.0239) and gut transit (Venkova et al., Journal of Pharmacology and Experimental Therapeutics, 2009, DOI: 10.1124/jpet.108.149211), all 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

2 registered human trials on ClinicalTrials.gov that we reviewed

Sources

  1. [1]

    ghrelin

    Primary my.clevelandclinic.org

  2. [2]
  3. [3]
  4. [4]
  5. [5]
  6. [6]
  7. [7]

    114 patients analyzed

    Primary PubMed

  8. [8]

    bulk drug substances nominated but withdrawn

    Primary U.S. Food and Drug Administration

  9. [9]
  10. [10]
  11. [11]

    Category 3 for 503A compounding

    Primary U.S. Food and Drug Administration

  12. [12]

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