Ipamorelin is popular as a supposedly selective growth-hormone secretagogue and is often discussed alongside CJC-1295.
A phase 2 postoperative study did not show efficacy, and FDA placed ipamorelin acetate in a 503B safety-concern category.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
3 names in this peptide family.
Ipamorelin acetate is the FDA-listed bulk drug substance. Shorthand references to ipamorelin do not erase salt, formulation, concentration, or route context.
4 evidence questions.
Human benefitLimited human evidenceDoes Ipamorelin acetate have established human clinical benefit for postoperative gastrointestinal recovery (study context)?
FDA approvalNo FDA approval identifiedIs Ipamorelin acetate FDA approved?
503A statusRegulatory recordIs Ipamorelin acetate on FDA's final 503A Bulks List or generally permitted because of committee activity?
Identity transferIdentity-sensitiveAre every product, alias, form, and related compound labeled Ipamorelin acetate automatically interchangeable?
See every Ipamorelin acetate evidence question →Open the machine-readable record ↗FDA placed ipamorelin acetate in 503B category 2
FDA listed the substance among bulk drug substances that raise significant safety risks for 503B evaluation.
FDA made a formal safety-concern classification in the outsourcing-facility pathway.
Category 2 is not a PCAC vote, an FDA approval decision, or a finding that every adverse event was caused by ipamorelin.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
FDA placed ipamorelin acetate in 503B category 2
FDA listed the substance among bulk drug substances that raise significant safety risks for 503B evaluation.
Read the source ↗A compounder recalled an ipamorelin-containing sterile product
Innoveix recalled all of its sterile compounded products, including a semorelin/ipamorelin product, because of a lack of sterility assurance.
Read the source ↗FDA cited one compounder's ipamorelin products
FDA said the firm's products did not qualify for the claimed 503A exemptions under the circumstances described in the letter.
Read the source ↗What has actually been studied?
Human studies appear on the left. Animal, cell, and laboratory studies appear on the right because they cannot establish that a treatment works in people.
In 114 patients after bowel surgery, intravenous ipamorelin did not significantly improve the main or secondary efficacy outcomes versus placebo. The study context and route should not be generalized to other products or uses.
Read the study on PubMed ↗Ipamorelin improved gastric emptying in a rat model. The later human phase 2 trial did not show a corresponding efficacy benefit.
Read the study on PubMed ↗Important unknowns.
- FDA cites a study reporting serious adverse events, including death, with intravenous use for gastric motility; that record does not by itself establish causation.
- FDA identified immunogenicity, unnatural-amino-acid, impurity, and active-ingredient characterization concerns.
- A 2021 recall involved lack of sterility assurance across a compounder's products; it was a product-quality event, not proof of peptide-specific harm.
These are evidence and regulatory uncertainties, not an individualized assessment of whether a treatment is appropriate.
Read the original sources.
Technical change history and comparison data
3 dated changes. 0 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.