Interest centers on the idea of a small anti-inflammatory peptide that might influence wound, gut, and skin biology.
FDA reported no identified human exposure data for the drug products it reviewed.
What a visitor should know.
Technical details: aliases, tracked claims, and data record
3 names in this peptide family.
KPV free base and KPV acetate are linked to the same compound family while preserving the form reviewed by FDA.
5 evidence questions.
Human benefitNo identified human exposureDoes KPV have established human clinical benefit for wound healing and inflammatory conditions?
FDA approvalNo FDA approval identifiedIs KPV FDA approved?
503A statusRegulatory recordIs KPV 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 KPV automatically interchangeable?
See every KPV evidence question →Open the machine-readable record ↗PCAC gave a favorable advisory recommendation
The committee recommended KPV-related bulk drug substances for possible inclusion on the 503A Bulks List.
FDA received advice from its expert compounding committee.
The compound was not FDA-approved, and the vote alone did not add it to the final 503A Bulks List.
How the FDA record developed.
This timeline separates early nominations and scientific reviews from committee votes and final FDA decisions.
PCAC gave a favorable advisory recommendation
The committee recommended KPV-related bulk drug substances for possible inclusion on the 503A Bulks List.
Read the source ↗FDA published its scientific briefing
FDA released its evaluation of KPV-related bulk drug substances for the committee meeting.
Read the source ↗KPV entered FDA's 503A nomination record
KPV was nominated for wound-healing and inflammatory uses. The nomination was later withdrawn, and FDA continued the evaluation on its own initiative.
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.
FDA reported no identified human exposure data for drug products containing KPV.
Read the FDA review ↗Preclinical findings were reviewed separately and do not establish clinical benefit in people.
Read the FDA review ↗KPV reduced inflammatory findings in two mouse models of colitis. FDA still reported no identified human exposure data for the reviewed drug products.
Read the study on PubMed ↗Important unknowns.
- FDA reported no identified human exposure data for the drug products it reviewed.
- FDA identified uncertainty around active-ingredient characterization, peptide-related impurities, or aggregation.
- Limited evidence of harm should not be interpreted as evidence of safety.
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. 3 comparison groups.
These records show what each source added and whether it changed Peplyst's public conclusion.