COMPARE PEPTIDES

Compare status, evidence, and next steps.

Put up to three peptides side by side to compare what FDA has done, what has been studied in people, and what comes next.

FDA statusFDA approved?What changed legallyHuman studiesWhat comes nextUse FDA reviewed
Committee favored

BPC-157

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Favorable PCAC voteAdvisory recommendation; FDA final action is still pending.
NoNo approved indication
No final legal changeNo final FDA action identified
LimitedAnimal and laboratory research shown separately
FDA actionFDA must decide whether and how to act on the committee recommendation.
Ulcerative colitisThe use FDA reviewed or expects to review
Committee favored

TB-500

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Favorable PCAC voteAdvisory recommendation; FDA final action is still pending.
NoNo approved indication
No final legal changeNo final FDA action identified
None identified by FDAAnimal and laboratory research shown separately
FDA actionFDA must decide whether and how to act on the committee recommendation.
Wound healingThe use FDA reviewed or expects to review
Committee did not favor

Emideltide / DSIP

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Unfavorable PCAC voteCommittee did not recommend inclusion; FDA final action is still pending.
NoNo approved indication
No final legal changeNo final FDA action identified
LimitedAnimal and laboratory research shown separately
FDA responseFDA may adopt, reject, or otherwise respond to the committee recommendation.
Opioid withdrawal, chronic insomnia, and narcolepsyThe use FDA reviewed or expects to review
THE BOTTOM LINE

These peptides are at different points in FDA review. None is FDA approved, and none has received final FDA action adding it to the 503A Bulks List.