This page tracks what US regulators have actually decided about specific peptides, with the source for each claim and the date it was true. It reports status. It does not rank compounds, and a compound appearing lower on this page is not a judgement about it.
The distinction that matters most on this page: an FDA advisory committee recommending a substance is not the FDA approving it, and is not the same as the FDA agreeing. Committee votes are advice. The status of every compound below is stated with that difference made explicit.
Reviewed by the FDA Pharmacy Compounding Advisory Committee
Seven peptides were reviewed on 23 and 24 July 2026 for the section 503A bulk drug substances list, under docket FDA-2025-N-6895. The FDA’s own scientific review team recommended against all seven. The committee recommended six of them. Each substance was voted separately in free base and acetate forms.
BPC-157
As of July 23, 2026
Advisory committee recommended
On 23 July 2026 an FDA advisory committee voted 8 to 6, with one abstention, to recommend BPC-157 for the 503A bulk drug substances list, in both free base and acetate forms. That is a recommendation to the FDA, not a decision by it. BPC-157 is not an FDA-approved drug and compounding pharmacies cannot legally prepare it unless and until the FDA completes rulemaking.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
KPV (Lys-Pro-Val)
As of July 23, 2026
Advisory committee recommended
On 23 July 2026 an FDA advisory committee voted 8 to 6, with one abstention, to recommend KPV for the 503A bulk drug substances list, in both free base and acetate forms, for wound healing and inflammatory conditions. It is a recommendation to the FDA, not an approval, and KPV is not an FDA-approved drug.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
MOTS-c
As of July 23, 2026
Advisory committee recommended
On 23 July 2026 an FDA advisory committee voted 7 to 5, with two abstentions, to recommend MOTS-c for the 503A bulk drug substances list, in both free base and acetate forms, for obesity and osteoporosis. This was the narrowest of the day one votes. It is a recommendation only; MOTS-c is not FDA-approved.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
TB-500 (thymosin beta-4 fragment)
As of July 23, 2026
Advisory committee recommended
On 23 July 2026 an FDA advisory committee voted 8 to 6, with one abstention, to recommend TB-500 for the 503A bulk drug substances list, in both free base and acetate forms, for wound healing. The FDA review team had recommended against it, and committee members who voted no cited limited efficacy data and questions about tumour progression. It is a recommendation only; TB-500 is not FDA-approved.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
DSIP (delta sleep-inducing peptide, emideltide)
As of July 24, 2026
Advisory committee did not recommend
On 24 July 2026 an FDA advisory committee voted 6 to 7, with one abstention, against recommending emideltide (DSIP) for the 503A bulk drug substances list. It was the only one of seven peptides at that meeting not recommended. Committee members noted that the substance was nominated as a subcutaneous injection while the cited human studies used an intravenous route.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
Epitalon (epithalon)
As of July 24, 2026
Advisory committee recommended
On 24 July 2026 an FDA advisory committee voted 7 to 4 to recommend epitalon for the 503A bulk drug substances list, in both free base and acetate forms, for insomnia. It is a recommendation only; epitalon is not an FDA-approved drug.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
Advisory committee recommended
On 24 July 2026 an FDA advisory committee voted 8 to 5 to recommend Semax for the 503A bulk drug substances list, in both free base and acetate forms, for cerebral ischaemia, migraine and trigeminal neuralgia. It is a recommendation to the FDA, not an approval, and Semax is not an FDA-approved drug.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
Scheduled for review
These are listed separately because “scheduled for review” is a materially weaker statement than “reviewed”. No vote has been taken on any of them and no status has changed.
Cathelicidin LL-37
As of July 24, 2026
Scheduled for advisory review
Cathelicidin LL-37 is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken and no regulatory status has changed.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
Dihexa acetate
As of July 24, 2026
Scheduled for advisory review
Dihexa acetate is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken and no regulatory status has changed.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
GHK-Cu
As of July 24, 2026
Scheduled for advisory review
GHK-Cu is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken and no regulatory status has changed.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
Melanotan II
As of July 24, 2026
Scheduled for advisory review
Melanotan II is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken and no regulatory status has changed.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
PEG-MGF
As of July 24, 2026
Scheduled for advisory review
PEG-MGF is scheduled for review by the FDA Pharmacy Compounding Advisory Committee at a meeting to be held before the end of February 2027. No committee vote has been taken and no regulatory status has changed.
What this does and does not change
The Pharmacy Compounding Advisory Committee advises the FDA; it does not decide. Its recommendation is not binding, no substance has been added to the 503A bulk drug substances list, and none of these compounds is an FDA-approved drug. Adding a substance requires the FDA to accept the recommendation and then complete notice-and-comment rulemaking, a proposed rule followed by a public comment period followed by a final rule. The FDA has declined to follow a committee recommendation before. Its own review team recommended against all seven substances at this meeting.
About this page
Every claim carries the source it came from and the date it was true. Where a primary regulator document was not reachable, the specialist legal or trade reporting that quotes it is cited instead, and both are listed so a reader can tell which is which.
Klarovel is a protocol intelligence platform. It does not sell, supply or ship peptides, and nothing here is medical advice or a recommendation to use any compound. See disclosures.
