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FDA tracker

MK-677: FDA regulatory status

Research use onlyUpdated Apr 23, 2026

See tracker for current status.

Editorially reviewedThe Peptide Examiner editorial team, Editorial review · Reviewed Apr 23, 2026

Regulatory timeline

  1. Feb 27, 2026 · Reclassification

    HHS proposes removal from Category 2

    HHS Secretary RFK Jr. announced proposed removal of 14 peptides from Category 2. Final FDA determination pending PCAC review (July 2026 hearing).

  2. Sep 7, 2023 · Reclassification

    FDA places on Category 2 list

    Listed among 19 peptide bulk substances potentially raising significant safety risks for compounding. Prohibits compounding under Section 503A or 503B pending review.

What this means for patients

MK-677 is not FDA approved for human use. As of April 2026, it is on the FDA's Category 2 list, preventing US compounding pharmacies from legally preparing it. Research-peptide vendors selling it 'for research use only' face continuing FDA enforcement risk.