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Cyclic octapeptide melanocortin-4 (MC4) receptor agonist

Setmelanotide — evidence

What has been published, classified by the kind of document it is. This is not a protocol, not a score, and not a recommendation for use.

Evidence overview

No evidence records in this file yet.

What we know

    Editorial reading of the records below, labelled as Therapept analysis. How records are built

    What remains uncertain

      Regulatory notes

      FDA-approved drug substance

      • IMCIVREE (setmelanotide acetate), NDA 213793, approved 25 November 2020 as a new molecular entity under priority review.
      • The label effective 1 April 2026 includes acquired hypothalamic obesity alongside the genetic indications.
      • Not named on the WADA 2026 Prohibited List.

      Regulatory status describes how a substance is classified. It is not a safety assessment of any particular material.

      No records in this file match the current filter. That is an empty result, not a finding about the compound.

      Last reviewed 15 September 2026 · Compiled by Therapept Editorial · How these records are built