Peptimes

Track setmelanotide in Peptimes

Setmelanotide is a synthetic cyclic peptide of eight amino acids, an analog of alpha-melanocyte-stimulating hormone (α-MSH), and a melanocortin 4 (MC4) receptor agonist. It is the active ingredient in Imcivree, an FDA-approved prescription injection. (Source: DailyMed label.)

Is setmelanotide FDA-approved?

Yes, as a specific product: Imcivree (setmelanotide) injection is FDA-approved, by prescription, for the uses in its label.

Checked 25 Oct 2026. The sources are below.

Setmelanotide

Also: Imcivree, setmelanotide acetate, RM-493, BIM-22493

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Subcutaneous
Updated
25 Oct 2026

US regulatory status

FDA approval belongs to the product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Imcivree (setmelanotide) injection

    Subcutaneous

    The uses in its label.

    Source: DailyMed label, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists the product above as "Prescription".

    Source: Drugs@FDA, checked 25 Oct 2026

  • Investigational

    No, for the product and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add setmelanotide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the detail.

  • Logging: the amount you took and how you feel.
  • Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell setmelanotide or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 213793 (Imcivree), checked 25 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Setmelanotide, checked 25 Oct 2026: the code names RM-493 and BIM-22493.

Peptide tracker appInjection-site history in PeptimesWhat FDA status terms mean

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