Is MK-677 FDA-approved?

No. MK-677 (ibutamoren) is investigational and isn't FDA-approved: Drugs@FDA lists no application with it, and FDA puts ibutamoren mesylate on its Category 2 list for compounding.

Checked 1 Nov 2026. The sources are below.

MK-677

Also: ibutamoren, ibutamoren mesylate, MK-0677, L-163,191, LUM-201

Status label in the Peptimes Library
Compounding Restricted
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-Approved. Drugs@FDA lists no application with ibutamoren (MK-677) as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • FDA status

    On FDA's Category 2 list: FDA lists ibutamoren mesylate among bulk drug substances for compounding that may present significant safety risks, under its interim policies for pharmacies (503A, added 29 Sep 2023) and outsourcing facilities (503B, added 29 Dec 2022).

    Source: FDA, checked 1 Nov 2026

  • Investigational

    Yes.

    Source: ClinicalTrials.gov, checked 1 Nov 2026

How to track it in Peptimes

Add MK-677 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 “Compounding Restricted”, the app’s label for compounds on FDA’s Category 2 list. Category 2 is FDA’s list of bulk drug substances for compounding that may present significant safety risks; it is not an approval. Ibutamoren is also being studied in clinical trials as LUM-201; that isn’t an approval.

  • Logging: the amount you took and how you feel.
  • 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 MK-677 or any other compound.

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