Is anamorelin FDA-approved?

Not in the US. Drugs@FDA lists no application with anamorelin as an active ingredient. Japan has approved Adlumiz tablets, but that doesn't apply in the US.

Checked 1 Nov 2026. The sources are below.

Anamorelin

Also: Adlumiz, anamorelin hydrochloride, ONO-7643, RC-1291, ST-1291

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved in the US. Drugs@FDA lists no application with anamorelin as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In humans

    A 1-year randomized, placebo-controlled pilot trial in 26 adults aged 50 and older with osteosarcopenia found no significant change in muscle mass or lean body mass. Knee flexion strength and a marker of bone formation rose; bone density did not change.

    Source: PMID 38057159, checked 1 Nov 2026

How to track it in Peptimes

Add anamorelin 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 “Approved outside the US”. In the US it is not FDA-approved. Ono Pharmaceutical reports that it received manufacturing and marketing approval in Japan for Adlumiz (anamorelin hydrochloride) tablets in January 2021. That approval doesn’t apply in the US, and other anamorelin products don’t share it.

  • 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 anamorelin or any other compound.

More sources

  • Ono Pharmaceutical, press release, 22 Jan 2021, checked 1 Nov 2026: manufacturing and marketing approval of Adlumiz (anamorelin hydrochloride) tablets in Japan (company-reported).
  • FDA, Drugs@FDA, searched 1 Nov 2026: no application lists anamorelin as an active ingredient.
  • FDA, Global Substance Registration System, Anamorelin, checked 1 Nov 2026: the hydrochloride salt and the codes ONO-7643, RC-1291 and ST-1291.

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