Peptide LibraryAnamorelin dosage in published studies and labels
These are the doses used for Anamorelin in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Anamorelin has no FDA-approved dosage; there is no anamorelin label on DailyMed. Human dosing comes from the ROMANA 1 and ROMANA 2 phase 3 trials, which gave 100 mg by mouth once daily for 12 weeks to people with advanced non-small-cell lung cancer and cachexia: lean body mass rose compared with placebo, but handgrip strength, the other co-primary endpoint, did not improve.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 100 mg once daily by mouth in phase 3 trials |
| Route | Oral |
| Frequency | Once daily |
| Duration studied | 12 weeks in the phase 3 trials |
| Evidence level | Clinical Trial Evidence |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| ROMANA 1 and ROMANA 2 — phase 3, Lancet Oncology 2016 (NCT01387269, NCT01387282)Clinical trial · Two randomised, double-blind, placebo-controlled phase 3 trials | Adults with inoperable stage III or IV non-small-cell lung cancer and cachexia (484 and 495 enrolled, randomised 2:1) | 100 mg, or placebo | Oral | Once daily | 12 weeks | Median lean body mass change +0.99 kg versus -0.47 kg (ROMANA 1) and +0.65 kg versus -0.98 kg (ROMANA 2); no difference in handgrip strength in either trial | Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016. |
| European Medicines Agency — Adlumiz application refused (2017)Research-reported · Regulatory assessment summary (refusal) | Proposed use: anorexia, cachexia or unintended weight loss in people with non-small-cell lung cancer | 100 mg tablets taken by mouth (proposed product) | Oral | Not stated on the EMA summary page | Not stated on the EMA summary page | The CHMP found a marginal effect on lean body mass, no proven effect on handgrip strength or quality of life, and inadequately recorded safety data, and recommended refusal; the refusal was confirmed on re-examination in September 2017 | Adlumiz (anamorelin) — refusal of marketing authorisation, European Medicines Agency |
Where sources disagree
- Anamorelin is a ghrelin receptor agonist taken by mouth, not an injection. Its trial dose is a fixed 100 mg tablet.
- The FDA has not approved anamorelin, and the European Medicines Agency refused its marketing authorisation in 2017.