Anamorelin
Anamorelin increased lean body mass in two phase 3 trials. The gain was seen in both trials. Handgrip strength did not improve (PMID 26906526; claims checked 24 August 2026). The strength test did not show the same gain. Both facts matter. This page keeps the gain and the failed strength test side by side. That split is clear in the trial data. Helsinn Therapeutics funded the trials. Japan approved Adlumiz for cancer cachexia. EMA refused EU marketing authorisation.
What kind of compound is anamorelin?
Anamorelin is a drug taken by mouth. It acts at the ghrelin receptor. The US FDA/NCATS GSRS lists it as a chemical. These fields were checked on 24 August 2026.
What did the phase 3 trials measure?
ROMANA 1 enrolled 484 people. ROMANA 2 enrolled 495 people. Both trials compared anamorelin with placebo for 12 weeks (PMID 26906526; claims checked 24 August 2026).
| Trial | Median lean-body-mass change with anamorelin | Placebo | Funder |
|---|---|---|---|
| ROMANA 1 | +0.99 kg (95% CI 0.61 to 1.36) | -0.47 kg (95% CI -1.00 to 0.21) | Helsinn Therapeutics |
| ROMANA 2 | +0.65 kg (95% CI 0.38 to 0.91) | -0.98 kg (95% CI -1.49 to -0.41) | Helsinn Therapeutics |
Handgrip strength did not differ between groups in either trial. Grade 3-4 treatment-related adverse events did not differ between groups. Hyperglycaemia was the most common event in that grade range (PMID 26906526; claims checked 24 August 2026).
Where is Adlumiz approved?
Japan's PMDA approved Adlumiz for cancer cachexia (PMDA review report; claim checked 24 August 2026). The approval is for anamorelin hydrochloride. This Japanese approval supports the register's tier-A field.
What is the EU status?
EMA confirmed refusal of Adlumiz on 14 September 2017 (EMEA/H/C/003847; claim checked 24 August 2026).
| EMA finding | EMA record |
|---|---|
| Lean body mass | Effect judged marginal |
| Handgrip and quality of life | Benefit not proven |
| Safety evidence | Recorded data did not support a full risk review |
These were the reasons in the EMA record. They do not erase the trial result or Japan's approval. Japan and the EU reached different decisions. One does not change the other. That is why both stay on this page.
What does evidence tier A mean here?
The tier reflects approval in Japan and phase 3 data. It does not mean EU approval. Status and trial evidence stay separate.
When was anamorelin first recorded?
The sources on this page give no first-observed month (checked 24 August 2026). The field stays empty instead of using a guess.
What other names and identifiers belong to anamorelin?
Adlumiz is the product name used by PMDA and EMA.
| GSRS field | Value |
|---|---|
| Development codes | ONO-7643, RC-1291, ST-1291 |
| UNII | DD5RBA1NKF |
| CAS | 249921-19-5 |
The GSRS fields were checked on 24 August 2026. The IDs let a reader match a source to this drug. A short sales name can hide that link.
What does this register entry cover?
This entry keeps trial results, Japan approval, EU refusal, and vial evidence apart. It has no test result for a specific vial. A vial can only be checked with evidence about that vial.