§ 01 Overview
Overview
Oral ghrelin-receptor agonist approved in Japan (2021) for cancer cachexia. Phase III ROMANA-1 and ROMANA-2 met weight gain endpoints but failed functional-improvement endpoints in the US/EU.
ROMANA-1 and ROMANA-2 (Phase III, ~900 NSCLC patients) met weight and lean-mass endpoints but missed co-primary functional endpoint; FDA rejected. Approved in Japan January 2021.
§ 02 Mechanism
Mechanism of action
Anamorelin activates GHS-R1a to increase appetite and stimulate GH/IGF-1 release. Downstream effects include improved lean body mass and appetite in cancer cachexia populations.
- 01Oral daily dosing
- 02Approved in Japan for NSCLC / pancreatic / gastric / colorectal cachexia
- 03Lean-mass gain demonstrated in Phase III
§ 03 Dosing
Dosing protocol
Standard Protocol
- Dose Range
- 100 mg daily
- Route
- Oral
- Timing
- Once daily, 1 hour before breakfast
- Frequency
- Daily
- Cycle
- Continuous during cachexia treatment window
§ 04 Evidence
Evidence & research
ROMANA-1 and ROMANA-2 (Phase III, ~900 NSCLC patients) met weight and lean-mass endpoints but missed co-primary functional endpoint; FDA rejected. Approved in Japan January 2021.
FDA Status
Not FDA-approved (complete response letter 2017). Approved in Japan (Adlumiz, 2021).
§ 06 News
In the news
1 article from the last 12 months · updates hourly
NSCLC with cachexia: Anamorelin with first-line chemoimmunotherapy did not prolong PFS - Vera Health
NSCLC with cachexia: Anamorelin with first-line chemoimmunotherapy did not prolong PFS Vera Health
§ 07 Sourcing
Sourcing & supply
Regulatory status
Authentic supply from international sources
Authentic product originates from specific international manufacturers, most commonly Russian pharmaceutical facilities for Khavinson bioregulators. RUO vendors selling the same name are typically Chinese-synthesized research vials, not the original product.
No suppliers in our directory currently stock this compound. For investigational or research-only compounds, legitimate channels may not exist outside clinical trials.
Browse full supplier directory§ 09 Safety
Safety & side effects
Side effects
- 01Hyperglycemia
- 02Elevated A1C
- 03Mild ECG changes
Contraindications
- 01CYP3A4 inhibitor co-administration
- 02QTc prolongation
§ 10 Questions
Anamorelin FAQ
- What is Anamorelin?
- Oral ghrelin-receptor agonist approved in Japan (2021) for cancer cachexia. Phase III ROMANA-1 and ROMANA-2 met weight gain endpoints but failed functional-improvement endpoints in the US/EU. Anamorelin activates GHS-R1a to increase appetite and stimulate GH/IGF-1 release. Downstream effects include improved lean body mass and appetite in cancer cachexia populations.
- What is Anamorelin used for?
- Reported uses include oral daily dosing, approved in japan for nsclc / pancreatic / gastric / colorectal cachexia, and lean-mass gain demonstrated in phase iii. Evidence strength is rated Clinical — see the evidence section for detail.
- How is Anamorelin dosed?
- Commonly referenced dosing is 100 mg daily, administered Oral. This is educational reference only; consult a licensed clinician before use.
- What are the side effects of Anamorelin?
- Commonly reported side effects include hyperglycemia, elevated a1c, and mild ecg changes. This list is not exhaustive.
- Is Anamorelin legal?
- Authentic product originates from specific international manufacturers, most commonly Russian pharmaceutical facilities for Khavinson bioregulators. RUO vendors selling the same name are typically Chinese-synthesized research vials, not the original product. FDA status: Not FDA-approved (complete response letter 2017). Approved in Japan (Adlumiz, 2021)..
§ 11 References
Selected references
- 01
Temel — ROMANA-1/2
Lancet Oncol 2016, PMID: 26936027