Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Anamorelin (ONO-7643): what the evidence says

Name: Anamorelin (ONO-7643)
Published: 2026-10-27

At a glance

What it is: an oral, non-peptide ghrelin-receptor agonist (growth hormone secretagogue) that raises appetite, GH and IGF-1. Developed by Helsinn and Ono. ^R1

What the evidence says: in two phase 3 RCTs (ROMANA 1 and 2, 979 people with lung cancer cachexia), lean mass rose (+0.99 and +0.65 kg) while placebo groups lost lean mass over 12 weeks, but handgrip strength did not improve. ^R2 Approved in Japan (Dec 2020) for cachexia in four cancers; refused in the EU (2017); not FDA-approved. ^{R1, R3}

Biggest risks: high blood sugar is the main concern; also nausea, liver and heart-conduction effects tracked in Japan. ^R4

Rating


Human Human evidence	Moderate for weight and lean mass in cancer cachexia ^{R2, R5} · Moderate, negative for handgrip strength ^{R2, R6} · No human data for bodybuilding
Animal Animal / lab evidence	Not reviewed for this page
Regulatory	Not FDA-approved · approved in Japan · EU refusal 2017 · not on the 503A/503B lists or FDA's safety-risk page · WADA 2026: named under S2.2.4, prohibited at all times ^{R1, R3, R7, R8, R9, R10}
Established human dose	Only per Japanese labeling (not reviewed). Study details lists what trials used

Evidence verdict: Body weight and lean mass in cancer cachexia: Moderate (phase 3 RCTs) · Strength (handgrip): no benefit · Muscle gain in healthy people: No human data · Not a peptide

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: the ROMANA trials were sponsored by Helsinn. EMA judged the lean-mass effect marginal and found safety data inadequately recorded at inspected sites. ^{R2, R3}

What is it?

Ghrelin is a stomach hormone that triggers hunger and GH release. Anamorelin mimics it as a pill. Related pages: Ipamorelin, MK-677, Macimorelin.

Does it work?

Human ROMANA 1 and 2 (Temel 2016): lean mass +0.99 kg and +0.65 kg with anamorelin vs losses on placebo; handgrip strength not improved. ^{R2, R11, R12}
Human ROMANA 3 extension: weight gains held to 24 weeks; handgrip still no better. ^R6
Human Later Helsinn phase 3 trials (2022-2023): body weight rose more than placebo (+1.9 vs +0.6 kg; +1.8 vs +0.5 kg), but the anorexia symptom score did not differ significantly. ^{R13, R14}
Human Meta-analysis (7 RCTs, 1,944 people): weight +1.73 kg, lean +1.06 kg, small QOL gain; no change in survival or grip. ^R5
Human Japan: approved for NSCLC, gastric, pancreatic and colorectal cancer cachexia. ^R1

Is it safe?

Human ROMANA 3: adverse events similar to placebo (52.2% vs 55.7%); no deaths judged drug-related. ^R2
Human Japan surveillance (6,016 patients): treatment-related hyperglycemia 3.9% and nausea 2.6%; hyperglycemia-, liver- and conduction-related events 4.8%, 1.2% and 1.1%. ^R4

Gray-market "anamorelin": extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Pipeline (sponsor, trials, expected readouts)

Sponsors: Helsinn (outside Japan), Ono (Japan). ^R1
NCT03743051 / NCT03743064: completed 2022-2023 with results posted on CT.gov; UNVERIFIED no US submission found. ^{R13, R14}
NCT03637816: M.D. Anderson phase 2/3 for anorexia in NSCLC; primary completion Dec 2026. ^R15

Is it legal?

US (FDA): not approved. Not on the compounding lists. ^{R7, R8}
EU: refused (Adlumiz), Nov 2017. ^R3
Japan: approved Dec 2020. UNVERIFIED Japanese brand name; not confirmed against a PMDA source. ^R1
Athletes: WADA 2026 names anamorelin under S2.2.4. ^R10

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
ROMANA 1 and 2	979 adults, NSCLC cachexia	Oral, once daily	100 mg	12 weeks	Lean +; grip not	PMID 26906526
ROMANA 3	513 who finished ROMANA 1/2	Oral, once daily	100 mg	+12 weeks	Weight held; grip not	PMID 28472437

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Wakabayashi H, et al. J Cachexia Sarcopenia Muscle. 2021. PMID 33382205
^R2 Temel JS, et al. Lancet Oncol. 2016. PMID 26906526
^R3 European Medicines Agency, Adlumiz (anamorelin): refusal of marketing authorisation, Nov 16, 2017. https://www.ema.europa.eu/en/medicines/human/EPAR/adlumiz
^R4 Takayama K, et al. Cancer Med. 2024. PMID 38693813
^R5 Taniguchi J, et al. Sci Rep. 2023. PMID 37709824
^R6 Currow D, et al. Ann Oncol. 2017. PMID 28472437
^R7 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R8 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R9 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R10 WADA. The 2026 Prohibited List, S2.2.4. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R11 ClinicalTrials.gov NCT01387269, Helsinn, ROMANA 1, phase 3, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT01387269
^R12 ClinicalTrials.gov NCT01387282, Helsinn, ROMANA 2, phase 3, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT01387282
^R13 ClinicalTrials.gov NCT03743051, Helsinn, phase 3, malignancy-associated weight loss and anorexia in NSCLC, completed Feb 2023, results posted, n = 318 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT03743051
^R14 ClinicalTrials.gov NCT03743064, Helsinn, phase 3, malignancy-associated weight loss and anorexia in NSCLC, completed Dec 2022, results posted, n = 318 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT03743064
^R15 ClinicalTrials.gov NCT03637816, M.D. Anderson, anamorelin for anorexia in NSCLC, phase 2/3, active not recruiting, primary completion Dec 2026 (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT03637816

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Anamorelin (ONO-7643). Talk to your oncology team, especially if you have diabetes, liver disease, a heart rhythm problem, or are a tested athlete. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).