Growth hormone & IGF Not a peptide

Anamorelin

Also known as: ONO-7643 · Adlumiz

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 10 of 176 publications on PubMed
Registered clinical trials 14 2 active
Adverse event reports 207 204 classified as serious
  • Anamorelin is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 176 publications mentioning it, including 10 randomized controlled trials and 6 animal-only studies.
  • ClinicalTrials.gov lists 14 registered studies testing it (2 active).
  • FDA's adverse event system (FAERS) holds 207 reports mentioning it; 204 classified as serious. Reports do not prove causation.

Research topics

  • Cachexia 102
  • Hydrazines 87
  • Neoplasms 62
  • Anorexia 31
  • Carcinoma, Non-Small-Cell Lung 28
  • Quality of Life 28
  • Lung Neoplasms 27
  • Receptors, Ghrelin 26
  • Ghrelin 20
  • Appetite 17

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 176
  • Human (MeSH) 127
  • Animal only 6
  • Clinical trials 13
  • Randomized controlled trials 10
  • Systematic reviews & meta-analyses 11
  • Case reports 6
  • Retracted 1

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
14
Active
2
With posted results
9

Conditions studied

  • Cancer Cachexia 4
  • Cachexia 3
  • Non-Small Cell Lung Cancer 3
  • Cachexia; Cancer 2
  • Non Small Cell Lung Cancer 2
  • Anorexia 1
  • Lung Non-Small Cell Carcinoma 1
  • Stage III Lung Cancer AJCC v8 1
  • Stage IIIA Lung Cancer AJCC v8 1
  • Stage IIIB Lung Cancer AJCC v8 1
  • Stage IIIC Lung Cancer AJCC v8 1
  • Stage IV Lung Cancer AJCC v8 1
Study Status Phase Start
Anamorelin Hydrochloride in Reducing Anorexia in Patients With Advanced Non-small Cell Lung Cancer
NCT03637816 M.D. Anderson Cancer Center
Active, not recruiting Phase 2, Phase 3 November 27, 2018
Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors
NCT03035409 M.D. Anderson Cancer Center Results posted
Active, not recruiting Phase 2 February 8, 2017
Anamorelin Study for Advanced Pancreatic Cancer
NCT04844970 Lahey Clinic Results posted
Terminated Phase 2 April 1, 2023
Effect of a Ghrelin Receptor Agonist on Muscle and Bone
NCT04021706 Tufts University Results posted
Completed Phase 1 December 5, 2019
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 2
NCT03743064 Helsinn Healthcare SA Results posted
Completed Phase 3 May 6, 2019
A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) - 1
NCT03743051 Helsinn Healthcare SA Results posted
Completed Phase 3 March 5, 2019
The Role of Ghrelin in Cancer Cachexia
NCT01505764 VA Office of Research and Development Results posted
Terminated Phase 2 Jun 2012
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 2)
NCT01387282 Helsinn Therapeutics (U.S.), Inc Results posted
Completed Phase 3 Jul 2011
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
NCT01387269 Helsinn Therapeutics (U.S.), Inc Results posted
Completed Phase 3 Jul 2011
Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): An Extension Study (ROMANA 3)
NCT01395914 Helsinn Therapeutics (U.S.), Inc Results posted
Completed Phase 3 Jul 2011
Show 4 more studies
Study Status Phase Start
Dose Range Study of Anamorelin in Patients With Non-small Cell Lung Cancer
NCT00622193 Helsinn Therapeutics (U.S.), Inc
Completed Phase 2 Mar 2008
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
NCT00378131 Helsinn Therapeutics (U.S.), Inc
Completed Phase 2 Sep 2006
Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia.
NCT00267358 Helsinn Therapeutics (U.S.), Inc
Completed Phase 2 Nov 2005
Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss
NCT00219817 Helsinn Therapeutics (U.S.), Inc
Completed Phase 2 Jun 2005

All 14 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
207
Serious
204
With death outcome
69

Most reported reactions

  • Malignant neoplasm progression 36
  • Decreased appetite 28
  • Interstitial lung disease 19
  • Nausea 16
  • Pyrexia 14
  • Diarrhoea 12
  • Non-small cell lung cancer 12
  • Oedema peripheral 12
  • Anaemia 10
  • Hepatic function abnormal 9
  • Platelet count decreased 9
  • Cytokine release syndrome 8

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.