Anamorelin

Fat LossInvestigational oral ghrelin receptor agonistEmerging

Anamorelin is an investigational oral ghrelin receptor agonist in the Growth Hormone Secretagogue class. Anamorelin is a non-peptide agonist at growth hormone secretagogue receptor 1a. Beyond stimulating growth hormone and IGF-1, ghrelin receptor activation in hypothalamic circuits increases appetite and food intake, which is the basis for its development in cachexia.

Calculate Dose

For research use only.

Key Facts

CAS: 249921-19-5
Molecular Weight (MW): 546.7 g/mol
Half-life: —
FDA status: Investigational New Drug (IND)
Evidence level: Clinical Trial Evidence
Human dose established: Yes
Administration Route: Oral
Frequency: Once daily
Last updated: Nov 7, 2026
Reviewed: Nov 7, 2026

Research summary

Orally active ghrelin receptor agonist developed for cancer cachexia and approved for that use in Japan. It has not been approved by the FDA, which cited insufficient evidence of functional benefit.

Research evidence

Regulatory review (FDA label)None in reviewed sources
Controlled human trials1 reviewed source
Early or uncontrolled human studiesOnly in 1 review or summary
Lab & animal studiesNone in reviewed sources

How it works

Each step shows whether the sources Peptide Library has reviewed include that kind of research. Counts are reviewed sources, not every study ever published. Reviews and programme summaries that describe human use are shown as "reported", not as trials, and registered trials without published results are listed but not counted. A higher step means research has progressed further; it does not mean a compound works better or is safer. Compounds whose evidence has not been reviewed yet show "Not reviewed" instead of a guess.

Peptide Library's Anamorelin profile summarises 5 cited studies listed in the Science section, the compound's regulatory status, and research-protocol parameters reported for it. It is a research reference, not medical advice.

Anamorelin dosage evidence

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.

Clinical Trial Evidence

Dosage evidence summary for Anamorelin
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.

Research-reported dosing for Anamorelin, one row per studied regimen
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.

Anamorelin dosage in published studies and labels →

Sequence & molecular data

Sequence and molecular data for Anamorelin
Molecular formula	C31H42N6O3
Molecular weight	546.7 g/mol
CAS number	249921-19-5
PubChem CID	9828911
FDA UNII	DD5RBA1NKF
ChEMBL	CHEMBL2110579
DrugBank	DB06645

Identifiers link to the public PubChem, FDA Substance Registration (UNII), ChEMBL and DrugBank records for the same entity.

Science

Mechanism of Action

Anamorelin is a non-peptide agonist at growth hormone secretagogue receptor 1a. Beyond stimulating growth hormone and IGF-1, ghrelin receptor activation in hypothalamic circuits increases appetite and food intake, which is the basis for its development in cachexia. Trials consistently showed gains in lean body mass and weight, but improvements in handgrip strength and other functional measures were not demonstrated.

Studies

Research statistics

148 PubMed publications · 46.6% human clinical research · 14 registered trials

Counts of published research through 2026-11-01, not evidence that it works. Publications by year, study types and trials · How publications are counted

Regulatory & research status

Anamorelin has been studied under an Investigational New Drug application. It is not approved for marketing.

Regulatory and research status for Anamorelin
FDA status	Investigational New Drug (IND)
Research status	Investigational; clinical development reported
Availability	Research-Only
WADA (sport)	Unknown / Not Listed
Library classification	Clinical Trial

How FDA approval, compounding and research-only status differ

Benefits

—

Anamorelin side effects

No side effects listed yet for this entry.

Storage & stability

This compound is not supplied as a powder to be mixed, so the freeze-dried powder and reconstitution handling described for research peptides does not apply. Storage conditions are product-specific: follow the label or packaging of the product itself.

Anamorelin: frequently asked questions

What is Anamorelin?

Orally active ghrelin receptor agonist developed for cancer cachexia and approved for that use in Japan. It has not been approved by the FDA, which cited insufficient evidence of functional benefit.

How does Anamorelin work?

Is Anamorelin FDA approved?

No. Anamorelin is investigational: it is in clinical development and has not been approved by the FDA for any indication. Investigational status means trials are ongoing or complete but regulatory review has not resulted in approval, and efficacy and safety are still being established.

What peptides are similar to Anamorelin?

Compounds most often compared with Anamorelin include MK-677, Macimorelin, Tabimorelin and Relamorelin. They are grouped by shared mechanism or research area rather than by equivalence, and their regulatory status and evidence base differ.

References

Related research, comparisons & guides

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Compiled by Peptide Library Editorial · Reviewed Aug 30, 2026 · Updated Nov 7, 2026 · Version 2

This Anamorelin profile is compiled from published literature (5 cited studies linked above), public regulatory records and chemical registries. It describes what research reports; it is not medical advice, and nothing here is a dosing recommendation for humans. Peptide Library does not sell peptides. Editorial policy · How profiles are compiled · Report an error

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