Relamorelin

Also known as: RM-131

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 49 publications on PubMed
Registered clinical trials 13 0 active
Adverse event reports 1 1 classified as serious
  • Relamorelin is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 49 publications mentioning it, including 10 randomized controlled trials and 1 animal-only study.
  • ClinicalTrials.gov lists 13 registered studies testing it (0 active).
  • FDA's adverse event system (FAERS) holds 1 report mentioning it; 1 classified as serious. Reports do not prove causation.

Research topics

  • Gastroparesis 23
  • Gastric Emptying 16
  • Gastrointestinal Agents 14
  • Gastrointestinal Motility 12
  • Ghrelin 11
  • Constipation 10
  • Receptors, Ghrelin 8
  • Diabetes Complications 5
  • Diabetes Mellitus, Type 2 5
  • Drug Design 5

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 49
  • Human (MeSH) 38
  • Animal only 1
  • Clinical trials 10
  • Randomized controlled trials 10
  • Systematic reviews & meta-analyses 2
  • Case reports 0
  • Retracted 0

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
13
Active
0
With posted results
6

Conditions studied

  • Gastroparesis 8
  • Diabetes Mellitus 6
  • Diabetes Mellitus Complications 3
  • Gastric Motility 1
  • Chronic Constipation 1
  • Parkinson's Disease 1
  • Constipation 1
  • Anorexia Nervosa 1
  • Diabetes Mellitus Type 1 and 2 1
  • Gastrointestinal Motility Disorder 1
Study Status Phase Start
Diabetic Gastroparesis Study 05
NCT03786380 Allergan Results posted
Terminated Phase 3 December 20, 2018
Study to Evaluate the Safety and Efficacy of Relamorelin in Participants With Diabetic Gastroparesis Study 02
NCT03426345 Allergan Results posted
Terminated Phase 3 February 16, 2018
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 04
NCT03383146 Allergan Results posted
Terminated Phase 3 February 1, 2018
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis Study 03
NCT03420781 Allergan Results posted
Terminated Phase 3 January 24, 2018
A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01
NCT03285308 Allergan Results posted
Terminated Phase 3 September 29, 2017
Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers
NCT02466711 Motus Therapeutics, Inc.
Completed Phase 1 Jun 2015
Safety and Efficacy of Relamorelin Administered to Participants With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis
NCT02357420 Allergan Results posted
Completed Phase 2 January 29, 2015
Study to Evaluate the Effects of RM-131 in Patients With Chronic Constipation
NCT02137642 Motus Therapeutics, Inc.
Completed Phase 1 Aug 2014
A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic Constipation
NCT01955616 Motus Therapeutics, Inc.
Terminated Phase 2 Sep 2013
Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation
NCT01781104 Motus Therapeutics, Inc.
Completed Phase 2 Mar 2013
Show 3 more studies
Study Status Phase Start
Phase 2 Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa
NCT01642550 Motus Therapeutics, Inc.
Completed Phase 2 Nov 2012
Phase 2 Study to Evaluate Safety & Efficacy of RM-131 Administered to Patients With Diabetic Gastroparesis
NCT01571297 Motus Therapeutics, Inc.
Completed Phase 2 Apr 2012
Study to Assess Pharmacodynamics of RM-131 in Patients With Diabetic Gastroparesis
NCT01394055 Motus Therapeutics, Inc.
Completed Phase 1 Jul 2011

All 13 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
1
Serious
1
With death outcome
0

Most reported reactions

  • Abdominal pain 1
  • Alanine aminotransferase increased 1
  • Aspartate aminotransferase increased 1
  • Blood albumin decreased 1
  • Blood alkaline phosphatase increased 1
  • Blood urea decreased 1
  • Electrocardiogram abnormal 1
  • Gamma-glutamyltransferase increased 1
  • Globulins increased 1
  • Headache 1
  • Nausea 1
  • Pancreatitis 1

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.