At a glance
- Efinopegdutide is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 12 publications mentioning it, including 3 randomized controlled trials and 0 animal-only studies.
- ClinicalTrials.gov lists 15 registered studies testing it (0 active).
- FDA’s adverse event system (FAERS) has no reports mentioning it.
Research topics
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
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
- Efficacy and Safety of Dual GLP-1/Glucagon Receptor Agonism in Overweight and Obesity: A Class-Specific Systematic Review and Meta-Analysis.
- Future GLP-1 receptor co-agonists and their cardiac effects.
- Efficacy and Safety of Glucagon-like Peptide-1 Receptor Agonists and Co-agonists for Weight Loss Among Adults Without Diabetes : An Updated Systematic Review.
- Evolution of incretin-based therapies: From GLP-1 monotherapy to dual and triple agonists: A new era in metabolic therapy.
- Comparative efficacy of pharmacologic therapies for MASH in reducing liver fat content: Systematic review and network meta-analysis.
- Efficacy of GLP-1-based Therapies on Metabolic Dysfunction-associated Steatotic Liver Disease and Metabolic Dysfunction-associated Steatohepatitis: A Systematic Review and Meta-analysis.
- Comparative Efficacy of Semaglutide Versus Liraglutide or Efinopegdutide on Weight Loss in Obese Patients: A Systematic Review and Meta-Analysis.
- Peptide Polyagonists for the Treatment of Nonalcoholic Fatty Liver Disease.
- A phase IIa active-comparator-controlled study to evaluate the efficacy and safety of efinopegdutide in patients with non-alcoholic fatty liver disease.
- Emerging glucagon-like peptide 1 receptor agonists for the treatment of obesity.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 15
- Active
- 0
- With posted results
- 5
Conditions studied
Show 5 more studies
| Study | Status | Phase | Start |
|---|---|---|---|
| A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus | Completed | Phase 2 | June 26, 2018 |
| A Study to Evaluate JNJ-64565111 Pharmacokinetics and Safety in Adult Participants With Varying Degrees of Renal Function | Completed | Phase 1 | June 6, 2018 |
| A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants | Completed | Phase 2 | March 26, 2018 |
| A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus | Completed | Phase 1 | August 1, 2017 |
| Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Type 2 Diabetes Mellitus (T2DM) | Terminated | Phase 1 | July 12, 2016 |
All 15 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
No FAERS reports mention this peptide.
Change history
No changes since monitoring began on October 30, 2026.