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danuglipron

Discontinued; not currently marketed in the US, not authorised in the European Union.

GLP-1 (oral small molecule) agonist, oral, from Pfizer. Every figure below is taken directly from ClinicalTrials.gov, Drugs@FDA, the FDA Drug Shortage Database, the EMA register or Europe PMC, and re-checked every four hours.

Status
discontinued
Target
GLP-1 (oral small molecule)
Route
oral
Sponsor
Pfizer
First FDA approval
Not approved
EU authorisation
Not authorised
Active trials
0 (0 in phase 3)
Participants enrolled
0
Trials with a reporting date
0
Approved FDA submissions
0

Structure

2D chemical structure of danuglipron
Structure of danuglipron. Source: PubChem, National Library of Medicine.

Recent papers

PublishedTitleJournal
2026-10-06Danuglipron and orforglipron engage GLP-1R through materially different interfaces: an unbiased molecular dynamics study
Oztekin A, Turker S.
bioRxiv preprint
2026-09-20Efficacy and Safety of Oral Small-Molecule (Non-Peptide) GLP-1 Receptor Agonists in Type 2 Diabetes and Obesity: A Systematic Review of the Complete Orforglipron and Danuglipron Clinical Development Programs
Labate AM, Villari P, Cimino E, Giacomelli L, Oladeji OA, Agosti B.
Preprints.org preprint
2025-12-10The efficacy and safety of danuglipron and orforglipron in patients with type 2 diabetes and obesity: a systematic review and meta-analysis
Zhou J, Wang F, Li S.
Front Endocrinol (Lausanne)
2025-08-26"Next-in-class" GLP-1R Danuglipron- and Lotiglipron-like Agonists: A Patent Review (2020-2024)
Tolkacheva EV, Saliev AY, Salakhov TL, Balakin KV, Ivanov RA, Chernyshov VV.
Curr Med Chem
2025-08-22Comprehensive identification and characterization of in vitro and in vivo metabolites of the novel GLP-1 receptor agonist danuglipron using UHPLC-QToF-MS/MS
Jaiswal A, Biradar R, Deshmukh V, Deshpande R, Nandi S.
J Pharm Biomed Anal
2025-07-24Molecular docking of danuglipron uncovers potential crossovers between GLP-1R and the endocannabinoid system
Dailey KA, Schneider LN, Petreaca RC, Yoder RJ.
MicroPubl Biol
2025-06-20Efficacy and safety of danuglipron (PF-06882961) in adults with obesity: A randomized, placebo-controlled, dose-ranging phase 2b study
Buckeridge C, Cobain S, Bays HE, Matsuoka O, Fukushima Y, Halstead P, Tsamandouras N, Sherry N, Gorman DN, Saxena AR.
Diabetes Obes Metab
2025-03-01Danuglipron Ameliorates Pressure Overload-Induced Cardiac Remodelling Through the AMPK Pathway
Wang P, Guo Z, Kong CY, Ma YL, Wang MY, Zhang XR, Yang Z.
J Cell Mol Med
2023-11-07Evaluating Glycemic Control Efficacy and Safety of the Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron in Type 2 Diabetes Patients: A Systemic Review and Meta-Analysis
Fatima H, Rangwala HS, Mustafa MS, Shafique MA, Abbas SR, Rizwan A, Fadlalla Ahmed TK, Arshad A.
Diabetes Metab Syndr Obes
2023-11-02Effect of Renal Impairment on the Pharmacokinetics of a Single Oral Dose of Danuglipron in Participants With Type 2 Diabetes
Fediuk DJ, Gorman DN, Stoddard SA, Zhang Y, Ogden AG, Winton JA, Saxena AR.
J Clin Pharmacol
2023-10-16Safety and efficacy of the new, oral, small-molecule, GLP-1 receptor agonists orforglipron and danuglipron for the treatment of type 2 diabetes and obesity: systematic review and meta-analysis of randomized controlled trials
Karakasis P, Patoulias D, Pamporis K, Stachteas P, Bougioukas KI, Klisic A, Fragakis N, Rizzo M.
Metabolism
2023-06-13Tolerability, safety and pharmacodynamics of oral, small-molecule glucagon-like peptide-1 receptor agonist danuglipron for type 2 diabetes: A 12-week, randomized, placebo-controlled, Phase 2 study comparing different dose-escalation schemes
Saxena AR, Frias JP, Gorman DN, Lopez RN, Andrawis N, Tsamandouras N, Birnbaum MJ.
Diabetes Obes Metab
2023-05-01Efficacy and Safety of Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist Danuglipron for Glycemic Control Among Patients With Type 2 Diabetes: A Randomized Clinical Trial
Saxena AR, Frias JP, Brown LS, Gorman DN, Vasas S, Tsamandouras N, Birnbaum MJ.
JAMA Netw Open
2022-12-19A phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of danuglipron (PF-06882961), an oral small-molecule glucagon-like peptide-1 receptor agonist, in Japanese adults with type 2 diabetes mellitus
Ono R, Furihata K, Ichikawa Y, Nakazuru Y, Bergman A, Gorman DN, Saxena AR.
Diabetes Obes Metab
2021-06-14Danuglipron (PF-06882961) in type 2 diabetes: a randomized, placebo-controlled, multiple ascending-dose phase 1 trial
Saxena AR, Gorman DN, Esquejo RM, Bergman A, Chidsey K, Buckeridge C, Griffith DA, Kim AM.
Nat Med

Every danuglipron trial on file

All 3 registered trials of danuglipron, largest first. Each links to its own page and to the registry record.

TrialStatusPhaseParticipants
A Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Obesity
NCT04707313 · Pfizer
CompletedP2628
A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus
NCT03985293 · Pfizer
CompletedP2412
A 12-WEEK TITRATE STUDY TO EVALUATE SAFETY, TOLERABILITY AND PHARMACODYNAMICS OF PF-06882961 IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND IN NON-DIABETIC ADULTS WITH OBESITY
NCT04617275 · Pfizer
CompletedP2151

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