Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Danuglipron (PF-06882961): what the evidence says

Name: Danuglipron (PF-06882961)
Published: 2026-10-27

At a glance

What it is: an oral small-molecule GLP-1 receptor agonist from Pfizer. Not a peptide; it is listed here because it is sold beside peptide GLP-1 drugs. ^R1

What the evidence says: twice-daily danuglipron lowered HbA1c and weight in phase 2b trials (411 people with type 2 diabetes; 628 with obesity). ^{R2, R3} In the obesity trial only 39% finished treatment; about 38% stopped because of side effects. ^R3 Pfizer ended all development on Apr 14, 2025 after a possible drug-induced liver injury in one participant. ^R4

Biggest risks: nausea and vomiting, high dropout, and a liver-injury case that resolved after stopping. ^{R3, R4}

Rating


Human Human evidence	Moderate for HbA1c and weight loss vs placebo (phase 2b RCTs) ^{R2, R3} · tolerability poor ^R3
Animal Animal / lab evidence	Discovery chemistry and humanized-mouse work ^R1
Regulatory	Never approved; development discontinued · not on the 503A/503B lists or FDA's safety-risk page · not named on WADA's 2026 list ^{R4, R5, R6, R7, R8}
Established human dose	None. Study details lists what trials used

Evidence verdict: Blood sugar and weight loss (twice-daily pill): Moderate (phase 2 RCTs) but poorly tolerated · Development stopped Apr 2025 · Not a peptide

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: all trials were Pfizer-sponsored. Phase 2b obesity results were published after the program ended. ^{R3, R4}

What is it?

A non-peptide pill that activates the GLP-1 receptor like injectable semaglutide. ^R1 Related pages: Orforglipron, Semaglutide, Liraglutide.

Does it work?

Human Type 2 diabetes, phase 1 (Saxena 2021): 98 people over 28 days; generally tolerated. ^R9
Human Type 2 diabetes, phase 2b (Saxena 2023): HbA1c down up to 1.16 points vs placebo at 16 weeks; weight down 2.0 to 4.2 kg vs placebo at the two highest doses only. ^{R2, R10}
Human Obesity, phase 2b (Buckeridge 2025): placebo-adjusted weight loss 5.0% to 12.9% at 26 or 32 weeks. ^{R3, R11}
Human Meta-analysis: consistent glucose and weight effects with more GI side effects. ^R12

Is it safe?

Human Nausea, vomiting and diarrhea, more at higher doses; ~38% stopped for side effects in the obesity trial (placebo dropout was also high). ^R3
Human Heart rate rose slightly. ^R9
Human Liver: one asymptomatic participant in a once-daily dose-optimization study had possible drug-induced liver injury that resolved. ^R4

Gray-market "danuglipron": extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe. A discontinued drug has no ongoing safety monitoring.

Pipeline (sponsor, trials, expected readouts)

Sponsor: Pfizer. Twice-daily development ended Dec 2023; all development ended Apr 14, 2025. No readouts expected. ^R4

Is it legal?

US (FDA): never approved; no prescription source. Not on the compounding lists. ^{R5, R6}
Athletes: not named on WADA's 2026 list. UNVERIFIED S0 applicability. ^R8

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
Saxena 2021 (phase 1)	98 adults with T2D on metformin	Oral	Multiple ascending doses, 8 cohorts	28 days	Tolerated; GI effects	PMID 34127852
Saxena 2023 (phase 2b)	411 adults with T2D	Oral, twice daily with food	2.5, 10, 40, 80 or 120 mg	16 weeks	HbA1c up to −1.16 vs placebo	PMID 37213102
Buckeridge 2025 (phase 2b)	628 adults (626 treated) with obesity	Oral, twice daily	Escalated to 40-200 mg	26 or 32 weeks	−5.0% to −12.9% vs placebo	PMID 40539310

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Griffith DA, et al. J Med Chem. 2022. PMID 35647711
^R2 Saxena AR, et al. JAMA Netw Open. 2023. PMID 37213102
^R3 Buckeridge C, et al. Diabetes Obes Metab. 2025. PMID 40539310
^R4 Pfizer, Pfizer Provides Update on Oral GLP-1 Receptor Agonist Danuglipron, Apr 14, 2025. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-provides-update-oral-glp-1-receptor-agonist
^R5 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R6 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R7 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R8 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R9 Saxena AR, et al. Nat Med. 2021. PMID 34127852
^R10 ClinicalTrials.gov NCT03985293, Pfizer, danuglipron in type 2 diabetes, phase 2b (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT03985293
^R11 ClinicalTrials.gov NCT04707313, Pfizer, danuglipron in obesity, phase 2b (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT04707313
^R12 Zhou J, et al. Front Endocrinol (Lausanne). 2025. PMID 41450584

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Danuglipron (PF-06882961). It was never approved and is no longer being developed. Talk to a clinician you trust about approved options, especially if you have liver disease or diabetes. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).