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Danuglipron Phase 3 Watch After Pfizer’s Phase 2b Obesity Win

Michael Rodriguez Managing Editor
Reviewed by James Park Regulatory Affairs Editor
danuglipron drug — Danuglipron Phase 3 Watch After Pfizer’s Phase 2b Obesity Win
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Decision brief

Answer first · skim in under a minute

Pfizer said its oral GLP-1 danuglipron met the primary endpoint in a Phase 2b obesity trial, showing a statistically significant change in body weight from baseline. The result strengthens the case for Pfizer's oral GLP-1 strategy and sets up investor and BD scrutiny around Phase 3 design, safety, and differentiation.

Danuglipron Phase 3 will not happen. Pfizer stopped the oral GLP-1 program in April 2025 after Phase 2b obesity data, once-daily formulation work, and a potential drug-induced liver injury case that resolved when dosing stopped.

Contents10 sections

Key Takeaways

  • Pfizer discontinued danuglipron (PF-06882961) for chronic weight management in April 2025.
  • Phase 2b NCT04707313 showed placebo-adjusted weight loss of about −8% to −13% at 32 weeks.
  • Twice-daily dosing had GI adverse-event rates up to 73% nausea and discontinuation over 50%.
  • Once-daily studies NCT06567327 and NCT06568731 met PK goals before the program ended.

Did Danuglipron Phase 3 ever start?

No pivotal Phase 3 start followed the 2023 Phase 2b readout. Pfizer said twice-daily danuglipron would not advance into Phase 3 because of high discontinuation.

Later once-daily dose-optimization work was framed as a possible Phase 3 path. That path closed when Pfizer discontinued the molecule. See the Business Wire discontinuation update.

What did Phase 2b show in obesity?

Pfizer’s Dec. 1, 2023 topline release covered a Phase 2b trial in adults with obesity without type 2 diabetes (NCT04707313). The study met its primary endpoint for body-weight change from baseline.

Placebo-adjusted mean weight reductions ranged from about −8% to −13% at 32 weeks and −5% to −9.5% at 26 weeks, depending on dose and titration. Details are in the Business Wire Phase 2b topline.

  • Nausea up to 73%
  • Vomiting up to 47%
  • Diarrhea up to 25%
  • Discontinuation >50% on drug vs ~40% placebo

Why did once-daily work still end?

Pfizer said once-daily studies NCT06567327 and NCT06568731 met key pharmacokinetic goals. The company also said a formulation and dose looked competitive enough, on paper, for Phase 3 testing.

Across more than 1,400 participants, liver-enzyme elevations were described as in line with approved GLP-1 agents. One asymptomatic participant still had potential drug-induced liver injury that resolved after stopping danuglipron. After that review plus regulator input, Pfizer ended development. The same facts appear on Pfizer’s press release page.

Trial records to keep on file

ClinicalTrials.gov still lists the Phase 2b obesity study as the efficacy anchor for the twice-daily program. Dose-optimization identifiers NCT06567327 and NCT06568731 document the once-daily pivot.

Those records do not change the commercial fact: there is no active Danuglipron Phase 3 plan from Pfizer. Confirm NCT04707313 on ClinicalTrials.gov NCT04707313.

What Pfizer said it will pursue instead

In the discontinuation note, Pfizer said it would keep working on an oral GIPR antagonist candidate and other earlier obesity programs. Later company updates discuss other obesity assets; those are separate molecules, not danuglipron.

For pipeline trackers, danuglipron should move to discontinued, not “Phase 3 watch.”

What remains unproven

Public sources do not publish a full peer-reviewed 52-week Phase 3 package for danuglipron, because Phase 3 did not proceed. Comparative oral GLP-1 rankings versus other pills remain outside this molecule’s closed dataset.

Investors should treat any older “Phase 3 watch” framing as outdated after the April 2025 stop.

Related NovaPharma coverage

Frequently Asked Questions

Will Danuglipron Phase 3 trials proceed?

No. In April 2025 Pfizer discontinued development of danuglipron after reviewing clinical data and regulator input, so a Phase 3 program will not advance.

What did the Phase 2b obesity trial show?

In NCT04707313, twice-daily danuglipron met its primary weight-loss endpoint, with placebo-adjusted mean reductions of about 8% to 13% at 32 weeks, but discontinuation exceeded 50%.

Why did Pfizer stop the oral GLP-1 program?

Once-daily dose-optimization studies met PK goals, but one asymptomatic participant had potential drug-induced liver injury that resolved after stopping the drug. Pfizer then ended the molecule.

Primary Sources

  1. Business Wire: Pfizer discontinues danuglipron
  2. Business Wire: Phase 2b obesity topline
  3. Pfizer: oral GLP-1 danuglipron update
  4. ClinicalTrials.gov NCT04707313

Regulatory catalyst tracker

Track PDUFA dates, approval milestones, and label updates for danuglipron.

  • Jul 12, 2026 — PDUFA target
  • Priority Review — designation
  • Oncology — therapeutic area
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