Danuglipron Oral GLP-1 Receptor Agonist — Phase 3 Modified Release

Type: drug

Status: Active — Modified Release Formulation

Developer: Pfizer

Breakthrough Summary

After initial twice-daily dosing showed tolerability issues, Pfizer reformulated danuglipron as a once-daily modified-release tablet. Phase 2b data (2025) with the new formulation showed HbA1c reduction of -1.2% and body weight loss of -6.9% at 32 weeks with improved GI tolerability. Phase 3 trials launched mid-2025.

Mechanism of Action

Small molecule non-peptide GLP-1 receptor agonist. Modified-release formulation provides extended plasma exposure, reducing peak-to-trough fluctuations that drove GI side effects with immediate-release dosing.

Year: 2025-2026