Danuglipron Dosing & Reconstitution Guide
Dosing Protocol
Route: Oral Frequency: Once daily (modified-release) or twice daily (immediate-release) Dose Range: 40–120 mg oral (Phase 2 tested up to 120 mg BID; MR formulation doses TBD)
Safety & Contraindications
Safety: Common: nausea (up to 42%), vomiting, diarrhea — significantly higher rates than injectable GLP-1 agonists High discontinuation rates in Phase II: up to 50% of patients in the highest dose group discontinued, primarily due to GI adverse events GI tolerability was the primary reason Pfizer discontinued the twice-daily formulation and pivoted to modified-release
Contraindications: Personal or family history of medullary thyroid carcinoma (GLP-1 class caution, though small molecules may have different risk); Multiple endocrine neoplasia syndrome type 2 (MEN2); Severe hepatic impairment (hepatically metabolized small molecule)