pdufa.bio
Home › Condition › Obesity & Metabolic

Upcoming Obesity & Metabolic FDA decisions & readouts

Updated ยทnext FDA decision on the calendar
PDUFA target dates and trial readouts in obesity & metabolic, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
Cancer & OncologyCNS & NeurologyImmunology & InflammationCardiovascularRare DiseaseInfectious Disease & VaccinesHematologyOphthalmology & Eye

PDUFA decisions (2)

CORT · 2026-12-17
Relacorilant - (GRACE resubmission): Cushing's syndrome (hypercortisolism)
NVO · Dec 2026 (est.)
CagriSema (AM833): Obesity / weight management

Trial readouts (5)

BHVN · Sep 2026 (est.)
Taldefgrobep Alfa
VKTX · 2026-09-30
VANQUISH-2 Phase 3 (VK2735) topline: Obesity with type 2 diabetes
MNOV · Dec 2026 (est.)
MN-166
VKTX · Jul 2027 (est.)
VK2735
LLY · Oct 2027 (est.)
Tirzepatide

Every upcoming FDA decision date, all therapeutic areas, on the 2026 PDUFA calendar · all conditions

We don't show an approval percentage for these obesity & metabolic catalysts: here's why.