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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.
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Trial readouts (30)

GPCR · Aug 2026 (est.)
aleniglipron: Obesity, Overweight, or Chronic Weight Management
NVO · Aug 2026 (est.)
Semaglutide: NAFLD
CORT · Sep 2026 (est.)
Relacorilant: Nonalcoholic Steatohepatitis (NASH)
BHVN · Sep 2026 (est.)
Taldefgrobep Alfa: Obesity
VTVT · Sep 2026 (est.)
Cadisegliatin: Diabetes Mellitus, Type 1
ARWR · Oct 2026 (est.)
Plozasiran: Obesity
MBX · Oct 2026 (est.)
MBX 2109: Obesity
BIOA · Nov 2026 (est.)
BGE-102: Obesity and Cardiovascular Risk
MDGL · Dec 2026 (est.)
Resmetirom: NASH
RANI · Dec 2026 (est.)
PG-102: Obesity
MNOV · Dec 2026 (est.)
MN-166: Diabetes Mellitus, Type 2
CELZ · Jan 2027 (est.)
CELZ-201 Administration: Type 1 Diabetes
MNKD · Mar 2027 (est.)
Afrezza: Type 1 Diabetes Mellitus
RYTM · Mar 2027 (est.)
Setmelanotide: Hypothalamic Obesity
VTVT · Apr 2027 (est.)
Cadisegliatin: Type 1 Diabetes (T1D)
ALNY · Apr 2027 (est.)
ALN-2232: Obesity
ALNY · May 2027 (est.)
ALN-4324: Type 2 Diabetes Mellitus (T2DM)
BMEA · Jun 2027 (est.)
icovamenib: Type 2 Diabetes
VKTX · Jul 2027 (est.)
VK2735: Weight Loss
ARWR · Aug 2027 (est.)
Plozasiran: Homozygous Familial Hypercholesterolemia
ALNY · Aug 2027 (est.)
ALN-4324: Obese or Overweight Healthy Volunteers
ARWR · Sep 2027 (est.)
Plozasiran: Obesity
IVA · Sep 2027 (est.)
IVA337: NASH - Nonalcoholic Steatohepatitis
LLY · Oct 2027 (est.)
Tirzepatide: Obesity
VERU · Oct 2027 (est.)
Enobosarm & Abemaciclib Combo: Obesity & Overweight
RYTM · Oct 2027 (est.)
Setmelanotide: Obesity Associated With Defects in Leptin-melanocortin Pathway
LXRX · Oct 2027 (est.)
Sotagliflozin: Type 1 Diabetes
RYTM · Nov 2027 (est.)
Setmelanotide: Hypothalamic Obesity
SABS · Nov 2027 (est.)
SAB-142: Type 1 Diabetes
WVE · Dec 2027 (est.)
WVE-210201: Overweight and Obesity
We don't show an approval percentage for these obesity & metabolic catalysts. Here's why.