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Upcoming Obesity & Metabolic FDA decisions & readouts

PDUFA target dates and trial readouts in obesity and metabolic disease disease, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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Trial readouts (35)

OCGN · Jul 2026 (est.)
OCU410ST — Center Involved Diabetic Macular Edema
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
SKYE · Nov 2026 (est.)
SBI-100 Ophthalmic Emulsion, — 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
OCUL · Mar 2027 (est.)
Otx-Tki — Non-Proliferative Diabetic Retinopathy
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
ALVO · Jul 2027 (est.)
Eylea Hd — Diabetic Macular Edema
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
EYPT · Oct 2027 (est.)
EYP-1901 — Diabetic Macular Edema
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
RGNX · Dec 2027 (est.)
Ranibizumab — Diabetic Macular Edema
We don't show an approval percentage for these obesity & metabolic catalysts — here's why.