Upcoming decisions
Dated events that can change a grade or an FDA status: decision deadlines, advisory committee meetings, filings and trial readouts, each with its source. Checked daily; when a date passes, the outcome goes on the compound's page.
Firm means the date is set by the FDA or a regulator. Announced means a company stated it. Estimated comes from a trial registry's planned completion date and often slips.
- AIcatibant
Primary completion of a phase 3 trial of icatibant to prevent intradialytic hypotension
- AZilucoplan
Primary completion of UCB's phase 2/3 trial of zilucoplan in children with generalized myasthenia gravis
- BRetatrutide
Primary completion of TRIUMPH-5, retatrutide versus tirzepatide head-to-head
- BThymosin beta-4
Topline results from the SEER-2 phase 3 trial of RGN-259 eye drops in neurotrophic keratopathy
- ATirzepatide
Primary completion of SURPASS-T1D-1, tirzepatide in type 1 diabetes with obesity
- ATirzepatide
Primary completion of SURPASS-T1D-2, long-term tirzepatide study in type 1 diabetes with obesity
- AAfamelanotide
Topline results from Clinuvel's CUV105 phase 3 trial of afamelanotide (Scenesse) with NB-UVB in vitiligo
- AMazdutide
Primary completion of Innovent's China phase 3 trial of mazdutide versus semaglutide in obesity with MASLD
- ACagriSema
FDA decision on CagriSema for weight management
- ADasiglucagon
Resubmission of the US NDA for dasiglucagon in congenital hyperinsulinism
- BGlepaglutide
Completion of EU marketing authorization review of glepaglutide for short bowel syndrome
- BPetrelintide
Topline results of phase 2 ZUPREME-2 trial of petrelintide in obesity with type 2 diabetes
- ASemaglutide
FDA decision on oral semaglutide 25 mg for type 2 diabetes
- BSetmelanotide
Japan MHLW decision on setmelanotide for acquired hypothalamic obesity
- ASomapacitan
European Commission decision on Sogroya for children with idiopathic short stature, born small for gestational age, or Noonan syndrome
- BSurvodutide
Results of the phase 3 SYNCHRONIZE-CVOT cardiovascular safety trial of survodutide
- AAfamelanotide
Clinuvel EMA filing to extend Scenesse (afamelanotide) to adolescents with EPP
- BRetatrutide
Phase 3 results from TRANSCEND-T2D-2 and -3, retatrutide in type 2 diabetes
- ATeduglutide
Primary completion of phase 3 trial of teduglutide in Chinese adults with short bowel syndrome
- AVosoritide
FDA decision on full (traditional) approval of vosoritide for achondroplasia
- CDihexa
FDA Pharmacy Compounding Advisory Committee review of dihexa acetate for the 503A bulks list
- CGHK-Cu
FDA Pharmacy Compounding Advisory Committee review of GHK-Cu for the 503A bulks list
- CLL-37
FDA Pharmacy Compounding Advisory Committee review of cathelicidin (LL-37) for the 503A bulks list
- CMelanotan II
FDA Pharmacy Compounding Advisory Committee review of Melanotan II for the 503A bulks list
- ACagriSema
Primary completion of REDEFINE 11, a phase 3 CagriSema weight-loss trial
- BSetmelanotide
Primary completion of phase 3 setmelanotide substudy in congenital hypothalamic obesity
- BRetatrutide
Lilly plans to submit retatrutide to the FDA for approval
- ARusfertide
Takeda EU marketing application for rusfertide in polycythemia vera
- BCorticotropin
Primary completion of Cerium's phase 3 trial of synthetic ACTH(1-39) gel in primary membranous nephropathy
- AMazdutide
Primary completion of Innovent's China phase 3 trial of mazdutide in obstructive sleep apnea
- BCagrilintide
Primary completion of RENEW 1, phase 3 trial of cagrilintide alone for weight loss
- BCagrilintide
Primary completion of RENEW 2, phase 3 trial of cagrilintide in people with obesity and type 2 diabetes
- BCagrilintide
Primary completion of RENEW 4, phase 3 trial comparing two versions of injectable cagrilintide
- AAbaloparatide
Primary completion of Qilu's phase 3 trial of abaloparatide injection (QLG2128) in postmenopausal osteoporosis in China
- APalopegteriparatide
Primary completion of phase 3 PaTHway60 trial of palopegteriparatide at higher doses
- AEtelcalcetide
Primary completion of Amgen's phase 3 trial of etelcalcetide in children with secondary hyperparathyroidism on hemodialysis
- BRetatrutide
Primary completion of TRIUMPH-8, phase 3 retatrutide obesity trial
- APalopegteriparatide
Primary completion of phase 3 trial of palopegteriparatide in adolescents with hypoparathyroidism
- ACagriSema
Primary completion of REDEFINE 3, the CagriSema cardiovascular outcomes trial
- BRetatrutide
Primary completion of TRIUMPH-7, retatrutide in obesity with chronic low back pain
- CFollistatin-344
Primary completion of Unlimited Bio's CALM-AF-AI phase 1/2 trial of AAV9-follistatin gene therapy for age-related muscle loss
- ATirzepatide
Primary completion of SURMOUNT-MMO, tirzepatide morbidity and mortality outcomes trial in obesity
- AMazdutide
Primary completion of Innovent's China phase 3 trial of mazdutide in adolescents with obesity
- CNNZ-2591
Primary completion of phase 3 Koala trial of NNZ-2591 in children with Phelan-McDermid syndrome
- ASemaglutide
Primary completion of FOCUS, semaglutide versus placebo in diabetic eye disease
- AZilucoplan
Primary completion of an investigator-led phase 3 trial of zilucoplan for severe myasthenia gravis exacerbations
- ADulaglutide
Primary completion of phase 3 trial of dulaglutide 3.0 and 4.5 mg in children with type 2 diabetes
- BElamipretide
Readout of phase 3 ReNEW trial of elamipretide in dry age-related macular degeneration
- BPemvidutide
Topline results of phase 2 RESTORE trial of pemvidutide in alcohol-associated liver disease
- AVosoritide
FDA decision on vosoritide for hypochondroplasia
- BSurvodutide
Primary completion of phase 3 SYNCHRONIZE-T2D trial of survodutide in type 2 diabetes
- ALutetium Lu-177 vipivotide tetraxetan
Primary completion of Novartis's phase 3 PSMA-DC trial of Pluvicto versus observation in oligometastatic prostate cancer
- BAmycretin
Primary completion of AMAZE 12, the earliest-ending phase 3 amycretin (zenagamtide) weight trial
- BAmycretin
Primary completion of AMAZE 9, phase 3 trial of oral zenagamtide tablets for weight loss
- BSurvodutide
Primary completion of phase 3 SYNCHRONIZE-HERA trial of survodutide in women with obesity
- BAmycretin
Primary completion of AMBITION 7, phase 3 trial of zenagamtide in type 2 diabetes
- BGlepaglutide
Primary completion of phase 3 EASE SBS 6 trial of glepaglutide
- BPetrelintide
Primary completion of phase 3 ZUPREME-4 trial of petrelintide in overweight or obesity
- BGlepaglutide
Primary completion of phase 3 EASE SBS 5 trial of glepaglutide, intended to support a US resubmission
- BApraglutide
Primary completion of confirmatory phase 3 STARS-2 trial of apraglutide in short bowel syndrome
- ALutetium Lu-177 dotatate
Primary completion of Novartis's phase 3 NETTER-3 trial of Lutathera in grade 1 and 2 advanced GEP-NETs
- BPetrelintide
Primary completion of phase 3 ZUPREME-3 trial of petrelintide in overweight or obesity
- AEtelcalcetide
Primary completion of Amgen's phase 3 trial of etelcalcetide in pediatric patients with secondary hyperparathyroidism and CKD
- BSurvodutide
Primary completion of phase 3 LIVERAGE-Cirrhosis trial of survodutide in MASH with cirrhosis
- BAmycretin
Primary completion of AMAZE 1, the main phase 3 zenagamtide weight-management trial
- AEnlicitide
Primary completion of CORALreef Outcomes, the phase 3 cardiovascular outcomes trial of enlicitide
- BPemvidutide
52-week readout of phase 3 PERFORMA trial of pemvidutide in MASH
- APegcetacoplan
Primary completion of Sobi's phase 3 trial of pegcetacoplan to prevent C3G or IC-MPGN recurrence after kidney transplant
- BSurvodutide
Primary completion of phase 3 LIVERAGE trial of survodutide in MASH with moderate or advanced fibrosis
- AEnlicitide
Primary completion of the phase 2/3 trial of enlicitide in children and adolescents with heterozygous familial hypercholesterolemia