Modality
ADC
MOA
TNFi
Target
Nectin-4
Pathway
Sphingolipid
PTSDHeart FailureEoE
Development Pipeline
Preclinical
~Jun 2013
→ ~Sep 2014
Phase 1
~Dec 2014
→ ~Mar 2016
Phase 2
~Jun 2016
→ ~Sep 2017
Phase 3
~Dec 2017
→ ~Mar 2019
NDA/BLA
~Jun 2019
→ ~Sep 2020
Approved
Dec 2020
→ Aug 2031
ApprovedCurrent
NCT08110986
2,086 pts·EoE
2025-07→2031-08·Completed
NCT06192213
685 pts·EoE
2021-09→2028-06·Completed
NCT07135796
1,196 pts·PTSD
2020-12→2029-08·Recruiting
3,967 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2025-10-106mo agoPDUFA· PTSD
2028-06-022.2y awayPh3 Readout· EoE
2029-08-183.4y awayPh3 Readout· PTSD
2031-08-115.4y awayPh3 Readout· EoE
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Recruit…
Approved
Complet…
Approved
Complet…
Catalysts
PDUFA
2025-10-10 · 6mo ago
PTSD
Ph3 Readout
2028-06-02 · 2.2y away
EoE
Ph3 Readout
2029-08-18 · 3.4y away
PTSD
Ph3 Readout
2031-08-11 · 5.4y away
EoE
RecruitingCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08110986 | Approved | EoE | Completed | 2086 | 6MWD |
| NCT06192213 | Approved | EoE | Completed | 685 | EASI-75 |
| NCT07135796 | Approved | PTSD | Recruiting | 1196 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-2473 | Merck & Co | Phase 1/2 | Nectin-4 | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Ribozanubrutinib | Genmab | Approved | GPRC5D | |
| ION-3857 | Ionis | Preclinical | Nectin-4 | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Semasacituzumab | Illumina | Phase 3 | Nectin-4 | |
| Elrainavolisib | Roivant Sciences | Preclinical | Nectin-4 |