Modality
ADC
MOA
TYK2i
Target
FcRn
Pathway
Amyloid
Bladder Ca
Development Pipeline
Preclinical
~Mar 2010
→ ~Jun 2011
Phase 1
~Sep 2011
→ ~Dec 2012
Phase 2
~Mar 2013
→ ~Jun 2014
Phase 3
~Sep 2014
→ ~Dec 2015
NDA/BLA
~Mar 2016
→ ~Jun 2017
Approved
Sep 2017
→ Aug 2027
ApprovedCurrent
NCT07932078
2,760 pts·Bladder Ca
2017-11→2026-01·Terminated
NCT05622652
2,057 pts·Bladder Ca
2017-09→2027-08·Recruiting
4,817 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2026-01-043mo agoPh3 Readout· Bladder Ca
2027-08-131.4y awayPh3 Readout· Bladder Ca
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
Approved
Recruit…
Approved
Termina…
Catalysts
Ph3 Readout
2026-01-04 · 3mo ago
Bladder Ca
Ph3 Readout
2027-08-13 · 1.4y away
Bladder Ca
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07932078 | Approved | Bladder Ca | Terminated | 2760 | ORR |
| NCT05622652 | Approved | Bladder Ca | Recruiting | 2057 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| Lisonaritide | Eli Lilly | Phase 3 | IL-13 | |
| MRK-2473 | Merck & Co | Phase 1/2 | Nectin-4 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Voxacagene | Gilead Sciences | Phase 2/3 | SOS1 | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET |