Modality
ERT
MOA
Anti-Tau
Target
PI3Kα
Pathway
Notch
Bladder CaEoE
Development Pipeline
Preclinical
~Aug 2012
→ ~Nov 2013
Phase 1
~Feb 2014
→ ~May 2015
Phase 2
~Aug 2015
→ ~Nov 2016
Phase 3
~Feb 2017
→ ~May 2018
NDA/BLA
~Aug 2018
→ ~Nov 2019
Approved
Feb 2020
→ Dec 2030
ApprovedCurrent
NCT07304793
2,545 pts·Bladder Ca
2023-10→TBD·Not yet recruiting
NCT03308016
397 pts·EoE
2020-02→2030-12·Completed
2,942 total pts2 indications
CompletedCurrentUpcoming
Catalysts (1)
2030-12-024.7y awayPh3 Readout· EoE
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2030-12-02 · 4.7y away
EoE
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07304793 | Approved | Bladder Ca | Not yet recr... | 2545 | OS |
| NCT03308016 | Approved | EoE | Completed | 397 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| BGN-3305 | BeiGene | Phase 2 | BCMA | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 |