Modality
Multispecific
MOA
KRASG12Di
Target
PI3Kα
Pathway
Wnt
MSIgAN
Development Pipeline
Preclinical
~Feb 2014
→ ~May 2015
Phase 1
~Aug 2015
→ ~Nov 2016
Phase 2
~Feb 2017
→ ~May 2018
Phase 3
~Aug 2018
→ ~Nov 2019
NDA/BLA
Feb 2020
→ Jun 2028
NDA/BLACurrent
NCT05143147
1,335 pts·MS
2020-02→2028-06·Completed
1,335 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-06-082.2y awayPh3 Readout· MS
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2028-06-08 · 2.2y away
MS
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05143147 | NDA/BLA | MS | Completed | 1335 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Zanusertib | AbbVie | Approved | PCSK9 | |
| Pexarelsin | AstraZeneca | Phase 1 | DLL3 | |
| Ivotuximab | GSK | NDA/BLA | GIP-R | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα |