Modality
mAb
MOA
USP1i
Target
PI3Kα
Pathway
Tau
Huntington'sCF
Development Pipeline
Preclinical
~Jan 2013
→ ~Apr 2014
Phase 1
~Jul 2014
→ ~Oct 2015
Phase 2
~Jan 2016
→ ~Apr 2017
Phase 3
~Jul 2017
→ ~Oct 2018
NDA/BLA
Jan 2019
→ Jul 2031
NDA/BLACurrent
NCT05041239
108 pts·CF
2019-01→TBD·Recruiting
NCT08428137
131 pts·Huntington's
2019-08→2031-07·Active
239 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-07-255.3y awayPh3 Readout· Huntington's
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Active
Catalysts
Ph3 Readout
2031-07-25 · 5.3y away
Huntington's
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05041239 | NDA/BLA | CF | Recruiting | 108 | PFS |
| NCT08428137 | NDA/BLA | Huntington's | Active | 131 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| GMA-729 | Genmab | Phase 2 | BCL-2 | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα |