Modality
Multispecific
MOA
FGFRi
Target
PI3Kα
Pathway
mTOR
AngelmanCKD
Development Pipeline
Preclinical
~Aug 2014
→ ~Nov 2015
Phase 1
~Feb 2016
→ ~May 2017
Phase 2
~Aug 2017
→ ~Nov 2018
Phase 3
Feb 2019
→ Aug 2027
Phase 3Current
NCT07778525
886 pts·Angelman
2019-02→2027-08·Recruiting
NCT05156938
1,958 pts·CKD
2025-02→TBD·Not yet recruiting
2,844 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-08-211.4y awayPh3 Readout· Angelman
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
P3
Recruit…
P3
Not yet…
Catalysts
Ph3 Readout
2027-08-21 · 1.4y away
Angelman
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07778525 | Phase 3 | Angelman | Recruiting | 886 | DOR |
| NCT05156938 | Phase 3 | CKD | Not yet recr... | 1958 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| SRP-9822 | Sarepta | Phase 3 | SOS1 | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα |