Modality
Fusion Protein
MOA
PI3Ki
Target
CD19
Pathway
Amyloid
MDDPSPRB
Development Pipeline
Preclinical
~Dec 2014
→ ~Mar 2016
Phase 1
~Jun 2016
→ ~Sep 2017
Phase 2
~Dec 2017
→ ~Mar 2019
Phase 3
~Jun 2019
→ ~Sep 2020
NDA/BLA
Dec 2020
→ Dec 2031
NDA/BLACurrent
NCT08525077
2,760 pts·PSP
2023-07→TBD·Not yet recruiting
NCT06078278
2,506 pts·RB
2020-12→2031-12·Recruiting
5,266 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-12-175.7y awayPh3 Readout· RB
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2031-12-17 · 5.7y away
RB
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08525077 | NDA/BLA | PSP | Not yet recr... | 2760 | FEV1 |
| NCT06078278 | NDA/BLA | RB | Recruiting | 2506 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-8662 | Pfizer | NDA/BLA | CD19 | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| SRP-3270 | Sarepta | Phase 1/2 | SGLT2 |