Modality
ERT
MOA
Anti-Tau
Target
SMN2
Pathway
RAS/MAPK
Prostate CaWM
Development Pipeline
Preclinical
~Jul 2016
→ ~Oct 2017
Phase 1
~Jan 2018
→ ~Apr 2019
Phase 2
~Jul 2019
→ ~Oct 2020
Phase 3
Jan 2021
→ Sep 2028
Phase 3Current
NCT06759738
2,647 pts·WM
2021-12→2028-09·Completed
NCT04701656
1,786 pts·WM
2021-01→TBD·Recruiting
NCT06002684
250 pts·Prostate Ca
2025-02→2025-04·Recruiting
4,683 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-04-2411mo agoPh3 Readout· Prostate Ca
2028-09-092.4y awayPh3 Readout· WM
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
P3
Recruit…
P3
Complet…
P3
Recruit…
Catalysts
Ph3 Readout
2025-04-24 · 11mo ago
Prostate Ca
Ph3 Readout
2028-09-09 · 2.4y away
WM
RecruitingCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06759738 | Phase 3 | WM | Completed | 2647 | DOR |
| NCT04701656 | Phase 3 | WM | Recruiting | 1786 | ACR20 |
| NCT06002684 | Phase 3 | Prostate Ca | Recruiting | 250 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| BGN-3305 | BeiGene | Phase 2 | BCMA | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 |