Modality
mRNA
MOA
IL-13i
Target
Aβ
Pathway
Checkpoint
Epilepsy
Development Pipeline
Preclinical
~Feb 2016
→ ~May 2017
Phase 1
~Aug 2017
→ ~Nov 2018
Phase 2
~Feb 2019
→ ~May 2020
Phase 3
~Aug 2020
→ ~Nov 2021
NDA/BLA
~Feb 2022
→ ~May 2023
Approved
Aug 2023
→ Mar 2029
ApprovedCurrent
NCT04950302
697 pts·Epilepsy
2024-09→2029-02·Terminated
NCT07721343
1,725 pts·Epilepsy
2025-09→2025-12·Active
NCT08755434
249 pts·Epilepsy
2023-08→2028-07·Terminated
+1 more trial
4,904 total pts1 indication
CompletedCurrentUpcoming
Catalysts (4)
2025-12-044mo agoPh3 Readout· Epilepsy
2028-07-132.3y awayPh3 Readout· Epilepsy
2029-02-012.8y awayPh3 Readout· Epilepsy
2029-03-062.9y awayPh3 Readout· Epilepsy
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Termina…
Approved
Active
Approved
Termina…
Approved
Active
Catalysts
Ph3 Readout
2025-12-04 · 4mo ago
Epilepsy
Ph3 Readout
2028-07-13 · 2.3y away
Epilepsy
Ph3 Readout
2029-02-01 · 2.8y away
Epilepsy
Ph3 Readout
2029-03-06 · 2.9y away
Epilepsy
ActiveTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04950302 | Approved | Epilepsy | Terminated | 697 | EDSS |
| NCT07721343 | Approved | Epilepsy | Active | 1725 | PFS |
| NCT08755434 | Approved | Epilepsy | Terminated | 249 | PASI75 |
| NCT04622127 | Approved | Epilepsy | Active | 2233 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| NVS-8902 | Novartis | Preclinical | TROP-2 | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ |