Modality
Multispecific
MOA
C5i
Target
SMN2
Pathway
Sphingolipid
Pancreatic CaMDD
Development Pipeline
Preclinical
~Sep 2019
→ ~Dec 2020
Phase 1
~Mar 2021
→ ~Jun 2022
Phase 2
~Sep 2022
→ ~Dec 2023
Phase 3
~Mar 2024
→ ~Jun 2025
NDA/BLA
Sep 2025
→ May 2028
NDA/BLACurrent
NCT05939023
964 pts·MDD
2025-09→2028-05·Completed
964 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-05-202.1y awayPh3 Readout· MDD
Trial Timeline
Q42026Q2Q3Q42027Q2Q3Q42028Q2
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2028-05-20 · 2.1y away
MDD
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05939023 | NDA/BLA | MDD | Completed | 964 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| DSN-2247 | Daiichi Sankyo | NDA/BLA | EZH2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| Rimabrutinib | Madrigal Pharma | Phase 1/2 | GPRC5D | |
| XEN-577 | Xenon Pharma | Phase 2/3 | C5 | |
| Olpafutibatinib | Immunocore | Approved | SMN2 | |
| EXA-4696 | Exscientia | Phase 2/3 | KRASG12C | |
| EME-9677 | Emerald Health | Phase 1 | SMN2 |