Modality
Gene Editing
MOA
CDK2i
Target
CGRP
Pathway
PI3K/AKT
PSP
Development Pipeline
Preclinical
~May 2016
→ ~Aug 2017
Phase 1
~Nov 2017
→ ~Feb 2019
Phase 2
~May 2019
→ ~Aug 2020
Phase 3
~Nov 2020
→ ~Feb 2022
NDA/BLA
May 2022
→ Sep 2027
NDA/BLACurrent
NCT05977533
2,480 pts·PSP
2025-07→2026-01·Completed
NCT04018200
1,812 pts·PSP
2022-05→2027-09·Active
4,292 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-01-262mo agoPh3 Readout· PSP
2027-09-201.5y awayPh3 Readout· PSP
Trial Timeline
Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
NDA/BLA
Active
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2026-01-26 · 2mo ago
PSP
Ph3 Readout
2027-09-20 · 1.5y away
PSP
ActiveCompleted|StartCompletionToday
Trials (2)
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R | |
| DSN-3066 | Daiichi Sankyo | Phase 3 | IL-13 | |
| GIL-9227 | Gilead Sciences | Phase 2/3 | GPRC5D | |
| REG-2328 | Regeneron | Phase 1 | BCMA |