Modality
Multispecific
MOA
KIF18Ai
Target
WRN
Pathway
Cell Cycle
Parkinson'sLGS
Development Pipeline
Preclinical
~Jun 2011
→ ~Sep 2012
Phase 1
~Dec 2012
→ ~Mar 2014
Phase 2
~Jun 2014
→ ~Sep 2015
Phase 3
~Dec 2015
→ ~Mar 2017
NDA/BLA
~Jun 2017
→ ~Sep 2018
Approved
Dec 2018
→ Mar 2031
ApprovedCurrent
NCT04449377
2,550 pts·LGS
2018-12→2031-03·Terminated
NCT07638151
1,060 pts·Parkinson's
2019-07→2029-12·Not yet recruiting
NCT05588994
380 pts·Parkinson's
2022-08→2025-10·Not yet recruiting
3,990 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-10-275mo agoPh3 Readout· Parkinson's
2029-12-193.7y awayPh3 Readout· Parkinson's
2031-03-094.9y awayPh3 Readout· LGS
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Termina…
Approved
Not yet…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-10-27 · 5mo ago
Parkinson's
Ph3 Readout
2029-12-19 · 3.7y away
Parkinson's
Ph3 Readout
2031-03-09 · 4.9y away
LGS
TerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04449377 | Approved | LGS | Terminated | 2550 | Biomarker |
| NCT07638151 | Approved | Parkinson's | Not yet recr... | 1060 | CfB |
| NCT05588994 | Approved | Parkinson's | Not yet recr... | 380 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| Lisorapivir | Takeda | Preclinical | WRN | |
| Nirafutibatinib | Bayer | Phase 2 | WRN |