Modality
Gene Editing
MOA
KIF18Ai
Target
CGRP
Pathway
Angiogenesis
ALS
Development Pipeline
Preclinical
~Aug 2012
→ ~Nov 2013
Phase 1
~Feb 2014
→ ~May 2015
Phase 2
~Aug 2015
→ ~Nov 2016
Phase 3
~Feb 2017
→ ~May 2018
NDA/BLA
Aug 2018
→ Mar 2030
NDA/BLACurrent
NCT08412429
245 pts·ALS
2018-08→2030-03·Active
245 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2030-03-254.0y awayPh3 Readout· ALS
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
NDA/BLA
Active
Catalysts
Ph3 Readout
2030-03-25 · 4.0y away
ALS
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08412429 | NDA/BLA | ALS | Active | 245 | eGFR |
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 | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 |