Modality
ERT
MOA
KIF18Ai
Target
DLL3
Pathway
Tau
CKDNASH
Development Pipeline
Preclinical
~Sep 2016
→ ~Dec 2017
Phase 1
Mar 2018
→ Aug 2030
Phase 1Current
NCT08969554
1,331 pts·NASH
2020-11→2030-08·Active
NCT03412009
2,595 pts·CKD
2018-03→2027-02·Terminated
3,926 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-02-0810mo awayPh2 Data· CKD
2030-08-044.3y awayPh2 Data· NASH
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P1/2
Termina…
P1/2
Active
Catalysts
Ph2 Data
2027-02-08 · 10mo away
CKD
Ph2 Data
2030-08-04 · 4.3y away
NASH
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08969554 | Phase 1/2 | NASH | Active | 1331 | SRI-4 |
| NCT03412009 | Phase 1/2 | CKD | Terminated | 2595 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Pexarelsin | AstraZeneca | Phase 1 | DLL3 | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Zenonesiran | GSK | Preclinical | DLL3 | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| AMG-7379 | Amgen | Preclinical | DLL3 |