Modality
Gene Editing
MOA
PCSK9i
Target
FGFR
Pathway
PI3K/AKT
NBLNIPF
Development Pipeline
Preclinical
~Feb 2014
→ ~May 2015
Phase 1
~Aug 2015
→ ~Nov 2016
Phase 2
~Feb 2017
→ ~May 2018
Phase 3
~Aug 2018
→ ~Nov 2019
NDA/BLA
Feb 2020
→ Oct 2031
NDA/BLACurrent
NCT03957431
1,348 pts·IPF
2020-02→2031-10·Recruiting
1,348 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-10-145.5y awayPh3 Readout· IPF
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2031-10-14 · 5.5y away
IPF
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03957431 | NDA/BLA | IPF | Recruiting | 1348 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| INC-1261 | Incyte | Phase 1/2 | PRMT5 | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα |