Modality
ASO
MOA
ALKi
Target
CD47
Pathway
Amyloid
AMLPNHIgAN
Development Pipeline
Preclinical
~Aug 2011
→ ~Nov 2012
Phase 1
~Feb 2013
→ ~May 2014
Phase 2
~Aug 2014
→ ~Nov 2015
Phase 3
~Feb 2016
→ ~May 2017
NDA/BLA
Aug 2017
→ Oct 2031
NDA/BLACurrent
NCT06124179
2,917 pts·PNH
2022-05→2031-10·Not yet recruiting
NCT05663987
545 pts·AML
2017-08→2031-08·Recruiting
3,462 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2031-08-275.4y awayPh3 Readout· AML
2031-10-245.6y awayPh3 Readout· PNH
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2031-08-27 · 5.4y away
AML
Ph3 Readout
2031-10-24 · 5.6y away
PNH
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06124179 | NDA/BLA | PNH | Not yet recr... | 2917 | Biomarker |
| NCT05663987 | NDA/BLA | AML | Recruiting | 545 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Miriosocimab | Pfizer | Phase 1 | PARP | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| DSN-5254 | Daiichi Sankyo | Phase 1 | B7-H3 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA |