Modality
mAb
MOA
PRMT5i
Target
IL-23
Pathway
Epigenetic
CLLCeliac
Development Pipeline
Preclinical
~Mar 2012
→ ~Jun 2013
Phase 1
~Sep 2013
→ ~Dec 2014
Phase 2
~Mar 2015
→ ~Jun 2016
Phase 3
~Sep 2016
→ ~Dec 2017
NDA/BLA
Mar 2018
→ Aug 2025
NDA/BLACurrent
NCT08278559
1,494 pts·CLL
2018-03→2025-08·Recruiting
1,494 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-08-038mo agoPh3 Readout· CLL
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2025-08-03 · 8mo ago
CLL
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08278559 | NDA/BLA | CLL | Recruiting | 1494 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| DSN-6862 | Daiichi Sankyo | Preclinical | IL-23 | |
| AMG-4531 | Amgen | Phase 2/3 | KRASG12C | |
| GIL-9142 | Gilead Sciences | Phase 1 | FXIa | |
| Semainavolisib | Gilead Sciences | Phase 2 | PARP |