Modality
ASO
MOA
EZH2i
Target
MALT1
Pathway
Amyloid
CML
Development Pipeline
Preclinical
~Feb 2013
→ ~May 2014
Phase 1
~Aug 2014
→ ~Nov 2015
Phase 2
~Feb 2016
→ ~May 2017
Phase 3
Aug 2017
→ Jun 2030
Phase 3Current
NCT06666673
2,063 pts·CML
2019-11→2030-06·Active
NCT08440621
1,897 pts·CML
2017-08→2025-05·Recruiting
NCT03254322
2,473 pts·CML
2017-12→2028-05·Not yet recruiting
6,433 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2025-05-0511mo agoPh3 Readout· CML
2028-05-202.1y awayPh3 Readout· CML
2030-06-244.2y awayPh3 Readout· CML
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P3
Recruit…
P3
Not yet…
P3
Active
Catalysts
Ph3 Readout
2025-05-05 · 11mo ago
CML
Ph3 Readout
2028-05-20 · 2.1y away
CML
Ph3 Readout
2030-06-24 · 4.2y away
CML
RecruitingActiveNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06666673 | Phase 3 | CML | Active | 2063 | FEV1 |
| NCT08440621 | Phase 3 | CML | Recruiting | 1897 | UPCR |
| NCT03254322 | Phase 3 | CML | Not yet recr... | 2473 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| Adagrazumab | Novartis | Phase 2/3 | Cl18.2 | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| NVO-9615 | Novo Nordisk | Phase 2/3 | PRMT5 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| ALN-3958 | Alnylam | Phase 2 | MALT1 | |
| Cevisacituzumab | Alnylam | Preclinical | MALT1 | |
| ION-8812 | Ionis | Phase 1 | MALT1 |