Modality
ERT
MOA
FXIai
Target
MALT1
Pathway
Checkpoint
NarcolepsyThymomaMCC
Development Pipeline
Preclinical
~May 2010
→ ~Aug 2011
Phase 1
~Nov 2011
→ ~Feb 2013
Phase 2
~May 2013
→ ~Aug 2014
Phase 3
~Nov 2014
→ ~Feb 2016
NDA/BLA
~May 2016
→ ~Aug 2017
Approved
Nov 2017
→ Nov 2029
ApprovedCurrent
NCT07975198
1,958 pts·Thymoma
2018-04→2027-10·Terminated
NCT05238422
38 pts·Narcolepsy
2018-03→2029-11·Completed
NCT07231228
1,147 pts·Thymoma
2017-11→2029-07·Not yet recruiting
3,143 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2027-10-051.5y awayPh3 Readout· Thymoma
2029-07-063.3y awayPh3 Readout· Thymoma
2029-11-023.6y awayPh3 Readout· Narcolepsy
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Not yet…
Approved
Complet…
Approved
Termina…
Catalysts
Ph3 Readout
2027-10-05 · 1.5y away
Thymoma
Ph3 Readout
2029-07-06 · 3.3y away
Thymoma
Ph3 Readout
2029-11-02 · 3.6y away
Narcolepsy
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07975198 | Approved | Thymoma | Terminated | 1958 | Mayo |
| NCT05238422 | Approved | Narcolepsy | Completed | 38 | PFS |
| NCT07231228 | Approved | Thymoma | Not yet recr... | 1147 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| TAK-8730 | Takeda | Phase 2 | VEGF | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 |