Modality
ADC
MOA
PLK4i
Target
Aβ
Pathway
Checkpoint
FTDRSVMCL
Development Pipeline
Preclinical
~Dec 2009
→ ~Mar 2011
Phase 1
~Jun 2011
→ ~Sep 2012
Phase 2
~Dec 2012
→ ~Mar 2014
Phase 3
~Jun 2014
→ ~Sep 2015
NDA/BLA
~Dec 2015
→ ~Mar 2017
Approved
Jun 2017
→ Jul 2030
ApprovedCurrent
NCT08748320
1,241 pts·FTD
2018-05→TBD·Terminated
NCT08264992
1,693 pts·FTD
2021-01→2030-07·Not yet recruiting
NCT08243164
921 pts·MCL
2017-06→2026-04·Completed
+1 more trial
4,182 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2026-04-122w awayPh3 Readout· MCL
2030-07-264.3y awayPh3 Readout· FTD
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Complet…
Approved
Termina…
Approved
Not yet…
Approved
Recruit…
Catalysts
Ph3 Readout
2026-04-12 · 2w away
MCL
Ph3 Readout
2030-07-26 · 4.3y away
FTD
RecruitingCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08748320 | Approved | FTD | Terminated | 1241 | Mayo |
| NCT08264992 | Approved | FTD | Not yet recr... | 1693 | MRD |
| NCT08243164 | Approved | MCL | Completed | 921 | ORR |
| NCT06790886 | Approved | MCL | Recruiting | 327 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| VRT-5853 | Vertex Pharma | Phase 3 | Aβ | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| ARG-314 | Argenx | Approved | Aβ | |
| BMR-9762 | BioMarin | Phase 3 | Aβ |