Modality
Bispecific Ab
MOA
PARPi
Target
JAK1
Pathway
Incretin
CLLNBMDD
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 2031
ApprovedCurrent
NCT03544093
859 pts·CLL
2024-05→TBD·Recruiting
NCT07190687
42 pts·MDD
2025-05→2031-07·Terminated
NCT03271951
632 pts·MDD
2022-12→2030-08·Recruiting
+1 more trial
2,441 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2030-08-224.4y awayPh3 Readout· MDD
2030-12-154.7y awayPh3 Readout· CLL
2031-07-225.3y awayPh3 Readout· MDD
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Termina…
Approved
Recruit…
Approved
Recruit…
Approved
Termina…
Catalysts
Ph3 Readout
2030-08-22 · 4.4y away
MDD
Ph3 Readout
2030-12-15 · 4.7y away
CLL
Ph3 Readout
2031-07-22 · 5.3y away
MDD
RecruitingTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03544093 | Approved | CLL | Recruiting | 859 | ORR |
| NCT07190687 | Approved | MDD | Terminated | 42 | Safety |
| NCT03271951 | Approved | MDD | Recruiting | 632 | MRD |
| NCT04277055 | Approved | CLL | Terminated | 908 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| MRK-3732 | Merck & Co | Phase 1 | TYK2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| BAY-3684 | Bayer | Approved | PD-L1 | |
| GIL-8529 | Gilead Sciences | Phase 1/2 | JAK1 | |
| BNT-5232 | BioNTech | NDA/BLA | TIGIT | |
| ALN-3958 | Alnylam | Phase 2 | MALT1 | |
| Cevifotisoran | Neurocrine | Approved | CD47 |