Modality
Fusion Protein
MOA
PD-L1i
Target
BCL-2
Pathway
NF-κB
RAT2D
Development Pipeline
Preclinical
~Nov 2009
→ ~Feb 2011
Phase 1
~May 2011
→ ~Aug 2012
Phase 2
~Nov 2012
→ ~Feb 2014
Phase 3
~May 2014
→ ~Aug 2015
NDA/BLA
~Nov 2015
→ ~Feb 2017
Approved
May 2017
→ Sep 2029
ApprovedCurrent
NCT04163574
2,563 pts·RA
2018-08→2028-02·Completed
NCT07005051
1,468 pts·T2D
2017-05→2029-09·Not yet recruiting
4,031 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2028-02-081.9y awayPh3 Readout· RA
2029-09-163.5y awayPh3 Readout· T2D
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Not yet…
Approved
Complet…
Catalysts
Ph3 Readout
2028-02-08 · 1.9y away
RA
Ph3 Readout
2029-09-16 · 3.5y away
T2D
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04163574 | Approved | RA | Completed | 2563 | CR |
| NCT07005051 | Approved | T2D | Not yet recr... | 1468 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-1085 | Pfizer | Preclinical | FXIa | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| Nirafutibatinib | Bayer | Phase 2 | WRN | |
| Motainavolisib | Amgen | NDA/BLA | CD47 | |
| BNT-8090 | BioNTech | Phase 2 | AuroraA | |
| Rimaglumide | Biogen | Phase 1/2 | BCL-2 | |
| Miriglumide | Alnylam | Phase 3 | CD3 | |
| ARG-4339 | Argenx | Phase 2 | BCL-2 |