Modality
Fusion Protein
MOA
C5i
Target
CD38
Pathway
Incretin
RSVSCDALL
Development Pipeline
Preclinical
~Oct 2010
→ ~Jan 2012
Phase 1
~Apr 2012
→ ~Jul 2013
Phase 2
~Oct 2013
→ ~Jan 2015
Phase 3
~Apr 2015
→ ~Jul 2016
NDA/BLA
~Oct 2016
→ ~Jan 2018
Approved
Apr 2018
→ May 2030
ApprovedCurrent
NCT03988470
2,922 pts·ALL
2025-10→2025-01·Completed
NCT07905075
2,533 pts·ALL
2020-08→2027-01·Not yet recruiting
NCT04335039
2,310 pts·SCD
2018-04→2029-02·Terminated
+1 more trial
9,413 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2025-01-241.2y agoPh3 Readout· ALL
2027-01-1910mo awayPh3 Readout· ALL
2029-02-112.9y awayPh3 Readout· SCD
2030-05-094.1y awayPh3 Readout· ALL
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Termina…
Approved
Not yet…
Approved
Termina…
Approved
Complet…
Catalysts
Ph3 Readout
2025-01-24 · 1.2y ago
ALL
Ph3 Readout
2027-01-19 · 10mo away
ALL
Ph3 Readout
2029-02-11 · 2.9y away
SCD
Ph3 Readout
2030-05-09 · 4.1y away
ALL
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03988470 | Approved | ALL | Completed | 2922 | UPDRS |
| NCT07905075 | Approved | ALL | Not yet recr... | 2533 | DOR |
| NCT04335039 | Approved | SCD | Terminated | 2310 | EDSS |
| NCT06859396 | Approved | ALL | Terminated | 1648 | PFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| DSN-2247 | Daiichi Sankyo | NDA/BLA | EZH2 | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| Ivosotorasib | Vertex Pharma | Preclinical | CD38 | |
| Zenotapinarof | Vertex Pharma | Preclinical | CD38 |