Modality
Cell Therapy
MOA
SGLT2i
Target
TROP-2
Pathway
PD-1/PD-L1
SLE
Development Pipeline
Preclinical
~Aug 2014
→ ~Nov 2015
Phase 1
~Feb 2016
→ ~May 2017
Phase 2
~Aug 2017
→ ~Nov 2018
Phase 3
~Feb 2019
→ ~May 2020
NDA/BLA
Aug 2020
→ Jul 2028
NDA/BLACurrent
NCT04187908
1,066 pts·SLE
2020-08→2028-07·Active
1,066 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-07-072.3y awayPh3 Readout· SLE
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Active
Catalysts
Ph3 Readout
2028-07-07 · 2.3y away
SLE
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04187908 | NDA/BLA | SLE | Active | 1066 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| NVS-8902 | Novartis | Preclinical | TROP-2 | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| Zanumavacamten | GSK | Phase 2/3 | TROP-2 | |
| BAY-3308 | Bayer | Phase 1 | ALK | |
| MRN-8225 | Moderna | Preclinical | TNFα | |
| Motazanubrutinib | Biogen | Preclinical | CD38 | |
| ALN-5628 | Alnylam | Phase 1/2 | APOC3 | |
| ION-1378 | Ionis | NDA/BLA | TROP-2 |