Modality
ERT
MOA
BCMA ADC
Target
VEGF
Pathway
PI3K/AKT
SLE
Development Pipeline
Preclinical
~May 2013
→ ~Aug 2014
Phase 1
~Nov 2014
→ ~Feb 2016
Phase 2
~May 2016
→ ~Aug 2017
Phase 3
~Nov 2017
→ ~Feb 2019
NDA/BLA
~May 2019
→ ~Aug 2020
Approved
Nov 2020
→ Aug 2030
ApprovedCurrent
NCT06238804
485 pts·SLE
2022-09→TBD·Recruiting
NCT07335449
1,753 pts·SLE
2022-09→2029-08·Recruiting
NCT04933301
1,090 pts·SLE
2020-11→2030-08·Not yet recruiting
3,328 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2025-10-205mo agoPDUFA· SLE
2029-08-213.4y awayPh3 Readout· SLE
2030-08-254.4y awayPh3 Readout· SLE
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Not yet…
Approved
Recruit…
Approved
Recruit…
Catalysts
PDUFA
2025-10-20 · 5mo ago
SLE
Ph3 Readout
2029-08-21 · 3.4y away
SLE
Ph3 Readout
2030-08-25 · 4.4y away
SLE
RecruitingNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06238804 | Approved | SLE | Recruiting | 485 | DOR |
| NCT07335449 | Approved | SLE | Recruiting | 1753 | EASI-75 |
| NCT04933301 | Approved | SLE | Not yet recr... | 1090 | CfB |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zanuderotide | Novartis | Phase 1/2 | VEGF | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| Olpatinib | GSK | Preclinical | PD-L1 | |
| TAK-8730 | Takeda | Phase 2 | VEGF | |
| GIL-9779 | Gilead Sciences | Phase 1 | IL-17A | |
| GIL-2011 | Gilead Sciences | Preclinical | VEGF | |
| Bemazumab | Regeneron | Phase 1 | VEGF | |
| Pemicapivasertib | Legend Biotech | Phase 3 | VEGF | |
| Sematapinarof | Legend Biotech | NDA/BLA | VEGF | |
| LEG-6533 | Legend Biotech | NDA/BLA | VEGF |