Modality
Nanobody
MOA
BTKi
Target
SMN2
Pathway
Apoptosis
SLE
Development Pipeline
Preclinical
~Jan 2019
→ ~Apr 2020
Phase 1
Jul 2020
→ Aug 2031
Phase 1Current
NCT05775403
2,216 pts·SLE
2023-11→2031-08·Not yet recruiting
NCT05656582
2,780 pts·SLE
2020-07→2025-10·Completed
4,996 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-10-146mo agoInterim· SLE
2031-08-135.4y awayInterim· SLE
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1
Complet…
P1
Not yet…
Catalysts
Interim
2025-10-14 · 6mo ago
SLE
Interim
2031-08-13 · 5.4y away
SLE
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05775403 | Phase 1 | SLE | Not yet recr... | 2216 | DOR |
| NCT05656582 | Phase 1 | SLE | Completed | 2780 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 | |
| Zanumavacamten | GSK | Phase 2/3 | TROP-2 | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Lisorapivir | Takeda | Preclinical | WRN | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| REG-647 | Regeneron | Preclinical | SMN2 | |
| Ivosotorasib | Vertex Pharma | Preclinical | CD38 |