Modality
ADC
MOA
Cl18.2
Target
HER2
Pathway
Epigenetic
MCCSLE
Development Pipeline
Preclinical
~Aug 2017
→ ~Nov 2018
Phase 1
~Feb 2019
→ ~May 2020
Phase 2
~Aug 2020
→ ~Nov 2021
Phase 3
~Feb 2022
→ ~May 2023
NDA/BLA
Aug 2023
→ May 2028
NDA/BLACurrent
NCT07097896
2,871 pts·SLE
2023-08→2025-08·Completed
NCT08496920
2,836 pts·SLE
2025-11→2028-05·Completed
5,707 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-08-018mo agoPh3 Readout· SLE
2028-05-212.1y awayPh3 Readout· SLE
Trial Timeline
Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
NDA/BLA
Complet…
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2025-08-01 · 8mo ago
SLE
Ph3 Readout
2028-05-21 · 2.1y away
SLE
Completed|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07097896 | NDA/BLA | SLE | Completed | 2871 | ORR |
| NCT08496920 | NDA/BLA | SLE | Completed | 2836 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| ROI-9675 | Roivant Sciences | NDA/BLA | HER2 | |
| VKT-6548 | Viking Therapeutics | Phase 2/3 | PD-L1 | |
| Tiratapinarof | Intellia | NDA/BLA | APOC3 | |
| Gelitapinarof | MacroGenics | Approved | CDK2 | |
| Lisoinavolisib | Schrodinger | Approved | TIGIT |