Modality
mAb
MOA
WRNi
Target
TIM-3
Pathway
Complement
SLEThymoma
Development Pipeline
Preclinical
~Jul 2011
→ ~Oct 2012
Phase 1
~Jan 2013
→ ~Apr 2014
Phase 2
~Jul 2014
→ ~Oct 2015
Phase 3
~Jan 2016
→ ~Apr 2017
NDA/BLA
Jul 2017
→ Aug 2031
NDA/BLACurrent
NCT08942541
1,379 pts·SLE
2017-07→2027-02·Active
NCT06146981
732 pts·SLE
2020-05→2031-08·Active
2,111 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-01-023mo agoOrphan Drug· Thymoma
2027-02-2211mo awayPh3 Readout· SLE
2031-08-025.3y awayPh3 Readout· SLE
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Active
NDA/BLA
Active
Catalysts
Orphan Drug
2026-01-02 · 3mo ago
Thymoma
Ph3 Readout
2027-02-22 · 11mo away
SLE
Ph3 Readout
2031-08-02 · 5.3y away
SLE
Active|StartCompletionToday
Trials (2)
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| GSK-4334 | GSK | Preclinical | CD47 | |
| AMG-2752 | Amgen | Preclinical | MDM2 | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| REG-7737 | Regeneron | Preclinical | CD123 | |
| VRT-5853 | Vertex Pharma | Phase 3 | Aβ | |
| Pemitapinarof | BeiGene | Approved | KRASG12C | |
| Nidasacituzumab | United Therapeutics | Phase 1/2 | TIM-3 | |
| VKT-4052 | Viking Therapeutics | Phase 2/3 | TNFα |