Modality
mRNA
MOA
CDK2i
Target
FLT3
Pathway
Ferroptosis
SLE
Development Pipeline
Preclinical
~Dec 2014
→ ~Mar 2016
Phase 1
~Jun 2016
→ ~Sep 2017
Phase 2
Dec 2017
→ Feb 2031
Phase 2Current
NCT07306786
2,728 pts·SLE
2017-12→2026-07·Not yet recruiting
NCT06112155
287 pts·SLE
2023-09→2031-02·Completed
3,015 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-07-123mo awayPh3 Readout· SLE
2031-02-054.9y awayPh3 Readout· SLE
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P2/3
Not yet…
P2/3
Complet…
Catalysts
Ph3 Readout
2026-07-12 · 3mo away
SLE
Ph3 Readout
2031-02-05 · 4.9y away
SLE
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07306786 | Phase 2/3 | SLE | Not yet recr... | 2728 | VA |
| NCT06112155 | Phase 2/3 | SLE | Completed | 287 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R | |
| DSN-3066 | Daiichi Sankyo | Phase 3 | IL-13 | |
| GIL-9227 | Gilead Sciences | Phase 2/3 | GPRC5D | |
| REG-2328 | Regeneron | Phase 1 | BCMA |