Modality
Radioligand
MOA
CDK2i
Target
LAG-3
Pathway
Fibrosis
RANASH
Development Pipeline
Preclinical
~Oct 2017
→ ~Jan 2019
Phase 1
~Apr 2019
→ ~Jul 2020
Phase 2
~Oct 2020
→ ~Jan 2022
Phase 3
Apr 2022
→ Jan 2028
Phase 3Current
NCT06917723
681 pts·RA
2025-11→2027-04·Active
NCT08428652
252 pts·NASH
2022-04→2028-01·Not yet recruiting
933 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-04-121.0y awayPh3 Readout· RA
2028-01-151.8y awayPh3 Readout· NASH
Trial Timeline
Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028
P3
Not yet…
P3
Active
Catalysts
Ph3 Readout
2027-04-12 · 1.0y away
RA
Ph3 Readout
2028-01-15 · 1.8y away
NASH
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06917723 | Phase 3 | RA | Active | 681 | Mayo |
| NCT08428652 | Phase 3 | NASH | Not yet recr... | 252 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| 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 | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| GIL-9227 | Gilead Sciences | Phase 2/3 | GPRC5D |