Modality
Fusion Protein
MOA
IL-13i
Target
TIM-3
Pathway
Ferroptosis
MCL
Development Pipeline
Preclinical
~Oct 2015
→ ~Jan 2017
Phase 1
~Apr 2017
→ ~Jul 2018
Phase 2
~Oct 2018
→ ~Jan 2020
Phase 3
~Apr 2020
→ ~Jul 2021
NDA/BLA
Oct 2021
→ Nov 2026
NDA/BLACurrent
NCT04826098
425 pts·MCL
2021-10→2026-11·Active
425 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-11-158mo awayPh3 Readout· MCL
Trial Timeline
Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
NDA/BLA
Active
Catalysts
Ph3 Readout
2026-11-15 · 8mo away
MCL
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04826098 | NDA/BLA | MCL | Active | 425 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| NVS-8902 | Novartis | Preclinical | TROP-2 | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Nidasacituzumab | United Therapeutics | Phase 1/2 | TIM-3 | |
| ROI-3353 | Roivant Sciences | Phase 1/2 | PLK4 |