Modality
Cell Therapy
MOA
TYK2i
Target
Menin
Pathway
Autophagy
Wilms
Development Pipeline
Preclinical
~Dec 2012
→ ~Mar 2014
Phase 1
~Jun 2014
→ ~Sep 2015
Phase 2
~Dec 2015
→ ~Mar 2017
Phase 3
~Jun 2017
→ ~Sep 2018
NDA/BLA
Dec 2018
→ May 2031
NDA/BLACurrent
NCT07839156
1,440 pts·Wilms
2018-12→2031-05·Not yet recruiting
NCT08291233
2,034 pts·Wilms
2022-03→2028-05·Recruiting
3,474 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-05-072.1y awayPh3 Readout· Wilms
2031-05-015.1y awayPh3 Readout· Wilms
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
NDA/BLA
Not yet…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2028-05-07 · 2.1y away
Wilms
Ph3 Readout
2031-05-01 · 5.1y away
Wilms
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07839156 | NDA/BLA | Wilms | Not yet recr... | 1440 | LiverFat |
| NCT08291233 | NDA/BLA | Wilms | Recruiting | 2034 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| LLY-8369 | Eli Lilly | Approved | Menin | |
| Lisonaritide | Eli Lilly | Phase 3 | IL-13 | |
| NVS-1475 | Novartis | Phase 2 | Menin | |
| MRK-2473 | Merck & Co | Phase 1/2 | Nectin-4 | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| Voxacagene | Gilead Sciences | Phase 2/3 | SOS1 | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET | |
| VRT-9481 | Vertex Pharma | Phase 1/2 | Menin |