Modality
siRNA
MOA
CGRPant
Target
CDK4/6
Pathway
Complement
Wilms
Development Pipeline
Preclinical
~Jul 2018
→ ~Oct 2019
Phase 1
Jan 2020
→ Jun 2031
Phase 1Current
NCT03694198
1,419 pts·Wilms
2024-11→TBD·Recruiting
NCT06881630
2,625 pts·Wilms
2020-01→2031-06·Active
4,044 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-07-198mo agoPDUFA· Wilms
2031-06-285.2y awayInterim· Wilms
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
P1
Active
P1
Recruit…
Catalysts
PDUFA
2025-07-19 · 8mo ago
Wilms
Interim
2031-06-28 · 5.2y away
Wilms
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03694198 | Phase 1 | Wilms | Recruiting | 1419 | Mayo |
| NCT06881630 | Phase 1 | Wilms | Active | 2625 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| Motavorutinib | Amgen | Phase 3 | CDK4/6 | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| INC-2432 | Incyte | Phase 2 | CD47 | |
| Sematapinarof | Legend Biotech | NDA/BLA | VEGF |