Modality
Radioligand
MOA
Anti-Tau
Target
MALT1
Pathway
Hedgehog
FabryRCCPV
Development Pipeline
Preclinical
~Nov 2020
→ ~Feb 2022
Phase 1
~May 2022
→ ~Aug 2023
Phase 2
~Nov 2023
→ ~Feb 2025
Phase 3
May 2025
→ Sep 2028
Phase 3Current
NCT03450065
2,306 pts·PV
2025-05→2028-09·Completed
2,306 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-09-262.5y awayPh3 Readout· PV
Trial Timeline
Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
P3
Complet…
Catalysts
Ph3 Readout
2028-09-26 · 2.5y away
PV
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03450065 | Phase 3 | PV | Completed | 2306 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| ALN-3958 | Alnylam | Phase 2 | MALT1 | |
| Cevisacituzumab | Alnylam | Preclinical | MALT1 |