Modality
Radioligand
MOA
ALKi
Target
PLK4
Pathway
NF-κB
PNHPV
Development Pipeline
Preclinical
~Apr 2013
→ ~Jul 2014
Phase 1
~Oct 2014
→ ~Jan 2016
Phase 2
~Apr 2016
→ ~Jul 2017
Phase 3
~Oct 2017
→ ~Jan 2019
NDA/BLA
Apr 2019
→ Mar 2031
NDA/BLACurrent
NCT06081154
1,271 pts·PV
2019-04→2031-03·Completed
1,271 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-11-105mo agoPh1 Dose Esc· PNH
2031-03-124.9y awayPh3 Readout· PV
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
NDA/BLA
Complet…
Catalysts
Ph1 Dose Esc
2025-11-10 · 5mo ago
PNH
Ph3 Readout
2031-03-12 · 4.9y away
PV
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06081154 | NDA/BLA | PV | Completed | 1271 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Miriosocimab | Pfizer | Phase 1 | PARP | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| DSN-5254 | Daiichi Sankyo | Phase 1 | B7-H3 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| ALN-3284 | Alnylam | Phase 2/3 | CDK2 | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 |