Modality
mAb
MOA
EZH2i
Target
PLK4
Pathway
RAS/MAPK
ADPKDASCSU
Development Pipeline
Preclinical
~May 2018
→ ~Aug 2019
Phase 1
~Nov 2019
→ ~Feb 2021
Phase 2
~May 2021
→ ~Aug 2022
Phase 3
~Nov 2022
→ ~Feb 2024
NDA/BLA
~May 2024
→ ~Aug 2025
Approved
Nov 2025
→ May 2027
ApprovedCurrent
NCT05803176
2,091 pts·ADPKD
2025-11→2027-05·Not yet recruiting
2,091 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2027-05-191.1y awayPh3 Readout· ADPKD
Trial Timeline
2026Q2Q3Q42027Q2
Approved
Not yet…
Catalysts
Ph3 Readout
2027-05-19 · 1.1y away
ADPKD
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05803176 | Approved | ADPKD | Not yet recr... | 2091 | UPDRS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Adagrazumab | Novartis | Phase 2/3 | Cl18.2 | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| NVO-9615 | Novo Nordisk | Phase 2/3 | PRMT5 | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 | |
| ASN-7038 | Ascendis Pharma | Phase 3 | VEGF | |
| ILM-2412 | Illumina | Phase 3 | PLK4 | |
| ROI-3353 | Roivant Sciences | Phase 1/2 | PLK4 |