Modality
ASO
MOA
Cl18.2
Target
PLK4
Pathway
Cell Cycle
ADHDADPKD
Development Pipeline
Preclinical
~Jul 2012
→ ~Oct 2013
Phase 1
~Jan 2014
→ ~Apr 2015
Phase 2
~Jul 2015
→ ~Oct 2016
Phase 3
~Jan 2017
→ ~Apr 2018
NDA/BLA
Jul 2018
→ Jun 2031
NDA/BLACurrent
NCT04827343
446 pts·ADPKD
2018-07→2028-05·Not yet recruiting
NCT06183786
2,228 pts·ADHD
2024-02→2031-06·Completed
2,674 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-05-252.2y awayPh3 Readout· ADPKD
2031-06-015.2y awayPh3 Readout· ADHD
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
NDA/BLA
Not yet…
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2028-05-25 · 2.2y away
ADPKD
Ph3 Readout
2031-06-01 · 5.2y away
ADHD
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04827343 | NDA/BLA | ADPKD | Not yet recr... | 446 | NT-proBNP |
| NCT06183786 | NDA/BLA | ADHD | Completed | 2228 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 | |
| ILM-2412 | Illumina | Phase 3 | PLK4 | |
| ROI-3353 | Roivant Sciences | Phase 1/2 | PLK4 | |
| VKT-6548 | Viking Therapeutics | Phase 2/3 | PD-L1 |