Modality
Peptide
MOA
Anti-Tau
Target
PLK4
Pathway
Autophagy
MCC
Development Pipeline
Preclinical
~Jan 2010
→ ~Apr 2011
Phase 1
~Jul 2011
→ ~Oct 2012
Phase 2
~Jan 2013
→ ~Apr 2014
Phase 3
~Jul 2014
→ ~Oct 2015
NDA/BLA
~Jan 2016
→ ~Apr 2017
Approved
Jul 2017
→ Nov 2031
ApprovedCurrent
NCT05390098
1,668 pts·MCC
2017-07→2030-08·Completed
NCT05201080
1,190 pts·MCC
2024-07→2026-01·Active
NCT04583891
1,663 pts·MCC
2019-03→2031-11·Active
4,521 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2026-01-053mo agoPh3 Readout· MCC
2030-08-104.4y awayPh3 Readout· MCC
2031-11-165.6y awayPh3 Readout· MCC
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Complet…
Approved
Active
Approved
Active
Catalysts
Ph3 Readout
2026-01-05 · 3mo ago
MCC
Ph3 Readout
2030-08-10 · 4.4y away
MCC
Ph3 Readout
2031-11-16 · 5.6y away
MCC
ActiveCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05390098 | Approved | MCC | Completed | 1668 | CfB |
| NCT05201080 | Approved | MCC | Active | 1190 | CR |
| NCT04583891 | Approved | MCC | Active | 1663 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| BGN-3305 | BeiGene | Phase 2 | BCMA | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 |