Modality
Small Molecule
MOA
SGLT2i
Target
PLK4
Pathway
RAS/MAPK
Parkinson'sCKDCF
Development Pipeline
Preclinical
~Oct 2011
→ ~Jan 2013
Phase 1
~Apr 2013
→ ~Jul 2014
Phase 2
~Oct 2014
→ ~Jan 2016
Phase 3
~Apr 2016
→ ~Jul 2017
NDA/BLA
Oct 2017
→ Sep 2031
NDA/BLACurrent
NCT04294528
1,739 pts·Parkinson's
2019-11→2028-05·Recruiting
NCT06374732
1,899 pts·Parkinson's
2017-10→2031-09·Active
3,638 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-05-212.1y awayPh3 Readout· Parkinson's
2031-09-135.5y awayPh3 Readout· Parkinson's
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Active
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2028-05-21 · 2.1y away
Parkinson's
Ph3 Readout
2031-09-13 · 5.5y away
Parkinson's
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04294528 | NDA/BLA | Parkinson's | Recruiting | 1739 | VA |
| NCT06374732 | NDA/BLA | Parkinson's | Active | 1899 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| BAY-3308 | Bayer | Phase 1 | ALK | |
| MRN-8225 | Moderna | Preclinical | TNFα | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| Motazanubrutinib | Biogen | Preclinical | CD38 | |
| ALN-5628 | Alnylam | Phase 1/2 | APOC3 | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 |