Modality
siRNA
MOA
PRMT5i
Target
B7-H3
Pathway
DDR
CTCLParkinson'sRCC
Development Pipeline
Preclinical
~Jan 2012
→ ~Apr 2013
Phase 1
~Jul 2013
→ ~Oct 2014
Phase 2
~Jan 2015
→ ~Apr 2016
Phase 3
~Jul 2016
→ ~Oct 2017
NDA/BLA
Jan 2018
→ Mar 2031
NDA/BLACurrent
NCT07447867
2,080 pts·CTCL
2021-07→2031-03·Recruiting
NCT07676796
2,451 pts·Parkinson's
2018-01→2027-08·Completed
4,531 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-08-261.4y awayPh3 Readout· Parkinson's
2031-03-285.0y awayPh3 Readout· CTCL
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
NDA/BLA
Complet…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2027-08-26 · 1.4y away
Parkinson's
Ph3 Readout
2031-03-28 · 5.0y away
CTCL
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07447867 | NDA/BLA | CTCL | Recruiting | 2080 | EASI-75 |
| NCT07676796 | NDA/BLA | Parkinson's | Completed | 2451 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D |