Modality
mRNA
MOA
PRMT5i
Target
CD38
Pathway
Tau
WilmsNSCLC
Development Pipeline
Preclinical
~May 2014
→ ~Aug 2015
Phase 1
~Nov 2015
→ ~Feb 2017
Phase 2
~May 2017
→ ~Aug 2018
Phase 3
~Nov 2018
→ ~Feb 2020
NDA/BLA
May 2020
→ Oct 2029
NDA/BLACurrent
NCT08161038
661 pts·NSCLC
2025-10→2029-10·Not yet recruiting
NCT05882063
976 pts·Wilms
2020-05→2028-08·Not yet recruiting
1,637 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-08-152.4y awayPh3 Readout· Wilms
2029-10-173.5y awayPh3 Readout· NSCLC
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2028-08-15 · 2.4y away
Wilms
Ph3 Readout
2029-10-17 · 3.5y away
NSCLC
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08161038 | NDA/BLA | NSCLC | Not yet recr... | 661 | PANSS |
| NCT05882063 | NDA/BLA | Wilms | Not yet recr... | 976 | PFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| LLY-6079 | Eli Lilly | Phase 2 | MDM2 | |
| RHH-8550 | Roche | Approved | BCL-2 | |
| RHH-682 | Roche | Phase 2 | FXIa | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D |