Modality
Gene Editing
MOA
BiTE
Target
IL-17A
Pathway
RNA Splicing
ADPKDMyelofibrosis
Development Pipeline
Preclinical
~Nov 2012
→ ~Feb 2014
Phase 1
~May 2014
→ ~Aug 2015
Phase 2
~Nov 2015
→ ~Feb 2017
Phase 3
~May 2017
→ ~Aug 2018
NDA/BLA
Nov 2018
→ Oct 2028
NDA/BLACurrent
NCT04221881
1,907 pts·Myelofibrosis
2018-11→2028-10·Not yet recruiting
NCT03535576
2,353 pts·ADPKD
2019-06→2027-01·Not yet recruiting
4,260 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-01-1510mo awayPh3 Readout· ADPKD
2028-10-072.5y awayPh3 Readout· Myelofibrosis
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2027-01-15 · 10mo away
ADPKD
Ph3 Readout
2028-10-07 · 2.5y away
Myelofibrosis
Not yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04221881 | NDA/BLA | Myelofibrosis | Not yet recr... | 1907 | PFS |
| NCT03535576 | NDA/BLA | ADPKD | Not yet recr... | 2353 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-3251 | Eli Lilly | Phase 2 | MDM2 | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| Zanutinib | Bristol-Myers Squibb | Phase 2/3 | APOC3 | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Bemarelsin | Daiichi Sankyo | Preclinical | GLP-1R | |
| DSN-7360 | Daiichi Sankyo | Approved | SGLT2 | |
| GIL-9779 | Gilead Sciences | Phase 1 | IL-17A | |
| BII-8315 | Biogen | NDA/BLA | CDK2 | |
| Geliglumide | Samsung Biologics | Phase 1 | Aβ | |
| RVM-7089 | Revolution Medicines | Phase 3 | IL-17A |