Modality
mAb
MOA
FcRni
Target
KIF18A
Pathway
DDR
FLCKDGIST
Development Pipeline
Preclinical
~Feb 2010
→ ~May 2011
Phase 1
~Aug 2011
→ ~Nov 2012
Phase 2
~Feb 2013
→ ~May 2014
Phase 3
~Aug 2014
→ ~Nov 2015
NDA/BLA
~Feb 2016
→ ~May 2017
Approved
Aug 2017
→ Feb 2031
ApprovedCurrent
NCT03898064
115 pts·CKD
2024-10→2029-11·Terminated
NCT08534521
109 pts·FL
2017-08→TBD·Terminated
NCT03567049
839 pts·CKD
2018-09→2031-02·Completed
+1 more trial
1,177 total pts3 indications
CompletedCurrentUpcoming
Catalysts (3)
2029-07-113.3y awayPh3 Readout· GIST
2029-11-023.6y awayPh3 Readout· CKD
2031-02-114.9y awayPh3 Readout· CKD
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Termina…
Approved
Complet…
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2029-07-11 · 3.3y away
GIST
Ph3 Readout
2029-11-02 · 3.6y away
CKD
Ph3 Readout
2031-02-11 · 4.9y away
CKD
ActiveCompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03898064 | Approved | CKD | Terminated | 115 | DAS28 |
| NCT08534521 | Approved | FL | Terminated | 109 | PFS |
| NCT03567049 | Approved | CKD | Completed | 839 | DAS28 |
| NCT07234921 | Approved | GIST | Active | 114 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| Zanufutibatinib | Intra-Cellular | NDA/BLA | CD38 | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A | |
| Lisoosocimab | Zealand Pharma | Approved | KIF18A | |
| Cevinaritide | Praxis Precision | Phase 3 | AuroraA |