Modality
Small Molecule
MOA
SGLT2i
Target
KIF18A
Pathway
T-cell
Cholangiocarcinoma
Development Pipeline
Preclinical
~Jul 2014
→ ~Oct 2015
Phase 1
~Jan 2016
→ ~Apr 2017
Phase 2
~Jul 2017
→ ~Oct 2018
Phase 3
~Jan 2019
→ ~Apr 2020
NDA/BLA
~Jul 2020
→ ~Oct 2021
Approved
Jan 2022
→ Mar 2031
ApprovedCurrent
NCT07507533
734 pts·Cholangiocarcinoma
2022-01→2027-02·Recruiting
NCT04567653
606 pts·Cholangiocarcinoma
2024-11→2031-03·Active
1,340 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2027-02-1210mo awayPh3 Readout· Cholangiocarcinoma
2031-03-275.0y awayPh3 Readout· Cholangiocarcinoma
Trial Timeline
2022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Recruit…
Approved
Active
Catalysts
Ph3 Readout
2027-02-12 · 10mo away
Cholangiocarcinoma
Ph3 Readout
2031-03-27 · 5.0y away
Cholangiocarcinoma
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07507533 | Approved | Cholangiocarcinoma | Recruiting | 734 | NT-proBNP |
| NCT04567653 | Approved | Cholangiocarcinoma | Active | 606 | Biomarker |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| 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 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| Motazanubrutinib | Biogen | Preclinical | CD38 | |
| ALN-5628 | Alnylam | Phase 1/2 | APOC3 | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A |