Modality
Fusion Protein
MOA
PLK4i
Target
KIF18A
Pathway
NF-κB
Cholangiocarcinoma
Development Pipeline
Preclinical
~Dec 2013
→ ~Mar 2015
Phase 1
~Jun 2015
→ ~Sep 2016
Phase 2
~Dec 2016
→ ~Mar 2018
Phase 3
~Jun 2018
→ ~Sep 2019
NDA/BLA
~Dec 2019
→ ~Mar 2021
Approved
Jun 2021
→ Jan 2031
ApprovedCurrent
NCT04681151
1,900 pts·Cholangiocarcinoma
2023-02→2028-10·Recruiting
NCT06422869
269 pts·Cholangiocarcinoma
2021-06→2025-06·Recruiting
NCT03747819
1,197 pts·Cholangiocarcinoma
2022-08→2027-11·Recruiting
+1 more trial
5,219 total pts1 indication
CompletedCurrentUpcoming
Catalysts (5)
2025-06-209mo agoPh3 Readout· Cholangiocarcinoma
2025-12-213mo agoEnrollment Complete· Cholangiocarcinoma
2027-11-081.6y awayPh3 Readout· Cholangiocarcinoma
2028-10-232.6y awayPh3 Readout· Cholangiocarcinoma
2031-01-114.8y awayPh3 Readout· Cholangiocarcinoma
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031
Approved
Recruit…
Approved
Recruit…
Approved
Recruit…
Approved
Complet…
Catalysts
Ph3 Readout
2025-06-20 · 9mo ago
Cholangiocarcinoma
Enrollment Complete
2025-12-21 · 3mo ago
Cholangiocarcinoma
Ph3 Readout
2027-11-08 · 1.6y away
Cholangiocarcinoma
Ph3 Readout
2028-10-23 · 2.6y away
Cholangiocarcinoma
Ph3 Readout
2031-01-11 · 4.8y away
Cholangiocarcinoma
RecruitingCompleted|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04681151 | Approved | Cholangiocarcinoma | Recruiting | 1900 | FEV1 |
| NCT06422869 | Approved | Cholangiocarcinoma | Recruiting | 269 | UPCR |
| NCT03747819 | Approved | Cholangiocarcinoma | Recruiting | 1197 | eGFR |
| NCT06547809 | Approved | Cholangiocarcinoma | Completed | 1853 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A | |
| Lisoosocimab | Zealand Pharma | Approved | KIF18A | |
| Talatenlimab | Praxis Precision | Phase 1/2 | KIF18A | |
| Liravorutinib | Biomea Fusion | Phase 1/2 | GPRC5D | |
| Talainavolisib | Fate Ther | Approved | KIF18A | |
| SLD-2973 | Solid Bio | NDA/BLA | KIF18A |