Modality
Radioligand
MOA
KIF18Ai
Target
KIF18A
Pathway
PI3K/AKT
PV
Development Pipeline
Preclinical
~Nov 2013
→ ~Feb 2015
Phase 1
~May 2015
→ ~Aug 2016
Phase 2
~Nov 2016
→ ~Feb 2018
Phase 3
~May 2018
→ ~Aug 2019
NDA/BLA
~Nov 2019
→ ~Feb 2021
Approved
May 2021
→ Dec 2029
ApprovedCurrent
NCT04148766
316 pts·PV
2025-09→2029-12·Completed
NCT04293714
1,316 pts·PV
2023-12→2026-01·Completed
NCT07242073
2,330 pts·PV
2021-05→2026-01·Not yet recruiting
3,962 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2026-01-093mo agoPh3 Readout· PV
2026-01-142mo agoPh3 Readout· PV
2029-12-083.7y awayPh3 Readout· PV
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Not yet…
Approved
Complet…
Approved
Complet…
Catalysts
Ph3 Readout
2026-01-09 · 3mo ago
PV
Ph3 Readout
2026-01-14 · 2mo ago
PV
Ph3 Readout
2029-12-08 · 3.7y away
PV
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04148766 | Approved | PV | Completed | 316 | 6MWD |
| NCT04293714 | Approved | PV | Completed | 1316 | DAS28 |
| NCT07242073 | Approved | PV | Not yet recr... | 2330 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 | |
| BMR-8526 | BioMarin | Phase 1/2 | CD38 | |
| Bemanaritide | Blueprint Medicines | Phase 2 | CD38 |