Modality
Nanobody
MOA
EZH2i
Target
KIF18A
Pathway
Cell Cycle
RB
Development Pipeline
Preclinical
~Jun 2016
→ ~Sep 2017
Phase 1
~Dec 2017
→ ~Mar 2019
Phase 2
Jun 2019
→ Jul 2029
Phase 2Current
NCT04704602
132 pts·RB
2020-11→2029-07·Terminated
NCT05312124
2,952 pts·RB
2019-06→2028-06·Active
3,084 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-06-022.2y awayPh3 Readout· RB
2029-07-083.3y awayPh3 Readout· RB
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
P2/3
Active
P2/3
Termina…
Catalysts
Ph3 Readout
2028-06-02 · 2.2y away
RB
Ph3 Readout
2029-07-08 · 3.3y away
RB
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04704602 | Phase 2/3 | RB | Terminated | 132 | PANSS |
| NCT05312124 | Phase 2/3 | RB | Active | 2952 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| Adagrazumab | Novartis | Phase 2/3 | Cl18.2 | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| NVO-9615 | Novo Nordisk | Phase 2/3 | PRMT5 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| Polalucimab | Jazz Pharma | Preclinical | PLK4 | |
| ASN-7038 | Ascendis Pharma | Phase 3 | VEGF | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| Liratinib | Krystal Biotech | NDA/BLA | TIM-3 | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A |