Modality
Small Molecule
MOA
Cl18.2
Target
AuroraA
Pathway
STING
EoEHNSCC
Development Pipeline
Preclinical
~Dec 2009
→ ~Mar 2011
Phase 1
~Jun 2011
→ ~Sep 2012
Phase 2
~Dec 2012
→ ~Mar 2014
Phase 3
~Jun 2014
→ ~Sep 2015
NDA/BLA
~Dec 2015
→ ~Mar 2017
Approved
Jun 2017
→ Dec 2030
ApprovedCurrent
NCT03369455
277 pts·HNSCC
2018-12→TBD·Active
NCT07571245
1,889 pts·HNSCC
2023-05→2030-12·Recruiting
NCT07572821
297 pts·EoE
2017-06→2027-04·Active
2,463 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2027-04-051.0y awayPh3 Readout· EoE
2030-12-044.7y awayPh3 Readout· HNSCC
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Active
Approved
Active
Approved
Recruit…
Catalysts
Ph3 Readout
2027-04-05 · 1.0y away
EoE
Ph3 Readout
2030-12-04 · 4.7y away
HNSCC
RecruitingActive|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03369455 | Approved | HNSCC | Active | 277 | CfB |
| NCT07571245 | Approved | HNSCC | Recruiting | 1889 | PASI75 |
| NCT07572821 | Approved | EoE | Active | 297 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| Motarapivir | GSK | Preclinical | AuroraA | |
| BAY-8733 | Bayer | Preclinical | AuroraA | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| BNT-8090 | BioNTech | Phase 2 | AuroraA | |
| ARG-6988 | Argenx | Preclinical | AuroraA | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| VKT-6548 | Viking Therapeutics | Phase 2/3 | PD-L1 | |
| Tiratapinarof | Intellia | NDA/BLA | APOC3 | |
| Semamavacamten | Ideaya Bio | Phase 1/2 | AuroraA |