Modality
Peptide
MOA
KIF18Ai
Target
USP1
Pathway
Innate Imm
CFRCC
Development Pipeline
Preclinical
~Aug 2013
→ ~Nov 2014
Phase 1
~Feb 2015
→ ~May 2016
Phase 2
~Aug 2016
→ ~Nov 2017
Phase 3
~Feb 2018
→ ~May 2019
NDA/BLA
Aug 2019
→ Oct 2029
NDA/BLACurrent
NCT03814279
2,464 pts·RCC
2019-08→2029-10·Active
NCT08023034
2,623 pts·CF
2023-11→2026-04·Not yet recruiting
5,087 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-04-152w awayPh3 Readout· CF
2029-10-163.5y awayPh3 Readout· RCC
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
NDA/BLA
Active
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2026-04-15 · 2w away
CF
Ph3 Readout
2029-10-16 · 3.5y away
RCC
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03814279 | NDA/BLA | RCC | Active | 2464 | EFS |
| NCT08023034 | NDA/BLA | CF | Not yet recr... | 2623 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 | |
| BMR-8526 | BioMarin | Phase 1/2 | CD38 | |
| Bemanaritide | Blueprint Medicines | Phase 2 | CD38 | |
| Talafotisoran | Blueprint Medicines | Phase 2/3 | IL-23 |