Modality
Peptide
MOA
KIF18Ai
Target
FGFR
Pathway
Checkpoint
LN
Development Pipeline
Preclinical
~Jul 2011
→ ~Oct 2012
Phase 1
~Jan 2013
→ ~Apr 2014
Phase 2
~Jul 2014
→ ~Oct 2015
Phase 3
~Jan 2016
→ ~Apr 2017
NDA/BLA
~Jul 2017
→ ~Oct 2018
Approved
Jan 2019
→ Dec 2031
ApprovedCurrent
NCT08620824
1,364 pts·LN
2023-10→TBD·Terminated
NCT08055995
2,371 pts·LN
2022-01→TBD·Terminated
NCT05277312
1,340 pts·LN
2025-04→2025-09·Not yet recruiting
+1 more trial
5,833 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2025-09-087mo agoPh3 Readout· LN
2031-12-045.7y awayPh3 Readout· LN
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Recruit…
Approved
Termina…
Approved
Termina…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-09-08 · 7mo ago
LN
Ph3 Readout
2031-12-04 · 5.7y away
LN
RecruitingTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08620824 | Approved | LN | Terminated | 1364 | EFS |
| NCT08055995 | Approved | LN | Terminated | 2371 | eGFR |
| NCT05277312 | Approved | LN | Not yet recr... | 1340 | 6MWD |
| NCT04356653 | Approved | LN | Recruiting | 758 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 |