Modality
Peptide
MOA
KIF18Ai
Target
JAK1
Pathway
Hedgehog
FTD
Development Pipeline
Preclinical
~Jul 2012
→ ~Oct 2013
Phase 1
~Jan 2014
→ ~Apr 2015
Phase 2
~Jul 2015
→ ~Oct 2016
Phase 3
Jan 2017
→ Nov 2031
Phase 3Current
NCT06722311
355 pts·FTD
2019-09→2029-04·Not yet recruiting
NCT06849678
546 pts·FTD
2024-05→2030-02·Completed
NCT08597723
2,597 pts·FTD
2017-01→2028-05·Completed
+1 more trial
4,043 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2028-05-202.1y awayPh3 Readout· FTD
2029-04-053.0y awayPh3 Readout· FTD
2030-02-163.9y awayPh3 Readout· FTD
2031-11-075.6y awayPh3 Readout· FTD
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P3
Complet…
P3
Not yet…
P3
Complet…
P3
Not yet…
Catalysts
Ph3 Readout
2028-05-20 · 2.1y away
FTD
Ph3 Readout
2029-04-05 · 3.0y away
FTD
Ph3 Readout
2030-02-16 · 3.9y away
FTD
Ph3 Readout
2031-11-07 · 5.6y away
FTD
CompletedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06722311 | Phase 3 | FTD | Not yet recr... | 355 | HAM-D |
| NCT06849678 | Phase 3 | FTD | Completed | 546 | SRI-4 |
| NCT08597723 | Phase 3 | FTD | Completed | 2597 | SRI-4 |
| NCT08728182 | Phase 3 | FTD | Not yet recr... | 545 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| GIL-8529 | Gilead Sciences | Phase 1/2 | JAK1 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 |