Modality
mRNA
MOA
TNFi
Target
FGFR
Pathway
Hedgehog
RBFTDEpilepsy
Development Pipeline
Preclinical
~Mar 2014
→ ~Jun 2015
Phase 1
~Sep 2015
→ ~Dec 2016
Phase 2
Mar 2017
→ Jun 2027
Phase 2Current
NCT03048633
1,983 pts·RB
2017-03→TBD·Not yet recruiting
NCT05157902
2,630 pts·FTD
2024-01→2027-06·Active
4,613 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-06-151.2y awayPh3 Readout· FTD
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3
P2/3
Not yet…
P2/3
Active
Catalysts
Ph3 Readout
2027-06-15 · 1.2y away
FTD
ActiveNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03048633 | Phase 2/3 | RB | Not yet recr... | 1983 | VA |
| NCT05157902 | Phase 2/3 | FTD | Active | 2630 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| Ribozanubrutinib | Genmab | Approved | GPRC5D | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Tixatapinarof | Recursion | Approved | FGFR | |
| Rimatinib | Ventyx Bio | Phase 1 | CD20 | |
| Talatuximab | Protagonist | Phase 2 | B7-H3 |