Modality
Small Molecule
MOA
TNFi
Target
PI3Kα
Pathway
Hedgehog
FTDMS
Development Pipeline
Preclinical
~Jun 2014
→ ~Sep 2015
Phase 1
~Dec 2015
→ ~Mar 2017
Phase 2
~Jun 2017
→ ~Sep 2018
Phase 3
Dec 2018
→ Mar 2031
Phase 3Current
NCT03412600
959 pts·MS
2018-12→2031-03·Not yet recruiting
NCT03908408
479 pts·MS
2020-02→2026-04·Terminated
1,438 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-04-112w awayPh3 Readout· MS
2031-03-215.0y awayPh3 Readout· MS
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P3
Not yet…
P3
Termina…
Catalysts
Ph3 Readout
2026-04-11 · 2w away
MS
Ph3 Readout
2031-03-21 · 5.0y away
MS
TerminatedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03412600 | Phase 3 | MS | Not yet recr... | 959 | Mayo |
| NCT03908408 | Phase 3 | MS | Terminated | 479 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| Ribozanubrutinib | Genmab | Approved | GPRC5D | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα |