Modality
Nanobody
MOA
FXIai
Target
PI3Kα
Pathway
Sphingolipid
Alzheimer's
Development Pipeline
Preclinical
~Jun 2013
→ ~Sep 2014
Phase 1
~Dec 2014
→ ~Mar 2016
Phase 2
~Jun 2016
→ ~Sep 2017
Phase 3
~Dec 2017
→ ~Mar 2019
NDA/BLA
Jun 2019
→ Jul 2028
NDA/BLACurrent
NCT06914999
1,137 pts·Alzheimer's
2019-06→2028-07·Active
1,137 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-07-092.3y awayPh3 Readout· Alzheimer's
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Active
Catalysts
Ph3 Readout
2028-07-09 · 2.3y away
Alzheimer's
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06914999 | NDA/BLA | Alzheimer's | Active | 1137 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-8730 | Takeda | Phase 2 | VEGF | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| Semazasiran | BeiGene | Phase 1 | PD-1 |