Modality
ERT
MOA
TNFi
Target
CD38
Pathway
Incretin
RSVEoEAlzheimer's
Development Pipeline
Preclinical
~Nov 2014
→ ~Feb 2016
Phase 1
~May 2016
→ ~Aug 2017
Phase 2
~Nov 2017
→ ~Feb 2019
Phase 3
May 2019
→ Dec 2031
Phase 3Current
NCT08249222
1,127 pts·Alzheimer's
2019-05→2029-06·Active
NCT08242364
2,894 pts·Alzheimer's
2025-12→2031-12·Active
NCT06983652
230 pts·Alzheimer's
2020-01→2030-12·Terminated
4,251 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2029-06-263.2y awayPh3 Readout· Alzheimer's
2030-12-184.7y awayPh3 Readout· Alzheimer's
2031-12-185.7y awayPh3 Readout· Alzheimer's
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P3
Active
P3
Termina…
P3
Active
Catalysts
Ph3 Readout
2029-06-26 · 3.2y away
Alzheimer's
Ph3 Readout
2030-12-18 · 4.7y away
Alzheimer's
Ph3 Readout
2031-12-18 · 5.7y away
Alzheimer's
ActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08249222 | Phase 3 | Alzheimer's | Active | 1127 | Biomarker |
| NCT08242364 | Phase 3 | Alzheimer's | Active | 2894 | PASI75 |
| NCT06983652 | Phase 3 | Alzheimer's | Terminated | 230 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-6360 | Novartis | Approved | CD38 | |
| Doxasotorasib | AbbVie | Phase 2 | CD38 | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn |