Modality
Fusion Protein
MOA
CGRPant
Target
MALT1
Pathway
Wnt
Alzheimer's
Development Pipeline
Preclinical
~May 2013
→ ~Aug 2014
Phase 1
~Nov 2014
→ ~Feb 2016
Phase 2
~May 2016
→ ~Aug 2017
Phase 3
Nov 2017
→ May 2028
Phase 3Current
NCT05351374
2,648 pts·Alzheimer's
2022-08→2028-05·Recruiting
NCT06627489
2,699 pts·Alzheimer's
2017-11→TBD·Completed
NCT06292665
872 pts·Alzheimer's
2022-12→2026-05·Completed
+1 more trial
6,461 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-05-151mo awayPh3 Readout· Alzheimer's
2028-05-232.1y awayPh3 Readout· Alzheimer's
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
P3
Complet…
P3
Recruit…
P3
Complet…
P3
Termina…
Catalysts
Ph3 Readout
2026-05-15 · 1mo away
Alzheimer's
Ph3 Readout
2028-05-23 · 2.1y away
Alzheimer's
RecruitingCompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05351374 | Phase 3 | Alzheimer's | Recruiting | 2648 | Mayo |
| NCT06627489 | Phase 3 | Alzheimer's | Completed | 2699 | Mayo |
| NCT06292665 | Phase 3 | Alzheimer's | Completed | 872 | eGFR |
| NCT06116897 | Phase 3 | Alzheimer's | Terminated | 242 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| ALN-3958 | Alnylam | Phase 2 | MALT1 |