Modality
Vaccine
MOA
Cl18.2
Target
ALK
Pathway
Autophagy
Alzheimer'sIgAN
Development Pipeline
Preclinical
~Apr 2011
→ ~Jul 2012
Phase 1
~Oct 2012
→ ~Jan 2014
Phase 2
~Apr 2014
→ ~Jul 2015
Phase 3
~Oct 2015
→ ~Jan 2017
NDA/BLA
~Apr 2017
→ ~Jul 2018
Approved
Oct 2018
→ Dec 2027
ApprovedCurrent
NCT08843278
432 pts·IgAN
2018-10→2025-05·Recruiting
NCT07673425
1,117 pts·Alzheimer's
2019-05→2027-12·Not yet recruiting
1,549 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-05-2010mo agoPh3 Readout· IgAN
2026-03-162w agoAdCom· Alzheimer's
2027-12-241.7y awayPh3 Readout· Alzheimer's
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
Approved
Recruit…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-05-20 · 10mo ago
IgAN
AdCom
2026-03-16 · 2w ago
Alzheimer's
Ph3 Readout
2027-12-24 · 1.7y away
Alzheimer's
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08843278 | Approved | IgAN | Recruiting | 432 | Safety |
| NCT07673425 | Approved | Alzheimer's | Not yet recr... | 1117 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Zorivorutinib | Bristol-Myers Squibb | Approved | DLL3 | |
| GSK-6983 | GSK | Phase 2 | ALK | |
| BAY-3308 | Bayer | Phase 1 | ALK | |
| Elrarapivir | Regeneron | Phase 1 | GIP-R | |
| Tixarelsin | Vertex Pharma | Phase 1 | ALK | |
| VRT-6833 | Vertex Pharma | Preclinical | ALK | |
| Niralucimab | Ionis | Phase 1 | ALK | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| 180-6098 | Innovent Bio | Phase 1 | ALK |