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AL001
AL001 is a monoclonal antibody that activates TREM2 signaling on microglia to promote neuroinflammatory resolution and clearance of pathogenic proteins in neurodegenerative disease.
AL001 is a monoclonal antibody that activates TREM2 signaling on microglia to promote neuroinflammatory resolution and clearance of pathogenic proteins in neurodegenerative disease. Used for Alzheimer's disease (early symptomatic or prodromal stage).
At a glance
| Generic name | AL001 |
|---|---|
| Also known as | lithium salicylate/L-proline cocrystal, Alzamend AL001 |
| Sponsor | Alector Inc. |
| Drug class | TREM2 agonist monoclonal antibody |
| Target | TREM2 |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
AL001 binds to TREM2 (triggering receptor expressed on myeloid cells 2) on microglial cells, enhancing their phagocytic capacity and shifting them toward a neuroprotective phenotype. This mechanism aims to reduce neuroinflammation and promote clearance of amyloid-beta and tau pathology in Alzheimer's disease and other neurodegenerative conditions.
Approved indications
- Alzheimer's disease (early symptomatic or prodromal stage)
Common side effects
- Amyloid-related imaging abnormalities (ARIA)
- Infusion-related reactions
- Headache
Key clinical trials
- A Phase 3 Study to Evaluate Efficacy and Safety of AL001 in Frontotemporal Dementia (INFRONT-3) (PHASE3)
- Continuation Study for Latozinemab (PHASE3)
- A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects (PHASE1)
- A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2) (PHASE2)
- A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS (PHASE2)
- Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects (PHASE1, PHASE2)
- Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD (PHASE1, PHASE2)
- Efficacy and Safety of AL-001 Ophthalmic Injection in Subjects with WAMD (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AL001 CI brief — competitive landscape report
- AL001 updates RSS · CI watch RSS
- Alector Inc. portfolio CI