AL001

PreclinicalBiologic

AAlector Inc.

AL001 is one of 13 biologic programs targeting Bipolar I Disorder. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Bipolar I DisorderRecruiting

Bipolar I DisorderPreclinical

Recruiting

Competition

Competitive Landscape

13 competitors in Bipolar I Disorder

#DrugCompanyPhaseTrials

Zyprexa

MMODAG GmbH

Approved

11 2

Risperdal

WWim Janssens

Approved

4 3

Lexapro

AbbVie

Approved

—4

Lithobid

SSolvay Pharmaceuticals

Approved

1 5

Acetadote

AArbor Pharmaceuticals, Inc.

OLZ/SAM

2 7

Endoxifen

JJina Pharmaceuticals Inc.

Phase 3

2 8

Icalcaprant

AbbVie

Phase 2

1 9

Treatment as Usual

AAB Biotics, SA

Preclinical

1 10

Loxitane

NNew Beta Innovation Limited

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalRecruiting

Bipolar I Disorder

NCT07540338

Clinical

Trials by Indication[1]

Frontotemporal Dementia3 trials

A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation

Completed·AAlector Inc.·Phase 1·NCT03636204·64 enrolled

A Phase 2 Study to Evaluate Safety of Long-term AL001 Dosing in Frontotemporal Dementia (FTD) Patients (INFRONT-2)

Completed·AAlector Inc.·Phase 2·NCT03987295·33 enrolled

A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of AL001 in Individuals at Risk for or With Frontotemporal Dementia Due to Heterozygous Mutations in the Progranulin Gene

Terminated·AAlector Inc.·Phase 3·NCT04374136·119 enrolled

Phase 21 trial

A Phase 2 Study to Evaluate AL001 in C9orf72-Associated ALS

Terminated·AAlector Inc.·Phase 2·NCT05053035·5 enrolled

Alzheimer's Disease1 trial

Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects

Completed·AAlzamend Neuro, Inc.·Phase 1/2·NCT05363293·65 enrolled

Neurology1 trial

A Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability 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

Completed·AAlzamend Neuro, Inc.·Phase 1·NCT06921590·15 enrolled

Bipolar I Disorder1 trial

A Randomized, Balanced, Phase 1/2A, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder

Recruiting·AAlzamend Neuro, Inc.·Preclinical·NCT07540338·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for AL001. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AL001 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AL001. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Alector Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Preclinical[1]
Company: AAlector Inc.

AL001

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Frontotemporal Dementia3 trials

Phase 21 trial

Alzheimer's Disease1 trial

Neurology1 trial

Bipolar I Disorder1 trial

References

Drug Info

Quick Facts

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