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ALK-001

Phase 3Small molecule

AAlkeus Pharmaceuticals, Inc.

1

Indications

5

Total Trials

3

Active Trials

0

Competitors

Pipeline

Status by Indication[3][1]

Indication

Stargardt DiseaseActive, not recruiting

Stargardt DiseasePhase 3

Active, not recruiting

Timeline

Expected Milestones

Q4 2028

Phase 2Active, not recruiting

Stargardt Disease

NCT02402660

Q4 2029

Phase 2Active, not recruiting

Stargardt Disease

NCT04239625

Q4 2030

Phase 3Recruiting

Stargardt Disease

NCT07419334

Clinical

Trials by Indication[1]

Stargardt Disease3 trials

A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease

Active, not recruiting·AAlkeus Pharmaceuticals, Inc.·Phase 2·NCT04239625·200 enrolled

A Phase 2 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease

Active, not recruiting·AAlkeus Pharmaceuticals, Inc.·Phase 2·NCT02402660·160 enrolled

A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK 001) on the Progression of Stargardt Disease (STGD)

Recruiting·AAlkeus Pharmaceuticals, Inc.·Phase 3·NCT07419334·230 enrolled

Geographic Atrophy1 trial

Phase 2/3 Study of ALK-001 in Geographic Atrophy

Completed·AAlkeus Pharmaceuticals, Inc.·Phase 2/3·NCT03845582·200 enrolled

Phase 11 trial

Phase 1 Safety Study of ALK-001 in Healthy Volunteers

Completed·AAlkeus Pharmaceuticals, Inc.·Phase 1·NCT02230228·40 enrolled

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for ALK-001. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — ALK-001 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for ALK-001. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Alkeus Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: AAlkeus Pharmaceuticals, Inc.

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