Alkeus Launches Phase 3 Stargardt Trial
At OIS Retina, Carlos Quezada Ruiz, MD, highlighted the launch of the global phase 3 NORTHSTAR trial evaluating investigational oral gildeuretinol for Stargardt disease.
By
Carlos Quezada Ruiz, MD
July 15, 2026
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Alkeus Pharmaceuticals has launched the global phase 3 NORTHSTAR trial for the investigational oral treatment gildeuretinol for Stargardt disease.
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The NORTHSTAR trial aims to enroll approximately 230 patients, randomized 1:1 to receive either placebo or gildeuretinol for 2 years.
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The primary endpoint of the trial will assess changes in the rate of growth of retinal atrophic lesions from month 6 to month 24.
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A key secondary endpoint will evaluate changes in low-luminance visual acuity, which showed positive results in previous phase 2 trials.
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Gildeuretinol has demonstrated significant benefits in both Stargardt disease and geographic atrophy programs in earlier studies.
