An oral drug improved wakefulness and cataplexy in narcolepsy trials
In two 12-week phase 3 trials, oveporexton also reduced daytime sleepiness but often caused increased urination and temporary insomnia.
Editorial illustration — not from the study.
The First Light and Radiant Light trials enrolled 273 people ages 16 to 70 with narcolepsy type 1. Participants received twice-daily oveporexton or a placebo for 12 weeks, with the studies testing whether the drug improved their ability to stay awake and reduced other symptoms.
Compared with placebo, oveporexton produced larger improvements in sleep-test results and daytime sleepiness scores, along with greater reductions in weekly cataplexy rates. Adverse events were more common with oveporexton, particularly increased urinary frequency and temporary insomnia.
What the trials found
In the First Light trial, participants received twice-daily oveporexton at 1 mg or 2 mg, or placebo. In the Radiant Light trial, they received 2 mg of oveporexton or placebo. After 12 weeks, oveporexton increased average sleep latency—the time participants could remain awake during a test—from 14.3 to 19.8 minutes, compared with a change of -0.4 to -0.8 minutes with placebo. All comparisons had adjusted P values below 0.001.
Daytime sleepiness, measured on a 0-to-24 scale, fell by 9.7 to 11.8 points with oveporexton, compared with 1.5 to 1.7 points with placebo. Weekly cataplexy rates fell by a median of 79.0% to 88.8% with oveporexton, compared with 27.7% to 39.1% with placebo.
Adverse events occurred in 86% to 89% of participants receiving oveporexton and 43% to 54% of those receiving placebo. Increased urinary frequency and temporary insomnia occurred in a majority of participants receiving oveporexton.
Why the results matter
Narcolepsy type 1 can cause excessive daytime sleepiness and sudden episodes of muscle weakness, known as cataplexy. These trials found that a drug designed to activate one type of orexin receptor improved both the ability to stay awake and a key symptom of the condition over 12 weeks.
Evidence and caveats
This was evidence from two randomized, placebo-controlled phase 3 trials involving 168 participants in First Light and 105 in Radiant Light. The trials lasted 12 weeks, so the abstract does not establish how well the benefits or side effects persist over longer periods. The results apply to the studied participants, ages 16 to 70, and the research was funded by Takeda Development Center Americas.
// Source
New England Journal of Medicine · 2026 · DOI: 10.1056/nejmoa2601598
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