Dr Rafael del Río Villegas, a researcher at CEU San Pablo University and the Vithas Foundation, and head of the Neurophysiology and Sleep Disorders Unit at Vithas Madrid Arturo Soria University Hospital and Vithas Madrid La Milagrosa University Hospital, has published a pioneering study in the esteemed New England Journal of Medicine on the use of TAK-861 (Oveporexton), a selective orexin receptor 2 agonist, for the treatment of Narcolepsy type 1 (NT1).
The results of this study are promising and suggest that TAK-861 could become an effective therapeutic option for patients with type 1 narcolepsy. Dr. Rafael del Río Villegas asserts that the enhancement in the ability to stay awake, the diminution of diurnal somnolence, and the management of cataplexy have a very significant impact on the quality of life of these patients.
Narcolepsy type 1 is a sleep disorder characterised by excessive daytime sleepiness, cataplexy, and other symptoms related to hypocretinergic signaling, which is deficient in these patients. The study, which comprised 112 participants from various regions of the world, demonstrated that TAK-861 significantly improves the ability to stay awake, reduces daytime sleepiness and reduces the frequency of cataplexy episodes.
According to data from the Spanish Society of Neurology, narcolepsy type 1 is a rare disease that affects between 20 and 60 people for every 100,000 inhabitants. Estimates suggest that approximately 25,000 individuals in Spain are affected by this condition.
Study results
The randomised, placebo-controlled phase 2 clinical trial demonstrated that subjects administered TAK-861 exhibited significant enhancements in sleep latency on the Maintenance of Wakefulness Test (MWT) and the Epworth Sleepiness Scale (ESS). Furthermore, a substantial decrease in the frequency of cataplexy episodes was observed on a weekly basis.
The study also proceeded to evaluate the safety and tolerability of TAK-861. The most common adverse events were insomnia, urgency and urinary frequency, the majority of which resolved within a week. There were no reported cases of hepatotoxicity, thus emphasising the safety of the drug in comparison to other substances that had previously been utilised.
For Dr del Río Villegas, the results are very promising: The results of this study have been met with great enthusiasm, and it is hoped that TAK-861 (Oveporexton) will offer new hope to patients suffering from type 1 narcolepsy. The investigation will be continued in order to confirm these results and to explore the potential of this treatment in phase 3 studies.
On 13 June, a scientific conference and a meeting with patients will be held at the CEU San Pablo University to publicise these advances. The event will be held in the Assembly Hall of the Escuela Politécnica Superior at the Montepríncipe campus, commencing at 10 am. Participation is open to both professionals and interested patients, who are requested to register via the following email address: [email protected] .
Further information: Dauvilliers, Y., et al (2025). Oveporexton, an Oral Orexin Receptor 2-Selective Agonist, in Narcolepsy Type 1, N Engl J Med 2025;392:1905-16.DOI: 10.1056