Takeda’s oral narcolepsy drug, oveporexton, has met the primary and secondary endpoints in two Phase III trials.
The FirstLight (NCT06470828) and RadiantLight (NCT06505031) trials both met all their endpoints in patients with narcolepsy type 1 (NT1) after 12 weeks of treatment.
The primary and secondary endpoints measured changes in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life and daily life functions. These were all statistically significant and clinically meaningful improvements, achieving near normal ranges across the broad range of symptoms investigated.
The drug also remained generally well-tolerated with a safety profile consistent with other oveporexton studies, with the most common adverse events (AEs) being insomnia, urinary urgency and frequency. No serious treatment-related adverse events were reported.
Based on the study results, Takeda plans to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) and other global regulators during the 2025 fiscal year.
Oveporexton (TAK-861) is an investigational oral orexin receptor 2 (OX2R)-selective agonist. It is designed to address the core cause of NT1 by compensating for orexin deficiency, aiming to improve wakefulness and restore normal sleep-wake patterns. Orexin is a natural brain chemical that plays a crucial role in maintaining wakefulness and regulating the sleep-wake cycle.
Takeda president Christophe Weber said: “We are thrilled to reach this pivotal milestone for the oveporexton program. Oveporexton is a testament to Takeda’s strength in discovering and developing a potential new class of medicines for difficult-to-treat diseases such as narcolepsy type 1.”
Of the patients across the two Phase III studies, more than 95% enrolled in the ongoing long-term extension (LTE) study.
In 2020, Jazz Pharmaceuticals’ Xywav (calcium, magnesium, potassium, and sodium oxybates) was approved by the FDA and was the first approved new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
Other treatment options for NT1 include trying to manage a regular sleeping pattern, as well as therapies, including stimulants such as Provigil (modafinil), Nuvigil (armodafinil), and Ritalin (methylphenidate) to promote wakefulness. Patients may also receive solriamfetol or pitolisant.
To help with cataplexy attacks, either sodium oxybate or some antidepressants such as SSRIs [selective serotonin reuptake inhibitors] and SNRIs [serotonin-norepinephrine reuptake inhibitors] can be used to manage symptoms.
If approved, GlobalData predicts sales of oveporexton will reach $1bn in 2030.
GlobalData is the parent company of Clinical Trials Arena.
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