Company: TAK
Filing Date: 2025-09-08
Form Type: 6-K
Source: 0001395064-25-000130
Chunk: 5

Company: TAKEDA PHARMACEUTICAL CO LTD
Filing Date: 2025-09-08
Form: 6-K
Chunk 5
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veporexton compared to placebo in patients with narcolepsy type 1 (NT1) over 12 weeks. The studies were conducted in 19 countries with enrollment completed within six months. The FirstLight study enrolled 168 participants randomized to one of three dosing arms (twice-daily 2mg, 1mg and placebo). The RadiantLight study enrolled 105 participants randomized to two dosing arms (twice-daily 2mg and placebo). The primary endpoint in both studies was improvement in excessive daytime sleepiness (EDS) as measured by the Maintenance of Wakefulness Test (MWT), a standard measure of wakefulness. Key secondary endpoints included improvement in EDS as measured by the Epworth Sleepiness Scale (ESS) and in the Weekly Cataplexy Rate (WCR), a measure evaluating cataplexy. The studies also evaluated the effect of oveporexton on participants' ability to maintain attention, participants’ overall quality of life, the spectrum of narcolepsy symptoms and daily life functions, as well as the safety and tolerability of oveporexton.

#### About Takeda’s Orexin Franchise
Takeda is the leader in orexin science with a franchise of tailored orexin assets in preclinical and clinical stages with optimized profiles for various orexin disorders. Orexin is a key regulator of sleep and wake patterns and contributes to other essential functions including attention, mood, metabolism and respiration. Oveporexton (TAK-861) is the lead investigational orexin receptor 2 (OX2R) agonist asset in Takeda’s orexin franchise and received Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in narcolepsy type 1 (NT1) from the U.S. Food and Drug Administration and the Center for Drug Evaluation of China’s National Medical Products Administration. The company is also investigating other orexin agonists in populations with orexin levels in the normal range, including TAK-360, an oral OX2R agonist initially being investigated for the treatment of narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) in Phase 2 studies, and other potential indications where orexin signaling is implicated. Additional preclinical assets are also in development including TAK-495, which is expected to enter the clinic in fiscal year 2025.

#### About Takeda
Takeda is focused on creating better health for people and