Japanese pharma major Takeda has commercially launched Orzeyful (oveporexton) in the US for the treatment for adult patients with narcolepsy type 1.
The therapy is an oral orexin receptor 2 agonist, formulated to target the orexin deficiency that causes the chronic neurological condition.
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Following approval by the US Food and Drug Administration (FDA) in August 2026, the drug received a Schedule IV controlled substance (CIV) classification.
Distribution across the country is being managed through Accredo Specialty Pharmacy, a division of Evernorth Health Services, with licensed healthcare practitioners able to prescribe the treatment.
Takeda is also offering patient support programmes to assist eligible adults with treatment initiation and healthcare coverage navigation.
Takeda US business unit president Rhonda Pacheco said: “We work for decades toward the defining moments that have the potential to make a real difference for patients.
“Bringing Orzeyful, a first-in-class medicine, to people living with narcolepsy type 1 in the US is one of those moments.
“We’re incredibly proud to be here, and equally focused on what comes next: supporting care and access for patients prescribed Orzeyful.”
Narcolepsy type 1 is described as a rare disorder caused by the loss of orexin-producing neurons. The condition leads to fragmented nocturnal sleep, excessive daytime sleepiness, cognitive difficulties, and cataplexy, which involves sudden and temporary muscle tone loss.
Orzeyful functions by selectively activating orexin receptor 2 pathways to restore signalling, thereby promoting daytime wakefulness and reducing abnormal rapid eye movement sleep phenomena.
In clinical evaluations, the most frequently reported adverse effects included insomnia, excessive saliva production, increased urinary urgency, and urinary frequency.
Regulatory authorities in China and Japan have also approved Orzeyful for adult patients with narcolepsy type 1.
The compound serves as the lead asset in Takeda’s pipeline of orexin-focused treatments.
Alongside Orzeyful, the company is advancing other investigational oral orexin agonists, including TAK-360, which is in clinical development for idiopathic hypersomnia, narcolepsy type 1, and narcolepsy type 2, as well as TAK-495.
Takeda is also creating digital tools and biomarker diagnostic solutions designed to identify and differentiate narcolepsy type 1 earlier.
Jazz Pharmaceuticals’ flagship oxybate blockbuster brands Xywav and Xyrem have traditionally been the top-selling narcolepsy drugs in the US.
