Takeda Launches ORZEYFUL for Narcolepsy Type 1 in the US

Takeda has launched ORZEYFUL (oveporexton) in the United States for adults living with narcolepsy type 1 (NT1), making the first-in-class orexin receptor treatment available by prescription. The medicine is designed to address the underlying cause of the condition rather than simply managing individual symptoms.

The launch, announced on November 12, 2026, follows the US Food and Drug Administration (FDA) approval of ORZEYFUL in August 2026. The medicine became available after completing the required controlled substance scheduling process, which classified it as a Schedule IV controlled substance.

Narcolepsy type 1 is a rare, lifelong neurological disorder caused by a loss of orexin, a chemical messenger in the brain that helps regulate wakefulness, sleep and muscle control.

People with the condition can experience excessive daytime sleepiness, cataplexy (sudden loss of muscle tone), disrupted nighttime sleep, sleep paralysis and hallucinations. These symptoms can affect their ability to work, study and carry out everyday activities.

A New Approach to Treating Narcolepsy

ORZEYFUL is an oral orexin receptor 2 (OX2R) agonist that works by selectively activating orexin receptors in the brain. This helps restore the signalling that is missing in people with narcolepsy type 1.

Unlike existing treatments that mainly focus on controlling individual symptoms, oveporexton is designed to address the underlying orexin deficiency. The treatment aims to improve wakefulness while reducing cataplexy and other symptoms associated with the condition.

The FDA approval was supported by two Phase 3 clinical trials, FirstLight and RadiantLight. The studies evaluated the medicine in adults with narcolepsy type 1 and showed significant improvements in daytime wakefulness, excessive sleepiness, cataplexy and health-related quality of life compared with placebo.

The results also demonstrated improvements in several other symptoms, including disrupted nighttime sleep, sleep paralysis and hallucinations.

Safety and Availability

ORZEYFUL is now available by prescription in the US through Accredo Specialty Pharmacy, part of Evernorth Health Services. Takeda is also providing patient support programmes to help eligible adults access the treatment and navigate insurance coverage.

The most common side effects reported in clinical studies included insomnia, increased urinary frequency, urinary urgency and excessive saliva production.

The medicine is not suitable for patients taking strong CYP3A inhibitors. Healthcare professionals are also advised to monitor patients for possible side effects and review their existing medications before starting treatment.

Takeda Expands Its Orexin Research Programme

Takeda believes the launch represents an important development in the treatment of narcolepsy type 1 and reflects years of research into the role of orexin in sleep and wakefulness.

Emmanuel Mignot, the principal US investigator in the ORZEYFUL Phase 3 programme, highlighted the importance of making the treatment available to patients. He noted that clinical studies showed improvements across a broad range of narcolepsy symptoms.

Oveporexton is the lead medicine in Takeda’s broader orexin research programme. The company is also developing other oral orexin agonists, including TAK-360, which is being investigated for narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia.

With ORZEYFUL now available in the US, Takeda is expanding access to a new treatment approach that targets the biological cause of narcolepsy type 1. The launch could mark an important step towards improving disease management for adults living with this chronic neurological condition.