Rapid DEA review clears way for Takeda's narcolepsy launch
Takeda has launched its first-in-class oral narcolepsy therapy Orzeyful in the US after a double-quick review of the drug's misuse potential by the Drug Enforcement Administration (DEA).
Orexin agonist Orzeyful (oveporexton) was approved by the FDA in August to treat narcolepsy type 1 (NT1) in adults, becoming the first drug to treat the underlying mechanism of the sleep disorder, and has now received a Schedule IV classification from the DEA. That means it is considered to have a low potential for abuse and dependence.
The twice-daily pill is now available on prescription and will be dispensed across the US exclusively through Accredo Specialty Pharmacy, which has expertise in handling controlled substance medications as well as providing support for rare disease patients.
"Clinical trials showed Orzeyful improved the full range of symptoms, and now we can bring those results into real-world practice," said Dr Emmanuel Mignot, professor of sleep medicine at Stanford University and principal US investigator in Takeda's phase 3 trials programme for the new drug.
"I can now start a new conversation with my patients about their symptoms and how using this new treatment approach may make a real difference for them," he added.
Working with Masashi Yanagisawa, Mignot identified orexin deficiency as the root cause of narcolepsy, a feat which earned them the 2026 Lasker Basic Medical Research Award.
Approximately 120,000 people in the US have NT1, according to Takeda, which also launched Orzeyful in China and Japan last month and has submitted it for approval in Europe.
Competitive pricing
Takeda has set a list price of $16,500 for a month's supply across all dosage strengths before discounts or rebates, or almost $200,000 a year, which is right in the middle of analysts' predictions.
That is also around $50,000 more than the current top-selling therapy for NT1, Jazz Pharma's Xywav (calcium, magnesium, potassium, and sodium oxybates), which costs around $142,000 per year and has a more restrictive Schedule III rating. Analysts think that pricing and disease-modifying mechanism will help drive rapid take-up of Takeda's drug, which has been predicted to make peak sales of between $2 billion and $5 billion a year.
For comparison, Xywav was first launched for NT1 in 2020 and has since become a blockbuster, with sales of $483 million in the third quarter of 2026, helped by an additional indication in idiopathic hypersomnia (IH) that was approved in 2021.
Takeda is not developing Orzeyful for IH. Rather, it is developing a second orexin agonist for that indication, balumorexton (TAK-360), which is in a phase 2 trial.
