Takeda Pharmaceutical's Orzeyful has been approved by the FDA for the treatment of type 1 narcolepsy.

The Orzeyful tablets from Takeda Pharmaceuticals America's subsidiary have been approved by the U.S. Food and Drug Administration, becoming the first drug to treat the full spectrum of symptoms of adult type 1 narcolepsy through targeted appetite signaling disruption. The efficacy of Orzeyful has been confirmed in two 12-week, placebo-controlled studies involving a total of 273 adult patients. Patients taking Orzeyful 2 mg showed improved daytime wakefulness and reduced frequency of cataplexy episodes compared to the placebo group. Orzeyful has been recommended for scheduling under the Controlled Substances Act and is currently awaiting a final decision from the Drug Enforcement Administration.