Takeda Launches ORZEYFUL™ (oveporexton), the First and Only Medicine of Its Kind for Narcolepsy Type 1 Now Available in the United States

Takeda Pharmaceutical announced the U.S. availability of ORZEYFUL, the first orexin agonist for narcolepsy type 1 in adults. It will be dispensed through Accredo Specialty Pharmacy. TAK stock was up 2.35% in pre-market trading at $21.35.

Takeda Pharmaceutical (TSE:4502/NYSE:TAK) launched Orzeyful, the first orexin agonist for narcolepsy type 1 in the U.S. The FDA approved it in August 2026. Clinical trials showed common side effects like insomnia and urinary frequency. The drug is available through Accredo Specialty Pharmacy, with patient support programs offered by Takeda. Orzeyful is also approved in China and Japan, and Takeda is developing other orexin agonists.

Takeda (4502) maintained full-year guidance, expecting a low-single-digit revenue decline at constant FX. The company raised revenue and core operating profit forecasts, launched ORZEYFUL for narcolepsy, and plans a U.S. launch. Takeda cut 3,000 roles, achieved procurement savings, and aims for ¥100B gross savings by FY2026. The FDA approved MIMRYLO for erythrocytosis, and accepted zasocitinib for priority review. ENTYVIO showed reduced UC complications in a study.

Takeda Pharmaceutical (TAK) reported on its Q2 earnings call, highlighting launches of ORZEYFUL for narcolepsy in Japan and China, with a U.S. launch expected in November. MIMRYLO for polycythemia vera received FDA approval and is commercially available. The company also announced positive phase III data for TAK-921 in gastric cancer. Takeda maintained its full-year revenue outlook but raised core operating profit guidance to ¥1.19 trillion, citing foreign-exchange assumptions.

Takeda (TAK) reported Q2 2026 earnings, highlighting successful product launches like ORZEYFUL and MIMRYLO, and progress in its pipeline. ORZEYFUL, a narcolepsy treatment, launched in Japan and China, with a U.S. launch expected in November. MIMRYLO, a polycythemia vera treatment, launched in the U.S. in August. The company also secured regulatory submissions for zasocitinib in psoriasis and TAK-881 for primary immunodeficiency.

Takeda (TAK) reported Q2 FY 2026 core revenue of JPY 2.4T, down 1% at CER. CEO Julie Kim forecasted JPY 1.19T core operating profit for FY 2026. The company targets an early November U.S. launch for ORZEYFUL.