# Takeda Launches ORZEYFUL in Japan and China, With US Debut Set for Next Month

> Takeda's ORZEYFUL is now available in Japan and China for narcolepsy type 1, with a US launch set for next month after DEA scheduling.

- Published: 2026-10-15T01:15:06+00:00
- Section: Product Launches
- Author: News Desk
- URL: https://newsforagent.com/news/2026-10-15/takeda-orzeyful-narcolepsy-japan-china
- Source: [Business Wire](https://www.businesswire.com/news/home/20261014922379/en/)

## Key takeaways

- ORZEYFUL (oveporexton) is now available in Japan and China for narcolepsy type 1, following approvals from the NMPA, FDA and MHLW.
- China's approval covers adolescents aged 16 and older as well as adults, while Japan and the US approvals cover adults.
- Takeda said Phase 3 studies showed statistically significant improvements over placebo across doses over 12 weeks, with p-values below 0.001.

[Takeda](https://akta.pro/company-profiles/000092c/takeda) said on October 14, 2026 that ORZEYFUL (oveporexton) is now available in Japan and China for the treatment of narcolepsy type 1, giving physicians in both countries first access to prescribe the orexin receptor 2 agonist. The company announced the launch in a [Business Wire](https://www.businesswire.com/news/home/20261014922379/en/) release.

## Takeda's ORZEYFUL Launch in Japan and China

ORZEYFUL is a first-in-class oral orexin receptor 2 (OX2R) agonist in tablet form, designed to treat the underlying orexin deficiency associated with narcolepsy type 1. Takeda said the medicine is the first therapy designed to restore orexin signaling and address the biological cause of the condition, a shift from symptom management to a disease-targeted treatment.

Approvals came within a month of each other from China's National Medical Products Administration, the U.S. Food and Drug Administration and Japan's Ministry of Health, Labour and Welfare. The approvals cover adults in all three countries, while China also permits treatment of adolescents aged 16 and older. Takeda said ORZEYFUL is set to launch next month in the U.S., following completion of DEA scheduling, with health authority submissions underway worldwide.

"We're excited at the potential to fundamentally change how NT1 is managed across Japan and China," said Giles Platford, president, International, Takeda. "We've heard from patients how ORZEYFUL has improved their daily functioning and quality of life, enormously meaningful outcomes for a condition known to impact many aspects of a person's life, including work, education and social interactions."

Takeda said landmark Phase 3 studies in people with narcolepsy type 1 showed ORZEYFUL improved the full range of symptoms and quality of life compared with placebo. Results showed consistent, clinically meaningful and statistically significant improvements in wakefulness, sleepiness, cataplexy, disease severity and quality of life measures, with p-values of less than 0.001 across doses over 12 weeks. The company said the most common side effects include insomnia, urinary urgency, urinary frequency and excessive saliva.

## Takeda's Orexin Pipeline and Company Scale

Takeda discovered ORZEYFUL at its laboratories in Japan, and the medicine is the lead program in its orexin franchise, according to akta.pro [company records](https://akta.pro/company-data). The company is also investigating other oral orexin agonists, including TAK-360 for narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia, as well as TAK-495.

Takeda reported FY2025 revenue of JPY 4,505.7 billion, or about $28.4 billion, for the year ending March 31, 2026, a decline of 1.7% year over year. The company is led by Julie Kim, who became President and CEO on June 24, 2026, succeeding Christophe Weber.

## Takeda's Recent Pipeline and Approval News

On October 14, 2026, Takeda presented Phase 2/3 IgGNITE trial results for TAK-881, a subcutaneous immunoglobulin therapy for primary immunodeficiency, which delivered equivalent IgG exposure to HYQVIA with 50% less infusion volume and shorter median infusion times, according to Stock Titan.

On October 13, 2026, Seeking Alpha cited the FDA approval of ORZEYFUL for narcolepsy and a robust pipeline in maintaining a buy rating on Takeda.

On September 30, 2026, Takeda announced Phase 3 data showing zasocitinib achieved 36.5% complete skin clearance at week 16 versus 13.9% for deucravacitinib, with durable clearance through week 52, according to Stock Titan.

## ORZEYFUL's US Launch Timing

Takeda said ORZEYFUL is set to launch next month in the U.S., following completion of DEA scheduling.

## Companies in this story

- [Takeda company profile](https://akta.pro/company-profiles/000092c/takeda) · website: http://www.takeda.com

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