Teijin: MHLW approves XEOMIN for cervical dystonia and blepharospasm
- Japan’s Ministry of Health, Labour and Welfare approved XEOMIN for cervical dystonia and blepharospasm.
- These approvals are XEOMIN’s fourth and fifth indications in Japan, joining upper and lower limb spasticity plus chronic sialorrhea.
- Approval relied on Phase III trials by Merz (multi‑region) and Teijin (Japan).
- XEOMIN contains incobotulinumtoxinA as sole active ingredient and is manufactured with a process that removes complexing proteins.
Regulatory update
Japan’s Ministry of Health, Labour and Welfare has approved additional indications for XEOMIN (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm. These become the fourth and fifth approved therapeutic indications for XEOMIN in Japan, alongside approvals for upper limb spasticity, lower limb spasticity and chronic sialorrhea.
Clinical evidence
The approval was based on Phase III clinical trials conducted by Merz Therapeutics across Europe, North America and Asia, together with Phase III trials run by Teijin in Japan. Clinical data showed XEOMIN reduces involuntary muscle contractions by inhibiting acetylcholine release from cholinergic nerve endings.
Product profile and manufacturing
XEOMIN’s sole active ingredient is incobotulinumtoxinA. Its manufacturing removes complexing proteins using technology developed by Merz Pharma GmbH & Co. KGaA.
Commercial and corporate context
Teijin and Merz describe the approval as a milestone in their collaboration. XEOMIN is approved in 79 countries for therapeutic and/or aesthetic uses and in 76 countries specifically for cervical dystonia and blepharospasm as of April 2026. Teijin signed an exclusive licence and co‑development agreement with Merz in 2017 and launched exclusive sales in Japan in December 2020.
Source: Teijin
