TOKYO, Japan and FRANKFURT, Germany, June 19, 2026
Teijin Pharma Limited and Merz Therapeutics GmbH have announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved additional indications for XEOMIN® (incobotulinumtoxinA) for the treatment of cervical dystonia and blepharospasm, significantly expanding treatment options for patients suffering from these debilitating neurological disorders. The approval marks the fourth and fifth authorized indications for XEOMIN® in Japan, complementing its existing approvals for upper limb spasticity, lower limb spasticity, and chronic sialorrhea. The regulatory milestone strengthens XEOMIN®’s position as an important therapeutic option within neurology and further reinforces Teijin Pharma’s commitment to addressing unmet medical needs in rare and difficult-to-treat neurological conditions. The decision follows successful Phase III clinical studies conducted globally by Merz Therapeutics and locally by Teijin Pharma in Japan, demonstrating the therapy’s efficacy and safety profile across diverse patient populations.
XEOMIN® Provides New Treatment Option for Dystonia Patients
The newly approved indications target two serious movement disorders that can significantly impair quality of life. Cervical dystonia is characterized by involuntary contractions of neck muscles, leading to painful abnormal postures and repetitive movements, while blepharospasm causes excessive involuntary contractions of muscles surrounding the eyes, often resulting in functional visual impairment and daily activity limitations. Both disorders are classified as focal dystonias and can have profound physical, emotional, and social consequences for affected individuals. Clinical trial data demonstrated that XEOMIN® effectively reduces abnormal muscle contractions through inhibition of acetylcholine release at cholinergic nerve endings.
This targeted mechanism helps restore muscle control and improve patient function. The approval provides physicians in Japan with an additional evidence-based therapeutic option to help manage these complex neurological disorders and potentially improve long-term patient outcomes.
Unique Formulation Supports Safety and Clinical Performance
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XEOMIN® contains incobotulinumtoxinA as its sole active ingredient and is manufactured using proprietary purification technology developed by Merz Pharma, which removes complexing proteins during production. This unique formulation distinguishes XEOMIN® from other botulinum toxin therapies and has contributed to its broad adoption in neurological and therapeutic applications globally. The product has now achieved approvals in 79 countries worldwide for therapeutic and aesthetic indications and is approved in 76 countries for cervical dystonia and blepharospasm treatment.
Extensive clinical development programs across Europe, North America, and Asia have established the therapy’s effectiveness and safety profile in multiple neurological conditions. The latest Japanese approval further expands the global clinical footprint of XEOMIN® and underscores the growing recognition of botulinum toxin therapies as important tools in managing movement disorders and neuromuscular conditions.
Strategic Collaboration Advances Neurology Innovation
The approval highlights the long-standing collaboration between Teijin Pharma and Merz Therapeutics, which began with an exclusive licensing and co-development agreement signed in 2017. Following regulatory approval, XEOMIN® was launched commercially in Japan in 2020 and has since expanded its clinical role within the country’s neurology market. Company leaders emphasized that the latest milestone reflects their shared commitment to improving patient care through innovative neurological therapies.
Teijin Pharma continues to pursue its long-term vision of supporting patients, families, and communities affected by rare and challenging diseases, while Merz Therapeutics remains focused on advancing specialty neurology treatments globally. As neurological disorders continue to represent a major area of unmet medical need worldwide, the expanded approval of XEOMIN® provides new opportunities to improve patient outcomes and demonstrates the ongoing value of international pharmaceutical partnerships dedicated to delivering innovative treatment solutions.
Source: Teijin Pharma, Merz Therapeutics press release
