Merz Therapeutics Announces Completion of Recruitment in Two Phase III Trials Investigating XEOMIN ® (incobotulinumtoxinA) for Migraine Prevention

Merz Therapeutics GmbH, a leading player in neurology-focused specialty pharma, today announced the completion of patient recruitment in two global Phase III clinical trials, MINT-E (NCT07018700) and MINT-C (NCT07018713), evaluating the efficacy and safety of XEOMIN^® (incobotulinumtoxinA) for the prevention of episodic and chronic migraine in adults. The trials recruited approximately 1800 adults across 109 study sites in North America and Europe. Migraine affects around 1.1 billion people worldwide, posing a significant burden on patients, society and healthcare systems.¹

Both trials are evaluating the change in monthly migraine days from baseline to Month 6 as the primary endpoint. Secondary endpoints include changes in monthly headache days, acute medication days and migraine frequency during two-week periods at the end of each injection cycle.

“Achieving patient recruitment for both MINT-C and MINT-E six months ahead of plan is an important milestone for our XEOMIN^® migraine prevention program. I am proud of what our teams, investigators and patients have achieved together,” said Dr. Stefan Albrecht, Chief Scientific and Medical Officer, Merz Therapeutics. “With recruitment now complete, our focus is on the main study period and subsequent analysis of the data. These results will guide our next clinical and regulatory decisions as we evaluate XEOMIN^® for the preventive treatment of chronic and episodic migraine.”

The main study period is expected to conclude in the coming year.

Understanding the Impact of Migraine

Migraine is characterized by recurrent attacks of moderate to severe head pain, often accompanied by nausea, vomiting, and sensitivity to light and sound.² Attacks can last from four to 72 hours and may be preceded by aura visual or sensory disturbances that signal onset.³ Episodic migraines affect people with fewer than 15 headache days a month, including 6–14 migraine days, while chronic migraines present with 15 or more headache days monthly, including at least 8 days with the features of a migraine headache.⁴

Beyond physical symptoms, migraine is associated with significant emotional, cognitive, and social and economic burden. It frequently co-occurs with depression, anxiety, and sleep disorders, and contributes to reduced quality of life, impaired productivity, and increased healthcare utilization.⁵

About XEOMIN^®

XEOMIN^® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles or glands and is currently approved in more than 80 countries, including US and Canada. The different national approvals cover various neurological and aesthetic indications, such as blepharospasm, hemifacial spasm, cervical dystonia, spasticity, sialorrhea, and upper facial lines in adult patients and spasticity and sialorrhea in pediatric patients. The use of XEOMIN^® for migraine prevention, including prevention of episodic and chronic migraine in adults, is not currently approved by regulatory authorities.

About Merz Therapeutics

Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients. With science as its foundation and the patient experience as its focus, the company relentlessly pursues innovative treatments and partnerships to address unmet needs in movement disorders, neurodegenerative conditions, liver disease, and other health conditions that severely impact patients’ quality of life.

Merz Therapeutics is headquartered in Frankfurt am Main, Germany, and is active in more than 80 countries. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company with a 117-year legacy. With passion and purpose, Merz Therapeutics continues to advance care in specialty neurology in ways that benefit both patients and society.

Please visit www.merztherapeutics.com.

References

1. Cen, J., Wang, Q., Cheng, L., Gao, Q., Wang, H., & Sun, F. (2024, June 7). Global, regional, and national burden and trends of migraine among women of childbearing age from 1990 to 2021: Insights from the Global Burden of Disease Study 2021. The Journal of Headache and Pain. https://doi.org/10.1186/s10194-024-01798-z
2. Dong, L., Dong, W., Jin, Y., Zhang, L., & Li, H. (2025). The global burden of migraine: A 30-year trend review and future projections by age, sex, country, and region. Pain and Therapy. https://doi.org/10.1007/s40122-024-00690-7
3. Gupta, J., & Gaur, S. (2022, August 24). Migraine: An underestimated neurological condition affecting billions. Cureus. https://doi.org/10.7759/cureus.28347
4. Headache Classification Committee of the International Headache Society (IHS).The International Classification of Headache Disorders, 3rd edition.Cephalalgia. 2018;38(1):1-211. https://doi.org/10.1177/0333102417738202
5. López-Medina, D. C., & Andrade-Romo, A.-D. (2025, March 14). Cognition, mental health, and quality of life in patients with chronic and episodic migraine during the interictal period. BMC Neurology. https://doi.org/10.1186/s12883-025-04122-7

This press release is not intended to offer recommendations, advice, endorsement, guidance or suggestions for administering or otherwise using XEOMIN^® in any manner inconsistent with its current prescribing information approved by the U.S. Food and Drug Administration.

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