VERTANICAL today announced that Exilby® (VER-01) has received marketing authorization in Germany for the treatment of chronic low back pain with a radicular (neuropathic) component. The authorization marks a major milestone for VERTANICAL and highlights the potential of Exilby® as a first-in-class non-opioid treatment in a therapeutic area where meaningful innovation has remained limited for decades.
The marketing authorization in Germany has been granted after two pivotal randomized, controlled Phase 3 trials involving more than 1,200 patients demonstrated significant pain reduction, a favorable tolerability profile, and no evidence of dependence1. In a direct Phase 3 head-to-head comparator study, Exilby® also showed superior pain reduction and better gastrointestinal tolerability than opioids, reinforcing its potential as a differentiated non-opioid alternative in chronic pain care2.
Chronic pain remains one of the largest unmet needs in healthcare. More than one billion people worldwide live with chronic pain, including more than 60 million Americans3. Despite its enormous medical, social, and economic burden, innovation in chronic pain treatment has substantially lagged behind other major disease areas. For many patients, opioids continue to play a central role in pain management despite well-documented risks, including dependence, abuse potential, and debilitating side effects.
"Today's marketing authorization of Exilby® in Germany is far more than a regulatory milestone for our company," said Dr. Clemens Fischer, CEO of FUTRUE Group and Founder of VERTANICAL. "It shows that meaningful therapeutic innovation in chronic pain is possible. Patients have waited far too long for real progress, and we believe Exilby® marks an important step toward changing how chronic pain is treated and providing patients and physicians an alternative to opioids."
"The European marketing authorization and the Phase 3 data suggest that Exilby® could mark the beginning of a new era in the treatment of chronic pain," said Prof. Charles E. Argoff, Professor of Neurology at Albany Medical College and Past President of the American Academy of Pain Medicine. "For patients with a neuropathic pain component in particular, Exilby® has the potential to represent a meaningful paradigm shift at a time when physicians and patients urgently need better alternatives."
While Exilby® is not yet approved for use in the U.S., VERTANICAL is committed to making the therapy available to U.S. patients, where the need for effective non-opioid innovation in chronic pain remains especially urgent. The company has initiated an additional pivotal U.S. Phase 3 trial to support a future FDA submission. Based on the current development plan, the company anticipates a first data read-out in 2027 and, subject to positive results, plans to submit a New Drug Application in 2028.
In an important recognition of the therapy's potential, the U.S. Food and Drug Administration has granted Exilby® Breakthrough Therapy Designation, underscoring Exilby's potential to substantially improve treatment in a field that has long lacked true innovation.
"For decades, patients with chronic pain have too often been forced to choose between insufficient relief and unacceptable risk,"Clemens Fischer added. "The German marketing authorization of Exilby® shows that a different path is possible. Our focus now is to move with urgency to bring this innovation to patients in the United States."
The marketing authorization of Exilby® in the first European country represents an important milestone for VERTANICAL and a potential inflection point in chronic pain treatment. As healthcare systems worldwide seek effective non-opioid approaches, Exilby® may help open the door to a new treatment paradigm for patients living with chronic pain.
About Exilby®
Exilby® is an investigational standardized full-spectrum extract derived from the Cannabis sativa strain DKJ127 L., a unique and proprietary plant genetics selected to provide a phytochemical profile tailored to chronic pain. Its composition includes a defined mixture of cannabinoids, terpenes and other bioactive compounds selected for their potential relevance in pain modulation and associated symptoms. Exilby® has been comprehensively characterized using chromatographic and spectrometric methods to quantify key constituents and ensure pharmaceutical-grade quality and product consistency. This level of standardization is critical, as cannabis-derived products differ substantially in their pharmacological profile, composition of bioactive constituents and product quality, depending on plant genetics, raw materials and manufacturing processes. Findings obtained with Exilby® can therefore not be extrapolated to other cannabis extracts or products.
About VERTANICAL
VERTANICAL is a leading biopharmaceutical company dedicated to developing and commercializing innovative therapies for chronic pain. Guided by the vision of a world free of chronic pain, the company is committed to advancing clinical research and development in chronic pain diseases. With over 20 completed preclinical and clinical studies and a comprehensive development program across multiple chronic pain indications, VERTANICAL is recognized as one of the global innovation leaders in the field of chronic pain.
VERTANICAL was founded in 2007 by Dr. Clemens Fischer and has its global headquarters in Munich, Germany. The company operates one of the world's most advanced GMP facilities for the development and manufacturing of biopharmaceuticals. It maintains an international network of several hundred research and clinical trial sites across the U.S. and multiple European countries.
SOURCE Vertanical