Exilby® Receives First European Marketing Authorization as VERTANICAL Prepares UK Submission for its First-in-Class Non-Opioid Treatment for Chronic Low Back Pain

GRÄFELFING, Germany, June 9, 2026 /PRNewswire/ -- 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.

Marketing authorization has been granted after two randomized, controlled Phase 3 trials, published in Nature Medicine and Pain & Therapy last September, demonstrated significant pain reduction, a favorable tolerability profile, and no evidence of dependence[1]. 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 care[2].

The first European marketing authorization marks a major milestone for VERTANICAL and underscores the potential of Exilby^® as a first-in-class non-opioid treatment in an area where therapeutic innovation has remained limited for decades.

Chronic pain remains one of the largest unmet needs in healthcare. More than one billion people worldwide live with chronic pain, including nearly 28 million adults in the UK[3]. 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.

"The 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 demonstrates 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."

In a placebo-controlled Phase 3 study, VER-01 demonstrated significant reductions in pain compared with placebo and met the study's primary endpoint, with effects sustained during long-term treatment. Patients receiving VER-01 also experienced significant improvements in key symptoms associated with chronic pain, including sleep disturbances and impaired physical function.

In a second Phase 3 head-to-head comparator study, VER-01 demonstrated greater pain reduction and better gastrointestinal tolerability compared with opioids. Across the clinical program, VER-01 was generally well tolerated, with no evidence of dependence or withdrawal symptoms observed.

"Chronic low back pain with a neuropathic component is particularly difficult to treat and remains a major burden for too many patients in the UK," said Dr. Stuart Ratcliffe, Chief Scientific Officer at St Pancras Clinical Research who also participated as a principal investigator in one of Vertanical's clinical trials. "The marketing authorization of Exilby^® in Germany signals that meaningful innovation in chronic pain is possible. For patients with a neuropathic pain component, Exilby^® may represent an important breakthrough and a much-needed new direction in long-term pain management."

While Germany is the first country where Exilby^® is moving toward patient care, VERTANICAL is already preparing a submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA), with UK marketing authorization targeted before the end of the year. With NICE topic selection completed, Exilby^® has already reached an important milestone in the UK health technology assessment pathway toward potential NHS availability.

"For decades, patients with chronic pain have too often been forced to choose between insufficient relief and unacceptable risk," Clemens Fischer added. "The marketing authorization of Exilby^® in Germany shows that a different path is possible. Our focus now is to move with urgency to bring this innovation to patients across all of Europe and the US."

The marketing authorization of Exilby^® in Germany represents an important milestone, 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^®

VER-01 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. VER-01 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 VER-01 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., the UK and multiple EU countries.

[1] Karst M, Meissner W, Sator S, Keßler J, Schoder V, Häuser W. Full-spectrum extract from Cannabis sativa DKJ127 for chronic back pain: a randomized, placebo-controlled phase 3 study. Nat Med (2025), published online on September 29, 2025, doi: 10.1038/s41591-025-03977-0
[2] Meissner W, Argoff C, Sator S, Schoder V, Karst M. VER-01 shows enhanced gastrointestinal tolerability, superior pain relief, and improved sleep quality compared to opioids in treating chronic low back pain: a randomized phase 3 clinical trial. Pain Ther (2025), published online on September 30, 2025, doi:10.1007/s40122-025-00773-z
[3] Cohen SP, Vase L, Hooten WM. Chronic pain: an update on burden, best practices, and new advances. The Lancet (2021), published online on May 29, 2021, doi: 10.1016/S0140-6736(21)00393-7

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