#Germany #Chronic Pain #VERTANICAL #Gräfelfing #Exilby®

VERTANICAL's Historic Milestone

On June 9, 2026, VERTANICAL announced a pivotal achievement in the healthcare sector with the marketing authorization of Exilby®, designated as VER-01, in Germany. This authorization is groundbreaking as it establishes Exilby® as a first-in-class non-opioid treatment specifically aimed at relieving chronic low back pain that includes a neuropathic component. The approval indicates a significant advancement in a medical field that has seen limited innovation for decades.

Exilby® gained its marketing approval following the successful completion of two extensive randomized controlled Phase 3 trials. These trials, which involved more than 1,200 participants, demonstrated compelling outcomes including notable reductions in pain, a commendable tolerability profile, and no signs of dependence. Additionally, in a direct head-to-head comparison with opioids, Exilby® exhibited superior pain reduction coupled with better gastrointestinal tolerability, further solidifying its role as a viable, non-opioid alternative for managing chronic pain.

Chronic pain is a pressing issue affecting millions globally, with over one billion individuals living with this condition. In the U.S. alone, around 60 million Americans suffer from chronic pain. Despite the significant societal and economic implications arising from chronic pain, the innovative progress in treatments has fallen behind other serious health conditions. Consequently, many individuals continue relying on opioids for pain management, despite well-documented hazards that include dependence, potential for abuse, and debilitating side effects.

Dr. Clemens Fischer, CEO of FUTRUE Group and founder of VERTANICAL, emphasizes the importance of this approval, stating, "Today's marketing authorization of Exilby® in Germany is far more than a regulatory milestone for our company. 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."

Prof. Charles E. Argoff, Professor of Neurology at Albany Medical College and past president of the American Academy of Pain Medicine, also highlighted the significance of Exilby® in the treatment of chronic pain. He noted, "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. 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."

Currently, Exilby® is not yet authorized for use in the United States. However, VERTANICAL is dedicated to ensuring that this revolutionary therapy reaches American patients where the demand for effective non-opioid innovations is critically high. The company has already initiated an additional pivotal U.S. Phase 3 trial to assist with future FDA submissions, projecting a first data readout by 2027, with hopes to submit a New Drug Application in 2028.

Recognizing Exilby®'s potential as a transformative therapy, the U.S. Food and Drug Administration awarded it the Breakthrough Therapy Designation. This distinction underscores Exilby®'s ability to significantly enhance treatment in a field that has traditionally lacked genuine innovation.

Dr. Fischer remarked, "For decades, patients with chronic pain have too often been forced to choose between insufficient relief and unacceptable risk. 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 acceptance of Exilby® in Germany symbolizes a crucial milestone for VERTANICAL and could potentially transform the landscape of chronic pain management. As global health systems actively seek effective, non-opioid solutions, Exilby® may pave the way for a new treatment paradigm that better addresses the needs of chronic pain patients.

About Exilby®

Exilby® is an investigational standardized full-spectrum cannabis extract derived from the Cannabis sativa strain DKJ127 L., designed specifically for chronic pain management. This unique formulation includes a carefully selected array of cannabinoids, terpenes, and other bioactive compounds that are significant for pain modulation.

The manufacturing process ensuring pharmaceutical-grade quality and product consistency is stringent for Exilby®, which is key in cannabis-derived products as they can vary significantly in pharmacological profiles and composition based on genetics and production methods. Results from studies conducted on Exilby® should not be generalized to other cannabis extracts or products due to these variations.

About VERTANICAL

Established in 2007 by Dr. Clemens Fischer, VERTANICAL is dedicated to the research and development of pioneering therapies for chronic pain. With its headquarters in Munich, Germany, the company operates state-of-the-art GMP facilities for biopharmaceutical development and maintains a vast network of research and clinical trial sites across the U.S. and Europe, solidifying its reputation as a leader in chronic pain innovation.