GRÄFELFING, Germany – June 9, 2026
VERTANICAL has achieved a major milestone in chronic pain treatment after receiving Germany’s marketing authorization for Exilby® (VER-01), making it the first approved non-opioid therapy of its kind for chronic low back pain with a radicular (neuropathic) component. The approval represents a significant advancement in a therapeutic area that has seen limited innovation for decades and provides patients and healthcare providers with a potential alternative to opioid-based pain management. Backed by positive Phase 3 clinical data involving more than 1,200 patients, Exilby demonstrated significant pain reduction, favorable tolerability, and no evidence of dependence, reinforcing its potential to address one of healthcare’s largest unmet needs. The approval also marks the first European authorization for the therapy and comes as VERTANICAL advances a pivotal U.S. Phase 3 clinical trial, positioning Exilby as a potential global breakthrough in chronic pain management.
Phase 3 Studies Demonstrate Superior Pain Relief and Safety
The German authorization was granted following two pivotal randomized, controlled Phase 3 studies that evaluated Exilby in patients suffering from chronic low back pain with neuropathic features. Across the clinical development program, the investigational therapy demonstrated statistically significant reductions in pain intensity while maintaining a favorable safety and tolerability profile. Importantly, researchers reported no evidence of dependence, a critical differentiator in a treatment landscape heavily dominated by opioid medications. In a direct head-to-head Phase 3 comparator study against opioids, Exilby delivered superior pain reduction while also showing improved gastrointestinal tolerability, addressing one of the most common side effects associated with conventional pain treatments.
These findings are particularly important given the ongoing global search for effective, long-term, non-opioid solutions capable of reducing reliance on opioid medications while maintaining strong clinical outcomes. The positive results have generated significant interest among pain specialists and healthcare systems seeking safer therapeutic alternatives for chronic pain patients.
Addressing a Global Chronic Pain Crisis
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Chronic pain remains one of the most significant public health challenges worldwide, affecting more than one billion people globally and over 60 million individuals in the United States alone. Despite the enormous social, medical, and economic burden associated with chronic pain conditions, therapeutic innovation has lagged behind many other disease areas. For decades, opioids have remained a cornerstone of pain management despite concerns surrounding dependence, abuse potential, tolerance, and serious adverse effects. Exilby has been developed specifically to address this unmet need by offering a novel non-opioid treatment option.
Derived from a highly standardized proprietary full-spectrum extract of Cannabis sativa, Exilby contains a precisely characterized composition of cannabinoids, terpenes, and bioactive compounds selected for their potential role in pain modulation. The product has undergone extensive pharmaceutical standardization and quality control processes to ensure consistency, reproducibility, and regulatory-grade manufacturing standards. This rigorous development approach differentiates Exilby from many cannabis-derived products currently available in various markets.
U.S. Phase 3 Program Advances Toward FDA Submission
While Exilby is now approved in Germany, VERTANICAL is simultaneously pursuing regulatory approval in the United States, where the need for innovative non-opioid pain therapies remains particularly urgent. The company has already initiated an additional pivotal Phase 3 clinical study designed to support a future New Drug Application (NDA) submission to the U.S. Food and Drug Administration. The FDA has granted Breakthrough Therapy Designation to Exilby, recognizing its potential to substantially improve treatment outcomes in an area with limited therapeutic innovation. VERTANICAL expects the first readout from the U.S. Phase 3 study in 2027 and, subject to positive results, plans to submit an NDA in 2028.
Industry experts believe the German approval could represent an important inflection point in chronic pain treatment by validating a new non-opioid therapeutic approach. As healthcare providers increasingly seek alternatives to opioids, Exilby’s combination of demonstrated efficacy, tolerability, and lack of dependence potential may position it as a transformative option for millions of patients living with chronic low back pain and related neuropathic conditions worldwide.
Source: Vertanical press release
