First cannabis-based chronic pain drug wins approval in Germany and Austria

Vertanical’s Cannabis Drug Exilby Wins Marketing Authorization in Germany and Austria for Chronic Pain

German biopharmaceutical company Vertanical announced on Monday that Exilby (VER-01), a cannabis-derived oral tincture, has received marketing authorization in Germany for the treatment of chronic low back pain with a neuropathic component, making it the first cannabis-based medication explicitly approved for chronic pain management.prnewswire

The drug also received marketing approval in Austria, and Vertanical plans to seek authorization in the United Kingdom and throughout the broader European Union. The company expects Exilby to be available to consumers this autumn.forbes

Clinical Evidence

The authorization follows two pivotal Phase 3 randomized controlled trials involving more than 1,200 patients. A placebo-controlled study of 820 patients, published in Nature Medicine in September 2025, found that VER-01 achieved its primary endpoint with a mean pain reduction of 1.9 points on an 11-point scale at 12 weeks, with effects sustained over 12 months.cannabishealthnews

A second head-to-head comparator study, the ELEVATE trial, conducted across Germany, the Czech Republic, Poland, and Spain with 384 patients, found that VER-01 delivered superior pain reduction and better gastrointestinal tolerability compared with opioids. Neither trial showed evidence of dependence or withdrawal.nature

“This study provides robust evidence that VER-01 offers better tolerability, as well as superior pain relief and sleep quality compared to opioids in patients with CLBP,” researchers concluded in the comparator trial.painnewsnetwork

Path to the United States

In May, the FDA granted VER-01 Breakthrough Therapy Designation, positioning it to become the first cannabis-derived medicine approved for pain in the United States and only the second such approval since Epidiolex in 2018. Vertanical has initiated an additional pivotal Phase 3 trial in the U.S. to satisfy FDA requirements, with a first data readout expected in 2027 and a new drug application planned for 2028.painnewsnetwork

Exilby is a full-spectrum extract from the proprietary Cannabis sativa strain DKJ127, containing cannabinoids, terpenes, and other bioactive compounds. It is administered orally as liquid drops. Vertanical CEO Clemens Fischer has said the drug “reduces pain without creating dependency or having an abuse potential” and has “the full potential to replace opiates as it’s more effective”.cannabishealthnews