Germany and Austria Approve Cannabis Drug Exilby for Back Pain

Germany and Austria have granted market authorization to the first cannabis-based prescription medicine indicated for chronic lower back pain, clearing the path for Vertanical to launch Exilby® commercially in both countries from September 2026. For the more than ten million people in Germany living with chronic back pain — and the healthcare providers who treat them — the authorization brings the first genuinely new pharmacological option to market in over 15 years.

Exilby® (developed as VER-01) is a standardized full-spectrum extract from a proprietary Cannabis sativa strain, authorized specifically for chronic low back pain with a radicular, or neuropathic, component. The indication is regulatory precision that matters: Exilby enters the market as a fully characterized pharmaceutical product, distinct from the unprocessed cannabis flower prescriptions available under Germany’s medical-cannabis prescribing rules since 2017. Unlike those prescriptions, Exilby carries a defined indication backed by two Phase 3 trials, and its reimbursement status will be assessed through Germany’s standard statutory health insurance benefit-assessment process.

First European cannabis pain drug through standard authorization

The authorizations came through national pharmaceutical procedures in Germany and Austria, not through a centralized process at the European Medicines Agency. While the EMA has centrally authorized one cannabis-derived medicine — Epidyolex, a purified cannabidiol for treatment-resistant epilepsy — no cannabis-based pain medicine has received EU-wide centralized approval. That means Exilby, like every cannabis-derived pharmaceutical indicated for pain, must clear individual national regulatory pathways in each target country rather than receiving a single EU-wide decision.

Vertanical ran its pivotal clinical program across sites in Germany and Austria and put Germany first. From here, the company plans to pursue mutual recognition, a procedure that uses Germany’s authorization as the reference and allows other member states to accept it without conducting a full assessment from scratch. The company has described further European approvals as expected “promptly,” without specifying individual countries.

In Germany, an authorized pharmaceutical product is generally eligible for assessment through the statutory health insurance benefit-assessment process that governs public reimbursement. The precise terms will depend on that process and on commercial negotiations with payers. Germany currently accounts for more than 18 million opioid prescriptions per year across pain indications, and Vertanical positions Exilby as a non-addictive alternative for the specific patient subgroup where opioids carry the heaviest dependency and tolerability burden.

The clinical program behind the approval

The authorizations rest on two Phase 3 randomized controlled trials published in autumn 2025. The primary study¹, published in Nature Medicine on September 29, 2025, enrolled 820 adults across 66 outpatient sites and university hospitals in Germany and Austria. Over a 12-week placebo-controlled phase, VER-01 reduced pain scores significantly more than placebo, with effects sustained through a six-month open-label extension. The benefit was most pronounced in the neuropathic pain subgroup — the specific population the authorization covers. No signs of dependence or withdrawal were observed across the full clinical program.

A second Phase 3 trial compared VER-01 directly against opioid therapy. Patients taking VER-01 achieved greater pain reduction and substantially fewer gastrointestinal problems than those on opioids — a head-to-head finding that strengthens the regulatory case beyond the standard placebo comparator. Recent observational data has linked medical cannabis access to measurable reductions in opioid use among chronic pain patients, but a Phase 3 head-to-head result against opioids is a different category of evidence.

Dr. Clemens Fischer, who founded Vertanical in 2007 and invested more than $250 million of his own capital into the development program, said the authorization “shows that meaningful therapeutic innovation in chronic pain is possible.”

What comes next

Commercial launch in Germany and Austria is planned for September 2026. Vertanical secured FDA Breakthrough Therapy Designation for VER-01 in May 2026 — a U.S. recognition that early evidence suggests the drug could substantially improve on available therapies for a serious condition. A U.S. Phase 3 trial is underway, with a data read-out targeted for 2027 and a potential application to the FDA in 2028.

For the UK, a separate authorization track applies. Vertanical plans to submit to the Medicines and Healthcare products Regulatory Agency later in 2026, with market authorization targeted before year-end. The National Institute for Health and Care Excellence has reportedly identified Exilby as a candidate for clinical and economic evaluation — the process that would determine NHS reimbursement eligibility.

The broader European picture depends on how quickly mutual recognition converts Germany’s authorization into operational approvals across other member states. That timeline remains unconfirmed. After more than a decade in development, the first cannabis-based pain drug with standard pharmaceutical authorization in Europe is on track to reach patients before the year is out.

References:

^{1. Karst, M., Meissner, W., Sator, S. et al. Full-spectrum extract from Cannabis sativa DKJ127 for chronic low back pain: a phase 3 randomized placebo-controlled trial. Nat Med 31, 4189–4196 (2025). https://doi.org/10.1038/s41591-025-03977-0}