Vertanical Eyes German Approval as FDA Backs Its Pain Drug

Munich-based Vertanical is weeks away from marketing authorization for its cannabis-derived pain drug in Germany, with the company’s European launch poised to trigger a continent-wide regulatory cascade that could put the first fully authorized cannabinoid pain medicine on formularies across the EU.

The context matters. On May 18, 2026, the US Food and Drug Administration granted Breakthrough Therapy Designation to VER-01 — the company’s full-spectrum cannabis extract for chronic low back pain — recognizing preliminary clinical evidence that it may offer substantial improvement over existing therapies. The designation doesn’t confer FDA approval; that remains years away for the US market. But it adds a signal that weighs on European regulators: an independent American review confirming that the clinical evidence is worth expediting.

For Germany’s drug regulator, currently assessing VER-01’s marketing authorization dossier, the FDA’s judgment is one more data point in a clinical record that is already deep.

Two Phase 3 Trials, One Clear Answer

The authorization application rests on two phase 3 randomized controlled trials, both published in late September 2025.

The first, a placebo-controlled trial of 820 patients, appeared in Nature Medicine and met its primary endpoint with pain effects sustained over the long term and improvements in sleep and physical function. The second — the ELEVATE trial, published in Pain and Therapy — enrolled 384 patients across Germany, the Czech Republic, Poland, and Spain, and put VER-01 directly against opioids in a head-to-head comparison.

The ELEVATE results are the ones that will matter most to prescribers. Patients receiving VER-01 were fourfold less likely to develop constipation than those on opioids, and they achieved greater pain reduction over six months — 2.5 points on an 11-point numeric scale versus 2.16 for opioids. Sleep interference improved more steeply in the VER-01 arm as well. Critically, when the drug was stopped abruptly at the end of the trial, no withdrawal symptoms appeared — a meaningful distinction from conventional opioid therapy, where tapering is standard to avoid dependence-related effects.

VER-01 is a standardized full-spectrum extract from the proprietary Cannabis sativa strain DKJ127 L., taken orally as liquid drops. Vertanical is explicit that results from the trials cannot be generalized to other cannabis extracts, prescribed flower, or isolated cannabinoids — the product’s profile is specific to its phytochemical composition. It will be sold under the brand name Exilby in European markets.

The company has spent more than eight years and over $250 million developing the drug, targeting an indication — chronic low back pain — that the ELEVATE investigators note affects over half a billion people worldwide.

Germany as the Regulatory Gateway

The structure of EU pharmaceutical regulation makes Germany’s decision consequential far beyond its own market. Once a member state grants a marketing authorization as the reference country, other EU member states can recognize it through the mutual recognition procedure — a pathway that allows regulators to rely on a completed review rather than conducting a full national assessment from scratch. Vertanical’s stated strategy is to use German approval as the anchor for broader continental rollout.

“We believe VER-01 has the potential to change how chronic pain is treated and offer physicians a much-needed non-opioid solution,” said Dr. Clemens Fischer, Founder of Vertanical and Chief Executive Officer of parent company FUTRUE Group.

That statement lands at a moment when European regulators and payers face real pressure to find alternatives to long-term opioid prescribing. Opioids remain the most common long-term pharmacotherapy for chronic low back pain across EU member states, despite clinical guidelines increasingly recommending against them — a gap that Vertanical is explicitly targeting.

For German physicians and pain specialists, Exilby’s regulatory status will determine what can actually be prescribed and reimbursed. Entry as a fully authorized medicinal product — rather than as a special-access preparation — would make it eligible for standard formulary listing and negotiations with statutory health insurers. That is a different commercial and clinical proposition from the existing landscape of physician-ordered cannabis preparations and imported products.

The US Pathway Runs on a Separate Timeline

In the United States, Vertanical’s position differs materially. The FDA’s Breakthrough Therapy Designation — granted weeks after cannabis was formally rescheduled in the US — accelerates the development program and guarantees intensive FDA engagement, but it does not abbreviate what remains a long road to approval. The company has initiated an additional pivotal trial in the US, with results expected in 2027 and a new drug application to the FDA planned for 2028, contingent on positive data.

Discussions at Cannabis Europa in London this week underscored how distinct the two markets remain. The US rescheduling order distinguishes sharply between FDA-approved cannabis-derived medicines and state-licensed cannabis products. Epidiolex — Jazz Pharmaceuticals’ (JAZZ ) CBD medicine for rare epilepsies — is currently the only plant-derived cannabis medicine to have cleared full FDA approval, and Vertanical’s new drug application pathway is built toward becoming the second.

European prescribers and operators don’t need to wait on the US outcome. The milestone to watch is Germany’s marketing authorization decision — expected in the coming weeks — and the mutual recognition dossier that follows. If German approval arrives on the timeline Vertanical has indicated, Exilby could be available to pain specialists across multiple EU member states before the end of 2026.