Vertanical

Vertanical is the company that succeeded where forty years of the cannabinoid pharmaceutical industry had failed: in obtaining approval from a European regulatory agency for a cannabis-based medication with a high THC content, in the form of a full-spectrum extract. Its product, Exilby (VER-01), authorized in Germany in 2026, is the fourth cannabis-derived drug to receive marketing authorization worldwide, and the first to break with the model of isolates or the 1:1 THC:CBD ratio that had prevailed since 1985.

Forty Years of a Three-Product Market

To understand what Vertanical has accomplished, one must consider the lack of progress that preceded it. Since the FDA approved dronabinol (Marinol) in 1985—a synthetic form of THC isolated for the treatment of chemotherapy-related nausea—the pharmaceutical cannabinoid market had produced
only two new drugs in four decades: Sativex from GW Pharmaceuticals, a botanical extract with a balanced THC:CBD ratio, approved in Canada in 2005 and in the United Kingdom in 2010 for the treatment of spasticity in
multiple sclerosis; and Epidiolex, GW’s purified CBD, which was approved by the FDA in 2018 for two rare forms of pediatric epilepsy. Only the latter
has become a commercial success, with sales exceeding $1.1 billion in 2025.

Exilby breaks this pattern on two fronts simultaneously: it is a full-spectrum extract with a high THC content (neither an isolate nor a balanced ratio), and it targets chronic radicular and neuropathic pain—an indication that GW Pharmaceuticals had never managed to break into.

An unusual clinical case for the field

The German approval is not based on a single study. Vertanical submitted a comprehensive Phase III program: a pivotal controlled trial
a placebo-controlled study demonstrating efficacy, long-term safety, and—a decisive factor for a THC-based medication—the absence of dependence or withdrawal syndrome; a head-to-head comparative trial against opioids involving 384 patients, demonstrating greater pain relief and better gastrointestinal tolerance; and a third Phase III trial involving 810 patients designed to confirm the effect in a population with predominantly neuropathic pain. The two completed trials enrolled more than 1,200 patients, a level of Phase III maturity that the rest of the cannabinoid sector has not yet achieved.

The business logic is straightforward: Germany issues approximately 18 million opioid prescriptions per year. A non-opioid pain reliever
with a clean track record regarding addiction has a clear alternative narrative. The commercial launch is expected around
September 2026.

U.S. Strategy and FDA Status

Exilby has the status of FDA Breakthrough Therapy Designation in the United States. A U.S. Phase III trial is currently underway, with results expected in 2027 and a New Drug Application (NDA) anticipated in 2028.

This timeline is set against the backdrop of a changing U.S. regulatory environment: As of April 1, 2026, the FDA reclassified medically approved cannabis from Schedule I to Schedule III, easing the tax burden associated with Section 280E and facilitating the supply of research materials to researchers. A major structural advantage also favors Exilby over cannabis dispensed in pharmacies: approved medications
are eligible for insurance reimbursement, whereas medical cannabis in the form of flowers or oil remains largely at the patients’ expense, including in Germany, where reimbursement for cannabis flowers is being gradually reduced.

An approval in an industry riddled with failures

Vertanical’s story must be viewed in contrast to the failures surrounding it. Corbus Pharmaceuticals missed all of its Phase III and Phase IIb targets with its lenabasum program. Zynerba Pharmaceuticals saw its Phase III RECONNECT trial fail in 2025. Tetra Bio-Pharma, a Canadian company, filed for bankruptcy in 2023. More than 50 companies are currently attempting to develop cannabinoid-based drugs,
all facing the same obstacle: navigating around the wall of patents erected by GW Pharmaceuticals (now Jazz Pharmaceuticals)
regarding Epidiolex, whose patent protection extends through 2035 and beyond.

Vertanical chose the fourth approach—using the full-spectrum botanical extract as a drug in its own right—and has demonstrated that it can overcome the regulatory hurdles that other strategies had failed to surmount.

Exilby’s approval is both validation of a hypothesis and a positive outlier in an industry where most cannabis-related ventures have stalled before Phase III.