New York has approved its first cannabis research license for a human clinical trial of an investigational cannabis medicine. The Cannabis Control Board approved the license at its October 1 meeting in Rochester, and the Office of Cannabis Management (OCM) announced it on October 2. It allows Upstate Clinical Research Associates in Williamsville, just outside Buffalo, to take part in a placebo-controlled study of VER-01, an oral THC extract developed by the German drugmaker Vertanical GmbH.
For New Yorkers, the news is less about a new product than about a new kind of activity. Until now, the state's cannabis system has been built around selling cannabis. Running a drug trial is a different job, and this license is the first time the state has signed off on one.
What the trial is testing
According to OCM, researchers will test whether VER-01 relieves chronic painful lumbosacral radiculopathy, the nerve-related back and leg pain usually called sciatica, better than a placebo. They will also look at whether any benefit lasts and at long-term safety. OCM said the treatment is intended for patients whose pain has not been adequately managed with non-opioid pain medications.
The federal trial registry gives more detail. The study, listed as NCT06956014 and nicknamed EXPAND, is a Phase III trial: double-blind, randomized and run at multiple sites. It compares two doses of VER-01 with a placebo. The registry describes VER-01 as a standardized extract of cannabis flower containing 19 mg of THC per milliliter. The main measure is the change in leg pain on a 0-to-10 scale after 12 weeks. The trial started on September 22, 2026, aims to enroll about 810 adults and estimates primary completion in September 2028.
Why a research license matters
Section 38 of the Cannabis Law lets the board license people to possess cannabis in order to run clinical investigations of cannabis-derived drug products. According to the board's meeting materials, OCM reviewed the Williamsville application for project quality, study design, value and impact, and for the applicant's expertise and infrastructure.
OCM Executive Director John Kagia called it "an important moment for cannabis research in New York." Dr. Nakesha Abel, who leads OCM's scientific programs, said good trials show whether a treatment works "at what dose, for which patients, and with what risks."
The license fits a wider push by OCM into clinical work. In August the agency named a second cohort of its Medical Cannabis Advisory Council, and with Montefiore Einstein it is hosting a clinical cannabis symposium in Tarrytown on November 19 and 20, including a free course for practitioners who certify medical patients.
Where VER-01 stands elsewhere
VER-01 is not a new name to High Today readers. In June we reported that Vertanical won marketing authorization for it in Germany and Austria, sold there as Exilby, for chronic low back pain with a nerve component (our coverage). The company has said it holds a Breakthrough Therapy designation from the U.S. Food and Drug Administration. The drug is not approved in the United States. A Phase III trial is one of the steps the FDA weighs before any approval decision.
What it means for New Yorkers
- It is not something you can buy. VER-01 is an investigational drug available only to enrolled trial participants. It is not sold at licensed dispensaries or through the medical program.
- The medical program is separate. Certified patients still buy at registered organizations under the rules that expanded this summer.
- Anyone curious about the trial should talk with their own doctor and check the registry listing, which names the active study sites.
What happens next
As of its September 28 update, the federal registry listed one recruiting site, in Katy, Texas. Watch for the Williamsville site to be added. Results are not expected until after the estimated 2028 completion date. With this approval, New York now has a way to license clinical research, and OCM says it wants more of it in the state.
This article is for information only and is not medical advice.