New York regulators have approved a cannabis research license that will allow a clinical research center near Buffalo to participate in a large Phase 3 trial testing a standardized THC-containing cannabis medicine for chronic sciatica pain. The approval gives Upstate Clinical Research Associates in Williamsville authority to participate in the U.S. development program for VER-01, an oral full-spectrum cannabis extract being studied in adults with chronic painful lumbosacral radiculopathy, the nerve-related condition commonly known as sciatica.
The Cannabis Control Board approved the research license on October 1, 2026, with the New York Office of Cannabis Management announcing the decision the following day. The nationwide study, known as EXPAND, is expected to enroll approximately 810 adults and compare two doses of VER-01 with placebo. Unlike most medical marijuana research based on patient surveys or dispensary records, this trial is designed as a randomized, double-blind, placebo-controlled Phase 3 study—the type of research normally required before an investigational medicine can move toward regulatory approval.
New York Opens the Door to a Pharmaceutical-Style Cannabis Trial
The New York portion of the study will be conducted by Upstate Clinical Research Associates, a dedicated clinical research facility in Williamsville that has previously conducted Phase 2, Phase 3 and Phase 4 pharmaceutical trials. The research license is important because clinical trials involving cannabis products require additional state and federal controls that do not apply to conventional investigational medicines. New York regulators described the authorization as an important step toward expanding rigorous cannabis science within the state.
The study is sponsored by Germany-based Vertanical GmbH, which has spent years developing VER-01 as a standardized cannabis-derived medicine for chronic pain. The company’s goal is not simply to market another cannabis product. VER-01 is being developed under pharmaceutical standards in which the cannabinoid concentration, manufacturing process, dosing schedule, safety profile and clinical effectiveness must be measured consistently. That distinction separates the program from state medical marijuana systems, where patients may use flower, concentrates, tinctures, edibles or other products that vary widely in THC content and chemical composition.
What Is VER-01?
VER-01 is a standardized full-spectrum extract made from Cannabis sativa DKJ127 L., a proprietary cannabis variety used as the botanical source material for the medicine. The finished oral formulation contains approximately 19 milligrams of delta-9 THC per milliliter. Earlier clinical research with the same product describes it as containing THC as the dominant cannabinoid along with much smaller quantities of compounds including cannabigerol, cannabidiol, terpenes, flavonoids, phytosterols and other naturally occurring cannabis constituents.
The product is administered orally rather than smoked or vaporized. That allows researchers to control dosing far more precisely than would be possible with inhaled cannabis. Oral administration also avoids the pulmonary exposure associated with smoking while allowing investigators to titrate participants toward doses that balance pain relief against unwanted THC effects. The standardized formulation is especially important in a Phase 3 trial because regulators need evidence that each participant receiving the active drug is being exposed to a reproducible medicine rather than an unpredictable cannabis preparation.
The EXPAND Trial Will Enroll About 810 Adults
EXPAND is formally registered as a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating VER-01 in chronic painful lumbosacral radiculopathy. Approximately 810 adults are expected to participate. Eligible patients must have chronic sciatica-related pain significant enough to require drug treatment and must previously have received inadequate relief from optimized non-opioid pain medications or been unable to use those treatments because of intolerance or contraindications.
Participants are assigned to one of two VER-01 dose groups or a placebo group. Neither the participants nor the clinicians assessing outcomes know who receives active medicine during the blinded portion of the study. The primary endpoint is the change in average leg-pain intensity after 12 weeks of treatment, measured using an 11-point numerical pain scale. Researchers will also evaluate safety, tolerability and other clinical outcomes to determine whether any improvement is large enough and consistent enough to justify continued development.
Why Sciatica Is Different From Ordinary Low Back Pain
Sciatica is not simply another name for lower-back discomfort. Lumbosacral radiculopathy occurs when one or more nerve roots in the lower spine become compressed, inflamed or otherwise irritated. Herniated discs and degenerative changes in the spine are common causes. The resulting pain often travels from the lower back or buttock down the leg and may be accompanied by burning, tingling, numbness or weakness.
That neuropathic component makes sciatica particularly difficult to treat. Anti-inflammatory medicines may help some patients, while physical therapy, exercise and time can improve many cases. Other patients receive medications intended to influence nerve pain, epidural steroid injections or, when structural compression and neurological impairment are severe enough, surgery. For people whose pain becomes chronic, however, treatment can become a long process of balancing incomplete pain relief against medication side effects.
Why Researchers Are Interested in THC for Nerve Pain
THC acts primarily through cannabinoid receptors in the nervous system, particularly CB1 receptors that are widely distributed throughout the brain, spinal cord and peripheral pain pathways. Activation of these receptors can alter pain signaling, change how unpleasant sensations are perceived and influence inflammatory and neural processes involved in chronic pain. These mechanisms have made cannabinoids a major target of pain research for decades.
Neuropathic pain has attracted particular interest because conventional analgesics frequently provide incomplete relief. Clinical studies of various cannabinoid medicines have produced mixed results, with some showing modest reductions in neuropathic pain and others finding limited benefit or frequent side effects. One problem has been the enormous variation among cannabis products, doses and study designs. A standardized medicine such as VER-01 gives researchers a better opportunity to determine whether a specific cannabis formulation actually works rather than trying to generalize findings from loosely defined “medical marijuana.”
Earlier Phase 3 Research Gave VER-01 an Important Starting Point
The new sciatica trial is not the first large study of VER-01. A major Phase 3 trial published in Nature Medicine in 2025 evaluated the medicine in 820 adults with chronic low back pain. Participants were randomly assigned to receive VER-01 or placebo during a 12-week double-blind treatment period, followed by longer extension phases examining continued treatment and withdrawal.
VER-01 met the trial’s primary endpoint. Participants receiving the cannabis extract experienced an average pain reduction of approximately 1.9 points on the numerical rating scale, with a statistically significant advantage of about 0.6 points compared with placebo. The difference was particularly notable among participants whose low back pain included a neuropathic component. That subgroup showed stronger improvements in pain and neuropathic symptom measurements, an observation that provides part of the scientific rationale for testing the drug specifically in patients with painful lumbosacral radiculopathy.
Neuropathic Pain Patients Appeared to Respond Particularly Well
In the Nature Medicine trial, researchers separately examined participants who had evidence of neuropathic pain. This group is especially relevant to sciatica because radiculopathy involves irritated or damaged nerve roots rather than purely muscular or mechanical back pain. Among patients with a substantial neuropathic component, the difference between VER-01 and placebo was larger than it was across the study population as a whole.
Researchers also observed reductions on the Neuropathic Pain Symptom Inventory, a validated measure covering symptoms such as burning pain, pressure, electric-shock sensations and abnormal sensitivity. Those findings did not prove VER-01 treats sciatica, because the original trial enrolled people with chronic low back pain rather than a population selected specifically for lumbosacral radiculopathy. The new EXPAND study is designed to answer that more focused question.
Another Trial Compared VER-01 Directly With Opioids
A separate randomized Phase 3 trial published in Pain and Therapy in 2025 compared VER-01 with commonly used opioid medications in 384 adults with chronic low back pain. Participants were treated for approximately six months after an initial dose-titration period. The study was designed partly around gastrointestinal tolerability because constipation is one of the most persistent adverse effects associated with long-term opioid treatment.
Patients receiving VER-01 were about four times less likely to develop constipation than those receiving opioids and were substantially less likely to require laxatives. Across the treatment period, pain reduction was also slightly greater with VER-01, while participants reported somewhat better sleep improvement. The size of the pain difference between treatments was modest, but the trial suggested that a standardized cannabis extract could potentially compete with conventional analgesics while producing a different side-effect profile.
Safety Will Be Closely Watched in the U.S. Trial
THC-containing medicines are not free of adverse effects. In the large placebo-controlled VER-01 study, adverse events occurred more frequently in people taking the active cannabis medicine than in those receiving placebo, although most were classified as mild to moderate and temporary. Typical cannabinoid-related effects can include dizziness, fatigue, nausea, dry mouth, altered attention and feelings of intoxication.
Previous VER-01 research did not identify evidence of withdrawal or dependence under the conditions studied, but the U.S. Phase 3 program will continue monitoring longer-term safety. EXPAND also excludes certain patients for whom THC could present elevated risks, including some people with severe psychiatric disorders and significant recent cardiovascular disease. These exclusions are important because THC can increase heart rate, alter blood pressure and worsen psychiatric symptoms in susceptible individuals.
Phase 3 Does Not Mean the Medicine Has Been Approved
The phrase “Phase 3 clinical trial” can sometimes be mistaken for regulatory approval. VER-01 remains an investigational medicine in the United States. New York’s decision authorizes clinical research; it does not authorize physicians to prescribe VER-01 generally or permit the drug to be purchased from cannabis dispensaries.
Phase 3 is generally the stage at which drug developers attempt to confirm effectiveness and safety in a comparatively large patient population after earlier research has established sufficient evidence to justify expanded testing. Positive results could eventually support a regulatory application, but regulators would still evaluate the total evidence involving manufacturing quality, pharmacology, clinical benefit, adverse events and risk management. A failed Phase 3 trial could also prevent or delay approval.
The Trial Could Help Separate Cannabis Medicine From Dispensary Cannabis
One of the most important aspects of the VER-01 program is its attempt to treat cannabis like any other pharmaceutical treatment. Medical marijuana programs have produced valuable real-world information, but products purchased from dispensaries can vary dramatically between batches and brands. Patients may also adjust their own dosing or combine several cannabis products simultaneously, making it difficult to determine exactly which chemical exposure produced a particular benefit or adverse effect.
A standardized botanical drug changes that equation. Researchers know the concentration, formulation and manufacturing specifications of VER-01, and participants receive predetermined dosing instructions. Placebo control allows scientists to separate pharmacological effects from expectations surrounding cannabis. If the medicine succeeds, the evidence could help establish a clearer distinction between physician-prescribed cannabinoid pharmacotherapy and general medical cannabis use.
Chronic Pain Remains One of the Biggest Targets for Cannabis Research
Pain is one of the most common reasons patients report using medical cannabis in the United States. Yet clinical evidence remains uneven because decades of federal restrictions made large pharmaceutical-style marijuana trials difficult to conduct. Many studies have been small, short or focused on products that do not closely resemble commercially available cannabis.
Large trials such as EXPAND may begin filling that gap. Instead of asking whether “cannabis” in general helps pain, investigators can determine whether a specific standardized product provides measurable improvement in a specific condition, at defined doses, over a defined period. That type of evidence is essential for establishing which patients are most likely to benefit and whether the improvement is meaningful enough to justify THC-related adverse effects.
New York Is Positioning Itself as a Cannabis Research Center
State regulators have emphasized that the Williamsville approval represents more than participation in a single trial. New York’s cannabis law provides a pathway for research licenses intended to support clinical, agricultural, product-development and public-health research involving the plant. The VER-01 license demonstrates how that authority can be used to connect state cannabis regulation with conventional pharmaceutical research.
For New York, the project may help establish infrastructure for additional clinical cannabis trials. Researchers studying cannabinoids have historically faced complicated layers of federal and state rules governing possession, storage and administration of cannabis products. Creating a functioning state research-license pathway can reduce one layer of uncertainty and potentially make New York sites more attractive to companies and academic investigators developing cannabinoid medicines.
The Most Important Question Is Whether VER-01 Works Specifically for Sciatica
Positive chronic low back pain results do not guarantee success in chronic sciatica. Lumbosacral radiculopathy is a distinct neurological pain condition, and therapies that improve general back pain do not necessarily relieve pain caused by irritated nerve roots. That is why a large dedicated study is necessary despite encouraging earlier VER-01 findings.
EXPAND is expected to continue through 2028, meaning definitive results are still years away. If VER-01 significantly reduces leg pain compared with placebo while maintaining an acceptable safety profile, the findings could provide some of the strongest evidence yet supporting a THC-containing botanical medicine for chronic neuropathic pain. If it fails to outperform placebo, the result will be equally important because it would define the limits of cannabis-based treatment.
A Major Test for Evidence-Based Cannabis Medicine
New York’s approval of the VER-01 research license represents a notable transition in American cannabis science. The study is not examining whether people who already use marijuana say it helps their pain. It is testing a standardized THC-containing medicine against placebo in hundreds of adults under the same type of blinded clinical framework used to evaluate conventional pharmaceuticals.
For patients with chronic sciatica, the stakes are substantial. Persistent radicular pain can interfere with sleep, work, mobility and quality of life, while existing medications often provide incomplete relief or create their own risks. Earlier Phase 3 research suggests VER-01 can reduce chronic low back pain and may have particularly meaningful effects when neuropathic symptoms are present. EXPAND will now test whether those findings translate to a clearly defined sciatica population. If they do, the trial could move cannabis medicine another step away from anecdote and toward a standardized prescription treatment backed by large-scale clinical evidence.
