As the United States continues to confront the long-term consequences of opioid addiction and chronic pain, biomedical researchers at the State University of New York at Stony Brook are helping advance a potential new class of pain therapies designed to provide relief without the risks associated with opioids.
The experimental treatment, known as ART26.12, is a first-in-class, non-opioid therapy developed to target neuropathic pain, a severe and often debilitating condition affecting millions of Americans. The therapy originated from discoveries led by Iwao Ojima, SUNY Distinguished Professor in the Department of Chemistry at Stony Brook, and has since advanced through an ongoing research and development partnership with Artelo Biosciences, the biotechnology company leading the therapy’s clinical development.
The advancement has also attracted growing financial support. In March 2026, Artelo Biosciences announced it had secured $11 million in private investment to help advance ART26.12 toward future FDA approval and commercialization. The investment reflects increasing interest in non-opioid pain therapies as healthcare systems and researchers continue searching for safer long-term pain management options.
Ojima, working in collaboration with Martin Kaczocha, professor in the Department of Anesthesiology in the Renaissance School of Medicine, helped identify fatty acid-binding proteins, or FABPs, as promising targets for a new class of pain therapies. Their work laid the scientific foundation for ART26.12, which targets fatty acid-binding protein 5 (FABP5), a protein associated with lipid signaling and the development of chronic pain.
Unlike traditional pain medications, ART26.12 does not rely on opioid pathways. Researchers believe this cost-effective biomedical approach could represent a fundamentally different strategy for managing neuropathic pain while avoiding the dependency and addiction risks and high costs commonly associated with opioid-based therapies.
Beyond chemotherapy-related neuropathy, researchers believe the treatment could eventually have applications for pain associated with diabetes, spinal cord injuries, autoimmune disorders and other neurological conditions. Supporting materials note that approximately one in 11 Americans experiences peripheral neuropathy.
The discovery arrives at a critical moment in pain medicine. More than 20 percent of Americans experience chronic pain annually, according to supporting materials provided by the researchers and company, while neuropathic pain frequently develops into a persistent condition that is difficult to treat effectively. Existing therapies often provide only partial relief and can carry significant side effects.
Researchers say one of the most immediate applications for ART26.12 may be chemotherapy-induced peripheral neuropathy, or CIPN, a painful condition affecting up to 40 percent of cancer patients undergoing chemotherapy. In severe cases, the condition can become so debilitating that patients reduce or discontinue potentially life-saving cancer treatments. Currently, there are no FDA-approved therapies indicated for CIPN.
Preclinical studies demonstrated that ART26.12 both prevented and reduced neuropathic pain associated with chemotherapy and other conditions. Researchers also observed reductions in weight loss, anemia and stress-related symptoms in laboratory models, while early findings suggested possible additional therapeutic benefits in certain cancer models.
“This is not just another non-opioid therapy; it is a completely new strategy using functional lipidomics to improve pain management,” said Gregory D. Gorgas, president and chief executive officer of Artelo Biosciences.
The therapy traces its origins to years of foundational research conducted by Ojima and Kaczocha and their collaborators at Stony Brook. Their work identified FABPs as promising drug targets within the body’s endocannabinoid system, helping establish the scientific basis for a new class of compounds designed to treat pain and inflammation.
After the technology was licensed to Artelo Biosciences in 2018, Ojima and Kaczocha continued collaborating with the company to synthesize and evaluate highly selective FABP5 inhibitor candidates, work that ultimately led to the development of ART26.12.
Momentum behind the therapy has continued to build in recent years. In 2024, the U.S. Food and Drug Administration cleared Artelo’s investigational new drug application, allowing the treatment to move into human clinical trials. Earlier this year, the company announced the successful completion of a Phase 1 single ascending dose and preliminary food effect clinical study, reporting no drug-related adverse effects, tolerability concerns or major safety signals among healthy volunteers.
Researchers are planning additional studies later in 2026, with patient trials anticipated in 2027.
The advancement of ART26.12 also reflects a broader shift in pharmaceutical innovation increasingly driven by American research universities.
In a 2025 analysis published in STAT, Michael Kinch and his co-author found that universities contributed patents underpinning 50 percent of FDA-approved drugs between 2020 and 2024, with American institutions accounting for 87 percent of those academic discoveries. The analysis highlighted the growing role universities play in translating basic scientific research into clinical therapies.
ART26.12 represents one example of that translational pipeline. Originating from research conducted at Stony Brook before being licensed to Artelo Biosciences in 2018 by Stony Brook’s Intellectual Property Partners (IPP) on behalf of the Research Foundation for the State University of New York, the therapy has advanced from laboratory discovery to FDA-cleared human clinical trials, with additional studies anticipated later this year.
“Behind nearly every prescription filled in America lies a powerful engine of innovation fueled by research conducted within the nation’s universities,” Kinch and his co-author wrote in the analysis.
For Stony Brook, the progress of ART26.12 highlights the university’s broader role in translating scientific discoveries into technologies and therapies with real-world impact. Through collaborations connecting academic research, biotechnology development and private investment, discoveries originating in university laboratories continue moving closer to clinical application and patient care.
The work also reflects Stony Brook’s expanding research and innovation enterprise, where interdisciplinary collaborations are helping address some of society’s most pressing healthcare challenges through scientific discovery and translational research.
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