Lexicon Announces Patient-Reported Data on Diabetic Peripheral Neuropathic Pain

Lexicon Pharmaceuticals, Inc. recently announced data from a study of patients describing the impact of diabetic peripheral neuropathic pain (DPNP) despite treatment with standard of care at the 7th Annual Meeting of the American Society of Pain and Neuroscience (ASPN 2025). The conference was held July 17-20, 2025, at the Fontainebleau Miami Beach Hotel in Miami Beach, FL.

DPNP is a highly prevalent but often overlooked debilitating chronic complication of diabetes. DPNP can result in burning pain, numbness, and other symptoms in the hands, feet, legs, and arms. There are approximately 9 million patients in the U.S. who are suffering with DPNP. Previous research shows that DPNP affects an estimated 30% of patients with type 1 diabetes and 50% of patients with type 2 diabetes.

“Our study focusing on the patient experience with DPNP is meant to give a “voice” to the nearly 100 million people worldwide who struggle with its impact on their activities of daily living,” said M. Belinda Hardin, PharmD, BCPS, Lexicon Pharmaceuticals. “We hope the new research raises awareness among healthcare professionals of the patient burden and empowers patients and caregivers to discuss treatment options with their providers.”

Discovered using Lexicon’s unique approach to gene science, pilavapadin (LX9211) is a potent, once-daily, orally delivered, selective, investigational small molecule inhibitor of AAK1, a novel target for neuropathic pain which inhibits reuptake and recycling of neurotransmitters involved in pain signaling without affecting opiate pathways. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain. Preclinical studies of pilavapadin demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways.

The efficacy, safety and pharmacokinetics of pilavapadin in DPNP were also evaluated in the Phase 2a proof-of-concept RELIEF-DPN-1 study, which met the primary endpoint of reducing ADPS at week 6 compared to placebo and demonstrated substantial and consistent benefits in addressing DPNP symptoms, including burning pain and pain interference on sleep. Pilavapadin has received Fast Track designation from the U.S. Food and Drug Administration for development in DPNP.

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000 program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications.  For more information, visit www.lexpharma.com.