Domperidone

CINCINNATI--(BUSINESS WIRE)--CinDome Pharma, a CinRx portfolio company dedicated to advancing a safe, chronic therapy for gastroparesis, announced today that enrollment in the Phase 2 envisionGI trial of deudomperidone (CIN-102) for adults with idiopathic gastroparesis has been completed. Deudomperidone is a new chemical entity being evaluated to treat and relieve symptoms of gastroparesis, which affects an estimated 16 million people in the U.S. and has no U.S. Food and Drug Administration (FDA)-approved long-term therapy. Topline safety and efficacy results from envisionGI are expected in the second half of 2026. “With the completion of enrollment for envisionGI, we’ve reached another important milestone for deudomperidone and most importantly for patients with idiopathic gastroparesis who need a chronic treatment option for this debilitating condition,” said Brian Murphy, M.D., Chief Medical Officer of CinRx Pharma. “Deudomperidone has the potential to be a transformative treatment for millions of patients, as the first safe, long-term therapy that could significantly improve gastroparesis symptoms, including reducing the severity of nausea and vomiting, and increasing the number of symptom-free days. We are encouraged by the interim, blinded data we’ve seen so far. We look forward to sharing the full data readout later this year.” Deudomperidone is a novel formulation of domperidone, a frequently prescribed first-line, short-term therapy for nausea, vomiting, and gastroparesis outside the U.S., but it is not approved in the US due to safety concerns around QT prolongation. CinDome’s novel formulation of domperidone is designed to reduce peak concentration (Cmax) and extend half-life compared with traditional domperidone. Deudomperidone is intended to provide therapeutic effects comparable to, or better than, domperidone, with reduced QT liability. “Deudomperidone has the potential to address a significant unmet medical need for patients struggling with gastroparesis and its symptoms, and for physicians who lack effective treatments,” said Henry P. Parkman, MD, Gastroenterology, Lewis Katz School of Medicine at Temple University. “The envisionGI study is critical to demonstrating the potential of this new treatment option and how it will positively impact patients’ lives both in the near and long-term.” Following the readout of the envisionGI data, CinDome plans to meet with the U.S. Food and Drug Administration (FDA) at an End of Phase 2 Meeting to discuss the next steps in the regulatory pathway and align on registrational study plans for deudomperidone as a potential chronic treatment for adults with gastroparesis. About the CIN-102 Phase 2 Clinical Trial: The phase 2 envisionGI study (NCT06899217) is a randomized, double-blind, placebo-controlled, multicenter trial to evaluate the efficacy and safety of CIN-102 (deudomperidone) in adult subjects with idiopathic gastroparesis. The total duration of study participation will be approximately 18 weeks, including a Screening Period and Lead-In Period of up to 5 weeks, a Double-Blind Treatment Period of 12 weeks, and a Follow-Up Period of up to 1 week. The 400 subjects enrolled will be randomized into three treatment groups: 15 mg CIN-102, 10 mg CIN-102, or placebo. About CinDome Pharma: CinDome, a CinRx portfolio company, is dedicated to filling the significant need for a safe, effective, and tolerable treatment for the millions of people living with the devastating impact of chronic gastroparesis. With nearly 16 million adults in the United States experiencing symptoms of gastroparesis, a safe and effective chronic treatment remains a significant unmet need. CinDome’s CIN-102 is an engineered formulation of domperidone, the first-line treatment for gastroparesis worldwide, which is not approved in the United States. Learn more at CinDome.com. About CinRx Pharma: CinRx Pharma is a hub-and-spoke, multi-asset clinical development organization advancing a diverse portfolio of high-impact medicines. Benefiting from a strategic partnership with a leading CRO, deep access to capital, and insights from thousands of development programs, CinRx identifies, funds, and advances promising drugs through clinical development. CinRx seeks to engage areas of high unmet medical need and is agnostic to drug modality and therapeutic area. CinRx Pharma is headquartered in Cincinnati, Ohio. For more information, please visit CinRx.com or follow the company on X and LinkedIn.