Deudomperidone represents the first potential therapeutic for the long-term treatment of gastroparesis

Topline data expected in early 2026

CinDome plans to engage with the U.S. Food and Drug Administration (FDA) to evaluate the registrational path forward for deudomperidone

CinDome Pharma, a CinRx portfolio company dedicated to advancing a safe, chronic therapy for gastroparesis, today announced that it has completed enrollment in the envision^3D Phase 2 clinical trial of deudomperidone in adults with diabetic gastroparesis, with topline safety and efficacy results anticipated in Q1 2026.

“Completing enrollment for this clinical trial signifies a major step toward our goal of delivering a much-needed new therapy for patients suffering from diabetic gastroparesis,” said Jon Isaacsohn, M.D., Founder and Chief Executive Officer of CinRx Pharma. “We remain encouraged by the interim, blinded data generated to date, which signal notable reductions from baseline in symptoms of gastroparesis, including nausea and vomiting. Deudomperidone represents a transformative treatment for patients with gastroparesis, for which there is no long-term treatment option currently available.”

After readout of the envision^3D data, CinDome will engage with the U.S. FDA to evaluate the registrational path forward for deudomperidone as a treatment for adults with diabetic gastroparesis. The additional envision^GI Phase 2 study investigating deudomperidone in idiopathic gastroparesis is currently ongoing and enrolling patients, with data expected mid-2026.

“The envision^3D study readout could be a major inflection point in the gastroparesis clinical pipeline, with the potential to unlock significant value and address a large, underserved market,” said Henry P. Parkman, MD, Chair, Gastroenterology, Lewis Katz School of Medicine at Temple University. “There is a clear need for a new option in gastroparesis, and this program has the potential to make a meaningful impact for patients and physicians.”

About the envision^3D Phase 2 Study:

The envision^3D Phase 2 study (NCT 05832151) is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of deudomperidone in adult patients with diabetic gastroparesis. The safety of deudomperidone will be assessed from the time of informed consent until the end of the Follow-Up Period. Patients will be followed for efficacy and adherence to study drug throughout the Double-Blind Treatment Period. The total duration of study participation will be approximately 18 weeks including a Screening Period and Lead-In Period of <5 weeks, a Double-Blind Treatment Period of 12 weeks, and a Follow-Up Period of up to 1 week. Approximately 400 subjects were randomized to complete the 12-week Double-Blind Treatment Period.

About Deudomperidone (CIN-102):

Deudomperidone (CIN-102) is a new chemical entity based upon deuteration and novel formulation of domperidone, a frequently prescribed first-line therapy for nausea, vomiting and gastroparesis outside of the U.S. In part due to safety concerns around QT prolongation, domperidone is not approved in the U.S. Deudomperidone has been engineered to alter the PK profile for sustained efficacy while significantly reducing cardiac liability. Multiple clinical trials of deudomperidone demonstrated it was well tolerated, including no sponsor-assessed drug related adverse events (AEs) or clinically meaningful laboratory abnormalities. CIN-102 was deemed to have no meaningful impact on QT at exposures well above a therapeutic dose in a thorough QT study and demonstrated target engagement and improvement in gastric emptying time in a previous Phase 2a trial.

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 adult patients in the United States experiencing symptoms of gastroparesis, a safe and effective treatment that can be taken on a chronic basis 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 www.CinDome.com.

About CinRx Pharma:

CinRx Pharma is a biotech company advancing a diverse portfolio of high-impact medicines through clinical development with a unique hub-and-spoke business model. CinRx’s approach combines financing with the efficient progression of therapeutic candidates within its portfolio, each managed by CinRx’s central infrastructure and operating team. Current CinCos address areas of high unmet medical need, including metabolic, gastrointestinal, and oncology. Differentiated by an asset selection process agnostic to therapeutic area, a strategic CRO partnership, and insights from thousands of development programs, CinRx identifies, funds, and accelerates promising drugs with the potential to have the highest impact on patients’ quality of life. CinRx Pharma is headquartered in Cincinnati, Ohio.

For more information, please visit www.CinRx.com or follow the company on LinkedIn.

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