CinDome Pharma Completes Enrollment in Phase 2 Trial for Diabetic Gastroparesis Treatment

What's Happening?

CinDome Pharma has announced the completion of enrollment for its envision3D Phase 2 clinical trial of deudomperidone (CIN-102) aimed at treating diabetic gastroparesis. The trial, which involves adult patients, is expected to yield topline safety and efficacy results in the first quarter of 2026. Deudomperidone is being developed as a potential long-term treatment for gastroparesis, a condition with no current long-term therapeutic options. The trial is a randomized, double-blind, placebo-controlled study assessing the drug's efficacy and safety over a 12-week treatment period. Following the trial, CinDome plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the drug's registration path. An additional study, envisionGI, is ongoing to evaluate deudomperidone in idiopathic gastroparesis, with results expected by mid-2026.

Why It's Important?

The development of deudomperidone is significant as it addresses a critical unmet need for a chronic treatment option for gastroparesis, a condition affecting nearly 16 million adults in the U.S. The successful development and approval of deudomperidone could provide a new therapeutic option for patients suffering from this debilitating condition, potentially improving their quality of life. The drug's progress also highlights the ongoing innovation in the pharmaceutical industry to address complex gastrointestinal disorders. If successful, deudomperidone could become a transformative treatment, offering a safer alternative to existing therapies that are not approved in the U.S. due to safety concerns.

What's Next?

CinDome Pharma will analyze the data from the envision3D trial once available and engage with the FDA to determine the next steps for deudomperidone's potential approval. The company will also continue its ongoing envisionGI study, which could further support the drug's efficacy and safety profile. The outcomes of these trials will be crucial in determining the drug's future in the market and its potential impact on the treatment landscape for gastroparesis.