Edgewise Therapeutics, Inc. ((EWTX)) announced an update on their ongoing clinical study.
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Edgewise Therapeutics, Inc. is conducting a Phase 1 study titled ‘A Phase 1, 2-Part, Open-Label Study to Evaluate the Pharmacokinetics of a Single Oral Dose of EDG-7500 in Participants With Impaired and Normal Renal Function.’ The study aims to assess the pharmacokinetics and safety of EDG-7500, a drug administered in a single dose, in individuals with varying degrees of renal impairment compared to those with normal kidney function. This research is significant as it could provide insights into how kidney function affects drug metabolism, potentially guiding future treatments for patients with renal impairments.
The intervention being tested is EDG-7500, a drug designed to be administered in a single dose. The primary purpose of this intervention is to evaluate how the drug is processed in the body, particularly in individuals with different levels of kidney function.
The study follows an interventional design with a parallel model, meaning participants are divided into groups based on their renal function. There is no masking involved, and the primary purpose is basic science, focusing on understanding the drug’s pharmacokinetics.
The study began on June 9, 2025, with the latest update submitted on August 15, 2025. These dates are crucial as they mark the progress and current status of the study, which is still recruiting participants.
From a market perspective, the successful completion of this study could positively impact Edgewise Therapeutics’ stock performance by demonstrating the potential of EDG-7500 in treating patients with renal impairments. This could also influence investor sentiment favorably, especially if the results show significant benefits over existing treatments. Competitors in the renal impairment treatment space may need to take note of these developments as they could alter the competitive landscape.
The study is ongoing, and further details are available on the ClinicalTrials portal.