Agios Pharmaceuticals ((AGIO)) announced an update on their ongoing clinical study.
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Study Overview: Agios Pharmaceuticals is conducting a Phase 1 clinical trial titled A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AG-181 in Healthy Participants. The study aims to evaluate the safety and tolerability of AG-181, a new drug, in healthy individuals, focusing on single and multiple ascending doses and the effect of food on its pharmacokinetics. This research is significant as it lays the groundwork for understanding AG-181’s potential therapeutic applications.
Intervention/Treatment: The intervention being tested is AG-181, an experimental drug administered in tablet form. The study includes a placebo control and investigates the drug’s effects under various conditions, including fasting and fed states, to assess its safety and pharmacokinetic profile.
Study Design: This interventional study is randomized and follows a sequential model with three parts. Parts 1 and 2 involve single and multiple ascending doses, respectively, while Part 3 examines the food effect using a 2×2 crossover design. The study employs quadruple masking, meaning participants, care providers, investigators, and outcomes assessors are blinded to the treatment allocation. The primary purpose is treatment-focused.
Study Timeline: The study began on February 23, 2024, with its primary completion expected by the end of 2025. The most recent update was submitted on September 16, 2025. These dates are crucial for tracking the study’s progress and anticipating future developments.
Market Implications: The ongoing study of AG-181 could influence Agios Pharmaceuticals’ stock performance as positive results may boost investor confidence and interest in the company’s pipeline. The study’s outcome could also impact the competitive landscape, particularly if AG-181 shows promise compared to existing treatments or similar drugs under development by competitors.
The study is currently recruiting, and further details are available on the ClinicalTrials portal.