Agios Pharmaceuticals ((AGIO)) announced an update on their ongoing clinical study.
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Agios Pharmaceuticals is conducting a Phase 2 clinical study titled A Phase 2, Double-blind, Randomized, Placebo-Controlled, Multicenter, Dose-Finding, Efficacy, and Safety Study of Tebapivat in Participants With Sickle Cell Disease. The study aims to evaluate the efficacy and safety of tebapivat, a drug intended to improve anemia and hemoglobin response in individuals with Sickle Cell Disease (SCD).
The intervention being tested is tebapivat, an oral drug administered in doses of 2.5 mg, 5.0 mg, and 7.5 mg. The purpose is to determine the optimal dose that provides the best hemoglobin response compared to a placebo.
The study design involves random allocation of participants into different groups receiving either tebapivat or a placebo. It follows a parallel intervention model with quadruple masking, meaning that participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocations. The primary aim is treatment-focused.
The study began on April 10, 2025, with the primary completion and estimated overall completion dates yet to be announced. The most recent update was submitted on October 24, 2025, indicating ongoing recruitment.
This study update could influence Agios Pharmaceuticals’ stock performance positively if the results show significant efficacy and safety, potentially boosting investor confidence. It also positions the company competitively in the SCD treatment market, where advancements are highly anticipated.
The study is currently ongoing, with further details available on the ClinicalTrials portal.