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Agios Pharma (AGIO) Drug Pipeline

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Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Mitapivat, Ag-348Sickle Cell DiseasePhase IIINot Yet RecruitingA Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)Jun 15, 2026―
Mitapivat, Ag-348Transfusion-Dependent Beta-Thalassemia, Transfusion-Dependent Alpha-ThalassemiaPhase IIINot Yet RecruitingA Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)Mar 26, 2026
Mitapivat, Ag-348Non-Transfusion-Dependent Alpha-Thalassemia, Non-Transfusion-Dependent Beta-ThalassemiaPhase IIINot Yet RecruitingA Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent ThalassemiaMar 26, 2026
Ag-181PhenylketonuriaPhase IRecruitingA Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With PhenylketonuriaNov 17, 2025
Ag-236Healthy ParticipantsPhase IActive Not RecruitingA Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy ParticipantsJul 11, 2025
TebapivatSickle Cell DiseasePhase IIActive Not RecruitingA Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)Apr 10, 2025
[14C]-Tebapivat, [13C2,15N3]-TebapivatHealthy ParticipantsPhase ICompletedA Study to Determine How Tebapivat is Absorbed, Broken Down, and Removed From the Body and the Extent to Which Tebapivat is Made Available in the Body in Healthy ParticipantsDec 17, 2024―
Midazolam, Mitapivat, Pyrukynd, Ag-348Healthy ParticipantsPhase ICompletedStudy of How Mitapivat Affects Midazolam Blood Levels in Healthy ParticipantsOct 17, 2024―
Ag-181Healthy VolunteersPhase IRecruitingSingle and Multiple Ascending Dose Study and Food Effect Study for AG181Feb 23, 2024
MitapivatSickle Cell Disease, NephropathyPhase IINot Yet RecruitingA Study of Mitapivat in Participants With Sickle Cell Disease and NephropathyFeb 23, 2024

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Agios Pharmaceuticals (AGIO) have in its pipeline
Agios Pharma AGIO is currently developing the following drugs: Mitapivat, Ag-348, Ag-181, Ag-236, Tebapivat, [14C]-Tebapivat, [13C2,15N3]-Tebapivat, Midazolam, Mitapivat, Pyrukynd, Ag-348, Mitapivat, Mitapivat, Pyrukynd, Ag-348, Ag881, Ag-348. These drug candidates are in various stages of clinical development as the company works toward FDA approval.