Mitapivat, Ag-348
Sickle Cell Disease
Phase III
Not Yet Recruiting
A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
Jun 15, 2026
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Mitapivat, Ag-348
Transfusion-Dependent Beta-Thalassemia, Transfusion-Dependent Alpha-Thalassemia
Phase III
Not Yet Recruiting
A 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
[14C]-Tebapivat, [13C2,15N3]-Tebapivat
Healthy Participants
Phase I
Completed
A 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 Participants
Dec 17, 2024
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Midazolam, Mitapivat, Pyrukynd, Ag-348
Healthy Participants
Phase I
Completed
Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants
Oct 17, 2024
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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
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 Pharma (8AP) have in its pipeline
8AP is currently developing the following drugs: Mitapivat, Ag-348, Mitapivat, Ag-348, Mitapivat, Ag-348. These drug candidates are in various stages of clinical development as the company works toward FDA approval.