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Agios Pharma (AGIO)
NASDAQ:AGIO
Ag-236
Healthy Participants
Phase I
Recruiting
A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants
Jul 11, 2025
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Tebapivat
Sickle Cell Disease
Phase II
Recruiting
A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
Apr 10, 2025
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[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
Healthy Participants
Phase I
Completed
Study of How Mitapivat Affects Midazolam Blood Levels in Healthy Participants
Oct 17, 2024
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Ag-181
Healthy Volunteers
Phase I
Recruiting
Single and Multiple Ascending Dose Study and Food Effect Study for AG181
Feb 23, 2024
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Mitapivat
Sickle Cell Disease, Nephropathy
Phase II
Not Yet Recruiting
A Study of Mitapivat in Participants With Sickle Cell Disease and Nephropathy
Feb 23, 2024
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Mitapivat
Pyruvate Kinase Deficiency, Anemia, Hemolytic
Phase IV
Enrolling By Invitation
A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study
Mar 09, 2023
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Tebapivat
Myelodysplastic Syndromes
Phase II
Recruiting
A Study of Tebapivat (AG-946) in Participants With Anemia Due to Lower-Risk Myelodysplastic Syndromes (LR-MDS)
Jul 26, 2022
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Mitapivat
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
Phase III
Active Not Recruiting
A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period
Nov 22, 2021
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Mitapivat
Pediatric Pyruvate Kinase Deficiency, Pediatric Hemolytic Anemia
Phase III
Active Not Recruiting
A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period
Nov 22, 2021
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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 (AGIO) have in its pipeline
AGIO is currently developing the following drugs: Ag-236, Tebapivat, [14C]-Tebapivat, [13C2,15N3]-Tebapivat. These drug candidates are in various stages of clinical development as the company works toward FDA approval.