Hemolytic Anemia
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EMA withdrawal · 2026-08-21EMA Suspended: Oxbryta (voxelotor) — Pfizer Europe MA EEIG
The EMA suspended Oxbryta (voxelotor) for treating sickle cell disease-related anemia.
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EMA approval · 2026-08-13EMA Authorised: Pyrukynd (mitapivat sulfate) — Agios Netherlands B.V.
Pyrukynd (mitapivat sulfate) has been authorised in the EU for genetic diseases inborn and hemolytic anemia, with orphan medicine designatio…
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EMA approval · 2026-07-09EMA Authorised: Pyrukynd (mitapivat sulfate) — Agios Netherlands B.V.
Pyrukynd (mitapivat sulfate) has been authorised in the EU for genetic diseases inborn and hemolytic anemia, orphan medicine designation.
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CLINICAL_TRIALS trial_result · 2026-04-27Clinical Trial Update: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat [Phase 1, Phase 2]
An ongoing extension study evaluating long-term safety, tolerability, pharmacokinetics, and pharmacodynamics of mitapivat in adults with sta…
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CLINICAL_TRIALS trial_result · 2026-04-24Clinical Trial Update: 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 [Phase 3]
An update on a Phase 3 pediatric trial evaluating the efficacy and safety of mitapivat in children with pyruvate kinase deficiency who are n…
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CLINICAL_TRIALS research · 2026-04-24Clinical Trial Update: 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 [Phase 3]
Phase 3 clinical trial to evaluate the efficacy and safety of mitapivat in pediatric patients with pyruvate kinase deficiency, including a 5…
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EMA approval · 2026-04-21EMA Authorised: Pyrukynd (mitapivat sulfate) — Agios Netherlands B.V.
The European Medicines Agency authorised Pyrukynd (mitapivat) for the treatment of pyruvate kinase deficiency—a genetic cause of hemolytic a…
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CLINICAL_TRIALS trial_result · 2026-04-21Clinical Trial Update: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat [Phase 1, Phase 2]
This clinical trial update reports on the safety, tolerability, pharmacokinetics, and pharmacodynamics of long-term mitapivat dosing in adul…
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CLINICAL_TRIALS research · 2026-03-30Clinical Trial Update: A Study to Provide Continued Access to Mitapivat for Participants Who Previously Completed an Agios-Sponsored Mitapivat Study [Phase 4]
This document outlines a Phase 4 study providing continued access to mitapivat for participants who previously completed an Agios-sponsored …
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CLINICAL_TRIALS trial_result · 2025-08-20Clinical Trial Update: Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects [Phase 1]
Phase 1 study evaluating potential drug-drug interactions between HRS-5965 and the drugs clopidogrel and clarithromycin in healthy subjects;…
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CLINICAL_TRIALS trial_result · 2025-07-04Clinical Trial Update: A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects [Phase 1]
Phase 1 safety, tolerability, pharmacokinetic/pharmacodynamic, and QT interval study of HRS-5965 capsules in healthy subjects has been compl…
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CLINICAL_TRIALS research · 2024-12-27Clinical Trial Update: Predisposing Factors for Liver Diseases in Patients With Chronic Hemolytic Anemia
This clinical trial update investigates predisposing factors for liver diseases in patients with chronic hemolytic anemia. The status indica…
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CLINICAL_TRIALS research · 2024-11-27Clinical Trial Update: Study of Acquired Hemolytic Anemia in Adult Hospitalized Patients
A Sohag University-sponsored clinical trial studying acquired hemolytic anemia in adult hospitalized patients. The study is currently not re…
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EMA withdrawal · 2024-10-08EMA Suspended: Oxbryta (voxelotor) — Pfizer Europe MA EEIG
The EMA has suspended the EU marketing authorization for Oxbryta (voxelotor) by Pfizer Europe MA EEIG, affecting its use for sickle cell dis…
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CLINICAL_TRIALS research · 2024-09-19Clinical Trial Update: Development of an Innovative Hemodialysis Method to Improve Dialytic Clearance of Protein-bound Uremic Toxins [Phase 2]
Phase 2 clinical trial evaluating an innovative hemodialysis method to improve clearance of protein-bound uremic toxins; the study is curren…
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CLINICAL_TRIALS withdrawal · 2017-10-10Clinical Trial Update: The Role of Ursodeoxycholic Acid in Treatment of Gallstones in Hemolytic Disorders [Phase 4]
Phase 4 trial evaluating ursodeoxycholic acid for treating gallstones in patients with hemolytic disorders was terminated.
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CLINICAL_TRIALS trial_result · 2016-06-27Clinical Trial Update: Long Term Effects of Erythrocyte Lysis
A completed clinical trial update assessing the long-term effects of erythrocyte lysis in conditions including sickle cell disease and hemol…
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CLINICAL_TRIALS trial_result · 2015-09-01Clinical Trial Update: Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel
This completed clinical trial reports demographic, clinical, and laboratory characteristics of children with alpha-thalassemia in Northern I…
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CLINICAL_TRIALS trial_result · 2013-01-03Clinical Trial Update: Safety and Efficacy of Levamisole Combined With Cyclosporine A in Patients With Subclinical Paroxysmal Nocturnal Hemoglobinuria and PNH in the Setting of Another Bone Marrow Failure Syndromes(PNH-2013) [Phase 2]
Phase 2 trial evaluating the safety and efficacy of combining levamisole with cyclosporine A in patients with paroxysmal nocturnal hemoglobi…
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CLINICAL_TRIALS trial_result · 2011-05-02Clinical Trial Update: Study of Deferasirox Relative to Subcutaneous Deferoxamine in Sickle Cell Disease Patients [Phase 2]
Phase 2 trial comparing deferasirox with subcutaneous deferoxamine in patients with sickle cell disease and iron overload; results were post…
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CLINICAL_TRIALS research · 2010-09-14Clinical Trial Update: Hemolysis in Patients With Hereditary Spherocytosis (HS) [NA]
A clinical trial update notes hemolysis observed in patients with hereditary spherocytosis; sponsor Wolfson Medical Center; trial status is …