Hypereosinophilic Syndrome
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CLINICAL_TRIALS research · 2026-04-21Clinical Trial Update: A Longitudinal Study of Familial Hypereosinophilia (FE): Natural History and Markers of Disease Progression
This clinical trial update describes a longitudinal study of familial hypereosinophilia to characterize natural history and biomarkers of di…
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CLINICAL_TRIALS research · 2026-04-17Clinical Trial Update: A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases [Phase 3]
A Phase 3 clinical trial is recruiting to evaluate benralizumab in children with eosinophilic diseases including eosinophilic granulomatosis…
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CLINICAL_TRIALS trial_result · 2026-04-08Clinical Trial Update: Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment [Phase 3]
Phase 3 rollover trial to continue benralizumab (Fasenra) in participants who completed a prior study and benefited from treatment; not yet …
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CLINICAL_TRIALS research · 2026-04-08Clinical Trial Update: Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents [Phase 2]
Phase 2 trial evaluating dupilumab as add-on therapy for hypereosinophilic syndrome in patients with partial response to eosinophil-depletin…
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CLINICAL_TRIALS research · 2026-04-02Clinical Trial Update: A Phase III Study to Evaluate the Efficacy and Safety of Benralizumab in Patients With Hypereosinophilic Syndrome (HES) [Phase 3]
A Phase III clinical trial is evaluating the efficacy and safety of benralizumab in patients with hypereosinophilic syndrome and is currentl…
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CLINICAL_TRIALS trial_result · 2026-03-16Clinical Trial Update: Tyrosine Kinase Inhibition to Treat Myeloid Hypereosinophilic Syndrome [Phase 2]
Phase 2 clinical trial update shows a tyrosine kinase inhibition approach for eosinophilic myeloid neoplasms, including hypereosinophilic sy…
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EMA approval · 2026-03-05EMA Authorised: Imatinib Teva (imatinib) — Teva B.V.
EMA authorised Imatinib Teva (imatinib) for multiple indications including chronic myeloid leukemia, precursor cell lymphoblastic leukemia-l…
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CLINICAL_TRIALS research · 2026-02-20Clinical Trial Update: Natural History of Hypereosinophilia and Hypereosinophilic Syndromes
A clinical trial sponsored by University Hospital Lille is studying the natural history of eosinophilia and hypereosinophilic syndromes; the…
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CLINICAL_TRIALS trial_result · 2026-01-08Clinical Trial Update: Identification of New Markers in the Hypereosinophilic Syndrome [NA]
This completed clinical trial explored identification of new biomarkers for hypereosinophilic syndrome. The study was conducted at Universit…
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CLINICAL_TRIALS research · 2025-12-23Clinical Trial Update: Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders [Phase 2]
A Phase 2 clinical trial update for ruxolitinib in treating hypereosinophilic syndrome and other primary eosinophilic disorders; the study i…
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CLINICAL_TRIALS research · 2025-12-10Clinical Trial Update: The Use of Machine Learning Techniques for the Differential Diagnosis Between Eosinophilic Granulomatosis With Polyangiitis and Hypereosinophilic Syndrome [NA]
A clinical trial update shows that recruitment is ongoing for a study using machine learning to differentiate between Eosinophilic Granuloma…
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CLINICAL_TRIALS trial_result · 2025-12-04Clinical Trial Update: Study in Pediatrics With HypEREosinophilic Syndrome (SPHERE) [Phase 3]
The SPHERE Phase 3 pediatric trial investigating treatment for hypereosinophilic syndrome has completed.
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CLINICAL_TRIALS research · 2025-11-25Clinical Trial Update: Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial [Phase 3]
A Phase 3 clinical trial evaluating depemokimab for hypereosinophilic syndrome is currently recruiting.
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EMA approval · 2025-11-12EMA Authorised: Glivec (imatinib) — Novartis Europharm Limited
The European Medicines Agency authorised Glivec (imatinib) for multiple indications, including precursor cell lymphoblastic leukemia-lymphom…
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EMA approval · 2025-05-06EMA Authorised: Imatinib Accord (imatinib) — Accord Healthcare S.L.U.
The EMA authorised Imatinib Accord (imatinib) for several indications, including Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dermatofibr…
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CLINICAL_TRIALS research · 2025-04-25Clinical Trial Update: This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Access for Patients With Hypereosinophilic
The document outlines compassionate-use and long-term access programs for mepolizumab in patients with hypereosinophilic syndrome, including…
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CLINICAL_TRIALS research · 2025-04-04Clinical Trial Update: Eosinophil Subpopulations in Eosinophilic-associated Diseases
A University of Florence trial update notes a study on eosinophil subpopulations in eosinophilic diseases. The study includes eosinophilic a…
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FDA approval · 2025-03-20FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for imatinib mesylate (Teva) under an ANDA, authorizing continued regulatory approval for this gener…
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CLINICAL_TRIALS trial_result · 2025-02-12Clinical Trial Update: TrinetX Study of Hypereosinophilic Syndrome (HES) Without an Identifiable Non-haematological Secondary Cause
This ClinicalTrials.gov update reports the completion of the TrinetX study on Hypereosinophilic Syndrome without an identifiable non-haemato…
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FDA approval · 2025-01-08FDA Approved: IMATINIB MESYLATE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental ANDA for Imatinib Mesylate (Chartwell RX, LLC), enabling marketing of a generic version of the cancer drug.
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EMA withdrawal · 2023-10-19EMA Withdrawn: Imatinib Koanaa (imatinib mesilate) — Koanaa Healthcare GmbH
The EMA status shows Imatinib Koanaa (imatinib mesilate) has been withdrawn from the market by Koanaa Healthcare GmbH.
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FDA approval · 2023-08-16FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)
FDA approved a supplemental application for Imatinib from Dr. Reddy's Laboratories Inc, resulting in regulatory approval for a change to the…
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EMA withdrawal · 2022-07-05EMA Withdrawn: Imatinib Actavis (imatinib) — Actavis Group PTC ehf
EMA withdrawn Imatinib Actavis (imatinib) from the market, with indications including chronic myeloid leukemia, precursor B-ALL/lymphoma, my…
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CLINICAL_TRIALS trial_result · 2022-02-15Clinical Trial Update: Steroid Treatment for Hypereosinophilic Syndrome [Phase 4]
Phase 4 trial update on steroid treatment for hypereosinophilic syndrome completed with results posted in 2022.
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CLINICAL_TRIALS trial_result · 2022-02-08Clinical Trial Update: Study to Evaluate Safety and Efficacy of Benralizumab in Subjects With Hypereosinophilic Syndrome [Phase 2, Phase 3]
A clinical trial update evaluating the safety and efficacy of benralizumab for hypereosinophilic syndrome across Phase 2 and Phase 3 stages.