Hypereosinophilic Syndrome
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CLINICAL_TRIALS trial_result · 2022-01-04Clinical Trial Update: Therapy of HES, PV, Atypical Chronic Myelocytic Leukemia (CML) or Chronic Myelomonocytic Leukemia (CMML), and Mastocytosis With Imatinib Mesylate [NA]
Clinical trial update of imatinib mesylate for various myeloproliferative and related neoplasms including CMML, CML, polycythemia vera, hype…
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CLINICAL_TRIALS trial_result · 2021-06-29Clinical Trial Update: A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies [Phase 1, Phase 2]
A Phase 1/2 study of oral AMN107 (imatinib) in adults with chronic myeloid leukemia and other hematologic malignancies has completed enrollm…
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FDA approval · 2021-03-25FDA Approved: IMATINIB — Supplemental Application (Dr.Reddy's Laboratories Inc)
FDA approved a supplemental application for imatinib from Dr. Reddy's Laboratories, supporting an update to the drug's labeling under the AN…
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CLINICAL_TRIALS trial_result · 2020-06-23Clinical Trial Update: A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622 [Phase 3]
Extension safety study update for mepolizumab in hypereosinophilic syndrome (Phase 3; completed; results posted).
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CLINICAL_TRIALS trial_result · 2020-05-05Clinical Trial Update: Intravenous Mepolizumab In Subjects With Hypereosinophilic Syndromes (HES) [Phase 3]
Phase 3 trial update for intravenous mepolizumab in subjects with hypereosinophilic syndromes (HES) has completed.
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CLINICAL_TRIALS trial_result · 2020-02-21Clinical Trial Update: Efficacy and Safety Study of Mepolizumab in Subjects With Severe Hypereosinophilic Syndrome (HES) [Phase 3]
Phase 3 trial evaluating efficacy and safety of mepolizumab in subjects with severe hypereosinophilic syndrome has completed with posted res…
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FDA approval · 2020-01-09FDA Approved: IMATINIB MESYLATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for imatinib mesylate from Teva Pharmaceuticals USA, Inc., under ANDA204285.
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EMA withdrawal · 2019-10-16EMA Withdrawn: Imatinib medac (imatinib) — Medac
The EMA has withdrawn Imatinib Medac (imatinib) from the market.
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CLINICAL_TRIALS trial_result · 2019-05-06Clinical Trial Update: Dasatinib as Therapy for Myeloproliferative Disorders (MPDs) [Phase 2]
Phase 2 trial evaluating dasatinib for myeloproliferative disorders; the study has completed and results were posted in 2019.
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CLINICAL_TRIALS research · 2017-12-07Clinical Trial Update: Study to Evaluate Safety and Efficacy of Dexpramipexole (KNS-760704) in Subjects With Hypereosinophilic Syndrome [Phase 2]
Phase 2 clinical trial evaluating the safety and efficacy of dexpramipexole (KNS-760704) in hypereosinophilic syndrome; current status is no…
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CLINICAL_TRIALS trial_result · 2017-02-23Clinical Trial Update: Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes [Phase 2]
Phase 2 clinical trial evaluating imatinib mesylate in patients with various activated tyrosine kinase-driven malignancies, including hypere…
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FDA approval · 2016-08-04FDA Approved: IMATINIB MESYLATE — Original Application (Teva Pharmaceuticals USA, Inc.)
FDA approval of Teva's Imatinib Mesylate Original Application under ANDA204285 for a generic Imatinib product.
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CLINICAL_TRIALS trial_result · 2015-12-15Clinical Trial Update: Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome [Phase 3]
Phase 3 open-label extension trial of intravenous mepolizumab for hypereosinophilic syndrome was terminated, with results posted in December…
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FDA approval · 2015-12-03FDA Approved: IMATINIB MESYLATE — Original Application (BluePoint Laboratories)
FDA approved the original application for Imatinib Mesylate from BluePoint Laboratories (ANDA078340), authorizing a generic version of the c…
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FDA approval · 2013-01-25FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for GLEEVEC (imatinib mesylate) submitted by Novartis, reflecting changes to the product labeling.
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CLINICAL_TRIALS trial_result · 2012-08-02Clinical Trial Update: 2-Chlorodeoxyadenosine and Cytarabine in Patients With Idiopathic Hypereosinophilic Syndrome (HES) [Phase 2]
Phase 2 trial evaluating cladribine (2-Chlorodeoxyadenosine) in combination with cytarabine for idiopathic hypereosinophilic syndrome has co…
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CLINICAL_TRIALS trial_result · 2012-05-01Clinical Trial Update: A Study to Determine the Safety and Efficacy of Imatinib Mesylate in Patients With Idiopathic Hypereosinophilic Syndrome [Phase 2]
A Phase 2 study evaluating the safety and efficacy of Imatinib Mesylate in patients with Idiopathic Hypereosinophilic Syndrome has been term…
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CLINICAL_TRIALS trial_result · 2012-03-13Clinical Trial Update: Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders. [Phase 1]
A pediatric pharmacokinetic study of Glivec/Gleevec (imatinib) in children aged 1 to less than 4 with chronic myeloid leukemia, Philadelphia…
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CLINICAL_TRIALS trial_result · 2010-12-29Clinical Trial Update: Efficacy of Imatinib Mesylate in Hypereosinophilic Syndromes [Phase 2]
A Phase 2 clinical trial evaluated the efficacy of imatinib mesylate in hypereosinophilic syndromes and has completed, reporting efficacy si…
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CLINICAL_TRIALS research · 2009-09-15Clinical Trial Update: Study of STI571 in the Treatment of Patients With Idiopathic Hypereosinophilic Syndrome (HES) and Eosinophilic Leukemias [Phase 2]
This entry outlines a Phase 2 study evaluating imatinib (STI571) in patients with hypereosinophilic syndrome and eosinophilic leukemias, wit…
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EMA withdrawal · 2009-07-29EMA Application withdrawn: Bosatria (Mepolizumab) — Glaxo Group Limited
The EMA withdrew the application for Bosatria (mepolizumab) by Glaxo Group Limited for hypereosinophilic syndrome.
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FDA approval · 2008-12-19FDA Approved: GLEEVEC — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for GLEEVEC (imatinib mesylate) from Novartis Pharmaceuticals Corporation, resulting in regulatory a…
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CLINICAL_TRIALS trial_result · 2008-03-04Clinical Trial Update: Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome [Phase 2]
A Phase 2 trial of an anti-Interleukin-5 antibody for hypereosinophilic syndrome has completed.