Hypercholesterolemia
📧 Sign up to get email alerts when something new happens for Hypercholesterolemia.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2021-02-01FDA Approved: PRAVASTATIN SODIUM — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for pravastatin sodium (a generic statin). This represents an approved suppleme…
-
CLINICAL_TRIALS trial_result · 2021-01-15Clinical Trial Update: Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan [Phase 3]
Phase 3 trial update assessing the combined Rosuvastatin/Ezetimibe with Telmisartan for hypercholesterolemia and hypertension has completed.
-
FDA approval · 2021-01-15FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for atorvastatin calcium (generic atorvastatin) manufactured by Mylan Pharmaceuticals Inc.
-
CLINICAL_TRIALS trial_result · 2020-12-29Clinical Trial Update: An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia [Phase 3]
Phase 3 trial update evaluating alirocumab for efficacy and safety in children and adolescents with homozygous familial hypercholesterolemia…
-
CLINICAL_TRIALS trial_result · 2020-12-22Clinical Trial Update: Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE) [Phase 3]
Phase 3 long-term safety and efficacy update of bempedoic acid (CLEAR Harmony OLE) completed; results posted in 2020.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
CLINICAL_TRIALS trial_result · 2020-12-17Clinical Trial Update: Evolocumab Plus Ezetimibe in Haemodialized Statin-intolerant Patients With Hypercholesterolemia [Phase 4]
A Phase 4 trial evaluating evolocumab plus ezetimibe in statin-intolerant patients with hypercholesterolemia undergoing hemodialysis.
-
FDA approval · 2020-12-17FDA Approved: EZETIMIBE AND SIMVASTATIN — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original-application generic fixed-dose combination of ezetimibe and simvastatin.
-
CLINICAL_TRIALS trial_result · 2020-12-09Clinical Trial Update: To Evaluate the Efficacy and Safety of Co-administrated Ezetimibe/Rosuvastatin and Telmisartan in Patients With Essential Hypertension and Primary Hypercholesterolemia [Phase 3]
A Phase 3 clinical trial evaluating the efficacy and safety of co-administered ezetimibe/rosuvastatin with telmisartan in patients with esse…
-
CLINICAL_TRIALS trial_result · 2020-10-29Clinical Trial Update: Effect of Tredaptive on Serum Lipoproteins and Inflammatory Markers [Phase 4]
Phase 4 clinical trial update evaluating the effect of Tredaptive on serum lipoproteins and inflammatory markers in hypercholesterolemia.
-
FDA approval · 2020-10-23FDA Approved: EZETIMIBE — Original Application (ScieGen Pharmaceuticals Inc)
FDA approved ScieGen Pharmaceuticals' original (ANDA) application for ezetimibe as a generic cholesterol-lowering medication.
-
FDA approval · 2020-10-19FDA Approved: FENOFIBRATE — Original Application (Alembic Pharmaceuticals Limited)
FDA approved Alembic's generic fenofibrate under an original drug application, confirming its use for lipid disorders. Fenofibrate lowers tr…
-
FDA approval · 2020-10-13FDA Approved: ATORVASTATIN CALCIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for ATORVASTATIN CALCIUM from Dr. Reddy's Laboratories Limited, granting approval for a generic ator…
-
FDA approval · 2020-09-25FDA Approved: EZALLOR SPRINKLE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for EZALLOR SPRINKLE (rosuvastatin), adding a sprinkle formulation to the rosuvas…
-
FDA approval · 2020-09-25FDA Approved: FLUVASTATIN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved Teva Pharmaceuticals USA, Inc.'s supplemental application for Fluvastatin (generic) under the ANDA.
-
FDA approval · 2020-09-25FDA Approved: LOVASTATIN — Supplemental Application (Carlsbad Technology, Inc.)
FDA approved a supplemental application for Lovastatin (Carlsbad Technology, Inc.) to modify an existing ANDA product.
-
FDA approval · 2020-09-15FDA Approved: FLUVASTATIN SODIUM — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for fluvastatin sodium submitted by Mylan Pharmaceuticals, updating the approved ANDA product.
-
CLINICAL_TRIALS trial_result · 2020-08-12Clinical Trial Update: Clinical Trial to to Compare of the Efficacy and Safety of Lipilou® 20 mg and Lipilou® 10 mg [Phase 4]
A Phase 4 trial comparing the efficacy and safety of Lipilou 20 mg versus Lipilou 10 mg in hypercholesterolemia has been completed.
-
CLINICAL_TRIALS trial_result · 2020-08-05Clinical Trial Update: Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH) [Phase 2]
Open-label extension study to assess long-term safety and efficacy of alirocumab in heterozygous familial hypercholesterolemia completed wit…
-
CLINICAL_TRIALS trial_result · 2020-08-04Clinical Trial Update: Dapagliflozin and Cholesterol Metabolism in Type 2 Diabetes (DM2) [Phase 4]
Phase 4 trial update on dapagliflozin examining cholesterol metabolism in type 2 diabetes and hypercholesterolemia; study completed with res…
-
FDA approval · 2020-07-15FDA Approved: COLESEVELAM HYDROCHLORIDE — Original Application (Cranbury Pharmaceuticals, LLC)
FDA approved the original application for COLESEVELAM HYDROCHLORIDE (colesevelam hydrochloride) by Cranbury Pharmaceuticals, LLC.
-
CLINICAL_TRIALS trial_result · 2020-06-25Clinical Trial Update: A 12-Week, Phase 2 Study of Gemcabene in Hypercholesterolemia Patients on Stable Moderate and High-Intensity Statins [Phase 2]
Phase 2 trial update for gemcabene in hypercholesterolemia patients on stable statin therapy has completed, with results posted in 2020.
-
FDA approval · 2020-06-24FDA Approved: PITAVASTATIN — Supplemental Application (Aurobindo Pharma Limited)
FDA granted a supplemental approval for a generic pitavastatin product from Aurobindo Pharma Limited.
-
CLINICAL_TRIALS trial_result · 2020-06-17Clinical Trial Update: A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene [Phase 2]
Phase 2 study evaluating alirocumab in participants with autosomal dominant hypercholesterolemia due to GOFm PCSK9 or LOFm ApoB mutations; s…
-
FDA approval · 2020-06-15FDA Approved: SIMVASTATIN — Supplemental Application (Micro Labs Limited)
FDA approved a supplemental application for simvastatin from Micro Labs Limited.
-
CLINICAL_TRIALS trial_result · 2020-05-29Clinical Trial Update: A Study of the Safety and Efficacy of Anacetrapib (MK-0859) Among Participants With Hypercholesterolemia When Added to Ongoing Statin Therapy (MK-0859-022) [Phase 3]
Phase 3 clinical trial evaluating safety and efficacy of anacetrapib (MK-0859) added to ongoing statin therapy in adults with hypercholester…