Drugs / Pitavastatin
last change Jul 2026 re-read 2 minutes ago

Pitavastatin

Small molecule targets HMGCR via inhibition

Developed for
hyperlipidemia · HIV infectious disease · hyperlipoproteinemia · chronic kidney disease · diabetes mellitus · metabolic syndrome X · atherosclerosis · atherosclerotic cardiovascular disease
+25 more · hypertensive disorder · obesity disorder · type 2 diabetes mellitus · acute coronary syndrome · acute myeloid leukemia · acute myocardial infarction · Alzheimer disease · B-cell chronic lymphocytic leukemia · breast cancer · cardiovascular disorder · coronary artery disorder · glucose metabolism disease · hyperlipidemia, combined, 2 · NAFLD1 · non-small cell lung carcinoma · pancreatic adenocarcinoma · platinum-induced ototoxicity · postmenopausal osteoporosis · vasculogenic impotence · benign paroxysmal positional vertigo · calcinosis · carotid artery disorder · congestive heart failure · ischemic stroke · myocardial ischemia
Investigated by
Kowa Research Europe · JW Pharmaceutical · Kowa Research Institute, Inc. · Kowa Company, Ltd. · Kowa Pharmaceuticals America, Inc. · Yonsei University
+67 more · Emalex Biosciences Inc. · Hanlim Pharm. Co., Ltd. · Hoffmann-La Roche · Massachusetts General Hospital · National Institute of Allergy and Infectious Diseases (NIAID) · Nuventra, Inc. · Peking University Third Hospital · University of California, Irvine · AbbVie · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Aichi Gakuin University · Alios Biopharma Inc. · Asan Medical Center · Basilea Pharmaceutica · Biomedical Advanced Research and Development Authority · Bundang CHA Hospital · C.Dirven · Chang Chen · Chinese Academy of Medical Sciences, Fuwai Hospital · Daewon Pharmaceutical Co., Ltd. · Dankook University · Dong-A University · Eli Lilly and Company · Eulji General Hospital · Fudan University · Gachon University Gil Medical Center · Gangnam Severance Hospital · Gilead Sciences · ICON plc · Inje University · Institute for Biomedical and Pharmaceutical Research (IBMP), Nürnberg-Heroldsberg, Germany · Janssen Research & Development, LLC · Jiangsu Wanbang Medicine Marketing Co., Ltd. · Jun Tao · Korea University Anam Hospital · Lomonosov Moscow State University Medical Research and Educational Center · Mansoura University · Merck Sharp & Dohme LLC · Minia University · Minia University Hospital · Myongji Hospital · NEAT ID Foundation · NYU Langone Health · National Health Insurance Service Ilsan Hospital · National Heart, Lung, and Blood Institute (NHLBI) · National Institute on Aging (NIA) · New York City Health and Hospitals Corporation · Nizhpharm · Novo Nordisk A/S · Orient Europharma Co., Ltd. · Orient Pharma Co., Ltd. · Osaka University · Peking University People's Hospital · Ramathibodi Hospital · Samjin Pharmaceutical Co., Ltd. · Samsung Medical Center · Seoul National University Bundang Hospital · Seoul National University Hospital · Severance Hospital · Sun Yat-sen University · Syneos Health · Tai Tien Pharmaceuticals Co., Ltd. · Tokyo University · Umm Al-Qura University · United States Department of Defense · University at Buffalo · University of Cologne

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) LIVALO 2016-11-18 – 2019-05-16 fda.gov
Approved US (FDA) LIVALO 2009-08-03 fda.gov

Trials 71 · started per year

today
US approved 2009
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20062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05977738 Jan → Jul 2024 adult glioblastoma C.Dirven Completed No outcome recorded
Phase 119 trials
Phase 1 NCT07567781 Apr → Jul 2026 overdue AbbVie Active not recruiting No outcome recorded
Phase 1 NCT07549958 Mar 2026 → Mar 2027 expected pancreatic adenocarcinoma University of California, Irvine Recruiting No outcome recorded
Phase 1 NCT07351565 Jan → Jun 2026 overdue non-small cell lung carcinoma Chang Chen Not yet recruiting No outcome recorded
Phase 1 NCT06982131 Jun 2025 → Dec 2026 expected obesity disorder Hoffmann-La Roche Recruiting No outcome recorded
Phase 1 NCT06813924 Feb → May 2025 inherited hemoglobinopathy Novo Nordisk A/S Completed No outcome recorded
Phase 1 NCT06808646 Jan → Feb 2025 Basilea Pharmaceutica Completed No outcome recorded
Phase 1 NCT05334108 Apr → Aug 2022 Emalex Biosciences Inc. Completed No outcome recorded
Phase 1 NCT04764851 Feb → Apr 2021 Emalex Biosciences Inc. Terminated No outcome recorded
Phase 1 NCT04512105 Dec 2020 → Jul 2024 B-cell chronic lymphocytic leukemia, acute myeloid leukemia University of California, Irvine Completed No outcome recorded
Phase 1 NCT03717064 Nov → Dec 2018 Hoffmann-La Roche Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT06553157 Sep 2024 → Jul 2025 cancer, platinum-induced ototoxicity Minia University Completed No outcome recorded
Phase 21 trial
Phase 2 NCT07460960 Mar 2026 → Dec 2027 expected atherosclerosis, vasculogenic impotence Lomonosov Moscow State University Medical Research and Educational Center Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT04705909 Jan → Sep 2021 breast cancer Mansoura University Unknown No outcome recorded
Phase 317 trials
Phase 3 NCT04289649 Apr → Nov 2020 hyperlipidemia Kowa Company, Ltd. Completed No outcome recorded
Phase 3 NCT04289662 Mar 2020 → Aug 2021 hyperlipidemia Kowa Company, Ltd. Completed No outcome recorded
Phase 3 NCT04584736 Jun 2019 → Jul 2020 hyperlipoproteinemia JW Pharmaceutical Completed No outcome recorded
Phase 3 NCT03070223 Mar 2017 → Aug 2023 HIV infectious disease Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Completed No outcome recorded
Phase 3 NCT02344290 Mar 2015 → Aug 2023 HIV infectious disease, cardiovascular disorder National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 3 NCT01710007 Nov 2011 → Sep 2012 hyperlipoproteinemia Orient Pharma Co., Ltd. Completed No outcome recorded
Phase 3 NCT01386853 Jul 2011 → Mar 2012 hyperlipidemia Tai Tien Pharmaceuticals Co., Ltd. Unknown No outcome recorded
Phase 3 NCT01402843 Jun 2011 → Jun 2012 hyperlipidemia, hypertensive disorder JW Pharmaceutical Completed No outcome recorded
Phase 3 NCT00344370 Aug 2006 → Apr 2008 hyperlipidemia, type 2 diabetes mellitus Kowa Research Europe Completed No outcome recorded
Phase 3 NCT00325780 Jul 2006 → Nov 2007 hyperlipidemia Kowa Research Europe Completed No outcome recorded
Phase 425 trials
Phase 4 NCT06767774 Apr 2025 → Aug 2029 expected atherosclerotic cardiovascular disease, diabetes mellitus Korea University Anam Hospital Recruiting No outcome recorded
Phase 4 NCT07442630 Aug 2023 → Jan 2026 overdue hyperlipidemia JW Pharmaceutical Active not recruiting No outcome recorded
Phase 4 NCT06273215 Mar 2023 → Dec 2025 diabetes mellitus Peking University Third Hospital Unknown No outcome recorded
Phase 4 NCT05747768 Jul 2022 → Jun 2024 chronic kidney disease Peking University Third Hospital Unknown No outcome recorded
Phase 4 NCT06359353 Apr 2019 → Feb 2022 hyperlipoproteinemia, postmenopausal osteoporosis Seoul National University Bundang Hospital Completed No outcome recorded
Phase 4 NCT03532620 Aug 2018 → Sep 2019 hyperlipidemia, hypertensive disorder, prediabetes syndrome Jun Tao Unknown No outcome recorded
Phase 4 NCT03418974 Nov 2017 → Dec 2021 hyperlipidemia Fudan University Unknown No outcome recorded
Phase 4 NCT02940366 Dec 2016 → Nov 2019 metabolic syndrome X Seoul National University Hospital Unknown No outcome recorded
Phase 4 NCT02863185 May 2016 → Dec 2020 chronic kidney disease Dong-A University Completed No outcome recorded
Phase 4 NCT02743260 Apr 2016 → Dec 2017 University of Cologne Completed No outcome recorded
Phase not applicable6 trials
NCT07626840 Jun 2026 → Jun 2028 expected acute coronary syndrome Samsung Medical Center Not yet recruiting No outcome recorded
NCT07524101 May 2026 → Jan 2031 expected atherosclerosis, chronic kidney disease, hyperlipidemia Yonsei University Recruiting No outcome recorded
NCT05705804 Jun 2023 → May 2027 expected atherosclerotic cardiovascular disease, hyperlipidemia Yonsei University Recruiting No outcome recorded
NCT03730038 Feb 2019 → Feb 2020 hyperlipidemia Yonsei University Completed No outcome recorded
NCT02290106 Mar 2015 → Apr 2018 NAFLD1, obesity disorder Massachusetts General Hospital Completed No outcome recorded
NCT00548145 Nov 2007 → Oct 2011 Alzheimer disease, hyperlipidemia Osaka University Terminated No outcome recorded
Also used as a comparator or background therapy in 32 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT01764178 Comparator Jan → Mar 2013 hyperlipidemia, hypertensive disorder JW Pharmaceutical Completed No outcome recorded
Phase 1 NCT01406431 Comparator Aug 2011 hyperlipidemia, hypertensive disorder JW Pharmaceutical Completed No outcome recorded
Phase 1 NCT00653913 Comparator Mar → Sep 2004 Organon and Co Completed No outcome recorded
Phase 22 trials
Phase 2 NCT07307989 Comparator Aug 2025 → Jul 2029 expected hyperlipidemia, ischemic stroke Chang Gung Memorial Hospital Recruiting No outcome recorded
Phase 2 NCT01890967 Background Jun 2013 → Apr 2014 hyperlipoproteinemia Eli Lilly and Company Completed No outcome recorded
Phase 36 trials
Phase 3 NCT06317051 Comparator Dec 2024 → Jul 2026 overdue HIV infectious disease Kirby Institute Active not recruiting No outcome recorded
Phase 3 NCT04643093 Comparator Aug 2020 → Aug 2021 hyperlipidemia, combined, 2, hyperlipoproteinemia Orient Pharma Co., Ltd. Completed No outcome recorded
Phase 3 NCT02956590 Comparator May 2018 → Apr 2023 hyperlipidemia, obesity disorder Carelon Research Completed No outcome recorded
Phase 3 NCT02670434 Comparator Jan 2016 → Jul 2017 hyperlipidemia Kowa Research Institute, Inc. Withdrawn No outcome recorded
Phase 3 NCT03618797 Comparator Nov 2015 → Jan 2018 hyperlipidemia, combined, 2 Hanlim Pharm. Co., Ltd. Completed No outcome recorded
Phase 414 trials
Phase 4 NCT06722521 Comparator Jul 2025 → Jun 2032 expected calcinosis Asan Medical Center Recruiting No outcome recorded
Phase 4 NCT05537948 Comparator Oct 2021 → Jan 2024 overdue hyperlipidemia, liver disorder National Medical Research Center for Therapy and Preventive Medicine Active not recruiting No outcome recorded
Phase 4 NCT04061824 Comparator May 2016 → Dec 2018 hyperlipidemia, hypertensive disorder Yonsei University Completed No outcome recorded
Phase 4 NCT02144922 Comparator May 2014 → Oct 2016 hypertensive disorder Asan Medical Center Completed No outcome recorded
Phase 4 NCT01648829 Comparator Jan 2014 → Dec 2015 coronary artery disorder University of Roma La Sapienza Unknown No outcome recorded
Phase not applicable7 trials
NCT06096909 Background Nov 2023 → Nov 2025 overdue acute coronary syndrome China National Center for Cardiovascular Diseases Not yet recruiting No outcome recorded
NCT06001047 Comparator Nov 2023 → Jul 2026 overdue benign paroxysmal positional vertigo Xi'an No.3 Hospital Recruiting No outcome recorded
NCT03606824 Comparator Mar 2019 → Feb 2020 atherosclerotic cardiovascular disease, hyperlipidemia, hypothyroidism Shaochun.Li Unknown No outcome recorded
NCT01042730 Comparator Feb 2010 → Jun 2016 coronary artery disorder Juntendo University Completed No outcome recorded
NCT00846118 Comparator Feb 2009 → Jan 2011 cardiovascular disorder Chieko Hamada Terminated No outcome recorded

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 106 sources stand behind the page.

FieldValueCited text
Known as Pitavastatin “A total of 293 patients were randomly assigned into four groups receiving 2 mg pitavastatin, 4 mg pitavastatin, 2 mg pitavastatin/10 mg ezetimibe (K-924 LD), and 4 mg...” PMID 36908150 Mar 2023
100

“One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin,...” NCT04061824

“The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release...” NCT02634034

“The original text is related to a medication called Pitavastatin Calcium Tablets, commonly known as "Minshilang" in Chinese, produced by Weicai (China) Pharmaceutical Co., Ltd.” NCT06001047

“A Clinical Trial to Evaluate the Pharmacokinetics of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca Under Fed Condition in Healthy Male Volunteers” NCT02250976

“In this study, the combination therapy strategy will utilize Pitavastatin 1-4 mg plus Ezetimibe 10 mg once daily or Atorvastatin 10-20 mg plus Ezetimibe 10 mg once daily.” NCT07524101

“Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.” NCT02107898

Pitavastatin is a unique lipophilic statin with moderate efficacy in lowering LDL-C levels by 30% to 50% with a tolerable safety profile.” PMID 36241463 Oct 2022

“Examples of Medications that Meet Study Requirements: Atorvastatin 20mg Po qn, Rosuvastatin 10mg Po qn or Pitavastatin 4mg Po qn.” NCT06096909

“Moderate- or high-intensity statin monotherapy, including atorvastatin 10-80 mg/d, rosuvastatin 5-20 mg/d, pitavastatin 1-4 mg/d” NCT07307989

“Statins include atorvastatin , fluvastatin , lovastatin , pitavastatin , pravastatin, rosuvastatin and simvastatin.” NCT06553157

“fixed-dose combination of pitavastatin/ezetimibe (K-924 LD: 2 mg/10 mg; K-924 HD: 4 mg/10 mg)” PMID 37722882 Sep 2023

Pitavastatin, a competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase” PMID 22410289 Mar 2012

“* dabigatran: 375 µg/mL and pitavastatin: 10 µg/mL given as 1mL oral solution” NCT04764851

“Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg” NCT03618797

“dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam” NCT05334108

Pitavastatin 4mg tablet by mouth once daily for 12 weeks” NCT01660191

pitavastatin 4mg” NCT06767774

pitavastatinNCT01890967

NCT06722521

NCT05537948

NCT03311841

NCT06273215

NCT02144922

NCT07351565

NCT00846118

NCT03717064

NCT02595268

NCT00444717

NCT00309738

NCT00249249

NCT00309751

NCT00309777

NCT04512105

NCT02545231

NCT04945122

NCT00711919

NCT01595828

NCT02056847

NCT00861861

NCT01057433

NCT04643093

NCT06359353

NCT01767610

NCT00786734

NCT02442700

NCT00640276

NCT00889226

NCT01042730

NCT01256476

NCT01422369

NCT06813924

NCT01764178

NCT03606824

NCT02863185

NCT02290106

NCT06982131

NCT07626840

NCT01502904

NCT01648829

NCT06808646

NCT05977738

NCT03730038

NCT01422382

NCT07549958

NCT00242944

NCT00257686

NCT00653913

NCT02344290

NCT07460960

NCT01402843

NCT00701285

NCT02888327

NCT02956590

NCT03532620

NCT00325780

NCT03418974

NCT00301392

NCT01043094

NCT00549926

NCT05747768

NCT02743260

NCT01301066

NCT02940366

NCT07567781

NCT00716846

NCT01386853

NCT07442630

NCT06317051

NCT03070223

NCT01695954

NCT01178853

NCT01871792

NCT00344175

NCT01406431

NCT05705804

NCT01166633

NCT04705909

NCT00548145

NCT00344370

NCT00330876

Known as 1PC002 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01710007
Known as Itavastatin calcium ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as Livalo “To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate the comparative pharmacokinetics and safety of fixed-dose...” NCT02250976
2

“Investigational Product Test group: Pitavastatin calcium (LIVALO) 4mg tab Control group: Pitavastatin calcium (LIVALO) 2mg tab” NCT02056847

NCT02670434

Known as Livalo Tab 1 mg “Once-daily dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tablets of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be...” NCT00301392
Known as Livaro “* Lipilfen cap.160mg : Micronized fenofibrate 160mg , Livaro tab. 2mg : Pitavastatin ca 2mg” NCT02250976
Known as Minshilang “The original text is related to a medication called Pitavastatin Calcium Tablets, commonly known as "Minshilang" in Chinese, produced by Weicai (China) Pharmaceutical Co., Ltd.” NCT06001047
Known as Nikita ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as NK-104 “The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release...” NCT02634034
3

“Pitavastatin (NK-104)” NCT01422369

“Pitavastatin (NK-104)” NCT01422382

“Pitavastatin (NK-104)” NCT01057433

Known as NSC-760423 ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as Pitavastatin Ca “To develop combination product of micronized fenofibrate plus pitavastatin, we would like to evaluate the comparative pharmacokinetics and safety of fixed-dose...” NCT02250976
1

“Livaro tab. 2mg (pitavastatin Ca 2mg) by Joong Wae Pharm.” NCT01767610

Known as Pitavastatin calcium “Nondiabetic, obese, HTG males (n = 12) received pitavastatin calcium (4 mg/day) for 180 days in a single-phase, unblinded study.” PMID 38160756 Dec 2023
1

“Investigational Product Test group: Pitavastatin calcium (LIVALO) 4mg tab Control group: Pitavastatin calcium (LIVALO) 2mg tab” NCT02056847

Known as Pitavastatin calcium salt ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as Pitavastatin Calcium Tablets “The original text is related to a medication called Pitavastatin Calcium Tablets, commonly known as "Minshilang" in Chinese, produced by Weicai (China) Pharmaceutical Co., Ltd.” NCT06001047
Known as Pitavastatin component of k-924 pivastatin ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as PITAVASTATIN MAGNESIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as PITAVASTATIN SODIUM ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as Pitavastatina ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as Pitavastatine ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Known as Zypitamag ChEMBL registry synonym — accepted as the source's own label CHEMBL1201753
Action Inhibit “Pitavastatin is a novel, potent, 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor.” PMID 21874537 Aug 2011
1

“HMG-CoA reductase inhibitor” CHEMBL1201753

Modality Small molecule “Pitavastatin is a chemically synthesized statin in Japan” NCT00242944
Route Oral “2 mg by orally/day” NCT00548145
Target HMGCR “HMG-CoA reductase inhibitor” CHEMBL1201753