Drugs / Pitavastatin
last change 10 days ago re-read 9 days ago

Pitavastatin

Small molecule targets HMGCR via inhibition

Developed for
hyperlipidemia · HIV infectious disease · chronic kidney disease · diabetes mellitus · hyperlipoproteinemia · hypertensive disorder · metabolic syndrome X · atherosclerosis
+26 more · atherosclerotic cardiovascular disease · NAFLD1 · 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 · non-small cell lung carcinoma · pancreatic adenocarcinoma · platinum-induced ototoxicity · postmenopausal osteoporosis · retinitis pigmentosa · 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
+68 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 · Eccogene · Eli Lilly and Company · Eulji General Hospital · Fudan University · Gachon University Gil Medical Center · Gangnam Severance Hospital · Gilead Sciences · Huons Co., Ltd. · 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 · Kyushu University · 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 · 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 73 · started per year

today
US approved 2009
5
5
2
2
2
6
4
1
2
2
5
4
2
3
3
3
2
2
3
2
4
9
20062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05977738 Jan → Jul 2024 adult glioblastoma C.Dirven Completed No outcome recorded
Phase 122 trials
Phase 1 NCT07774975 Oct 2026 → Jan 2028 expected retinitis pigmentosa Kyushu University Recruiting No outcome recorded
Phase 1 NCT07784621 Oct 2026 → Feb 2027 expected hypertensive disorder Huons Co., Ltd. Not yet recruiting No outcome recorded
Phase 1 NCT07726368 Aug → Dec 2026 expected NAFLD1, hyperlipidemia Eccogene Recruiting No outcome recorded
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 Active not 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 1/21 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 Mixed
Phase 316 trials · 3 met primary · 1 missed
Phase 3 NCT04289649 Apr → Nov 2020 hyperlipidemia Kowa Company, Ltd. Completed Met primary
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 Missed primary
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 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 3 NCT00344175 Jun 2006 → Aug 2007 coronary artery disorder, hyperlipidemia Kowa Research Europe Completed No outcome recorded
Phase 425 trials · 4 met primary · 1 missed
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 Met primary
Phase not applicable6 trials · 1 missed
— 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 Missed primary
— NCT00548145 Nov 2007 → Oct 2011 Alzheimer disease, hyperlipidemia Osaka University Terminated No outcome recorded
Comparator or background therapy32 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 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

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2023-11-21 Lupin Limited Regulatory Lupin Receives Approval from U.S. FDA for Pitavastatin Tablets lupin.com ↗
it has received approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated New Drug Application for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg
2020-12-04 JW Pharmaceutical Results [JW중외제약] 이상지질혈증치료제 ‘피타바스타틴’,심뇌혈관질환 예방효과 입증 jw-pharma.co.kr ↗
특히 먼저 출시된 스타틴 제제에 비해 관련 학술근거가 부족했던 피타바스타틴의 효능이 동등함을 확인했다.
2020-03-23 JW Pharmaceutical Results [JW중외제약] ‘리바로’, 온라인 국제 학술심포지엄서 연구결과 공개 jw-pharma.co.kr ↗
안정형 관상 동맥 질환이 있는 13,000명 이상의 일본 환자를 대상으로 한 전향적 무작위 시험인 ‘REAL-CAD study’는 피타바스타틴(리바로)의 저용량(1mg) 대비 고용량(4mg)의 이점을 분명히 보여준다
2017-11-17 JW Pharmaceutical Results [JW중외제약] ‘리바로’, 동양인 관상동맥질환 환자에게 효과적 jw-pharma.co.kr ↗
그 결과 ‘리바로 4mg’가 ‘리바로 1mg’ 5.4% 보다 19% 감소시킨 4.3%를 나타냈다.
2017-08-09 Lupin Limited Regulatory Lupin receives FDA approval for Nikita™ (Pitavastatin) Tablets lupin.com ↗
Mumbai: Pharma Major Lupin Limited (Lupin) announced that it has received a 505 (b) (2) NDA approval for its NikitaTM (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA).
2016-12-30 Lupin Limited Regulatory Lupin Receives Tentative Approval for Generic Livalo® Tablets lupin.com ↗
2014-12-08 JW Pharmaceutical Results [JW중외제약] JW중외제약 고지혈증 치료제 리바로, 대사증후군 개선 효과 최초 입증 jw-pharma.co.kr ↗
총 48주 동안 진행된 임상시험 결과, 리바로를 복용한 환자 중 65%가 콜레스테롤 수치가 낮아지고, 44%의 환자가 대사증후군 환자 분류에서 제외되는 등 비약물군에 비해 월등한 개선 효과가 나타났다.
2013-06-17 Eli Lilly and Company Results New Data Showed LIVALO® (pitavastatin) 4 mg had Neutral Effects on Fasting Serum Glucose and HbA1c Levels in HIV-infected Adults with Dyslipidemia lilly.com ↗
The results of this pre-specified safety analysis, presented yesterday at the Endocrine Society's 95th Annual Meeting & Expo in San Francisco, CA, showed neutral effects of pitavastatin 4 mg and pravastatin 40 mg on fasting serum glucose (FSG) and HbA1c levels over 12 weeks.
2013-03-07 Eli Lilly and Company Results New Superiority Trial Showed LIVALO® (pitavastatin) 4 mg Provided Significantly Greater LDL-C Reduction in HIV-Infected Adults with Dyslipidemia versus Pravastatin 40 mg lilly.com ↗
Results showed that, after 12 weeks of therapy, pitavastatin had a significantly greater decrease in LDL-C compared with pravastatin (pitavastatin -49.4 mg/dL and pravastatin -33.6 mg/dL, 31% vs 21% reduction in LDL-C, respectively, p &#60 0.001).
2012-07-22 Eli Lilly and Company Results Pharmacokinetic Study Results Released Evaluating Interactions Between LIVALO® (pitavastatin) and Protease Inhibitor Combination (darunavir/ritonavir) in Healthy Volunteers lilly.com ↗
The study, presented at the 19th International AIDS Conference in Washington, DC, found that when co-administered, the blood levels for LIVALO and each of the PIs were not significantly affected.
2012-05-31 Eli Lilly and Company Results New Data Showed LIVALO® (pitavastatin) Met Primary Endpoint of LDL-C Reduction When Compared with Pravastatin lilly.com ↗
LIVALO 4 mg showed superior LDL-C reduction compared with pravastatin 40 mg after 12 weeks of therapy.
2011-07-18 Eli Lilly and Company Results New Data Showed Minimal Potential for Drug Interaction Between Cholesterol Drug LIVALO® and a Common Antiretroviral Therapy lilly.com ↗
The study, presented at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Rome, Italy, found that when co-administered, the individual drug blood levels for LIVALO or each of the PIs was minimally affected.

All press releases naming this drug 22 releases

DateIssuerRelease

Evidence & citations 23 cited values

Every value below carries the sentence it was read from. 108 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
103

“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

“ULREA-PVS-NP is a poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulation containing pitavastatin and administered intravenously.” NCT07774975 ↗

“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 ↗

Show 93 more sources

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)” NCT01422382 ↗

“Pitavastatin (NK-104)” NCT01057433 ↗

“Pitavastatin (NK-104)” NCT01422369 ↗

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 ↗