A Phase I, Randomized, Investigator/Participant-Blind, Placebo-Controlled, Fixed-Sequence Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Orally Administered RO7795081 and the Effect of Steady-State Dose of Orally Administered RO7795081 on the Pharmacokinetics of Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants

This is a randomized, investigator-and-participant-blind, placebo-controlled, fixed sequence, cross-over, Phase 1 study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of orally administered RO7795081 and the effect of a steady-state dose of orally administered RO7795081 on the pharmacokinetics of pitavastatin and rosuvastatin in otherwise healthy, overweight or obese adult participants.

Start Date04 Jun 2025

Sponsor / Collaborator

Roche Holding AG

CTR20242862

/ TerminatedNot Applicable

匹伐他汀钙片在健康受试者中的单剂量、随机、开放、交叉、两制剂、两周期空腹和餐后人体生物等效性试验

[Translation] A single-dose, randomized, open-label, crossover, two-dose, two-period fasting and fed bioequivalence study of pitavastatin calcium tablets in healthy subjects

主要目的：以四川赛卓药业股份有限公司的匹伐他汀钙片（规格：2mg）为受试制剂，以Kowa Company,Ltd.的匹伐他汀钙片（商品名：力清之®（LIVALO KOWA ®），规格：2mg）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To investigate the bioequivalence of the two preparations in healthy subjects, using pitavastatin calcium tablets (specification: 2 mg) of Sichuan Saizhuo Pharmaceutical Co., Ltd. as the test preparation and pitavastatin calcium tablets (trade name: LIVALO KOWA ®, specification: 2 mg) of Kowa Company, Ltd. as the reference preparation according to the relevant provisions of bioequivalence tests. Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date01 Aug 2024

Sponsor / Collaborator

Sichuan Saizhuo Pharmacy Co., Ltd.

ChiCTR2400084812

Not ApplicableIIT

A randomized, double-blind, placebo-controlled, dual-center clinical study to evaluate the efficacy and safety of pitavastatin calcium dispersible tablets in the treatment of active systemic lupus erythematosus

Start Date01 Aug 2024

Sponsor / Collaborator

Nanjing Drum Tower Hospital

100 Clinical Results associated with Pitavastatin Calcium

100 Translational Medicine associated with Pitavastatin Calcium

100 Patents (Medical) associated with Pitavastatin Calcium

180

Literatures (Medical) associated with Pitavastatin Calcium

01 Apr 2025·ACTA PHARMACOLOGICA SINICA

Ivacaftor, a CFTR potentiator, synergizes with osimertinib against acquired resistance to osimertinib in NSCLC by regulating CFTR-PTEN-AKT axis

Article

Author: Fang, Liang-Jie ; Zeng, Chen-Ming ; Ge, Fu-Jing ; Qu, Jing-Jing ; Li, Yue-Kang ; Qian, Mei-Jia ; Zhou, Jian-Ya ; Yang, Bo ; Li, Yong-Hao ; Zhu, Hong ; He, Qiao-Jun ; Liu, Xiang-Ning ; Lu, Jin-Jian ; Zheng, Ming-Ming

Osimertinib, a third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), has demonstrated significant clinical benefits in the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). However, inevitable acquired resistance to osimertinib limits its clinical utility, and there is a lack of effective countermeasures. Here, we established osimertinib-resistant cell lines and performed drug library screening. This screening identified ivacaftor, a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, as a synergistic enhancer of osimertinib-induced anti-tumor activity both in vitro and in vivo. Mechanistically, ivacaftor facilitated the colocalization of CFTR and PTEN on the plasma membrane to promote the function of PTEN, subsequently inhibiting the PI3K/AKT signaling pathway and suppressing tumor growth. In summary, our study suggests that activating CFTR enhances osimertinib-induced anti-tumor activity by regulating the PTEN-AKT axis. Furthermore, ivacaftor and osimertinib constitute a potential combination strategy for treating osimertinib-resistant EGFR-mutated NSCLC patients.

01 Mar 2025·JAMA Cardiology

Pitavastatin, Procollagen Pathways, and Plaque Stabilization in Patients With HIV

Article

Author: Grinspoon, Steven K. ; Fichtenbaum, Carl J. ; deFilippi, Christopher ; Foldyna, Borek ; Diggs, Marissa R. ; Douglas, Pamela S. ; Lu, Michael T. ; Sadreyev, Ruslan ; McCallum, Sara ; Eckard, Allison Ross ; Curran, Adrian ; Currier, Judith ; Fitch, Kathleen V. ; Malvestutto, Carlos D. ; Karady, Julia ; Bloomfield, Gerald S. ; Mayrhofer, Thomas ; Aberg, Judith A. ; Taron, Jana ; Kolossváry, Márton ; Ribaudo, Heather J. ; Zanni, Markella V. ; Centinbas, Murat ; Schnittman, Samuel R.

Importance:

In a mechanistic substudy of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) randomized clinical trial, pitavastatin reduced noncalcified plaque (NCP) volume, but specific protein and gene pathways contributing to changes in coronary plaque remain unknown.

Objective:

To use targeted discovery proteomics and transcriptomics approaches to interrogate biological pathways beyond low-density lipoprotein cholesterol (LDL-C), relating statin outcomes to reduce NCP volume and promote plaque stabilization among people with HIV (PWH).

Design, Setting, and Participants:

This was a post hoc analysis of the double-blind, placebo-controlled, REPRIEVE randomized clinical trial. Participants underwent coronary computed tomography angiography (CTA), plasma protein analysis, and transcriptomic analysis at baseline and 2-year follow-up. The trial enrolled PWH from April 2015 to February 2018 at 31 US research sites. PWH without known cardiovascular diseases taking antiretroviral therapy and with low to moderate 10-year cardiovascular risk were eligible. Data analyses were conducted from October 2023 to February 2024.

Intervention:

Oral pitavastatin calcium, 4 mg per day.

Main Outcomes and Measures:

Relative change in plasma proteomics, transcriptomics, and noncalcified plaque volume among those receiving treatment vs placebo.

Results:

Among 558 individuals (mean [SD] age, 51 [6] years; 455 male [82%]) included in the proteomics assessment, 272 (48.7%) received pitavastatin and 286 (51.3%) received placebo. After adjusting for false discovery rates, pitavastatin increased abundance of procollagen C-endopeptidase enhancer 1 (PCOLCE), neuropilin 1 (NRP-1), major histocompatibility complex class I polypeptide-related sequence A (MIC-A) and B (MIC-B), and decreased abundance of tissue factor pathway inhibitor (TFPI), tumor necrosis factor ligand superfamily member 10 (TRAIL), angiopoietin-related protein 3 (ANGPTL3), and mannose-binding protein C (MBL2). Among these proteins, the association of pitavastatin with PCOLCE (a rate-limiting enzyme of collagen deposition) was greatest, with an effect size of 24.3% (95% CI, 18.0%-30.8%; P &lt; .001). In a transcriptomic analysis, individual collagen genes and collagen gene sets showed increased expression. Among the 195 individuals with plaque at baseline (88 [45.1%] taking pitavastatin, 107 [54.9%] taking placebo), changes in NCP volume were most strongly associated with changes in PCOLCE (%change NCP volume/log2-fold change = −31.9%; 95% CI, −42.9% to −18.7%; P &lt; .001), independent of changes in LDL-C level. Increases in PCOLCE related most strongly to change in the fibro-fatty (&lt;130 Hounsfield units) component of NCP (%change fibro-fatty volume/log2-fold change = −38.5%; 95% CI, −58.1% to −9.7%; P = .01) with a directionally opposite, although nonsignificant, increase in calcified plaque (%change calcified volume/log2-fold change = 34.4%; 95% CI, −7.9% to 96.2%; P = .12).

Conclusions and Relevance:

Results of this secondary analysis of the REPRIEVE randomized clinical trial suggest that PCOLCE may be associated with the atherosclerotic plaque stabilization effects of statins by promoting collagen deposition in the extracellular matrix transforming vulnerable plaque phenotypes to more stable coronary lesions.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02344290

01 Jan 2025·AIDS

Proteinuria and albuminuria among a global primary cardiovascular disease prevention cohort of people with HIV

Article

Author: Fichtenbaum, Carl J. ; Grinspoon, Steven K. ; Overton, Edgar T. ; Lu, Michael T. ; Douglas, Pamela S. ; McComsey, Grace A. ; Negredo, Eugenia ; Mosepele, Mosepele ; Ribaudo, Heather ; Fitch, Kathleen V. ; Hickman, Aubri B. ; Malvestutto, Carlos ; Zanni, Markella ; Wyatt, Christina ; Aberg, Judith A. ; Kantor, Amy ; Bernardino, Jose

Objective(s)::

To determine baseline prevalence of proteinuria and albuminuria among participants from the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) and evaluate associated risk factors.

Design::

Cross sectional analysis of a baseline sample of participants from the REPRIEVE Trial.

Methods::

REPRIEVE is an international primary cardiovascular prevention randomized controlled trial (RCT) of pitavastatin calcium vs. placebo among people with HIV (PWH) on antiretroviral therapy (ART). A representative subset (2791 participants) had urine collected at study entry. Urine protein to creatinine ratios (uPCR) and albumin to creatinine ratios (uACR) were classified as normal, moderately increased and severely increased. These were dichotomized to Normal or Abnormal for log-binomial regression analysis. Demographic, cardiometabolic, and HIV-specific data were compared among those with normal versus abnormal results.

Results::

Overall, median age 49 years, 41% female sex, 47% black or African American race, 36% had estimated glomerular filtration rate (eGFR) less than 90 ml/min/1.73 mm2. For uPCR, 27% had moderately or severely increased values. For uACR, 9% had moderately or severely increased values. In the fully adjusted model for proteinuria, female sex, older age, residence in sub-Saharan Africa or East Asia, lower BMI, lower CD4+ cell count, and use of tenofovir disoproxil fumarate (TDF) were associated with abnormal values. In the fully adjusted model for albuminuria, a diagnosis of hypertension (HTN) was associated with abnormal values.

Conclusion::

Abnormal proteinuria and albuminuria remain common (27 and 9%) despite controlled HIV. Lower current CD4+ count and TDF use were strongly associated with proteinuria. Certain modifiable comorbidities, including HTN and smoking, were associated with abnormal values. In PWH with preserved eGFR, urine measures identify subclinical kidney disease and afford the opportunity for intervention.

News (Medical) associated with Pitavastatin Calcium

12 Mar 2025

·www.globenewswire.com

ACTG Presents Important Findings from REPRIEVE at CROI 2025

Presentations Address Frailty, Inflammation, Asymptomatic Heart Muscle Damage, and Mental FunctionLOS ANGELES, March 12, 2025 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today presented findings from the REPRIEVE trial about the use of statins among people living with HIV with frailty and the relationship between major adverse cardiovascular events (MACE) and measurements of inflammation and asymptomatic heart muscle damage. These results were shared in two oral abstracts: “Frailty is Associated with Higher MACE Incidence but Does Not Appear to Modify Pitavastatin Effects” and “Plaque, Inflammation, Subclinical Myocardial Injury and MACE in the REPRIEVE Mechanistic Substudy” at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, California. REPRIEVE (The Randomized Trial to Prevent Vascular Events in HIV) was the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of MACE by 36 percent compared with those receiving a placebo over a median duration of five years of follow up. “We are eager to share data from REPRIEVE at CROI about the relationship between frailty and major cardiovascular events, the importance of inflammation and asymptomatic heart muscle damage, and the impact of statin therapy on neurocognition (mental function) and heart failure risk,” said ACTG Chair Joseph J. Eron, M.D., University of North Carolina. “REPRIEVE was a groundbreaking study that has informed a multitude of international guidelines, which now recommend statins to prevent cardiovascular disease in many people living with HIV and we expect that it will continue to generate meaningful findings that improve the care of people living with HIV.” Frailty is Associated with Higher MACE Incidence but Does Not Appear to Modify Pitavastatin EffectsToday’s presentation examined whether frailty is associated with MACE among people living with HIV and whether statins may prevent MACE across a spectrum of frailty. Researchers found that higher levels of frailty were associated with increased risk of MACE among participants. They also determined that while adults living with HIV and frailty were routinely under-prescribed key preventive therapies such as statins, frailty status did not appear to modify the protective effects of pitavastatin that were seen in the primary trial. While further research is needed, the study concluded that incorporating frailty assessments such as the frailty index may help identify people living with HIV who are at risk of MACE. “The strong association in this analysis between the age-related syndrome of frailty and major adverse cardiovascular events may suggest similar underlying mechanisms and, further, that screening for frailty can help identify the participants at highest risk for cardiovascular events,” said Presenting Author Kristine Erlandson, M.D., University of Colorado Anschutz Medical Campus. “While providers and patients may question the added benefit of statins in patients with numerous comorbidities, the data presented today support the use of pitavastatin among adults living with HIV and frailty.” Plaque, Inflammation, Subclinical Myocardial Injury and MACE in the REPRIEVE Mechanistic SubstudyThis secondary analysis presented today assessed for the first time the relationship between coronary plaque and measurements of inflammation and asymptomatic heart muscle damage with MACE. Today’s presentation demonstrated that among participants in REPRIEVE’s mechanistic substudy, individuals with noncalcified coronary plaque (buildup of plaque in the arteries that can cause a heart attack) and higher blood levels of inflammation and heart muscle injury at study entry were at higher risk of having a cardiovascular event over six years of follow up even though they did not have symptoms. In exploratory analyses, plaque and biomarker (blood proteins associated with cardiovascular disease) combinations further improved the accuracy of predicting the risk of MACE beyond traditional risk scores. The data also suggested that the benefit of pitavastatin to prevent MACE may be greater among individuals who have noncalcified coronary plaque and evidence of low-grade myocardial damage, which may precede symptoms. Additional investigation is necessary to determine how pitavastatin can be most effective for these individuals. “These data suggest that key plaque, inflammatory, and asymptomatic heart muscle damage markers are strongly related to MACE, even among people living with HIV who are not experiencing cardiac-related symptoms,” said Presenting Author and Study Chair Steven Grinspoon, M.D, Harvard Medical School and Massachusetts General Hospital. “These data highlight the need for additional studies to identify people living with HIV who might benefit most from statin therapy and to identify new mechanistic pathways to target,” said REPRIEVE Mechanistic Substudy Protocol Chair and Lead Author Michael Lu, M.D., M.P.H., Harvard Medical School and Massachusetts General Hospital. ACTG also presented two posters at CROI reporting on additional REPRIEVE findings: No Evidence of a Detrimental Effect of Pitavastatin on Neurocognitive Function Among People with HIV found no evidence to suggest that pitavastatin impacted neurocognitive function among people living with HIV at low to moderate cardiovascular disease risk, even among those who entered the study with some existing level of impairment.“Concerns about potential detrimental cognitive effects of statins are often raised when considering statin therapy,” said Presenting Author Dr. Erlandson. “The results from this randomized, blinded study, which show no relationship between statin therapy and change in neurocognitive function, should provide reassurance to patients and providers.” Heart Failure Risk and Events In People with HIV: The Randomized Trial To Prevent Vascular Events In HIV (REPRIEVE)” (Gerald Bloomfield, et al.) found that the number of heart failure events among people living with HIV in REPRIEVE was consistent with the low estimated PREVENT (Predicting Risk of Cardiovascular Disease Events) heart failure risk rates. Participants who were Black, female, lived in sub-Saharan Africa, had pre-existing hypertension, and/or elevated body mass were more likely to experience heart failure. REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes, and ACTG (AI068636). It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare. The study is led by Dr. Grinspoon and Pamela S. Douglas, M.D., Duke University School of Medicine (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D., Harvard School of Public Health (Lead Statistician) and Dr. Lu, who led the Data Coordinating Center. ACTG is led by Dr. Eron and Rajesh T. Gandhi, M.D., Massachusetts General Hospital and Harvard Medical School (ACTG Vice-Chair). To learn more, please visit www.reprievetrial.org. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Rachel Reiss, ACTGRLReiss@mednet.ucla.edu

Clinical StudyClinical Result

23 Jul 2024

·www.globenewswire.com

ACTG Presents Data Analysis at AIDS 2024 Showing Association between Elevated Risk of Cardiovascular Events and Abacavir Use Among People Living with HIV

Additional ACTG Presentations Address Muscle Density and Area among People Living with HIV and COVID-19 TreatmentLOS ANGELES, July 23, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, will present an exploratory analysis from the REPRIEVE trial demonstrating that former and current use of abacavir was associated with a higher incidence of major adverse cardiovascular events at AIDS 2024 in Munich, Germany. The oral presentation will take place on July 26, 2024, as part of the session Comorbidities: The Heart of the Matter, from 10:30-11:30 am CEST at Hall B0b/Channel 5 and virtually. “This carefully constructed analysis adds to the body of evidence that abacavir use is associated with a higher risk of cardiovascular events like heart attacks and strokes,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles. “These data align with prior studies that had been considered somewhat controversial because no exact mechanism was clearly demonstrated and should be taken into account by clinicians when they evaluate treatment options for people living with HIV.” These are the latest findings from REPRIEVE, the first large-scale clinical trial to test a primary prevention strategy to reduce the increased risk of cardiovascular disease among people living with HIV. It found that participants who took pitavastatin calcium (a daily statin pill that lowers cholesterol) reduced their risk of major adverse cardiovascular events by 36 percent compared with those receiving a placebo over a median duration of five years of follow up. The analysis being presented at AIDS 2024 evaluated the role of prior and current use of select antiretroviral treatments (including abacavir, tenofovir, thymidine analogs, and protease inhibitors) on the development of major cardiovascular events. These antiretrovirals were selected based upon prior association with cardiovascular risk and kidney impairment (future analyses are planned to examine the role of other antiretrovirals). Among 7,769 participants, 31.3 percent were born female and 65.2 percent were not white. The median age was 50, LDL (low-density lipoprotein, a kind of cholesterol) was 108 mg/dL, CD4 count was 621 cell/mm3, and 88 percent had a viral load under 400 copies/mL. Participants had been taking HIV treatment for a median of 9.5 years. Researchers found that current or past use of abacavir increased the risk of major adverse cardiovascular events by 42 and 50 percent, respectively, while current or past use of other antiretroviral treatments caused no such increase. “This analysis is important as we seek to tease out the various factors that may help reduce cardiovascular risk in people living with HIV,” said lead study author Carl Fichtenbaum, M.D., University of Cincinnati. “While the association between abacavir and cardiovascular risk is disappointing, it is not a surprise. It is, however, reassuring that the other HIV therapies included in the analysis like tenofovir were not associated with a higher risk.” REPRIEVE had a number of unique aspects: study participants had no known prior history of cardiovascular disease, the global cohort from 12 countries had low-to-moderate risk for cardiovascular disease, and all study endpoints were independently vetted by the national study Thrombolysis in Myocardial Infarction (TIMI). REPRIEVE began in 2015 as cooperative agreements (HL12339, HL123336, HL164284, and HL164285) and was a collaborative effort between the National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), two of the largest NIH institutes. It received additional funding from the NIH Office of AIDS Research, Kowa Pharmaceuticals America, Inc. (providers of pitavastatin calcium and placebo), Gilead Sciences, Inc., and ViiV HealthCare. The trial is led by Steven Grinspoon, M.D. (Chair) and Pamela S. Douglas, M.D. (Co-chair), who led the Clinical Coordinating Center and Heather Ribaudo, Ph.D. (Lead Statistician) and Michael Lu, M.D., M.P.H. (Protocol Chair, Mechanistic Substudy of REPRIEVE), who led the Data Coordinating Center. To learn more, please visit www.reprievetrial.org. In addition to these data from REPRIEVE, ACTG will also make the following presentations at AIDS 2024: No Evidence of Pitavastatin Effect on Muscle Density or Area Among People with HIV (REPRIEVE; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kristine Erlandson, et al. This analysis from the REPRIEVE mechanistic substudy found that statins did not reduce muscle density or area. This two-year study of middle-aged people living with HIV at low-to-moderate risk of cardiovascular disease, confirmed through imaging that statins were safe and did not cause significant muscle damage. This is reassuring to people who want to use statins to lower their risk of cardiovascular events like heart attacks and strokes. Efficacy and Safety of Ensitrelvir in Non-Hospitalized Adults at Standard or High-Risk of Progression to Severe COVID-19: the SCORPIO-HR Phase 3, Randomized, Double-Blind Placebo-Controlled Trial (ACTG 5407; Poster Presentation: Tuesday, July 23rd, 12:00-1:00 pm CEST, Poster Exhibition Hall) Kara Chew, et al. While the oral protease inhibitor ensitrelvir demonstrated anti-viral activity, safety, and a trend toward shorter time to symptom resolution compared to placebo, SCORPIO-HR (ACTG 5407) did not meet its primary endpoint of time to two or more days sustained resolution of 15 COVID-19 symptoms in outpatient participants at standard and higher risk for severe disease. About ACTG ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes under award numbers UM1 AI068636, UM1 AI107716, and UM1 AI068634. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at 65 locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve. Disclaimer: This content is solely the responsibility of ACTG and does not necessarily represent the official views of the NIH. Media Contact:Jenna Conley, ACTGjenna@conleycommunications.net

Clinical ResultPhase 3AHAClinical Study

21 Nov 2023

·www.pharmaindustrial-india.com

Lupin Gets Approval from US FDA for Pitavastatin Tablets

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Pitavastatin Tablets, 1 mg, 2 mg, and 4 mg, to market a generic equivalent of Livalo® Tablets, 1 mg, 2 mg, and 4 mg, of Kowa Company Limited. The product will be manufactured at Lupin's Pithampur facility in India. Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in Adults with primary hyperlipidemia, Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). Pitavastatin Tablets (RLD Livalo®) had estimated annual sales of USD 298 million in the US (IQVIA MAT September 2023).

Drug ApprovalNDA

100 Deals associated with Pitavastatin Calcium

External Link

KEGG	Wiki	ATC	Drug Bank
D01862	Pitavastatin Calcium	C10AA08	DB08860

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Complex dyslipidemia	Brazil	Libbs Farmacêutica Ltda.	24 Jun 2019
Primary Hyperlipidemia	Brazil	Libbs Farmacêutica Ltda.	24 Jun 2019
Hyperlipidemia, Familial Combined	United States	Kowa Co., Ltd.	16 May 2019
Heterozygous familial hypercholesterolemia	Australia	Advantage Medical Products LLC	27 Aug 2013
Dyslipidemias	China	Kowa Co., Ltd.	28 Sep 2008
Hyperlipidemias	China	Kowa Co., Ltd.	28 Sep 2008
Hypercholesterolemia	Japan	Kowa Co., Ltd.	17 Jul 2003
Hyperlipoproteinemia Type II	Japan	Kowa Co., Ltd.	17 Jul 2003

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	United States	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Botswana	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Brazil	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Canada	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Haiti	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	India	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Peru	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	South Africa	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Spain	Kowa Pharmaceuticals America, Inc.	26 Mar 2015
HIV Infections	Phase 3	Thailand	Kowa Pharmaceuticals America, Inc.	26 Mar 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02344290 (REPRIEVE, CTgov)	Phase 3	HIV Infections	7,769	Pitavastatin (Pitavastatin)	slcfbygjxp = utjabnyfqm lrnpcuccyi (piwjnnwvuo, rnonubhtsr - ebgpzawywn) View more	-	15 Oct 2024
				Placebo (Placebo)	slcfbygjxp = hmukarguge lrnpcuccyi (piwjnnwvuo, kxecmllvjz - hijfcxmxpq) View more
NCT01710007 (CTgov)	Phase 3	Primary hypercholesterolemia \| Hypercholesterolemia	202	Lipitor (Lipitor)	bpnrptyrvn(rxeszgcvpr) = aviamqjqsz hkumeecppo (mvdyqswnsd, 12.80) View more	-	17 Jul 2023
				1PC002 (1PC002)	bpnrptyrvn(rxeszgcvpr) = thkzkxbfov hkumeecppo (mvdyqswnsd, 17.97) View more
NCT01695954 (CTgov)	Phase 1	Hyperlipidemias \| HIV Infections	34	Pitavastatin+Efavirenz (Arm A: (Pitavastatin and Efavirenz))	wvoffkyqhg(tjsvqvfvja) = tkyfghoaex ovsdwutihu (iwxjmmfohj, 5.72) View more	-	11 Aug 2020
				Pitavastatin+Darunavir (Arm B: (Pitavastatin and Darunavir))	wvoffkyqhg(tjsvqvfvja) = gkkgmpwtlz ovsdwutihu (iwxjmmfohj, 6.24) View more
NCT00889226 (ESPRIT, CTgov)	Phase 4	Diabetes Mellitus, Type 2 \| Hypercholesterolemia	161	Pitavastatin (Pitavastatin Group)	qufoombigi = aozixmbkws zxtzdsitgh (dvpqlkpyhf, zhbhttmzeq - elufimsxnx) View more	-	17 Sep 2019
				Atorvastatin (Atorvastatin Group)	qufoombigi = ewpyzwunqf zxtzdsitgh (dvpqlkpyhf, qwpblbncyh - yjmsqdpjgc) View more
NCT01660191 (SPARQ, CTgov)	Phase 4	Hypercholesterolemia	134	Pitavastin 4mg+Rosuvastatin 5mg (Atorvastatin 20mg)	kauppgmjvb(fbdxysmlcw) = xozdrarxua csryxsqbgf (eoebzhwsae, 224.24) View more	-	18 Jan 2017
				Atorvastatin 20mg+Rosuvastatin 5mg (Pitavastatin 4mg)	kauppgmjvb(fbdxysmlcw) = txdhkkiljn csryxsqbgf (eoebzhwsae, 136.29) View more
NCT01256476 (Pubmed \| Clin Ther)	Phase 4	Primary Hyperlipidemia \| Dyslipidemias	328	Pitavastatin 4 mg	huhxnocvuj(afjcvcpgup) = lwewlhvhyy qyfssnhpuc (skniijodrv )	Positive	01 Aug 2014
				Pravastatin 40 mg	huhxnocvuj(afjcvcpgup) = mcuzdvtwpq qyfssnhpuc (skniijodrv )
NCT01301066 (INTREPID, CTgov)	Phase 4	Dyslipidemias \| HIV Infections	252	Pitavastatin (Pitavastatin 4 mg QD)	bzvokvtmyu(nwpuwmskhw) = tiutuezirc izmohvxejj (fbnhconafk, 25.93) View more	-	29 Apr 2014
				Pravastatin (Pravastatin 40 mg QD)	bzvokvtmyu(nwpuwmskhw) = nuphmkpcxh izmohvxejj (fbnhconafk, 23.91) View more
NCT01043094 (CTgov)	Phase 4	Renal Insufficiency	16	Pitavastatin 4mg (Pitavastatin 4mg Renal Impaired)	lurmbrlecl(fekofahedb) = lraibwqbyd gmbxtgplud (klgsudoayg, 39) View more	-	13 Aug 2012
				Pitavastatin 4mg (Pitavastatin 4mg Healthy Subjects)	lurmbrlecl(fekofahedb) = zjzcbidpco gmbxtgplud (klgsudoayg, 55) View more
NCT01256476 (PREVAIL-US \| PREVAIL US, CTgov)	Phase 4	Primary Hyperlipidemia	328	pitavastatin (Pitavastatin 4 mg Once Daily (QD))	eevacasoxs(hbcbobrmwz) = eqgwqxqxhj ieoqkqqpgw (cwszzidpgm, 1.20)	-	30 Apr 2012
				pravastatin (Pravastatin 40 mg Once Daily (QD))	eevacasoxs(hbcbobrmwz) = ojzlsvwkwg ieoqkqqpgw (cwszzidpgm, 1.22)
NCT01422382 (CTgov)	Phase 4	-	28	NK-104+Cardizem LA+Diltiazem	imlofaiblb(aomhsokjin) = litvogbaze ebuctluvdv (qqymnyvfir, 86.54) View more	-	12 Apr 2012

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