Altoprev

(Lovastatin)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Altoprev is a small molecule that works as a HMG-Coa Reductase Inhibitor.[2] It is being used across 22 indications, with its most advanced program in Approved.[1]

Altoprev is one of 516 small molecule programs targeting Breast Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

515

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Breast CancerTerminated

Cardiovascular DiseaseActive, not recruiting

Coronary Artery DiseaseActive, not recruiting

Coronary AtherosclerosisActive, not recruiting

HypercholesterolemiaActive, not recruiting

Metabolic DiseaseApproved

Fragile X SyndromeApproved

Intermittent Vascular ClaudicationApproved

Prostate CancerApproved

StrokeApproved

Breast CancerPhase 2

Terminated

Cardiovascular DiseaseApproved

Active, not recruiting

Coronary Artery DiseaseApproved

Active, not recruiting

Coronary AtherosclerosisApproved

Active, not recruiting

HypercholesterolemiaApproved

Active, not recruiting

Metabolic DiseaseApproved

Approved

Fragile X SyndromeApproved

Approved

Intermittent Vascular ClaudicationApproved

Approved

Prostate CancerApproved

Approved

StrokeApproved

Approved

Showing 10 of 22 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Altoprev

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

3 2

Blenoxane

Bristol-Myers Squibb

Preclinical

1 3

Voltaren

Novartis

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 6

Spravato

WWim Janssens

Preclinical

2 7

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 8

Tricor

JJagotec

Preclinical

1 9

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Acupan

YYonsei University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2Active, not recruiting

Neurofibromatosis Type 1

NCT02964884

Q4 2028

Phase 2Recruiting

Metastatic Head and Neck Cancer

NCT06636734

Q3 2031

Phase 2Not yet recruiting

Breast Cancer

NCT07619365

Clinical

Trials by Indication[1]

Statin7 trials

Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers

Completed· Luye Pharma Group Ltd. logo

Luye Pharma Group Ltd.·Phase 1·NCT02603770·20 enrolled

The Pharmacokinetic Study of Red Yeast Rice Capsule Compared to Lovastatin Tablet in Healthy Subjects

Completed·NNational Taiwan University Hospital·Phase 4·NCT01527669·12 enrolled

Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00684723·54 enrolled

Show 4 more trials

Fasting Bioavailability Study of Lovastatin Tablets and Mevacor Tablets

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00685685·54 enrolled

Evaluation, the Histomorphometric Study of Nanocrystalline Hydroxyapatite (Nano Bone) Wif Lovastatin in the Preservation of the Tooth Socket

Unknown status·IIslamic Azad University, Sanandaj·Phase 2·NCT03981601·20 enrolled

Lovastatin: Immunomodulatory Value Evaluation

Completed·UUniversidad de Antioquia·Phase 2·NCT00721305·112 enrolled

Effects of Lovastatin on Human Platelet Proteome

Completed·UUniversité de Sherbrooke·Phase 2·NCT02389868·15 enrolled

Breast Cancer3 trials

Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer

Terminated·VVirginia Commonwealth University·Phase 2·NCT00902668·3 enrolled

Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention

Terminated·SStanford University·Phase 2·NCT00285857·30 enrolled

Phase II Trial Evaluating Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer (MBC)

Not yet recruiting·WWashington University School of Medicine·Phase 2·NCT07619365·60 enrolled

Melanoma2 trials

Lovastatin in Treating Patients At High Risk of Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00462280·80 enrolled

Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma

Withdrawn·NNeoPlas Innovation·Phase 2·NCT00963664·250 enrolled

Atherosclerosis2 trials

Familial Atherosclerosis Treatment Study

Completed·UUniversity of Washington·Phase 3·NCT00000512·146 enrolled

MARS - Monitored Atherosclerosis Regression Study

Completed· Merck & Co. logo

Merck & Co.·Phase 2/3·NCT00116870·270 enrolled

Neurofibromatosis Type 12 trials

A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT00853580·146 enrolled

Neurobiology and Treatment of Reading Disability in NF1

Active, not recruiting·VVanderbilt University·Phase 2·NCT02964884·120 enrolled

30 more indications

Metastatic Head and Neck Cancer1 trial

Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial

Recruiting·EEmory University·Phase 2·NCT06636734·28 enrolled

Parkinson's Disease1 trial

Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease

Unknown status·NNational Taiwan University Hospital·Phase 2·NCT03242499·80 enrolled

Diabetes1 trial

High Potency Statins and the Risk of Diabetes

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02518503·136,966 enrolled

Asthma1 trial

Evaluation of Lovastatin in Severe Persistent Asthma

Withdrawn·UUniversity of Chicago·Phase 1/2·NCT00689806

Rett syndrome1 trial

Pharmacological Treatment of Rett Syndrome With Statins

Completed·MMontefiore Medical Center·Phase 2·NCT02563860·20 enrolled

Carotid Artery Plaque1 trial

Asymptomatic Carotid Artery Plaque Study (ACAPS)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000469

Acute1 trial

Neurophysiological and Acute Pharmacological Studies in FXS Patients

Completed·—·Phase 1·NCT02998151·29 enrolled

Cognitive Function1 trial

Synaptic Plasticity and Cognitive Function in RASopathies

Terminated·TTechnical University of Munich·Phase 2·NCT03504501·16 enrolled

Prostate Cancer1 trial

Pre-Prostatectomy Lovastatin on Prostate Cancer

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·N/A·NCT01478828·2 enrolled

Ovarian Cancer1 trial

A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer

Terminated·UUniversity of Iowa·Phase 2·NCT00585052·11 enrolled

Cerebrotendinous Xanthomatosis1 trial

Phase II Study of Cholesterol- and Cholestanol-Free Diet, Lovastatin, and Chenodeoxycholic Acid for Cerebrotendinous Xanthomatosis

Unknown status·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004346·5 enrolled

Epilepsy1 trial

The GABAergic Inhibitory System in Drug Resistant Epilepsy

Completed·UUniversity of Coimbra·N/A·NCT06789497·5 enrolled

Cognition1 trial

From Molecules to Cognition: Inhibitory Mechanisms in ASD and NF1

Completed·UUniversity of Coimbra·N/A·NCT03826940·16 enrolled

Chronic Periodontitis1 trial

The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis

Completed·IIslamic Azad University, Sanandaj·Phase 2/3·NCT03178526·15 enrolled

Cancer1 trial

A Study of the Proper Dosage of Lovastatin and Docetaxel for Patients With Cancer

Terminated·SSusan L Roeder·Phase 1·NCT00584012·9 enrolled

Homozygous Familial Hypercholesterolemia1 trial

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510715·18 enrolled

Rheumatoid Arthritis1 trial

Lovastatin for the Treatment of Mildly Active Rheumatoid Arthritis

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00302952·64 enrolled

Injury1 trial

Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury

Completed·VVirginia Commonwealth University·Phase 2·NCT00580970·73 enrolled

Fragile X Syndrome1 trial

Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome

Completed·UUniversity of California, Davis·Phase 4·NCT02642653·30 enrolled

Coronary Artery Bypass1 trial

Post Coronary Artery Bypass Graft (CABG) Study

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000463

Recovery1 trial

Neuroprotection With Statin Therapy for Acute Recovery Trial (Neu-START)

Completed·—·Phase 1·NCT00243880·33 enrolled

Familial Hypercholesterolemia1 trial

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Completed· Sanofi logo

Sanofi·Phase 3·NCT03510884·153 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)

Completed·NNational Jewish Health·Phase 2·NCT00700921·30 enrolled

Venous malformation1 trial

Lovastatin for Treatment of Brain Arteriovenous Malformations

Unknown status·—·Phase 2·NCT04297033·1,244 enrolled

Neurofibromatosis1 trial

Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)

Completed·UUniversity of California, Los Angeles·Phase 1·NCT00352599·44 enrolled

Acute Kidney Injury1 trial

High Potency Statins and Acute Kidney Injury

Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02518516·2,067,639 enrolled

Relapsed AML1 trial

Dose Escalation Phase I/II Study of Lovastatin With High-Dose Cytarabine for Refractory or Relapsed AML

Terminated·UUniversity of Iowa·Phase 1/2·NCT00583102·23 enrolled

Cholesterol1 trial

Cholesterol Reduction in Seniors Program (CRISP)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000477

Drug Interactions1 trial

Human Cytochrome P450 4F Enzymes and Drug Interactions

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT01250535·19 enrolled

Treatment1 trial

Novel Treatment for Syndromic Ichthyoses

Withdrawn·NNorthwestern University·Phase 2·NCT01110642

Regulatory

FDA Approval Timeline[4]

Mar 28, 1991

MEVACOR

NDA NDA019643

Jun 26, 2002

ALTOPREV

NDA NDA021316

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for Lovastatin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lovastatin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lovastatin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA021316). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: HMG-Coa Reductase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Altoprev

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2028

Q3 2031

Trials by Indication[1]

Statin7 trials

Breast Cancer3 trials

Melanoma2 trials

Atherosclerosis2 trials

Neurofibromatosis Type 12 trials

Metastatic Head and Neck Cancer1 trial

Parkinson's Disease1 trial

Diabetes1 trial

Asthma1 trial

Rett syndrome1 trial

Carotid Artery Plaque1 trial

Acute1 trial

Cognitive Function1 trial

Prostate Cancer1 trial

Ovarian Cancer1 trial

Cerebrotendinous Xanthomatosis1 trial

Epilepsy1 trial

Cognition1 trial

Chronic Periodontitis1 trial

Cancer1 trial

Homozygous Familial Hypercholesterolemia1 trial

Rheumatoid Arthritis1 trial

Injury1 trial

Fragile X Syndrome1 trial

Coronary Artery Bypass1 trial

Recovery1 trial

Familial Hypercholesterolemia1 trial

Chronic Obstructive Pulmonary Disease1 trial

Venous malformation1 trial

Neurofibromatosis1 trial

Acute Kidney Injury1 trial

Relapsed AML1 trial

Cholesterol1 trial

Drug Interactions1 trial

Treatment1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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