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Data updated: Jun 28, 2026

MEVACOR (lovastatin) · Merck

Metabolic Approved 1987-08-31

MEVACOR is FDA-approved to treat 7 conditions (same as LOVASTATIN).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
7
Indications
--
Phase 3 Trials
2
Priority Reviews
38
Years on Market

Details

Status
Discontinued
First Approved
1987-08-31
Routes
ORAL
Dosage Forms
TABLET

Companies

Merck
Active Ingredient: LOVASTATIN

MEVACOR Approval History

1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
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2011
2012
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2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
222 FDA actions from 1987 to 2014 · 6 indication expansions
Feb 2014 SUPPL
Label · Labeling
FDA Letter Label
Oct 2012 SUPPL
Label · Labeling
FDA Letter Label
Feb 2012 SUPPL
Label · Labeling
FDA Letter Label

What MEVACOR Treats

7 indications

MEVACOR is approved for 7 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as LOVASTATIN (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

17 trials
Trial Sponsor ID Phase Status Title
NCT06636734 STUDY00007740 NCI-2024-06118, STUDY00007740 Ph 2 recruiting Lovastatin and Pembrolizumab for the Treatment of Patients With Recurrent or Metastatic Head and Neck Cancer, LAPP Trial
NCT02964884 161159 1R01HD089474-01 Ph 2 active not recruiting Interventions for Reading Disabilities in NF1
NCT03504501 SynCoRAS SYN-1748-MAL-0030-I 2016-005022-10 Ph 2 terminated Synaptic Plasticity and Cognitive Function in RASopathies
NCT03510884 results posted EFC14643 2017-001903-60, U1111-1193-0721 Ph 3 completed An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
NCT00700921 NJMRC HS-2163 NIH grant #HL088138 Ph 2 completed Lovastatin as a Potential Modulator of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)
NCT03510715 results posted EFC14660 2017-002297-39, U1111-1200-2046 Ph 3 completed An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
NCT02642653 results posted 520144 Ph 4 completed Combining Lovastatin and a Parent-Implemented Language Intervention for Fragile X Syndrome
NCT02563860 Statins results posted 2014-4253 Ph 2 completed Pharmacological Treatment of Rett Syndrome With Statins
NCT02603770 LY02405/CT-USA-102 Ph 1 completed Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers
NCT00352599 NF1 05-08-069-01 Ph 1 completed Trial to Evaluate the Safety of Lovastatin in Individuals With Neurofibromatosis Type I (NF1)
NCT02389868 LovaC 14221 Ph 2 completed Effects of Lovastatin on Human Platelet Proteome
NCT01110642 2010-04-15 Ph 2 withdrawn Novel Treatment for Syndromic Ichthyoses
NCT00902668 results posted MCC-12044 HM12044, CDR0000642246 Ph 2 terminated Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer
NCT01250535 10-0576 1R01GM089994-01A1 Ph 1 completed Human Cytochrome P450 4F Enzymes and Drug Interactions
NCT00721305 LIVE COLCIENCIAS 111540820508 Ph 2 completed Lovastatin: Immunomodulatory Value Evaluation
NCT00963664 NI-MM-009 Ph 2 withdrawn Evaluation of Interferon-Lovastatin Therapy for Malignant Melanoma
NCT07619365 26-x146 Ph 2 not yet recruiting Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MEVACOR FDA Label Details

Indications & Usage

FDA Label (PDF)

MEVACOR is FDA-approved to treat 7 conditions — same approved indications as LOVASTATIN.

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Data Sources

FDA Approval: NDA019643 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.