TheraRadar
Data updated: May 26, 2026

ALTOPREV (lovastatin)

Trial Activity: Declining 2 active trials
Metabolic Approved 2002-06-26
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Sanofi conducting 2 trials (11%)
48 indications explored (Broad Platform)
→ neurofibromatosis type 1 (2 trials)
→ neurofibromatosis 1 (2 trials)
→ clinical stage iv hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 (1 trials)
2
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Discontinued
First Approved
2002-06-26
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

AZURITY
Active Ingredient: LOVASTATIN

ALTOPREV Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
72 FDA actions from 2002 to 2024 · 1 indication expansions
Mar 2024 SUPPL
Label · Labeling
Label
Sep 2020 SUPPL
Label · Labeling
FDA Letter Label
Feb 2018 SUPPL
Label · Labeling
FDA Letter Label

What ALTOPREV Treats

2 FDA approvals

Originally approved for its first indication in 2002 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

16 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
🔬

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.

ALTOPREV FDA Label Details

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Data Sources

FDA Approval: NDA021316 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment