Drugs / Lovastatin
Lovastatin
also known as
Mevacor · 6.alpha.-methylcompactin · Altoprev · C10AA02 · L-154803 · LOV · Lovastatin component of advicor · Lovastatina · +13 more
Small molecule targets CAV1, HMGCR, MYC via inhibition
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | MEVACOR | — | 1991-03-28 – 2005-04-07 | fda.gov ↗ |
| Label expansion | US (FDA) | ALTOPREV | — | 2002-09-11 | fda.gov ↗ |
| Approved | US (FDA) | MEVACOR | — | 1987-08-31 | fda.gov ↗ |
Trials 47
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials · 1 met primary | ||||||
| Phase 0 | NCT02998151 | Jan 2016 → Nov 2020 | fragile X syndrome | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 0 | NCT00741013 | Mar 2007 → Mar 2008 | pneumonitis | Washington University School of Medicine | Completed | Met primary |
| Phase 16 trials | ||||||
| Phase 1 | NCT04359823 | Aug 2020 → Apr 2021 | disseminated superficial actinic porokeratosis | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 1 | NCT01250535 | Dec 2010 → Dec 2011 | — | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT00243880 | Sep 2005 → May 2008 | ischemic stroke | Columbia University | Completed | No outcome recorded |
| Phase 1 | NCT00685685 | Sep → Oct 2004 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00684723 | Jul 2004 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00584012 | Apr 2004 → Apr 2009 | breast cancer, cancer, familial, with in vitro Radioresistance | Susan L Roeder | Terminated | No outcome recorded Stop: Business |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06553157 | Sep 2024 → Jul 2025 | cancer, platinum-induced ototoxicity | Minia University | Completed | No outcome recorded |
| Phase 1/2 | NCT00583102 | Jun 2001 → Feb 2013 | acute myeloid leukemia | University of Iowa | Terminated | No outcome recorded Stop: Enrollment |
| Phase 222 trials · 3 missed | ||||||
| Phase 2 | NCT07619365 | Oct 2026 → Oct 2030 expected | breast cancer | Washington University School of Medicine | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06636734 | Dec 2024 → Dec 2027 expected | human papillomavirus-related squamous cell carcinoma, hypopharynx squamous cell carcinoma, laryngeal squamous cell carcinoma, nasopharyngeal carcinoma +4 | Emory University | Recruiting | No outcome recorded |
| Phase 2 | NCT04297033 | Jan 2021 → Jun 2024 | arteriovenous malformations of the brain | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03504501 | Mar 2019 → Feb 2023 | cognitive disorder, synaptopathy | Technical University of Munich | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03242499 | May 2017 → Dec 2019 | Parkinson disease | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02680379 | Mar 2016 → Oct 2017 | fragile X syndrome | University of Sherbrooke | Completed | No outcome recorded |
| Phase 2 | NCT02563860 | Jul 2015 → Jul 2016 | Rett syndrome | Montefiore Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02389868 | Feb → Jun 2015 | — | University of Sherbrooke | Completed | No outcome recorded |
| Phase 2 | NCT01110642 | Jul 2011 → ? | CHILD syndrome, Smith-Lemli-Opitz syndrome, ichthyosis | Northwestern University | Withdrawn | No outcome recorded |
| Phase 2 | NCT00963664 | Dec 2009 → Dec 2016 | melanoma | NeoPlas Innovation | Withdrawn | No outcome recorded |
| Phase 2 | NCT00853580 | Jul 2009 → May 2014 | neurofibromatosis type 1 | University of Alabama at Birmingham | Completed | Missed primary |
| Phase 2 | NCT00902668 | Apr 2009 → Apr 2011 | breast cancer, radiation-induced disorder | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00721305 | Aug 2008 → Jul 2011 | AIDS-related disorder | Universidad de Antioquia | Completed | Missed primary |
| Phase 2 | NCT00700921 | Apr 2008 → Nov 2012 | chronic obstructive pulmonary disease | National Jewish Health | Completed | No outcome recorded |
| Phase 2 | NCT00302952 | Nov 2007 → Apr 2012 | rheumatoid arthritis | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT00462280 | May 2007 → Apr 2011 | cutaneous melanoma, precancerous condition | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2 | NCT00580970 | Apr 2007 → Aug 2015 | prostate cancer | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT00285857 | Nov 2005 → May 2010 | breast cancer | Stanford University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00585052 | Aug 2003 → Feb 2010 | ovarian cancer | University of Iowa | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00004346 | Jan 1996 → ? | cerebrotendinous xanthomatosis | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
| Phase 2 | NCT00000477 | Jul 1990 → Jun 1992 | atherosclerosis, coronary artery disorder, hyperlipidemia, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2 | NCT00000469 | May 1988 → Aug 1998 | carotid stenosis, cerebral atherosclerosis, heart disorder | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00116870 | Jun 1985 → Feb 1992 | atherosclerosis, coronary artery disorder | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 35 trials · 1 missed | ||||||
| Phase 3 | NCT00132717 | Jan 2005 → Jun 2007 | hyperlipidemia | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00071266 | Oct 2003 → ? | intermittent vascular claudication | Kos Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00062556 | Jan 2003 → Mar 2006 | intermittent vascular claudication, peripheral arterial disease | Kos Pharmaceuticals | Completed | Missed primary |
| Phase 3 | NCT00000463 | Apr 1987 → Dec 1998 | coronary artery disorder, myocardial ischemia | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000512 | Jan 1984 → Aug 1989 | coronary atherosclerosis, myocardial ischemia | University of Washington | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT01527669 | Feb 2012 | — | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01346670 | Oct 2006 | — | Taipei Medical University WanFang Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00345657 | Jul 2003 → May 2004 | hyperlipidemia, combined, 2 | In His Image | Completed | No outcome recorded |
| Phase 4 | NCT00046358 | Sep 2002 → Aug 2005 | Alzheimer disease | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase not applicable5 trials · 1 missed | ||||||
| — | NCT07282756 | Jul 2025 → Dec 2026 expected | periodontitis | Medical University of Silesia | Recruiting | No outcome recorded |
| — | NCT06789497 | Jan 2020 → Jan 2024 | temporal lobe epilepsy | University of Coimbra | Completed | No outcome recorded |
| — | NCT03826940 | Feb 2019 → Mar 2020 | autism spectrum disorder, neurofibromatosis type 1 | University of Coimbra | Completed | No outcome recorded |
| — | NCT01478828 | Jul 2012 → Apr 2013 | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Terminated | No outcome recorded |
| — | NCT01361217 | Sep 2011 → Jun 2012 | — | University of Washington | Completed | Missed primary |
| Comparator or background therapy14 trials | ||||||
| Phase 1 | NCT02603770 Comparator | Nov 2015 → Jan 2016 | inherited lipid metabolism disorder | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT00352599 Comparator | Sep 2009 → Mar 2014 | neurofibromatosis type 1 | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 1/2 | NCT00689806 Comparator | — | chronic asthma | University of Chicago | Withdrawn | No outcome recorded |
| Phase 2 | NCT03763175 Comparator | Dec 2018 → Oct 2020 | irritable bowel syndrome | Cedars-Sinai Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT03981601 Comparator | Feb 2018 → Mar 2019 | bone resorption disease | Islamic Azad University, Sanandaj | Unknown | No outcome recorded |
| Phase 2 | NCT02964884 Comparator | Nov 2016 → Jan 2027 expected | neurofibromatosis type 1, reading disorder | Vanderbilt University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01890967 Background | Jun 2013 → Apr 2014 | hyperlipoproteinemia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT01976936 Comparator | Feb 2009 → Nov 2015 | hyperbilirubinemia, ischemic stroke, myopathy | Columbia University | Completed | No outcome recorded |
| Phase 2/3 | NCT03178526 Comparator | Dec 2015 → Jan 2016 | chronic periodontitis | Islamic Azad University, Sanandaj | Completed | No outcome recorded |
| Phase 3 | NCT03510715 Background | Aug 2018 → Feb 2020 | hyperlipidemia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03510884 Background | May 2018 → Jan 2021 | hyperlipidemia | Sanofi | Completed | Met primary |
| Phase 3 | NCT00532311 Comparator | Jul 2007 → Apr 2008 | hyperlipidemia | Takeda | Terminated | No outcome recorded |
| Phase 3 | NCT00092846 Background | Dec 2002 → Sep 2003 | hyperlipidemia | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT02642653 Comparator | Jan 2016 → Jul 2018 | fragile X syndrome | University of California, Davis | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2015-05-18 | Theriva Biologics, Inc. | Results Synthetic Biologics’ Novel SYN-010 Preclinical Data Featured in Digestive Disease Week® Poster therivabio.com ↗
Lovastatin reduced Methanobrevibacter smithii (M. smithii) levels in the ileum (but not other intestinal segments) of rats administered a high-fat diet; and Lovastatin improved stool water content in these rats. |
| 2001-12-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval of Lovastatin Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received final FDA approval of its Abbreviated New Drug Application (ANDA) for Lovastatin Tablets 10, 20 and 40 mg, following the expiration of Merck's period of pediatric exclusivity for Mevacor. |
| 2001-06-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Lovastatin Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has awarded final approval for Lovastatin Tablets 10, 20 and 40 mg. |
All press releases naming this drug 17 releases
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lovastatin | “Healthy subjects were randomly allocated to receive a single dose of either four 600 mg red yeast rice capsules or one 20 mg lovastatin tablet; after 7-day washout period, they...” NCT01346670 ↗59“The purpose of this study is to determine whether short-term use of the drugs ibuprofen and lovastatin affects levels of a protein called beta-amyloid in people who are at risk...” NCT00046358 ↗ “Statins include atorvastatin , fluvastatin , lovastatin , pitavastatin , pravastatin, rosuvastatin and simvastatin.” NCT06553157 ↗ “SYN-010 is a modified release, oral formulation of lovastatin being developed for the treatment of IBS-C.” NCT03763175 ↗ “lovastatin” NCT01890967 ↗ |
| Known as | 6.alpha.-methylcompactin | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Altoprev | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | C10AA02 | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | L-154803 | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | LOV | “In animal studies, pathway-specific pharmacological interventions with lovastatin (LOV) and lamotrigine (LTG) have been shown to improve synaptic plasticity as well as...” PMID 37280688 ↗ Jun 2023 |
| Known as | Lovastatin component of advicor | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Lovastatina | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Lovastatine | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Mevacor | “Both Niaspan and lovastatin (Mevacor®) are approved by the United States Food and Drug Administration (FDA) to treat high cholesterol.” NCT00071266 ↗1“Mevacor” NCT00532311 ↗ |
| Known as | Mevinacor | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Mevinacor 10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Mevinacor 40 | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Mevinolin | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Mevlor | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | MK-803 | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | MK0803 | “MK0803, lovastatin” NCT00092846 ↗ |
| Known as | Monacolin k | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | NSC-758662 | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Simvastatin impurity, lovastatin- | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | Sivlor | ChEMBL registry synonym — accepted as the source's own label CHEMBL503 ↗ |
| Known as | SYN-010 | “SYN-010 is a modified release, oral formulation of lovastatin being developed for the treatment of IBS-C.” NCT03763175 ↗ |
| Action | Inhibit | “inhibits 3-hydroxy, 3-methyl glutaryl coenzyme A reductase” NCT00000469 ↗ |
| Modality | Small molecule | “hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins)” PMID 19574441 ↗ Jul 2009 |
| Route | Oral | “Lovastatin 80 mg/day as 40 mg orally twice daily.” NCT00285857 ↗ |
| Target | HMGCR | “hydroxymethylglutaryl-coenzyme A reductase inhibitors” PMID 19574441 ↗ Jul 2009 |