HMG-CoA reductase (3-hydroxy-3-methyl-glutaryl-coenzyme A reductase, HMGCR) is a rate-controlling enzyme of the mevalonate pathway, which produces cholesterol. HMGCR catalyzes the conversion of HMG-CoA to mevalonic acid, a necessary step in the biosynthesis of cholesterol. HMG-CoA reductase inhibitors, competitively reduce inhibit the enzyme HMG-CoA reductase, and thereby reducing hepatic cholesterol concentrations, which stimulates the upregulation of hepatic low-density lipoprotein (LDL) receptors which increases hepatic uptake of LDL. HMG-CoA reductase inhibitors are indicated as an adjunct to diet in the treatment of triglyceridemia, primary dysbetalipoproteinemia, and homozygous familial hypercholesterolemia. It is also indicated for the prevention of major cardiovascular events such as myocardial infarction, nonfatal stroke, and coronary artery revascularization. JW Pharma, Boryung Group, Kowa Pharmaceutical America, Eli Lilly & Company, Merck (MSD), Alvogen, and Daiichi Sankyo Pharmaceutical are the major players in the HMG-CoA reductase inhibitors market.
Key Market Developments:
- In Nov 2022, Merck & Co’s Atorvastatin was launched in Chile and France for hypercholesterolemia.
Approved Drug Molecules and Brand Names for HMG-CoA Reductase Inhibitors:
- Atorvastatin
- Simvastatin
- Rosuvastatin
- Pravastatin
- Ezetimibe/Simvastatin
- Livalo (Pitavastatin)
- Lovastatin
- Fluvastatin
- Amlodipine/Atorvastatin
- Atorvastatin/Ezetimibe
- Cholib (Fenofibrate/Simvastatin)
- Rosuzet (Rosuvastatin/Ezetimibe)
- Amlodipine/Ezetimibe/Rosuvastatin
- Atorvastatin/Fenofibrate
- Laropiprant/Niacin/Simvastatin
- Rosuvastatin/Telmisartan
- Altoprev (Lovastatin extended-release formulation)
- Olomax (Amlodipine/Olmesartan/Rosuvastatin)
- Tuvero (Fimasartan/Rosuvastatin)
- Newvast (Atorvastatin strontium pentahydrate)
- Olostar (Rosuvastatin/Olmesartan Medoxomil)
- Atorvastatin/Fenofibrate (CKD-337)
- Dukaro (Amlodipine/Fimasartan/Rosuvastatin)
- Exone-R (Amlodipine/Rosuvastatin)
- Juvisync (Sitagliptin/Simvastatin)
- Telmiduo Plus (Amlodipine/Rosuvastatin)
- Telotan (Rosuvastatin/Telmisartan)
- ZemiStatin (Gemigliptin/Rosuvastatin FDC)
- Amlodipine/Rosuvastatin
- Fenofibrate/Pravastatin
- Fluvastatin XL
- Advicor (Lovastatin/Niacin ER)
- Atomet SR (Atorvastatin/Metformin XR)
- Livasupril (micronized Fenofibrate/Pitavastatin)
- Rocanduo (Candesartan cilexetil/Rosuvastatin calcium)
- Rovelito (Atorvastatin/Irbesartan)
- Simcor (Simvastatin/Niacin extended-release formulation)
- Rosuampin (YHP1701)
- Rosumet (Metformin/Rosuvastatin)
- Rovatitan (Rosuvastatin/Valsartan)
- Simvast CR (Simvastatin controlled-release)
- Trezete (Ezetimibe/Rosuvastatin)
Drugs under the Pipeline for HMG-CoA Reductase Inhibitors:
- Livasartan (Pitavastatin/Valsartan)
- modified-release formulation of Lovastatin lactone (SYN-010)
- Metformin/Rosuvastatin (HCP1201)
- Amlodipine/Rosuvastatin (DP-R212)
- Atorvastatin immediate-release/Losartan potassium delayed release (HL 040)
- Ezetimibe/Rosuvastatin (DP-R207)
- Ezetimibe/Rosuvastatin (NVP-1205)
- Rosuvastatin/omega-3 fatty acid (HCP 1007)
- Rosuvastatin/omega-3-acids ethyl esters (HCP1105)
- Amosartan Q (Amlodipine/Losartan/Rosuvastatin)
- ClowZ Tab (Ezetimibe/Rosuvastatin)
- Copaxone/Zocor (Glatiramer acetate/Simvastatin)
- Lipimet SR (Atorvastatin/Metformin)
- Metformin/Rosuvastatin (BCWP_C003)
- Olpadronic acid (IG-8801)
- Rosuvastatin/Valsartan
Clinical Activity and Developments of HMG-CoA Reductase Inhibitors:
Currently, there are about 60 drug products in the HMG-CoA reductase inhibitors, including more than 20 approved drugs in the market, and others in the clinical development phases
- In Feb 2023, Kowa Pharmaceuticals America presented the pharmacodynamics data from a phase-III REPRIEVE trial in cardiovascular disorders for Pitavastatin.
- In Jun 2022, Sanofi completed the phase-III ROZEL trial in hypercholesterolemia in China for Ezetimibe/Rosuvastatin combination.
|
Molecule Name |
Number of Studies |
|
Livasartan (Pitavastatin/Valsartan) |
7 |
|
modified-release formulation of Lovastatin lactone (SYN-010) |
5 |
|
Metformin/Rosuvastatin (HCP1201) |
4 |
|
Amlodipine/Rosuvastatin (DP-R212) |
3 |
|
Amlodipine/valsartan (IN-C008) |
2 |
|
Amlodipine/rosuvastatin/telmisartan (DW-1501) |
2 |
|
Atorvastatin immediate-release/Losartan potassium delayed release (HL 040) |
2 |
|
Ezetimibe/Rosuvastatin (DP-R207) |
2 |
|
Ezetimibe/Rosuvastatin (NVP-1205) |
2 |
|
Rosuvastatin/omega-3 fatty acid (HCP 1007) |
2 |
|
Rosuvastatin/omega-3-acids ethyl esters (HCP1105) |
2 |
|
AmosartanQ (Amlodipine/Losartan/Rosuvastatin) |
1 |
|
ClowZ Tab (Ezetimibe/Rosuvastatin) |
1 |
|
Copaxone/Zocor (Glatiramer acetate/Simvastatin) |
1 |
|
Lipimet SR (Atorvastatin/Metformin) |
1 |
|
Metformin/Rosuvastatin (BCWP_C003 |
1 |
|
Olpadronic acid (IG-8801) |
1 |
|
Rosuvastatin/Valsartan |
1 |
Target Indication Analysis of HMG-CoA Reductase Inhibitors:
HMG-CoA reductase inhibitors such as rosuvastatin, simvastatin, atorvastatin, pravastatin, and others are primarily indicated for the conditions like diabetes mellitus, clinical atherosclerosis including myocardial infarction, acute coronary syndromes, stable angina, stroke, ischemic attack, peripheral artery disease, claudication, and abdominal aortic aneurysm, chronic kidney disease, and severely elevated LDL-C levels. A number of drug molecules are in ongoing clinical trial phases for conditions like dyslipidemia, hypertension, hypercholesterolemia, and hyperlipidemia.
Regional Analysis of HMG-CoA Reductase Inhibitors:
HMG-CoA Reductase Inhibitors Market
Cardiovascular diseases (CVD) are the leading cause of death globally. According to the World Health Organization Report 2020, an estimated 17.9 million deaths were attributed to CVD globally, with the highest mortality rate in Eastern Europe and Central Asia. Globally, it was estimated that in 2020, 244.1 million people were living with ischemic heart disease, being more prevalent in males (141.0 million) and North Africa, the Middle East, Central and South Asia, and Eastern Europe had the highest prevalence rate in 2020. The global prevalence rate of stroke in 2020 was 89.1 million with the highest prevalence rates in Southeastern United States and East and Southeast Asia. Based on 2020 data, age-standardized mortality rates attributed to high systolic blood pressure were highest in Central and Southeast Asia, Eastern and Central Europe, and parts of Africa and the Middle East. The age-standardized prevalence rate of diabetes was highest in high-income North America, the Middle East, and Central Latin America with an overall 472 million patients.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Atorvastatin, Simvastatin, Rosuvastatin, Pravastatin, Ezetimibe/Simvastatin, Livalo (Pitavastatin), Lovastatin, and Fluvastatin are some of the approved HMG-CoA reductase inhibitors in the market.
JW Pharma, Boryung Group, Kowa Pharmaceutical America, Eli Lilly & Company, Merck (MSD), Alvogen, and Daiichi Sankyo Pharmaceutical are the major market players in the HMG-CoA reductase inhibitors.
Major indications for HMG-CoA reductase inhibitors are triglyceridemia, primary dysbetalipoproteinemia, homozygous familial hypercholesterolemia, diabetes mellitus, abdominal aortic aneurysm, chronic kidney disease, and severely elevated LDL-C levels.
There are about 16 drug molecules in the phase-I/II clinical development for HMG-CoA reductase inhibitors.
- JW Pharma
- Boryung Group
- Kowa Pharmaceutical America
- Eli Lilly & Company
- Merck (MSD)
- Alvogen
- Daiichi Sankyo Pharmaceutical
- Yuhan Corporation
- LG Chemicals
- NVP Healthcare
- AbbVie