(Ezetimibe + rosuvastatin calcium) is a Small Molecule owned by Hanmi Science, and is involved in 15 clinical trials, of which 8 were completed, 5 are ongoing, and 2 are planned.

Ezetimibe binds to Niemann-Pick C1and blocks cholesterol absorption. It localizes and appears to act at the brush border of the small intestine and inhibits the absorption of cholesterol. It appears to bind to a critical mediator of cholesterol absorption, the Niemann-Pick C1-Like 1 (NPC1L1) protein on the gastrointestinal tract epithelial cells as well as in hepatocytes.

Rosuvastatin is a statin with antilipidemic and potential antineoplastic activities. Rosuvastatin selectively and competitively binds to and inhibits hepatic hydroxymethyl-glutaryl coenzyme A (HMG-CoA) reductase, the enzyme which catalyzes the conversion of HMG-CoA to mevalonate, a precursor of cholesterol. This leads to a decrease in hepatic cholesterol levels and increase in uptake of LDL cholesterol.

The revenue for (Ezetimibe + rosuvastatin calcium) is expected to reach a total of $746m through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the (Ezetimibe + rosuvastatin calcium) NPV Report.

(Ezetimibe + rosuvastatin calcium) is currently owned by Hanmi Science. Organon is the other company associated in development or marketing of (Ezetimibe + rosuvastatin calcium).

(Ezetimibe + rosuvastatin calcium) Overview

Ezetimibe and rosuvastatin calcium (Ezalo, Rosuzet, Naxzalla, Toreza) is a fixed dose combination, which acts as cholesterol lowering agent. It is formulated as tablets, capsules and film coated tablets for oral route of administration. It is indicated for the treatment of adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia where use of a combination product is appropriate in those patients who are not appropriately controlled with rosuvastatin or ezetimibe alone, or already treated with rosuvastatin and ezetimib, also indicated for homozygous familial hypercholesterolaemia, and dyslipidaemia.

Ezetimibe and rosuvastatin calcium is under development for the treatment of hypercholesterolemia and familial hypercholesterolemia (type II hyperlipoproteinemia).

Organon Overview

Organon is a healthcare company. The company discovers and develops biosimilars and medicines. It provides medicines and solutions for various conditions including respiratory, cardiovascular, dermatology, non-opioid pain, women’s health and others. The company’s products include mometasone furoate inhalation powder, follitropin beta injection, alendronate sodium, acetate injection, chorionic gonadotropin and others. It conducts patient assistance and Organon access program, which provide free medicines to individuals. Organon markets its products through a network of distribution channels in domestic and overseas markets. It works in collaboration with pharmaceutical and biopharmaceutical companies to commercialize its products. Organon is headquartered in Jersey City, New Jersey, the US.

The company reported revenues of (US Dollars) US$6,304 million for the fiscal year ended December 2021 (FY2021), a decrease of 3.5% over FY2020. In FY2021, the company’s operating margin was 24.3%, compared to an operating margin of 42.1% in FY2020. In FY2021, the company recorded a net margin of 21.4%, compared to a net margin of 33.1% in FY2020. The company reported revenues of US$1,537 million for the third quarter ended September 2022, a decrease of 3% over the previous quarter.

Quick View – (Ezetimibe + rosuvastatin calcium)

Report Segments
  • Innovator (Non-NME)
Drug Name
  • (Ezetimibe + rosuvastatin calcium)
Administration Pathway
  • Oral
Therapeutic Areas
  • Metabolic Disorders
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.