Pitavastatin is a Small Molecule owned by Kowa, and is involved in 59 clinical trials, of which 55 were completed, 3 are ongoing, and 1 is planned.

Pitavastatin acts by inhibiting HMG-CoA reductase enzyme. The drug candidate binds to this enzyme and down regulates the cholesterol concentration. This low level of cholesterol activates the cellular signaling cascade leading to the activation of sterol regulatory element binding protein (SREBP) which stimulates the production of LDL receptors. The drug candidate by increasing the uptake of plasma LDL decreases the plasma LDL-cholesterol level.

The revenue for Pitavastatin is expected to reach a total of $801m 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 Pitavastatin NPV Report.

Pitavastatin is currently owned by Kowa. Recordati is the other company associated in development or marketing of Pitavastatin.

Pitavastatin Overview

Pitavastatin (Livalo, Livazo, Alipza, Vezepra) is a synthetic lipid-lowering agent. It is formulated as film-coated tablets for oral route of administration. Pitavastatin is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholest erol  (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult  patients with primary hyperlipidemia or mixed dyslipidemia, indicated for the reduction of elevated total cholesterol (TC) and LDL-C, in adult patients with primary hypercholesterolaemia, including heterozygous familial  hypercholesterolaemia, and combined (mixed) dyslipidaemia, when response to diet and other non- pharmacological measures is inadequate.

Recordati Overview

Recordati, a subsidiary of Fimei SpA, is a pharmaceutical company that researches, develops, manufactures and markets pharmaceuticals. The company offers pharmaceuticals for cardiovascular diseases, central nervous system disorders, dermatology, musculoskeletal disorders and analgesia, and urology diseases. It also offers cosmetics, dietary supplements, pregnancy test products, over-the-counter (OTC) and non-prescription pharmaceuticals, anti-infectives and others. It manufactures pharmaceutical chemicals such as active pharmaceutical ingredients (APIs) and intermediates. The company sells its pharmaceuticals directly in the countries of its operations and through licensees in other places. Recordati is headquartered in Milan, Italy.

The company reported revenues of (Euro) EUR1,580.1 million for the fiscal year ended December 2021 (FY2021), an increase of 9.1% over FY2020. In FY2021, the company’s operating margin was 31%, compared to an operating margin of 32.4% in FY2020. In FY2021, the company recorded a net margin of 24.4%, compared to a net margin of 24.5% in FY2020. The company reported revenues of EUR485.1 million for the third quarter ended September 2022, an increase of 2.5% over the previous quarter.

Quick View – Pitavastatin

Report Segments
  • Innovator (NME)
Drug Name
  • Pitavastatin
Administration Pathway
  • Oral
Therapeutic Areas
  • Metabolic Disorders
Key Companies
  • Sponsor Company: Kowa
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, drug margins and company expenses. 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 valuation, 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.