Ursodiol is a Small Molecule owned by Dr. Falk Pharma, and is involved in 11 clinical trials, of which 9 were completed, 1 is ongoing, and 1 is planned.

Ursodiol (also known as Ursodeoxycholic acid ) reduces elevated liver enzyme levels by facilitating bile flow through the liver and protecting liver cells. Ursodiol concentrated in bile and decreases biliary cholesterol by suppressing hepatic synthesis and secretion of cholesterol and by inhibiting its intestinal absorption. The reduced cholesterol saturation permits the gradual solubilization of cholesterol from gallstones, resulting in their eventual dissolution.

The revenue for Ursodiol is expected to reach a total of $1.1bn through 2027. 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 Ursodiol NPV Report.

Ursodiol is currently owned by Dr. Falk Pharma. China Medical System Holdings is the other company associated in development or marketing of Ursodiol.

Ursodiol Overview

Ursodeoxycholic Acid (Ursofalk, Urdafalk, Urso, Bilifalk) is an epimer of chenodeoxycholic acid is a naturally occurring bile acid found in normal human bile in small quantities. It is formulated as hard gelatin capsules, suspension and film-coated tablets for oral route of administration. It is indicated for the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder, for the treatment of painful dyspeptic complaints, fat intolerance, flatulence of biliary origin, and hepatobiliary disorders associated with cystic fibrosis in children.

Liversol (ursodeoxycholic acid) was under development for the treatment of primary biliary cirrhosis in the United States. It was also under development for the treatment of cystic fibrosis associated with liver disease.

China Medical System Holdings Overview

China Medical System Holdings (CMS), subsidiary of Treasure Sea Ltd, is a pharmaceutical company that markets, promotes and sells pharmaceutical drugs. Its offering product includes plendil, deanxit, xinhuosu, ursofalk, bioflor, combizym, hirudoid, aethoxysklerol, lansoprazole enteric, tacrolimus, cyclosporine, paliperidone, latanoprost, levetiracetam, pons, extendedrelease and doxorubicin hydrochloride liposome, among others. CMS medical aesthetic product comprises vmonalisa, stratamark, mesoestetic-mesohyal, and neauvia hyaluronic series. Its also offer clinical development services. The company’s product pipeline provides various therapeutic fields which include nervous system, ophthalmology, dermatology, endocrine system, oncology, nephrology, immune system, digestive system and anti-infection. CMS is headquartered in Hong Kong city, Hong Kong.

The company reported revenues of (Renminbi) CNY8,337.2 million for the fiscal year ended December 2021 (FY2021), an increase of 20% over FY2020. In FY2021, the company’s operating margin was 40.9%, compared to an operating margin of 38.7% in FY2020. In FY2021, the company recorded a net margin of 36.2%, compared to a net margin of 36.4% in FY2020.

Quick View – Ursodiol

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Ursodiol
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Respiratory
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.