Chenodiol by Leadiant Biosciences for Cerebrotendinous Xanthomatosis: Likelihood of Approval

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Chenodiol overview

Chenodiol (Xenbilox, Chenix, Chenofalk, Chenodeoxycholic acid ) is an anticholelithogenic agent which belongs to the dihydroxy bile acids, alcohols, and derivatives. It is formulated as hard gelatin capsules and tablets for oral route of administration. It is indicated for the patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease or age and also indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.

Chenodiol is under development for the treatment of cerebrotendinous xanthomatosis (CTX) in the U.S.

Leadiant Biosciences overview

Leadiant Biosciences, formerly Sigma-Tau Pharmaceuticals, is a pharmaceutical company. It discovers and develops novel medicines. The company provides products such as abelcet, adagen, carnitor, cystaran, depocyt, matulane and revcovi, among others. It also offers services including patient support, discovery, and development of novel medicines for the unmet needs of patients with rare diseases. Leadiant Biosciences also conducts research and development for the treatment of cerebrotendinous xanthomatosis, adenosine deaminase severe combined immunodeficiency, necrotizing enterocolitis, and GNE myopathy. The company markets its products through a network of distributors in the US and abroad. Leadiant Biosciences is headquartered in Rockville, Maryland, the US.

For a complete picture of Chenodiol’s drug-specific PTSR and LoA scores, buy the report here.

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

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.