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Review

Osilodrostat: Short Chapter

No authors listed
In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.
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Review

Osilodrostat: Short Chapter

No authors listed.
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Excerpt

Osilodrostat is an inhibitor of cortisol synthesis that is used in the treatment of Cushing disease not controlled by standard therapy. Osilodrostat therapy has not been linked to serum aminotransferase elevations during therapy or with instances of clinically apparent liver injury.

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References

    1. FDA. Integrated Review. 2020.
    1. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212801Orig1s000M... [ (FDA summary data on the safety and efficacy of osilodrostat, submitted in support of the application for approval as therapy of Cushing disease, mentions that 34% of 137 treated subjects in the registration trial had an ALT or AST elevation, but they were mostly mild, frequently attributable to co-existing conditions, only 2.9% were above 3 times the upper limit or normal (ULN), and no patient developed enzyme elevations with jaundice or symptoms). ]
    1. Bertagna X, Pivonello R, Fleseriu M, Zhang Y, Robinson P, Taylor A, Watson CE, et al. LCI699, a potent 11β-hydroxylase inhibitor, normalizes urinary cortisol in patients with Cushing's disease: results from a multicenter, proof-of-concept study. J Clin Endocrinol Metab. 2014;99:1375-83. - PubMed
    1. Fleseriu M, Pivonello R, Young J, Hamrahian AH, Molitch ME, Shimizu C, Tanaka T, et al. Osilodrostat, a potent oral 11β-hydroxylase inhibitor: 22-week, prospective, Phase II study in Cushing's disease. Pituitary. 2016;19:138-48. - PMC - PubMed
    1. Duggan S. Osilodrostat: first approval. Drugs. 2020;80:495-500. - PubMed

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