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Case Studies , First-in-Human , Clinical Trial Manufacturing , Commercial Manufacturing

Case Study: Corcept Therapeutics

Overview

A case study on Quotient Sciences' accelerated approach to integrated clinical manufacturing and Phase 1 clinical trials

Corcept Therapeutics, based in California, USA, is a pharmaceutical company focused on the impact of cortisol on health and the development of glucocorticoid receptor (GR) antagonists. Following its foundation in 1998, the company successfully developed Korlym® (mifepristone), a dual GR and progesterone receptor (PR) antagonist for the treatment of endogenous Cushing’s syndrome (Hypercortisolism), a disorder associated with significant morbidity and mortality. However, the dual action of mifepristone limited the circumstances in which the drug could be used, and there was a need for a selective 'next generation' medication offering all of the benefits but without the associated risks.

Quotient Sciences was approached to help Corcept Therapeutics in their development of CORT125134. This was contracted out to us due to our ability to integrate clinical manufacturing and clinical trial dosing at the same location. Request a copy of our case study today and contact us to find out how we can accelerate drug development timelines saving as much as 12 months in the process with our Translational Pharmaceutics® platform.

 

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More information about Translational Pharmaceutics®

Combining services, scientific expertise, operational efficiency, and real-time data, we help reduce timelines by an average of 12 months or more while delivering cost and efficiency savings in drug development.

Translational Pharmaceutics® is an integrated platform that combines drug product formulation development, drug product manufacturing, and clinical testing within a single program. Translational Pharmaceutics® programs are delivered by Quotient Sciences, a global CRDMO provider with locations in the United States and the United Kingdom.

Translational Pharmaceutics® applies to drug development, integrating drug product formulation and manufacturing with clinical testing. These programs are performed by Quotient Sciences at our manufacturing and clinical sites in the United States and United Kingdom.

Translational Pharmaceutics® applies to drug development, integrating drug product formulation and manufacturing with clinical testing. It can be applied in scenarios including first-in-human, Phase I clinical testing; for drug product optimization in Phase Ib/IIa clinical studies; and for more efficient, integrated human ADME studies. 

Overall, Translational Pharmaceutics® can significantly decrease development timelines by 12 months or more while providing financial benefits, as quantified by the Tufts Center for Drug Development (Tufts CSDD).

Translational Pharmaceutics® helps reduce development timelines, improves formulation selection using clinical data, and minimizes project risk through real-time decision-making. Overall, it can significantly decrease timelines in early drug development, by 12 months or more, while providing financial benefits. This has been quantified by the Tufts Center for Drug Development (Tufts CSDD) in a published report.

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