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Cushing’s Syndrome Therapeutics Pipeline Analysis 2022, Clinical Trials and Results, Patents

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Pramod Kumar
Cushing’s Syndrome Therapeutics Pipeline Analysis 2022, Clinical Trials and Results, Patents

Overproduction of cortisol hormone leads to Cushing’s syndrome. Also, exposure to glucocorticoids is expected to be one of the prime causes of the disease. Glucocorticoids are usually prescribed for diseases such as asthma, rheumatoid arthritis (RA), and lupus. Pituitary tumor, adrenal tumors, and ectopic adrenocorticotropic hormone (ACTH)-producing tumors result in increased cortisol level, eventually becoming a cause for Cushing’s syndrome. According to the American Association of Neurological Surgeons (AANS) 2019 factsheet, Cushing’s syndrome is more common in females than males and majorly affects adults aged 20–50 years.


Some common symptoms of the disease include a fatty lump between shoulders; weight gain; wide purple stretch marks mainly on abdomen, breasts, hips, and under the arms; thin arms and legs; weak muscles; easy bruising; and increased fat around the base of neck. The disease can be diagnosed through late-night salivary cortisol test, 24-hour urinary free-cortisol test, dexamethasone–CRH test, and low-dose dexamethasone suppression test (LDDST).


According to the research, many drugs being developed for Cushing’s syndrome are administered intravenously. It has been found that intravenous route of administration surpasses gastrointestinal tract, and there is rapid onset of drug effect.


There are several companies that are involved in developing therapeutics for Cushing’s syndrome have shown positive results of clinical trials. For instance, in March 2019, Strongbridge Biopharma plc announced positive results of extended evaluation phase of the pivotal Phase III Sonics study of Recorlev, a cortisol synthesis inhibitor. According to the results of the study, Recorlev demonstrated long-term efficacy to reduce mean urinary free cortisol (mUFC), as well as cardiovascular risk markers such as weight and low-density lipoprotein (LDL)-cholesterol.


Companies are actively involved in advancing their pipeline candidates for the treatment of this rare disease. For instance, Strongbridge Biopharma plc is planning to submit a new drug application (NDA) to the USFDA for Recorlev, which is indicated for the treatment of Cushing’s syndrome. Similarly, in January 2019, Corcept Therapeutics Incorporated was issued a new patent by the United States Patent and Trademark Office (USPTO), covering the use of Korlym in combination with CYP3A inhibitors for the treatment of patients with Cushing’s syndrome.


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Pramod Kumar
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