Endogenous Cushing’s

We estimate that 25,000 patients in the US are currently diagnosed with endogenous Cushing’s syndrome, a rare endocrine disorder characterized by sustained elevated cortisol levels.*


Endogenous Cushing’s syndrome, is a rare, serious and potentially lethal endocrine disease caused by chronic elevated cortisol exposure - often the result of a benign tumor of the pituitary gland.1 This benign tumor tells the body to overproduce high levels of cortisol for a sustained period of time, and this often results in undesirable physical changes.1 The disease is most common among adults between the ages of 30 to 50, and it affects women three times more often than men.1 Women with Cushing's syndrome may experience a variety of health issues including menstrual problems, difficulty becoming pregnant, excess male hormones (androgens), primarily testosterone which can cause hirsutism (growth of coarse body hair in a male pattern), oily skin, and acne.1 Additionally, the internal manifestations of the disease are potentially life threatening.1 These include metabolic changes such as high blood sugar, or diabetes, high blood pressure, high cholesterol, fragility of various tissues including blood vessels, skin, muscle and bone, and psychologic disturbances such as depression, anxiety and insomnia.1-4 Untreated, the five-year survival rate is only approximately 50 percent.4

Clinical Development in Endogenous Cushing’s Syndrome

RECORLEV® (levoketoconazole) is an investigational cortisol synthesis inhibitor, previously studied in SONICS, and currently being evaluated in LOGICS and OPTICS, phase 3 clinical trials for endogenous Cushing’s syndrome.

The safety and efficacy of RECORLEV (levoketoconazole) for treatment of endogenous Cushing’s syndrome have not been established.

Educational Segment on Endogenous Cushing’s Syndrome

Strongbridge Biopharma sponsored an educational segment about endogenous Cushing’s syndrome on The Balancing Act, “Behind the Mystery: Rare and Genetic Diseases.” The segment features Leslie Edwin, a patient with endogenous Cushing’s syndrome and Director of Support Groups for Cushing’s Support & Research Foundation, and Maria Fleseriu, MD, Professor/Director at the Pituitary Center at Oregon Health and Science University (OHSU). A broad range of topics related to Cushing’s syndrome are addressed within the segment, including symptoms, misdiagnosis, the importance of seeing an endocrinologist, screening methods, treatment options, and research efforts that are underway.

*Based on proprietary Strongbridge Biopharma plc market research.


  1. The National Institute of Diabetes and Digestive and Kidney Diseases Health Information Center. Cushing’s Syndrome. Accessed Sept. 14, 2020. https://www.niddk.nih.gov/health-information/endocrine-diseases/cushings-syndrome.
  2. Pereira AM, Tiemensma J, Romijn JA. Neuropsychiatric disorders in Cushing’s syndrome. Neuroendocrinology. 2010;92(suppl 1):65-70.
  3. Cushing’s disease. University of Virginia Health System: Neurosciences website. Accessed Sept. 21, 2020. https://uvahealth.com/services/skull-base-pituitary/cushings-disease.
  4. Greenman Y. Management of dyslipidemia in Cushing’s syndrome. Neuroendocrinology. 2010;92(suppl 1):91-95.
  5. CSRF fact sheet. Cushing’s Support & Research Foundation website. http://csrf.net/understanding-cushings/fact-sheet/.
  6. Nieman LK, Biller BMK, Findling MHM, et al. Treatment of Cushing’s syndrome: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831.
  7. Cushing’s syndrome. NIH Publication No. 08-3007. July 2008. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases website. http://www.niddk.nih.gov/health-information/health-topics/endocrine/cushings-syndrome/Documents/Cushings_Syndrome_508.pdf.
  8. Bolanowski M, Halupczok J, Jawiarczyk-Przybylowska A. Pituitary disorders and osteoporosis. Int J Endocrinol. 2015:206853. Available at http://dx.doi.org/10.1155/2015/206853.

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