Endogenous Cushing’s

~25,000 patients in the United States are currently diagnosed with Cushing's syndrome*

Endogenous Cushing's syndome (CS) 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 that tells the body to overproduce high levels of cortisol for a sustained period of time, CS results in undesirable physical changes in patients. It is most common among adults aged 30 to 50 years and is more prevalent in females, accounting for 70% of cases.1,2

Women with CS may experience health issues including1

  • Menstrual problems
  • Difficulty becoming pregnant
  • Hirsutism (coarse body hair growth), acne, and oily skin due to excess male hormones (androgens), primarily testosterone
  • Weight gain

Additionally, internal manifestations of CS are potentially life threatening1,3-5

  • High blood sugar/diabetes
  • High blood pressure
  • High cholesterol
  • Fragile blood vessels, skin, muscle and bone
  • Depression
  • Anxiety
  • Insomnia

Untreated, the 5-year survival rate for CS is only ~50%.5


Clinical Development in Endogenous Cushing’s Syndrome

Levoketoconazole is an investigational adrenal steroidogenesis inhibitor, previously studied in phase 3 SONICS and LOGICS studies, and currently being evaluated in OPTICS, an extension study for endogenous CS.

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

Educational Segment on Endogenous Cushing’s Syndrome

Watch our segment on The Balancing Act, featuring Leslie Edwin, a patient with endogenous CS and President of Support Groups for Cushing’s Support & Research Foundation, and Maria Fleseriu, MD, Professor and Director at the Pituitary Center at Oregon Health and Science University (OHSU), as they discuss a broad range of topics related to CS.

*Based on proprietary Strongbridge Biopharma plc market research.

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


  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. Javanmard P, Duan D, Geer EB. Mortality in Patients with endogenous cushing’s syndrome. Endocrinol Metab Clin North Am. 2018;47(2):313-333. doi:10.1016/j.ecl.2018.02.005.
  3. Pereira AM, Tiemensma J, Romijn JA. Neuropsychiatric disorders in Cushing’s syndrome. Neuroendocrinology. 2010;92(suppl 1):65-70.
  4. Cushing’s disease. University of Virginia Health System: Neurosciences website. Accessed Sept. 21, 2020. https://uvahealth.com/services/skull-base-pituitary/cushings-disease.
  5. Greenman Y. Management of dyslipidemia in Cushing’s syndrome. Neuroendocrinology. 2010;92(suppl 1):91-95.
  6. CSRF fact sheet. Cushing’s Support & Research Foundation website. http://csrf.net/understanding-cushings/fact-sheet/.
  7. Nieman LK, Biller BMK, Findling JW, et al; for the Endocrine Society. Treatment of Cushing’s syndrome: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831.
  8. 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.
  9. Bolanowski M, Halupczok J, Jawiarczyk-Przybylowska A. Pituitary disorders and osteoporosis. Int J Endocrinol. 2015;2015:206853. doi:10.1155/2015/206853.