A Comprehensive Safety Assessment of Relacorilant: Insights From Phase 2 and Phase 3 Trials in Patients With Endogenous Hypercortisolism

Summary  

• Relacorilant was well tolerated in patients with endogenous hypercortisolism and demonstrated an acceptable and consistent safety profile
  • Most treatment-emergent adverse events (TEAEs) reported by patients treated with relacorilant were mild to moderate in severity, and the frequency of serious TEAEs was low
  • Consistent with its high selectivity for the glucocorticoid receptor, patients treated with relacorilant reported no TEAEs associated with other hormone receptors
  • There were no cases of excessive glucocorticoid receptor antagonism, adrenal insufficiency, or vaginal bleeding associated with endometrial hypertrophy
  • There were no cases of drug-induced hypokalemia, new onset or exacerbation of hypertension, or QT interval prolongation
  • No patients met Hy’s law criteria for potential drug-induced liver injury
• Certain frequently reported TEAEs, such as musculoskeletal symptoms, abdominal pain, nausea, and fatigue, likely reflect glucocorticoid withdrawal, which occurs with any surgical or pharmacologic treatment for hypercortisolism, and can be indicative of clinical benefit
  • These events often improved or resolved with continued treatment and did not worsen with dose escalation

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