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This is a combination regimen used in clinical trials for advanced metastatic castration-resistant prostate cancer (mCRPC). It consists of INV-9956, an orally available, selective, and potent inhibitor of the cholesterol side chain cleavage enzyme (Cyp11A1), co-administered with dexamethasone (a synthetic glucocorticoid) and fludrocortisone acetate (a synthetic mineralocorticoid). INV-9956 potently inhibits the biosynthesis of pregnenolone and other androgens in adrenocortical cells, targeting androgen biosynthesis critical for prostate cancer progression, especially in drug-resistant settings. The inclusion of dexamethasone and fludrocortisone acetate serves as corticosteroid replacement therapy to mitigate adrenal insufficiency and potential adrenal toxicity from Cyp11A1 inhibition. The regimen is in Phase 1/2 trials for mCRPC and developed by Ionova Life Science. Fludrocortisone acetate is supplied as Florinef and is primarily used to replace aldosterone and manage various forms of adrenal insufficiency, with both mineralocorticoid and glucocorticoid actions[1][2][3][4][5][6][7][8][9].
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