The Food and Drug Administration (FDA) has granted Orphan Drug designation to relacorilant (Corcept Therapeutics), a selective cortisol modulator, for the treatment of patients with pancreatic cancer. 

Previous studies have suggested that a glucocorticoid receptor antagonist, such as relacorilant, may enhance the effectiveness of chemotherapy. The Company is investigating the treatment in combination with nab-paclitaxel (Abraxane; Celgene) for pancreatic cancer and other solid tumors. In a Phase 1/2 trial of patients with solid tumors, 5 out of 9 patients who received the minimum therapeutic dose demonstrated durable disease control. 

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Clinical trials of the treatment are ongoing. “We are pleased the FDA has granted relacorilant orphan drug status for the treatment of pancreatic cancer,” said Joseph K. Belanoff, MD, Corcept’s CEO. “By year-end we expect to have learned enough to determine a potential path toward a pivotal study in this indication.” 

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