Corcept Therapeutics Submits New Drug Application for Relacorilant to FDA for Hypercortisolism Treatment

Corcept Therapeutics Incorporated (NASDAQ: CORT) has recently disclosed in an 8-K filing that the company has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for relacorilant, a selective cortisol modulator, aimed at treating patients suffering from endogenous hypercortisolism, also known as Cushing’s syndrome.

The NDA submission follows a press release issued on December 30, 2024, where Corcept Therapeutics announced the milestone. This new drug application is grounded on favorable outcomes from the pivotal GRACE trial, along with supporting data from the Phase 3 GRADIENT and extended studies, as well as a Phase 2 trial conducted in patients with hypercortisolism.

Patients who participated in these trials and were treated with relacorilant showed improvements in a broad range of symptoms associated with hypercortisolism, with a manageable safety profile. Noteworthy is the absence of major adverse events commonly linked with existing therapies, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation, and no adverse effects related to progesterone receptor activity.

Dr. Joseph Belanoff, the Chief Executive Officer of Corcept, expressed confidence in relacorilant’s potential to set a new standard in the medical management of hypercortisolism. He highlighted the compound’s efficacy and safety profile, signaling a promising future for patients grappling with this challenging medical condition.

Relacorilant, a patented proprietary medication of Corcept, selectively targets the glucocorticoid receptor, differentiating it from other hormone receptors. Beyond Cushing’s syndrome, Corcept is exploring the utility of relacorilant in several severe conditions, including ovarian, adrenal, and prostate cancer. The drug holds orphan drug designation in both the U.S. and the European Union for Cushing’s syndrome treatment.

Hypercortisolism, typified by excessive cortisol levels, can lead to a spectrum of symptoms like high blood pressure, central obesity, and glucose dysregulation, often culminating in severe health complications if left untreated.

Corcept Therapeutics, with a robust portfolio of over 1,000 selective cortisol modulators, is dedicated to advancing clinical programs in various critical conditions like hypercortisolism, solid tumors, ALS, and liver disease. Notably, the company previously introduced Korlym® in 2012, the first FDA-approved therapy for endogenous hypercortisolism.

The press release contained forward-looking statements mentioning the results of trials involving relacorilant, its safety and efficacy profiles, regulatory milestones, and market acceptance. It noted potential risks that could impact the company’s anticipated outcomes, emphasized its ongoing commitment to enhancing patient care, and urged stakeholders to review the company’s SEC filings for comprehensive information.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Corcept Therapeutics’s 8K filing here.

Corcept Therapeutics Company Profile

Corcept Therapeutics Incorporated engages in discovery and development of drugs for the treatment of severe endocrinologic, oncologic, metabolic, and neurologic disorders in the United States. It offers Korlym tablets medication for the treatment of hyperglycemia secondary to hypercortisolism in adult patients with endogenous cushing's syndrome; and who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.