Regulators demand further evidence of relacorilant’s clinical efficacy before granting market authorization.
As 2025 drew to a close, the U.S. Food and Drug Administration (FDA) issued a setback to Corcept Therapeutics by declining to approve relacorilant. The drug was intended to treat hypertension secondary to hypercortisolism, a hallmark of the rare hormonal condition known as Cushing’s syndrome.
Clinical trial hurdles
In its Complete Response Letter (CRL), the U.S. regulator stated that additional evidence of efficacy is required before relacorilant can be approved.
Cushing’s syndrome involves abnormally high levels of the stress hormone cortisol, leading to debilitating symptoms such as central obesity, muscle weakness, severe hypertension, and hyperglycemia.
While the drug met its primary endpoints in the Phase 3 GRACE trial, showing significant blood pressure control, the GRADIENT study failed to meet its primary goal regarding systolic blood pressure. This discrepancy appears to have prompted the FDA’s request for more comprehensive data.
Impact on Corcept’s corporate strategy
This rejection is a major blow to Corcept as the company seeks to diversify its revenue. Their long-standing product, Korlym, which has been on the market since 2012, is beginning to face pressure from generic competitors.
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Company response: CEO Joe Belanoff expressed disappointment but reaffirmed the company’s commitment to the drug. Corcept plans to meet with the FDA immediately to discuss whether a new clinical trial will be necessary, which could significantly delay the program.
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Other potential indications: Despite the endocrine setback, relacorilant showed positive results in the Phase 3 ROSELLA study for platinum-resistant ovarian cancer. An FDA decision for this oncology indication is expected by July 11.
Source: https://pharmaphorum.com/news/fda-declines-approve-corcepts-rare-disorder-drug