FDA CRL for Relacorilant; Corcept Therapeutics Faces Legal Probes, Must Provide More Evidence

FDA CRL Halts Approval Path for Relacorilant

Corcept Therapeutics is facing a regulatory setback after the U.S. Food and Drug Administration issues a Complete Response Letter for its New Drug Application for relacorilant, an investigational therapy for hypertension secondary to hypercortisolism. The agency acknowledges that Corcept’s pivotal GRACE trial meets its primary endpoint and that data from the GRADIENT study provide confirmatory evidence, but concludes it cannot reach a favorable benefit‑risk assessment without additional evidence of effectiveness.

The CRL signals that the FDA requires further data or analyses before approval, prompting Corcept to consider next steps that likely include additional discussions with regulators and potential new or supplemental studies to bolster efficacy claims. Regulators are increasingly focused on the clinical meaningfulness of trial endpoints and consistency across datasets, and the FDA’s position underscores the challenge of translating statistically positive trial results into a conclusive demonstration of patient benefit.

For Corcept and clinicians tracking therapies for hypercortisolism‑related hypertension, the CRL slows the pathway to market access and patient availability. Relacorilant, a selective glucocorticoid receptor modulator, addresses a condition with limited targeted treatment options, and the regulatory outcome highlights the scrutiny applied to drugs for endocrine and cardiovascular complications. Corcept is expected to engage with the FDA to define the specific evidence needed to resolve the agency’s concerns.

Legal Probes Open After Disclosure

Following Corcept’s disclosure of the CRL, two law firms — The Schall Law Firm in Los Angeles and the DJS Law Group in New York — announce investigations into whether the company, its officers or directors made false or misleading statements about relacorilant’s development, trial data interpretation or communications with the FDA. Both firms invite affected shareholders to contact them to discuss potential securities‑law claims and preservation of documents, saying they will examine whether prior public statements materially mischaracterized the strength of the GRACE and GRADIENT evidence.

Clinical and Regulatory Context

The GRACE trial’s primary endpoint success and GRADIENT’s confirmatory signals form the factual basis for Corcept’s application and the FDA’s request for more evidence. The company now faces decisions about additional analyses, possible new trials, or targeted data packages to address the agency’s concerns. The outcome will shape the development timeline for relacorilant and may influence regulatory expectations for future therapies in the hypercortisolism treatment landscape.