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# Corcept Plans Resubmission of Cushing’s NDA
- URL: https://www.fdaweb.com/corcept-plans-resubmission-of-cushings-nda/
- Published: 2026-05-27T12:00:00.000Z
- Updated: 2026-09-14T13:39:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161208

Corcept Therapeutics plans to resubmit its NDA for relacorilant as a treatment for patients with Cushing’s syndrome, following additional analyses requested by FDA after issuing a complete response letter late last year.

The company says FDA requested further analyses of data already included in the application. Corcept CEO **Joseph K. Belanoff** notes that the outcome of those analyses was positive and that discussions with the agency had been productive.

Corcept intends to resubmit the application in the coming weeks. According to the company, FDA indicated that a new Prescription Drug User Fee Act decision date would likely be set for six months after the resubmission is accepted.

Relacorilant is being developed for the treatment of hypercortisolism, also known as Cushing’s syndrome, a rare endocrine disorder caused by excessive cortisol activity. The condition is associated with symptoms including hypertension, obesity, elevated blood sugar, severe fatigue and muscle weakness, as well as psychiatric and cognitive complications. Untreated hypercortisolism can be fatal, with cardiovascular disease representing a leading cause of death among patients.

A [corrected version](https://download.open.fda.gov/crl/CRL%5FNDA219398%5F20260128.pdf?ref=fdaweb.com) of the 12/30/2025 complete response letter shows that the agency had repeatedly warned the company against submitting the NDA. It says that during pre-submission meetings, “we informed you on several occasions of our concerns about the adequacy of the clinical development program to assess the effect of relacorilant on hypertension in the intended population, including the design of CORT125134-455 \[study\], and to expect significant review issues if you were to submit your application.”

According to the letter, relacorilant failed to demonstrate superior efficacy over placebo in its main clinical trial, showing virtually no meaningful difference in blood pressure outcomes between treatment and control groups. FDA’s review also raised significant safety concerns, citing four cases of probable drug-induced liver injury. One patient experienced liver enzyme elevations more than 50 times the upper limit of normal, a level the agency associated with increased risk of serious liver complications.

The company’s CORT125134-455 trial included a 22-week open-label treatment phase followed by a 12-week randomized, placebo-controlled withdrawal phase. While the trial met its primary endpoint — loss of blood pressure response during the withdrawal phase — FDA says the results were derived from a “highly enriched population” that limited their interpretability.

Of 102 patients with hypertension at baseline, 39% discontinued during the open-label phase, and only 46 patients entered the randomized withdrawal period, according to the agency. As a result, FDA says the observed treatment effect likely overestimated relacorilant’s benefit in the intended population. Although the agency acknowledged a mean systolic blood pressure reduction of 5.2 mm Hg at the end of the open-label phase, it said the estimate was unreliable due to extensive missing data and the absence of a control group.

The second pivotal study, CORT125134-456, was a randomized, double-blind, placebo-controlled trial in patients with autonomous cortisol secretion or Cushing’s syndrome and uncontrolled systolic hypertension and/or glucose abnormalities. That trial failed to meet its primary endpoint, showing no meaningful difference between relacorilant and placebo in 24-hour systolic blood pressure reduction at Week 22, FDA says. The between-arm difference was less than 1 mm Hg and was not statistically significant, it adds.

Corcept also conducted a post-hoc subgroup analysis in a small subset of patients with Cushing’s syndrome that showed a nominally significant blood pressure reduction with relacorilant. However, FDA says the analysis was not pre-specified, relied on a small sample size with substantial missing data, and failed to show significance when the agency applied its own imputation methods.

The 1/28 corrected version of the letter was issued following additional communications between Corcept and FDA, according to the letter.