FDA Declines to Approve Relacorilant for Hypertension Linked to Hypercortisolism

Posted on January 6, 2026 by MaryO

Key takeaways:

  • The FDA issued a complete response letter for relacorilant to treat hypertension tied to hypercortisolism.
  • The investigational drug induced BP reductions for adults with hypertension in the phase 3 GRACE trial.

The FDA has issued a complete response letter for an oral selective glucocorticoid receptor antagonist under investigation for the treatment of hypertension secondary to hypercortisolism, according to an industry press release.

Corcept Therapeutics announced the FDA issued a complete response letter for relacorilant (Corcept Therapeutics). The drug is under investigation for the treatment of endogenous hypercortisolism, ovarian cancer and other disorders, according to the company.

As Healio previously reported, the phase 3 GRACE trial enrolled 152 adults with Cushing’s syndrome plus hypertension, hyperglycemia or both conditions. Participants received relacorilant for 22 weeks during an open-label phase. At 22 weeks, adults who met criteria for hypertension or hyperglycemia control entered a withdrawal phase where they were randomly assigned, 1:1, to continue relacorilant or switch to placebo for 12 weeks.

In the GRACE trial, adults with hypertension had a 7.9 mm Hg decrease in systolic blood pressure and a 5.1 mm Hg decline in diastolic BP at 22 weeks. During the randomized withdrawal phase, adults who remained on relacorilant had no change in systolic and diastolic BP, whereas those receiving placebo had a BP increase from the start of the phase to week 12.

In a press release from Corcept Therapeutics from 2024, the company announced results from the phase 3 GRADIENT trial, a randomized, double-blind, placebo-controlled trial where adults with Cushing’s syndrome caused by an adrenal adenoma or adrenal hyperplasia were randomly assigned, 1:1, to relacorilant or placebo for 22 weeks. According to the press release, the relacorilant group had a 6.6 mm Hg decline in mean systolic BP compared with baseline at 22 weeks. However, there was no significant difference in mean systolic BP change between the relacorilant and placebo groups.

As Healio previously reported, relacorilant was also assessed in a long-term extension study that enrolled adults who completed the GRACE and GRADIENT trials as well as a phase 2 hypercortisolism study. In that trial, relacorilant conferred a 10 mm Hg drop in 24-hour ambulatory systolic BP and a 7.3 mm Hg reduction in 24-hour ambulatory diastolic BP at 24 months.

In the company’s press release announcing receipt of the complete response letter, Corcept Therapeutics said the FDA acknowledged that the GRACE trial met its primary endpoint and that the GRADIENT trial provided “confirmatory evidence.” However, the FDA said it did not view relacorilant offered “a favorable benefit-risk assessment” without more data of its effectiveness, according to the press release.

“We are surprised and disappointed by this outcome,” Joseph K. Belanoff, MD, CEO of Corcept Therapeutics, said in a press release. “Our commitment to patients suffering from the effects of hypercortisolism is unwavering. I am confident we will find a way to get relacorilant to the patients it could help. We will meet with the FDA as soon as possible to discuss the best path forward.”

https://www.healio.com/news/endocrinology/20251231/fda-declines-to-approve-relacorilant-for-hypertension-linked-to-hypercortisolism?utm_source=selligent&utm_medium=email&utm_campaign=20251231ENDO&utm_content=20251231ENDO

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Corcept’s relacorilant GRADIENT trial misses primary endpoint

Posted on November 6, 2024 by MaryO

Corcept Therapeutics has shared some results from its Phase III GRADIENT trial for relacorilant – its experimental treatment for Cushing’s syndrome caused by adrenal gland pathology.

The trial will be used alongside data from the earlier GRACE trial to support the company’s new drug application (NDA) submission this quarter. However, it missed its primary endpoint.

The complete results of the company’s GRADIENT trial will be presented at a medical conference next year, but current results – released on 30 October – demonstrate that there was no statistically significant difference in hypertension in relacorilant and placebo patients.

The randomised double-blind trial included 137 patients across sites in the US, Europe and Israel. Over 22 weeks, half of the patients received relacorilant while the other half received a placebo.

The trial’s primary endpoint was the improvement in systolic blood pressure (SBP) compared to placebo. Its secondary endpoints were concerned with hyperglycemia, weight and body composition.

Mean SBP saw a reduction of 6.6 mm Hg in relacorilant patients compared to baseline. This is in contrast to a reduction of 2.1 mm Hg in placebo patients. The difference between these results was not statistically significant.

However, Corcept’s GRADIENT trial did meet some secondary endpoints and was well-tolerated. Patients taking relacorilant exhibited clinically meaningful and statistically significant improvements in hypertension, hyperglycemia, weight and body composition compared to baseline. In contrast, placebo patients did not.

Cushing’s syndrome is caused by an excess of cortisol and primarily affects those using steroid medications, which contain a synthetic version of the hormone. The condition is characterised by an increase of fat (particularly on the neck and shoulders), a change in face shape, stretch marks and skin which bruises easily. Cushing’s syndrome can also cause hypertension.

Corcept Therapeutics also shared that relacorilant was well-tolerated in the GRADIENT trial. It reported that there were no cases of relacorilant-induced hypokalemia, endometrial hypertrophy or related vaginal bleeding, adrenal insufficiency or QT prolongation.

The NDA submission for relacorilant for Cushing’s syndrome is expected this quarter. The GRADIENT trial will support results from the company’s GRACE trial, which were shared in June. The GRACE trial included 152 patients and met its primary endpoint of loss of hypertension control in the randomised-withdrawal phase.

Considering the results of the GRADIENT trial, Corcept Therapeutics’ chief development officer Bill Guyer said: “GRADIENT’s positive results in patients with Cushing’s syndrome confirm relacorilant’s promise as a significant medical advancement for the treatment of this deadly disease. As was true in the GRACE study, patients in GRADIENT who received relacorilant experienced clinically meaningful improvements in a broad range of hypercortisolism signs and symptoms, without suffering some of the serious adverse effects that can arise in patients taking currently approved treatments.

“These data will be a powerful addition to relacorilant’s NDA, which we plan to submit by year-end.”

https://www.clinicaltrialsarena.com/news/corcepts-relacorilant-gradient-trial-misses-primary-endpoint/?cf-view

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Corcept Completes Enrollment in Phase 3 Gradient Trial of Relacorilant in Patients With Adrenal Cushing’s Syndrome

Posted on April 3, 2024 by MaryO

Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced completion of enrollment in GRADIENT, a Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with Cushing’s syndrome (hypercortisolism) caused by an adrenal adenoma or adrenal hyperplasia.

“Hypercortisolism with adrenal etiology affects many patients and is associated with serious cardiometabolic comorbidities, including hypertension and hyperglycemia, and increased risk of premature death,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “GRADIENT is the first prospective placebo-controlled study to be conducted exclusively in these patients with Cushing’s syndrome. We expect data from GRADIENT in the fourth quarter of this year.”

GRADIENT is a randomized, double-blind, placebo-controlled trial conducted at sites in the United States, Europe and Israel. One-hundred thirty-seven patients were randomized 1:1 to receive relacorilant or placebo for 22 weeks. Primary endpoints are improvement in glucose metabolism and hypertension.

About Cushing’s Syndrome (Hypercortisolism)
Cushing’s syndrome is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system and can be lethal if not treated effectively.

About Relacorilant
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor (GR), but does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. Relacorilant has orphan drug designation in the United States and the European Union for the treatment of Cushing’s syndrome.

About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients across a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept’s advanced clinical trials are being conducted in patients with hypercortisolism, solid tumors, amyotrophic lateral sclerosis (ALS) and liver disease (NASH). In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome. Corcept is headquartered in Menlo Park, California. For more information, visit Corcept.com.

Forward-Looking Statements
Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business; risks related to the study and development of Korlym as well as relacorilant, miricorilant, dazucorilant and our other product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website.

In this press release, forward-looking statements include those concerning the development of relacorilant as a treatment for Cushing’s syndrome, and design, timing and expectations regarding our GRADIENT trial. We disclaim any intention or duty to update forward-looking statements made in this press release.

From https://finance.yahoo.com/news/corcept-completes-enrollment-phase-3-120000179.html

Filed under: adrenal, adrenal crisis, Cushing's, Treatments | Tagged: , , , | Leave a comment »

(Korlym) Corcept settles patent dispute with Hikma over Cushing’s syndrome drug

Posted on December 12, 2022 by MaryO
  • Corcept Therapeutics (NASDAQ:CORT) announced an agreement with Hikma Pharmaceuticals (OTCPK:HKMPF) USA on Thursday to resolve the ongoing patent lawsuit related to Korlym, an oral therapy indicated for patients with Cushing’s syndrome.
  • The litigation was filed in the New Jersey district court in 2021, shortly after Hikma (OTCPK:HKMPF) informed Corcept (CORT) about its submission of an Abbreviated New Drug Application (ANDA) seeking FDA approval for a generic version of Korlym.
  • Per the terms of the settlement, Corcept (CORT) has allowed Hikma (OTCPK:HKMPF) the rights to market a generic version of Korlym from Oct. 01, 2034, or earlier subject to certain conditions.
  • The companies plan to submit the agreement for the review of the U.S. Federal Trade Commission (FTC) and the United States Department of Justice (DOJ).
  • A similar patent lawsuit filed by Corcept (CORT) against the U.S. unit of Teva Pharmaceutical (TEVA) remains pending.
  • Thanks mainly to higher sales volumes of Korlym, Corcept (CORT) added $366.0M net product revenue in 2021 with ~3% YoY growth.

 

    • From

https://seekingalpha.com/news/3915421-cort-stock-on-watch-after-patent-settlement-with-hikma-for-korlym

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Cushing’s Syndrome Diagnostic and Treatment Market See Huge Growth for New Normal

Posted on April 29, 2022 by MaryO

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Chapter 1: Global Cushing’s Syndrome Diagnostic and Treatment Industry Overview
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