FDA Files Corcept’s New Drug Application for Relacorilant as Treatment for Patients With Hypercortisolism
Corcept Therapeutics (NASDAQ: CORT) announced that the FDA has filed its New Drug Application (NDA) for relacorilant, a selective cortisol modulator designed to treat patients with endogenous hypercortisolism (Cushing's syndrome). The FDA has set a PDUFA target action date of December 30, 2025.
The NDA submission is supported by positive results from multiple clinical trials, including the pivotal GRACE trial, Phase 3 GRADIENT trial, long-term extension trial, and a Phase 2 trial. Patients receiving relacorilant showed improvements in various hypercortisolism symptoms. The drug demonstrated favorable safety profiles with no instances of serious adverse events commonly associated with current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation.
Corcept Therapeutics (NASDAQ: CORT) ha annunciato che la FDA ha ricevuto la sua Domanda di Nuovo Farmaco (NDA) per il relacorilant, un modulatore selettivo del cortisolo progettato per trattare i pazienti con ipercortisolismo endogeno (sindrome di Cushing). La FDA ha fissato una data di azione target PDUFA per il 30 dicembre 2025.
La presentazione dell'NDA è supportata da risultati positivi provenienti da molteplici studi clinici, incluso il trial cruciale GRACE, il trial di fase 3 GRADIENT, uno studio di estensione a lungo termine e un trial di fase 2. I pazienti che hanno ricevuto relacorilant hanno mostrato miglioramenti in vari sintomi di ipercortisolismo. Il farmaco ha dimostrato profili di sicurezza favorevoli con nessun caso di eventi avversi gravi comunemente associati ai trattamenti attuali, come insufficienza surrenalica indotta da farmaci, ipokalemia o prolungamento del QT.
Corcept Therapeutics (NASDAQ: CORT) anunció que la FDA ha presentado su Solicitud de Nuevo Medicamento (NDA) para el relacorilant, un modulador selectivo de cortisol diseñado para tratar a pacientes con hipercortisolismo endógeno (síndrome de Cushing). La FDA ha establecido una fecha objetivo de acción PDUFA para el 30 de diciembre de 2025.
La presentación de la NDA está respaldada por resultados positivos de múltiples ensayos clínicos, incluido el ensayo clave GRACE, el ensayo de fase 3 GRADIENT, un estudio de extensión a largo plazo y un ensayo de fase 2. Los pacientes que recibieron relacorilant mostraron mejoras en varios síntomas de hipercortisolismo. El fármaco demostró perfiles de seguridad favorables con ningún caso de eventos adversos graves comúnmente asociados con los tratamientos actuales, como insuficiencia adrenal inducida por fármacos, hipocalemia o prolongación del QT.
Corcept Therapeutics (NASDAQ: CORT)는 FDA가 내분비성 고코르티솔혈증(쿠싱증후군) 환자를 치료하기 위해 설계된 선택적 코르티솔 조절제인 relacorilant에 대한 신약신청서(NDA)를 접수했다고 발표했습니다. FDA는 2025년 12월 30일을 PDUFA 목표 조치 날짜로 설정했습니다.
NDA 제출은 주요 GRACE 시험, 3상 GRADIENT 시험, 장기 연장 시험 및 2상 시험을 포함한 여러 임상 시험의 긍정적인 결과에 의해 뒷받침됩니다. relacorilant를 투여받은 환자들은 다양한 고코르티솔혈증 증상에서 개선을 보였습니다. 이 약물은 현재 치료와 일반적으로 연관된 심각한 부작용이 없는 유리한 안전성 프로파일을 보여주었습니다. 예를 들어, 약물 유도 부신 기능 부전, 저칼륨혈증, 또는 QT 연장 등이 있습니다.
Corcept Therapeutics (NASDAQ: CORT) a annoncé que la FDA a déposé sa Demande de Nouveau Médicament (NDA) pour le relacorilant, un modulateur sélectif du cortisol conçu pour traiter les patients atteints d'hypercortisolisme endogène (syndrome de Cushing). La FDA a fixé une date cible d'action PDUFA au 30 décembre 2025.
La soumission de la NDA est soutenue par des résultats positifs provenant de plusieurs essais cliniques, y compris l'essai clé GRACE, l'essai de phase 3 GRADIENT, un essai d'extension à long terme et un essai de phase 2. Les patients recevant du relacorilant ont montré des améliorations dans divers symptômes d'hypercortisolisme. Le médicament a démontré des profils de sécurité favorables avec aucun cas d'événements indésirables graves couramment associés aux traitements actuels, tels que l'insuffisance surrénalienne induite par les médicaments, l'hypokaliémie ou le prolongement du QT.
Corcept Therapeutics (NASDAQ: CORT) gab bekannt, dass die FDA ihren Antrag auf Zulassung eines neuen Arzneimittels (NDA) für Relacorilant eingereicht hat, einen selektiven Kortisolmodulator, der zur Behandlung von Patienten mit endogenem Hyperkortisolismus (Cushing-Syndrom) entwickelt wurde. Die FDA hat ein Zieltermin für die PDUFA-Aktion auf den 30. Dezember 2025 festgelegt.
Die NDA-Einreichung wird durch positive Ergebnisse aus mehreren klinischen Studien unterstützt, einschließlich der entscheidenden GRACE-Studie, der Phase-3-GRADIENT-Studie, einer langfristigen Erweiterungsstudie und einer Phase-2-Studie. Patienten, die Relacorilant erhielten, zeigten Verbesserungen bei verschiedenen Symptomen des Hyperkortisolismus. Das Medikament zeigte günstige Sicherheitsprofile mit keiner einzigen schwerwiegenden unerwünschten Ereignissen, die häufig mit den aktuellen Behandlungen in Verbindung gebracht werden, wie z.B. medikamenteninduzierte Nebenniereninsuffizienz, Hypokaliämie oder QT-Verlängerung.
- FDA acceptance of NDA for relacorilant
- Positive efficacy results from multiple clinical trials
- Superior safety profile compared to current treatments
- Potential to become new standard of care
- Long wait for FDA decision (December 2025)
FDA assigns a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025
Corcept’s NDA is based on positive results from the pivotal GRACE trial and confirmatory evidence from the Phase 3 GRADIENT trial, long-term extension trial, and a Phase 2 trial in hypercortisolism. Patients in these trials who received relacorilant experienced improvements in a wide array of hypercortisolism’s signs and symptoms. Relacorilant was well tolerated. Notably, there were no instances of drug-induced adrenal insufficiency, hypokalemia or QT prolongation – serious adverse events that can arise in patients taking currently approved medications – and no adverse events associated with activity at the progesterone receptor, such as endometrial thickening or vaginal bleeding.
“The FDA’s acceptance of our New Drug Application takes us another step closer to bringing relacorilant to patients with hypercortisolism,” said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. “Relacorilant’s combination of efficacy and safety gives it the potential to become the new standard of care for patients struggling with the devastating impact of this disease.”
About Relacorilant
Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body's other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders in addition to endogenous hypercortisolism (Cushing’s syndrome), including ovarian and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. Relacorilant has orphan drug designation in
About Hypercortisolism (Cushing’s Syndrome)
Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively.
About Corcept Therapeutics
For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym®, the first medication approved by the
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 and 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 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 statements concerning: the results of our GRACE, GRADIENT, long-term extension and Phase 2 studies; relacorilant’s efficacy, safety and other clinical attributes and its potential to receive regulatory approval and become a standard-of-care treatment for patients with endogenous hypercortisolism; regulatory oversight of relacorilant, including the outcome of its NDA submission and the timing of the FDA’s decision; relacorilant’s acceptance and use by physicians and patients and its commercial prospects; and relacorilant’s orphan drug designation and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
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Source: Corcept Therapeutics Incorporated
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