Corcept Submits New Drug Application for Relacorilant as a Treatment for Patients With Hypercortisolism
Corcept Therapeutics (NASDAQ: CORT) has submitted a New Drug Application (NDA) to the FDA for relacorilant, its selective cortisol modulator designed to treat endogenous hypercortisolism (Cushing's syndrome). The application is supported by positive results from multiple studies, including the pivotal GRACE trial, Phase 3 GRADIENT, long-term extension studies, and a Phase 2 study.
The drug demonstrated improvements in various hypercortisolism symptoms with an acceptable safety profile. Notably, relacorilant showed no instances of serious adverse events common in current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation. The company believes relacorilant could become the standard of care for medical treatment of hypercortisolism patients.
Corcept Therapeutics (NASDAQ: CORT) ha presentato una Domanda di Autorizzazione all'Immissione in Commercio (NDA) alla FDA per relacorilant, il suo modulatore selettivo del cortisolo progettato per trattare l'iperCortisolismo endogeno (sindrome di Cushing). La domanda è supportata da risultati positivi provenienti da diversi studi, inclusi il trial cruciale GRACE, il trial di Fase 3 GRADIENT, studi di estensione a lungo termine e uno studio di Fase 2.
Il farmaco ha dimostrato miglioramenti nei vari sintomi dell'iperCortisolismo con un profilo di sicurezza accettabile. In particolare, relacorilant non ha mostrato casi di eventi avversi gravi comuni nei trattamenti attuali, come l'insufficienza surrenale indotta da farmaci, ipokalemia o prolungamento del QT. L'azienda ritiene che relacorilant possa diventare lo standard di cura per il trattamento medico dei pazienti con iperCortisolismo.
Corcept Therapeutics (NASDAQ: CORT) ha presentado una Solicitud de Nuevo Medicamento (NDA) a la FDA para relacorilant, su modulador selectivo de cortisol diseñado para tratar el hiperCortisolismo endógeno (síndrome de Cushing). La solicitud está respaldada por resultados positivos de múltiples estudios, incluidos el ensayo clave GRACE, el ensayo de Fase 3 GRADIENT, estudios de extensión a largo plazo y un estudio de Fase 2.
El fármaco demostró mejoras en varios síntomas del hiperCortisolismo con un perfil de seguridad aceptable. Notablemente, relacorilant no mostró casos de eventos adversos graves comunes en los tratamientos actuales, como insuficiencia adrenal inducida por medicamentos, hipopotasemia o prolongación del QT. La empresa cree que relacorilant podría convertirse en el estándar de atención para el tratamiento médico de los pacientes con hiperCortisolismo.
Corcept Therapeutics (NASDAQ: CORT)는 내분비 고코르티솔증(쿠싱 증후군)을 치료하기 위해 설계된 선택적 코르티솔 조절제인 relacorilant에 대한 신약 허가 신청(NDA)을 FDA에 제출했습니다. 이 신청은 중추적인 GRACE 시험, 3상 GRADIENT 시험, 장기 연장 연구 및 2상 연구를 포함한 여러 연구의 긍정적인 결과에 기반하고 있습니다.
이 약물은 다양한 고코르티솔증 증상에서 개선 효과를 보였으며, 안전성 프로필도 수용 가능한 수준이었습니다. 특히 relacorilant는 현재 치료에서 일반적으로 발생하는 약물 유도 부신 기능 부전, 저칼륨혈증 또는 QT 간격 연장과 같은 심각한 부작용 사례가 없었습니다. 회사는 relacorilant가 고코르티솔증 환자의 의료 치료를 위한 표준으로 자리 잡을 수 있을 것이라고 믿고 있습니다.
Corcept Therapeutics (NASDAQ: CORT) a soumis une Demande de Nouveau Médicament (NDA) à la FDA pour le relacorilant, son modulateur sélectif du cortisol conçu pour traiter l'hypercortisolisme endogène (syndrome de Cushing). La demande est soutenue par des résultats positifs issus de plusieurs études, y compris l'essai clé GRACE, l'essai de phase 3 GRADIENT, des études d'extension à long terme et une étude de phase 2.
Le médicament a démontré des améliorations de divers symptômes de l'hypercortisolisme avec un profil de sécurité acceptable. Notamment, le relacorilant n'a montré aucune instance d'événements indésirables graves courants dans les traitements actuels, tels que l'insuffisance surrénalienne induite par des médicaments, l'hypokaliémie ou le prolongement du QT. L'entreprise croit que le relacorilant pourrait devenir la norme de soins pour le traitement médical des patients atteints d'hypercortisolisme.
Corcept Therapeutics (NASDAQ: CORT) hat einen Neuen Arzneimittelantrag (NDA) bei der FDA für Relacorilant eingereicht, einen selektiven Cortisolmodulator, der zur Behandlung des endogenen Hyperkortisolismus (Cushing-Syndrom) entwickelt wurde. Der Antrag wird durch positive Ergebnisse aus mehreren Studien unterstützt, einschließlich der entscheidenden GRACE-Studie, der Phase-3-Studie GRADIENT, langfristigen Erweiterungsstudien und einer Phase-2-Studie.
Das Medikament zeigte Verbesserungen bei verschiedenen Symptomen des Hyperkortisolismus mit einem akzeptablen Sicherheitsprofil. Bemerkenswert ist, dass Relacorilant keine Fälle schwerwiegender unerwünschter Ereignisse auftrat, die bei den derzeitigen Behandlungen häufig sind, wie z.B. medikamenteninduzierte Nebenniereninsuffizienz, Hypokaliämie oder QT-Verlängerung. Das Unternehmen ist der Ansicht, dass Relacorilant zum Standard der Behandlung für die medizinische Therapie von Hyperkortisolismus-Patienten werden könnte.
- Successful completion and submission of NDA to FDA
- Positive clinical trial results from multiple studies
- Superior safety profile compared to existing treatments
- Potential to become standard of care in hypercortisolism treatment
- None.
Insights
The NDA submission for relacorilant represents a pivotal milestone in Cushing's syndrome treatment. Current approved therapies like ketoconazole and metyrapone have significant drawbacks, including potentially dangerous side effects such as adrenal insufficiency and QT prolongation. The absence of these complications in relacorilant's safety profile, combined with positive efficacy data from multiple clinical trials, positions it as a potential game-changer in this
The GRACE trial's positive results, supported by data from GRADIENT and extension studies, create a robust clinical package. Most notably, relacorilant's selective cortisol modulation mechanism avoids progesterone receptor interaction, eliminating concerning side effects like endometrial thickening. For a rare disease affecting approximately 10-15 people per million annually, this development could significantly impact treatment paradigms and market dynamics.
This NDA submission is a major catalyst for Corcept's valuation and market position. With their current drug Korlym generating approximately
Key financial implications include:
- Potential peak sales estimates of
$500 million to $1 billion annually if approved - Strengthened competitive position against existing treatments
- Possible expansion into additional indications, leveraging the cortisol modulation platform
Corcept’s NDA is based on positive results from the pivotal GRACE trial and confirmatory evidence from the Phase 3 GRADIENT and long-term extension studies and a Phase 2 study in hypercortisolism. Patients in these studies who received relacorilant experienced improvements in a wide array of hypercortisolism’s signs and symptoms, with an acceptable safety burden. 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.
“Relacorilant’s combination of efficacy and safety give it the potential to become the standard of care for the medical treatment of patients with hypercortisolism,” said Joseph Belanoff, MD, Corcept’s Chief Executive Officer. “Our commitment to the health of patients with hypercortisolism is unwavering. We are optimistic that relacorilant will be of great benefit to them.”
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, adrenal 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 Phase 2, GRACE, GRADIENT, and long-term extension 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 and the scope, pace and outcome of its NDA submission; relacorilant’s acceptance and use by physicians and patients and its commercial prospects; and the scope and protective power of relacorilant’s orphan drug designation and our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241230947567/en/
Investor inquiries:
ir@corcept.com
Media inquiries:
communications@corcept.com
www.corcept.com
Source: Corcept Therapeutics Incorporated
FAQ
What is the status of Corcept's (CORT) relacorilant FDA application?
What clinical trials support CORT's relacorilant NDA submission?
What advantages does relacorilant show over existing hypercortisolism treatments?
What medical conditions will CORT's relacorilant treat if approved?
