Corcept Therapeutics Incorporated, a commercial-stage company, engages in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol.
The company markets Korlym in the United States for the treatment of patients suffering from hypercortisolism (also known as Cushing’s syndrome). In June 2024, the company made available an authorized generic version of Korlym for the same indication....
Corcept Therapeutics Incorporated, a commercial-stage company, engages in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol.
The company markets Korlym in the United States for the treatment of patients suffering from hypercortisolism (also known as Cushing’s syndrome). In June 2024, the company made available an authorized generic version of Korlym for the same indication.
On December 30, 2024, the company submitted to the United States Food and Drug Administration (FDA) a New Drug Application (NDA) for a proprietary cortisol modulator it has developed, relacorilant, that, like Korlym, modulates the effects of cortisol by binding at the GR.
The company’s lead compounds are being evaluated in clinical trials as potential treatments for a variety of serious disorders – hypercortisolism, advanced ovarian cancer, prostate cancer, Amyotrophic Lateral Sclerosis (ALS) and MASH.
Hypercortisolism (Cushing’s Syndrome)
Products
The company sells Korlym and a generic version of Korlym in the United States (Products), using sales representatives to call on physicians caring for patients with hypercortisolism. The company also has a field-based force of medical science liaisons. The company uses a specialty pharmacy and a specialty distributor to distribute its Products and provide logistical support to physicians and patients. The company’s policy is that no patient with hypercortisolism will be denied access to its Products for financial reasons. The company has patient support programs and donate money to independent charitable foundations that help patients pay for all aspects of their hypercortisolism care, whether or not that care includes taking its Products.
Because most people who suffer from hypercortisolism are undiagnosed or inadequately treated, the company has developed and continues to refine and expand programs to educate physicians and patients about screening for hypercortisolism and the role its Products can play in treating patients with the disorder. In 2024, the company conducted the CATALYST study to determine the prevalence of hypercortisolism in patients with difficult-to-control diabetes (defined as HbA1c of 7.5 percent or higher) despite receiving optimum treatment. CATALYST’s primary endpoint was the difference in HbA1c in patients who received Korlym compared to patients who received placebo. The CATALYST data will help physicians better identify patients with hypercortisolism and determine their optimal treatment.
Relacorilant
The company is developing its proprietary, selective cortisol modulator, relacorilant, as a treatment for patients with hypercortisolism.
In December 2024, the company submitted an NDA to the FDA seeking approval to market relacorilant as a treatment for patients with endogenous hypercortisolism. The NDA is based on positive results from the company’s pivotal trial GRACE, as well as confirmatory evidence from its Phase 3 GRADIENT trial, its Phase 3 long-term extension study and its Phase 2 study.
The company’s Phase 3 GRADIENT study enrolled patients with hypercortisolism caused by adrenal adenomas or adrenal hyperplasia. Patients who completed the company’s Phase 2 study or the GRACE or GRADIENT trials were eligible to enter its open-label, long-term extension study.
Oncology
Relacorilant in Patients with Platinum-Resistant Ovarian Cancer: The company is conducting a pivotal Phase 3 trial (ROSELLA) of its proprietary, selective cortisol modulator, relacorilant combined with nab-paclitaxel as a treatment for patients with platinum-resistant ovarian cancer. ROSELLA has dual primary endpoints – progression free survival (PFS) and overall survival (OS). ROSELLA will have a statistically positive outcome if either endpoint is met. Patients enrolled in ROSELLA were required to have received prior bevacizumab therapy, which is the approved standard of care for patients with platinum-resistant ovarian cancer.
ROSELLA seeks to replicate the positive results of the company’s Phase 2 trial, a 178-patient, controlled, multi-center, trial of relacorilant combined with nab-paclitaxel in patients with platinum-resistant ovarian cancer.
Relacorilant in Patients with Adrenal Cancer with Cortisol Excess: The company has completed an open-label, Phase 1b trial of relacorilant plus the PD-1 checkpoint inhibitor pembrolizumab in 14 patients with metastatic or unresectable adrenal cancer whose tumors produce cortisol. Patients with this form of adrenal cancer virtually never respond to immunotherapy and their disease progresses very rapidly. The company’s trial sought to test whether adding relacorilant to pembrolizumab therapy would reduce cortisol-activated immune suppression sufficiently to help the patient’s immune system reduce or eradicate the patient’s tumors while also reducing the symptoms of hypercortisolism caused by the tumors’ hypersecretion of cortisol.
Relacorilant in Patients with Prostate Cancer: The company’s collaborators at the University of Chicago have initiated a randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer, pre-prostatectomy. The company provides relacorilant and placebo for the study. Patents the company has licensed from the University of Chicago cover the use of relacorilant combined with anticancer agents, including enzalutamide, to treat patients with this disease.
ALS
ALS, also known as Lou Gehrig’s disease, is a devastating neuromuscular illness. The company’s selective cortisol modulator dazucorilant improved motor performance and reduced neuroinflammation and muscular atrophy in an animal model of ALS. Following these compelling results, the company initiated a Phase 2 trial (DAZALS) of dazucorilant in patients with ALS.
Metabolic Diseases
Liver Disease: The company’s Phase 1b trial of the selective cortisol modulator miricorilant as a potential treatment for metabolic dysfunction-associated steatohepatitis(MASH) identified a dosing regimen that reduced liver fat, improved liver health and key metabolic and lipid measures and was well-tolerated.
Development of Other Selective Cortisol Modulators
The company’s portfolio of proprietary selective cortisol modulators consists of four structurally distinct series. More than 1,000 of these compounds, including relacorilant, miricorilant and dazucorilant, potently bind to the GR but not the progesterone, estrogen or androgen receptors. The company holds U.S. and foreign patents covering these compounds and their methods of use in a wide range of indications. The company has applied, and will continue to apply, for patents covering the composition and method of use of its Products and product candidates.
The company continues to create new selective cortisol modulators, the most promising of which it advances towards the clinic.
Clinical Trial Agreements
The company typically conducts its clinical trials with the assistance of clinical research organizations (CROs). Syneos Health is helping the company conducts its ROSELLA trial. Medpace Research is helping it conduct its MONARCH trial.
Research and Development Spending
The company incurred $246.9 million of research and development expense in the years ended December 31, 2024.
Competition
The company’s Products compete with established treatments, including surgery, radiation and other medications, including off-label uses of drugs such as ketoconazole, an anti-fungal medication, and metyrapone, which is approved for testing hypothalamic-pituitary function. The company’s Products also compete with Signifor (pasireotide) Injection and Isturisa (osilodrostat). Both of these drugs are approved by the FDA for the treatment of adult patients with Cushing’s disease who are not candidates for pituitary surgery or for whom surgery did not work, and both are sold by the Italian pharmaceutical company Recordati S.p.A (Recordati). The company’s Products also compete with Recorlev (levoketoconazole), a chiral form of the commonly-prescribed cortisol synthesis inhibitor ketoconazole, that is sold by Xeris Biopharma Holdings, Inc. (Xeris), as a treatment for patients with hypercortisolism.
Intellectual Property
The company owns U.S. composition of matter patents related to its next-generation cortisol modulators. Foreign counterparts of some of these patents have been issued in Europe, Japan, China, Canada, Australia and other countries. The expiration dates of these patents and their foreign counterparts range from 2025 to 2041. The company also owns U.S. and foreign patents directed to the use of its selective cortisol modulators in the treatment of a variety of serious disorders, including hypercortisolism, various cancers, fatty liver disease, and other disorders.
Hypercortisolism: The company owns U.S. method of use patents directed to the use of Korlym in the treatment of patients with hypercortisolism, with expiration dates ranging from 2028 to 2038. Furthermore, the company owns U.S. composition of matter and method of use patents using its proprietary selective cortisol modulators directed to the treatment of patients with hypercortisolism, with expiration dates ranging from 2033 to 2041. The company has asserted two patents directed to patients with hypercortisolism in a lawsuit against Teva Pharmaceuticals USA, Inc. (Teva) in a lawsuit filed in Federal District Court.
Oncology: The company owns U.S. patents covering methods of treating cancer using its proprietary selective cortisol modulators with expiration dates ranging from 2033 to 2041. In addition, the company has exclusively licensed from the University of Chicago U.S. patents for (a) the use of cortisol modulators in the treatment of triple-negative breast cancer, and (b) the use of cortisol modulators to treat castration resistant prostate cancer (CRPC). The company is required to pay the University of Chicago customary milestone fees and royalties on revenue from products commercialized under the issued patents or patents that may issue pursuant to the pending applications. The company’s license will end upon expiration of the licensed patents in 2031 and 2033 or upon notification by it to the University of Chicago.
The company holds U.S. and international patents covering relacorilant’s composition of matter, as well as U.S. patents covering its use to treat patients with ovarian and pancreatic cancer. The company also owns or has exclusively licensed U.S. and European patents covering the use of GR modulators, including relacorilant, miricorilant, dazucorilant, and other of its proprietary compounds to treat a variety of disorders, including CRPC and other solid tumors. Relacorilant has been designated an orphan drug in both the United States and the EU for the treatment of pancreatic cancer.
Other Indications: In addition to the United States and foreign patents the company owns or has licensed relating to hypercortisolism and various cancers, it owns U.S. and foreign patents for the use of cortisol modulators to treat ALS, fatty liver disease, delirium, catatonia, psychosis induced by interferon-alpha therapy, migraine headaches, gastroesophageal reflux disease, neurological damage in premature infants, for the improvement of therapeutic response to electroconvulsive therapy, and in the treatment of diseases using combined steroid and GR modulator therapy. The expiration dates of these patents and their foreign counterparts range from 2025 to 2039.
History
Corcept Therapeutics Incorporated was founded in 1998. The company was incorporated in the state of Delaware in 1998.