Company: CORT
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001628280-25-008167
Chunk: 1

Company: CORCEPT THERAPEUTICS INC
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 1
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 vaginal bleeding, a debilitating condition suffered by a significant portion of women who take Korlym. On December 30, 2024, we submitted to the United States Food and Drug Administration (“FDA”) a New Drug Application (“NDA”) for a proprietary cortisol modulator we have developed, relacorilant, that, like Korlym, modulates the effects of cortisol by binding at the GR, but has no affinity for the PR and so does not cause PR-related side effects.

In addition to relacorilant, we have discovered more than 1,000 proprietary cortisol modulators that bind to the GR but have no affinity for the PR and therefore do not cause effects arising from antagonism of progesterone activity, such as termination of pregnancy, endometrial thickening and vaginal bleeding. The composition of these “selective” cortisol modulators and their methods of use in a wide range of indications are covered by U.S. and foreign patents.

Our lead compounds are being evaluated in clinical trials as potential treatments for a variety of serious disorders – hypercortisolism, advanced ovarian cancer, prostate cancer, ALS and MASH.

Hypercortisolism (Cushing’s Syndrome)

Background. Hypercortisolism is the result of a tumor that produces either cortisol or adrenal corticotropic hormone, a hormone that causes the adrenal glands to produce cortisol. Abnormally high levels of cortisol lead to overstimulation of the GR, which gives rise to a wide range of serious adverse effects. Most people with hypercortisolism have one or more of the following symptoms: hypertension, diabetes, impaired glucose tolerance, obesity, fatty liver disease, wasting of the arms and legs, edema, fatigue and insomnia. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system in the body and can be lethal if not treated. If the tumor can be found, the preferred treatment is surgery, which, if successful, can cure the disease. In approximately half of patients who receive surgery, the procedure is not successful. Depending on the type of tumor, surgery can also result in a range of complications and recurrence of the disease is common.

Our Products. We sell Korlym and a generic version of Korlym in the United States (our “Products”), using sales representatives to call on physicians caring for patients with hypercortisolism. We also have a field-based force of medical science liaisons. We use a specialty pharmacy and a