Efavirenz

Joint recommendation cites Corcept’s CATALYST study on the prevalence and treatment of hypercortisolism in patients whose blood sugar remains high despite use of multiple glucose-lowering medications REDWOOD CITY, Calif.--(BUSINESS WIRE)--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 that the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) published their consensus report on the Management of Type 2 Diabetes, 2026 , which recommends that clinicians screen adults for hypercortisolism if their type 2 diabetes remains difficult to control despite multiple glucose-lowering medications. Citing Corcept’s CATALYST trial, the report notes that cortisol-directed medical therapy with mifepristone reduced HbA1c substantially in such patients and may be beneficial for the management of their hyperglycemia. “Evidence continues to mount that patients whose hyperglycemia does not respond to standard-of-care medications should be screened for hypercortisolism. Excess cortisol can contribute to cardiometabolic disease, including type 2 diabetes and high blood pressure, and cortisol-directed therapy may benefit these patients,” said John B. Buse, MD, PhD, Professor of Medicine, University of North Carolina School of Medicine, and co-chair of the writing group for the ADA/EASD consensus report. Among its consensus recommendations, the report states that “targeted screening for secondary causes of hyperglycemia (e.g., hypercortisolism) should be considered for adults with treatment-resistant type 2 diabetes despite guideline-directed therapy with multiple agents.” The report also advises that, at diagnosis of type 2 diabetes and at regular intervals, hypercortisolism and other alternative diagnoses should be considered based on clinical context and in particular the response of individuals to treatment. In individuals with an HbA1c above 7.5 percent despite multiple glucose-lowering medications and non-ACTH-dependent hypercortisolism, the report states that “cortisol-directed medical therapy with mifepristone reduced HbA1c substantially and may be beneficial for the management of hyperglycemia.” In its discussion of key knowledge gaps, the report observed that “recent studies suggest screening for hypercortisolism identifies a treatable cause in ~25%” and that “developing a better understanding of the role of cortisol-directed therapy in type 2 diabetes is needed.” “There is an urgent need for improved screening for and treatment of hypercortisolism. The findings from our CATALYST study are an important advance in the understanding of this disease. We are heartened that ADA and EASD have recognized this practice-changing research and now recommend that physicians screen patients for hypercortisolism-induced hyperglycemia,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. The CATALYST trial screened 1,057 patients with difficult-to-control diabetes and found that 24 percent of them had hypercortisolism. The 136 participants with hypercortisolism who proceeded to the trial’s treatment phase were randomized 2:1 to receive either mifepristone or placebo for 24 weeks. HbA1c in patients given mifepristone declined by 1.47 percent, compared to a 0.15 percent reduction in patients given placebo (difference -1.32 percent, p10 percent) were hypokalemia, fatigue, nausea, vomiting, headache, peripheral edema, diarrhea and dizziness. Results from CATALYST were published in Diabetes Care in April and December 2025. Independent experts identified by the two organizations developed the consensus report, which was published simultaneously in Diabetes Care and Diabetologia on October 2, 2026. The full report is available here . The ADA and EASD do not endorse any company or product and were not involved in the preparation of this press release. 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 fatal if not treated effectively. Cardiovascular events are the most common cause of death. Recent research shows that hypercortisolism is more prevalent than previously believed. In one study 24 percent of patients with difficult-to-control type 2 diabetes were identified as having hypercortisolism. Among patients with both difficult-to-control diabetes and difficult-to-control hypertension, this number increased to 37 percent. About Korlym ® Korlym (mifepristone) modulates the effect of cortisol at the glucocorticoid receptor, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness. Korlym Indication & Usage Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. Limitations of use: Korlym should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing’s syndrome. IMPORTANT SAFETY INFORMATION BOXED WARNING: TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential. CONTRAINDICATIONS Pregnancy; patients taking simvastatin or lovastatin and CYP3A substrates with narrow therapeutic ranges; patients receiving systemic corticosteroids for lifesaving purposes; women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma; patients with known hypersensitivity to mifepristone or to any of the product components. WARNINGS AND PRECAUTIONS Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency. See full Prescribing Information for further management instructions. Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. Measure serum potassium 1-2 weeks after starting or increasing the Korlym dose, and periodically thereafter. Mifepristone-induced hypokalemia should be treated with potassium supplementation based on severity. If hypokalemia persists despite potassium supplementation, consider adding mineralocorticoid antagonists. Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if the patient also has a hemorrhagic disorder or is on anticoagulant therapy. Women who experience vaginal bleeding during treatment should be referred to a gynecologist for further evaluation. QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval. Exacerbation/Deterioration of Conditions Treated with Corticosteroids: For medical conditions in which chronic corticosteroid therapy is lifesaving, Korlym is contraindicated. Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Use only when necessary and do not exceed a Korlym dose of 900 mg per day. The labeling contains warnings and precautions for Pneumocystis jiroveci Infection and potential effects of hypercortisolemia. See full Prescribing Information for further management instructions. ADVERSE REACTIONS Most common adverse reactions in Cushing’s syndrome (≥20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, and endometrial hypertrophy. DRUG INTERACTIONS Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Use only when necessary, and do not exceed a Korlym dose of 900 mg. CYP3A inducers: Do not use Korlym with CYP3A inducers. Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym. Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz. Hormonal contraceptives: Do not use with Korlym. DOSAGE AND ADMINISTRATION Obtain a negative pregnancy test prior to initiating treatment with Korlym in females of reproductive potential, or if treatment is interrupted for more than 14 days. Administer once daily orally with a meal. The recommended starting dose is 300 mg once daily. Renal impairment: Do not exceed 600 mg once daily. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment. Based on clinical response and tolerability, the dose may be increased in 300-mg increments to a maximum of 1200 mg once daily. Do not exceed 20 mg/kg per day. Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 900 mg per day if clinically indicated. When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: for patients receiving a daily dose of 600 mg, reduce dose to 300 mg. For patients receiving a daily dose of 900 mg, reduce dose to 600 mg. For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor. USE IN SPECIFIC POPULATIONS Lactation: Mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone. About Corcept Therapeutics For over 25 years, we have focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders. We have discovered more than 1,000 proprietary selective glucocorticoid receptor antagonists. Our development activities include advanced clinical trials in patients with hypercortisolism, a variety of solid tumors, ALS and liver disease. In 2012, we introduced Korlym ® , the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous Cushing’s syndrome. In March 2026, we introduced Lifyorli ® as a treatment for patients with platinum-resistant ovarian cancer. Lifyorli is the first selective glucocorticoid receptor antagonist approved for the treatment of any disease. We are headquartered in Redwood City, 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 and are subject to risks and uncertainties that might cause our actual results to differ materially from any future results expressed or implied by such forward-looking statements. In this press release, forward-looking statements include statements concerning the potential for patients to benefit from cortisol-directed therapy, such as mifepristone. A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes, regulatory approvals, mandates, oversight and other requirements; 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. Contacts Investor inquiries: ir@corcept.com Media inquiries: communications@corcept.com