This section highlights FDA-related milestones and regulatory updates for drugs developed by Corcept Therapeutics (CORT).
Over the past two years, Corcept Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
dazucorilant, Korlym, and Relacorilant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
dazucorilant - FDA Regulatory Timeline and Events
dazucorilant is a drug developed by Corcept Therapeutics for the following indication: In patients with ALS along with cortisol's proinflammatory effects.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- dazucorilant
- Announced Date:
- June 5, 2025
- Indication:
- In patients with ALS along with cortisol's proinflammatory effects
Announcement
Corcept Therapeutics Incorporated presented results from its DAZALS study of dazucorilant in patients with ALS at the European Network to Cure ALS (ENCALS) 2025 annual meeting.
AI Summary
Corcept Therapeutics recently presented key results from its DAZALS study at the ENCALS 2025 annual meeting. The trial evaluated dazucorilant, a selective cortisol modulator, in patients with ALS. Although the study did not meet its primary endpoint of improving the ALS Functional Rating Scale-Revised scores, the treatment showed promising results as a secondary endpoint. In patients receiving 300 mg of dazucorilant, there was a significant improvement in overall survival compared to the placebo group. At week 24, no deaths occurred among patients given the 300 mg dose, while the placebo group saw five deaths. An exploratory one-year analysis confirmed that this survival benefit continued over time. The findings offer hope for future ALS treatment, as Corcept is now seeking guidance from both U.S. and European regulators on the best path forward for dazucorilant.
Read Announcement- Drug:
- dazucorilant
- Announced Date:
- December 11, 2024
- Indication:
- In patients with ALS along with cortisol's proinflammatory effects
Announcement
Corcept Therapeutics Incorporated announced results from the DAZALS study, a randomized, double-blind, placebo-controlled, Phase 2 trial evaluating two doses (150 mg and 300 mg) of its proprietary selective cortisol modulator dazucorilant in patients with ALS. Upon completion of the trial, patients were eligible to enter an open-label, long-term extension study, in which they received 300 mg of dazucorilant.
AI Summary
Corcept Therapeutics recently announced results from its DAZALS study, a Phase 2 trial that tested dazucorilant—a selective cortisol modulator—in patients with ALS. The trial was randomized, double-blind, and placebo-controlled, with patients receiving either 150 mg or 300 mg daily. Although the study did not meet its primary endpoint of slowing the decline in motor skills measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), the trial provided useful safety insights. Patients who received dazucorilant experienced more gastrointestinal upset at the start of treatment compared to the placebo group. Notably, none of the patients in the 300 mg group died during the 24-week period, while five deaths occurred in the placebo group. After the trial, patients had the option to enroll in an open-label, long-term extension study, where all received a daily dose of 300 mg dazucorilant.
Read Announcement- Drug:
- dazucorilant
- Announced Date:
- April 15, 2024
- Indication:
- In patients with ALS along with cortisol's proinflammatory effects
Announcement
Corcept Therapeutics announced completion of enrollment in DAZALS, a randomized, double-blind, placebo-controlled Phase 2 trial of its proprietary selective cortisol modulator dazucorilant in patients with amyotrophic lateral sclerosis (ALS).
AI Summary
Corcept Therapeutics has completed enrollment in its DAZALS Phase 2 trial, a randomized, double-blind, placebo-controlled study assessing the effects of its selective cortisol modulator dazucorilant in patients with amyotrophic lateral sclerosis (ALS). The trial enrolled 249 participants who will receive either 150 mg or 300 mg of dazucorilant, or a placebo daily for 24 weeks. The primary goal is to evaluate changes in motor function using the ALS Functional Rating Scale-Revised (ALSFRS-R), which tracks motor impairment and progressive functional decline. Secondary outcomes include overall survival and quality of life measures. According to Corcept’s Chief Development Officer, the study is a promising step towards better treatments for ALS, as earlier animal studies showed improvements in motor performance and reductions in neuroinflammation and muscle loss. Data from the DAZALS trial is expected by the end of this year.
Read Announcement
Korlym - FDA Regulatory Timeline and Events
Korlym is a drug developed by Corcept Therapeutics for the following indication: In patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Korlym
- Announced Date:
- June 23, 2025
- Indication:
- In patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes.
Announcement
Corcept Therapeutics Incorporated today presented data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym® in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes at the American Diabetes Association's 85th Scientific Sessions.
AI Summary
Corcept Therapeutics presented new data at the American Diabetes Association’s 85th Scientific Sessions from the treatment phase of its CATALYST trial. This randomized, double-blind, placebo-controlled study focused on patients with hypercortisolism (Cushing’s syndrome) and difficult-to-control type 2 diabetes. Participants who received Korlym experienced meaningful improvements in blood sugar control; their hemoglobin A1c levels dropped by 1.47% compared to nearly no change in the placebo group. Higher doses of Korlym resulted in even greater reductions. In addition, patients saw significant decreases in body weight and waist circumference, even while lowering or stopping their other glucose-lowering medications. These findings suggest that targeting cortisol can effectively manage symptoms in these hard-to-treat patients, offering hope for more tailored treatment options in diabetes care.
Read Announcement- Drug:
- Korlym
- Announced Date:
- April 21, 2025
- Indication:
- In patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes.
Announcement
Corcept Therapeutics Incorporated announced the publication of findings from the prevalence phase of the CATALYST trial in Diabetes Care, a peer-reviewed journal published by the American Diabetes Association.
AI Summary
Corcept Therapeutics Incorporated recently announced that the findings from the prevalence phase of its CATALYST trial have been published in Diabetes Care, a peer-reviewed journal of the American Diabetes Association. The study aimed to explore factors contributing to difficult-to-control type 2 diabetes by examining over 1,000 patients whose blood sugar levels remained high despite receiving multiple treatments.
Using the simple 1-mg dexamethasone suppression test, the trial found that 24 percent of these patients had hypercortisolism, also known as Cushing’s syndrome. These results suggest that excess cortisol may be an often-overlooked factor in the management of type 2 diabetes. The published study adds important clinical insights that could guide healthcare providers in recognizing and addressing this underlying issue in patients with uncontrolled diabetes.
Read Announcement- Drug:
- Korlym
- Announced Date:
- December 12, 2024
- Indication:
- In patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes.
Announcement
Corcept Therapeutics Incorporated announced that the primary endpoint was met in the treatment phase of CATALYST, a randomized, double-blind, placebo-controlled study of Korlym® in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes.
AI Summary
Corcept Therapeutics Incorporated announced that it achieved the primary endpoint in the treatment phase of the CATALYST study. This randomized, double-blind, placebo-controlled Phase 4 trial evaluated Korlym® (mifepristone) in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes. In the study, over 1,000 patients with poorly controlled diabetes were screened, and nearly 24% were found to have hypercortisolism. These patients then entered the treatment phase where 136 participants were randomly assigned to receive either Korlym or a placebo.
The results showed that patients taking Korlym experienced a significant and clinically meaningful reduction in hemoglobin A1c levels, with a 1.47% decrease compared to a 0.15% reduction for the placebo group, adjusting for a 1.32% improvement overall (p-value < 0.0001). The safety profile was consistent with previous findings, with no new side effects reported in the study.
Read Announcement
Relacorilant - FDA Regulatory Timeline and Events
Relacorilant is a drug developed by Corcept Therapeutics for the following indication: Recurrent Platinum-Resistant Ovarian Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Relacorilant
- Announced Date:
- June 2, 2025
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated today shared data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the ASCO 2025 (American Society of Clinical Oncology) Annual Meeting.
AI Summary
Corcept Therapeutics presented promising data from its Phase 3 ROSELLA trial at the ASCO 2025 Annual Meeting. The trial evaluated the combination of relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer. Results showed that adding relacorilant reduced the risk of disease progression by 30% and the risk of death by 31% compared to nab-paclitaxel alone. Patients receiving the combination treatment experienced longer progression-free survival and overall survival, with median overall survival increasing to 16.0 months from 11.5 months. Importantly, the treatment did not increase side effects, making it a well-tolerated option. These significant improvements offer a potential new standard-of-care for patients with limited treatment choices. The promising findings signal major progress in addressing this difficult-to-treat cancer and support further regulatory review to accelerate patient access to this innovative therapy.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- March 31, 2025
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated announced that ROSELLA, the company's pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer, met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR).
AI Summary
Corcept Therapeutics Incorporated announced positive results from their Phase 3 ROSELLA trial in patients with platinum-resistant ovarian cancer. In this study, relacorilant was combined with nab-paclitaxel chemotherapy. The trial met its primary endpoint by showing improved progression-free survival as assessed by blinded independent central review (PFS-BICR).
Patients receiving the combination treatment experienced a 30% lower risk of disease progression compared to those receiving chemotherapy alone. The median progression-free survival was 6.5 months for the combination group, versus 5.5 months for the nab-paclitaxel only group. These promising results may soon pave the way for relacorilant plus nab-paclitaxel to become a new standard of care for this difficult-to-treat form of ovarian cancer.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- March 3, 2025
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA) filed its New Drug Application (NDA) submission for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism (Cushing's syndrome).
AI Summary
Corcept Therapeutics announced that the U.S. Food and Drug Administration (FDA) has filed its New Drug Application (NDA) for its proprietary, selective cortisol modulator, relacorilant, intended for treating patients with endogenous hypercortisolism (Cushing’s syndrome). Relacorilant is designed to reduce the harmful effects of excessive cortisol. This significant submission comes on the heels of positive clinical trial results, including data from the pivotal GRACE trial and supportive evidence from additional Phase 3, long-term extension, and Phase 2 studies in hypercortisolism. In these studies, patients experienced notable improvements in symptoms such as high blood pressure, central obesity, and elevated blood sugar, without any serious adverse events like adrenal insufficiency or the side effects seen with current treatments. The FDA’s filing of the NDA marks an important step toward potentially establishing relacorilant as a new standard-of-care treatment for Cushing’s syndrome.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- December 16, 2024
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated presented results from its Phase 3 long-term, open-label extension study of relacorilant to treat patients with endogenous hypercortisolism (Cushing's syndrome) at the WCIRDC.
AI Summary
Corcept Therapeutics Incorporated recently presented long-term results from its Phase 3 open-label extension study of relacorilant, a treatment for endogenous hypercortisolism (Cushing’s syndrome), at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease (WCIRDC). The study enrolled 116 patients who received relacorilant for up to six years, with findings showing that the drug led to significant and sustained improvements in cardiometabolic parameters. During the study, patients experienced meaningful reductions in blood pressure, with average decreases of 10.0 mm Hg in systolic and 7.3 mm Hg in diastolic readings, as measured at 24 months.
The long-term data also demonstrated that relacorilant was well-tolerated over the extended treatment period. These promising results support relacorilant’s potential as a safe and effective option for managing hypercortisolism, reinforcing the drug's prospects as a new standard of care for patients suffering from this condition.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- May 28, 2024
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics announced that GRACE, the Phase 3 trial of its proprietary selective cortisol modulator relacorilant in patients with hypercortisolism (Cushing's syndrome), met its primary endpoint.
AI Summary
Corcept Therapeutics announced positive results from its GRACE Phase 3 trial of relacorilant, a selective cortisol modulator used to treat patients with Cushing’s syndrome, a condition caused by high cortisol levels. The trial met its primary endpoint in the randomized withdrawal phase, demonstrating a clear difference between patients who continued to receive relacorilant and those who were given a placebo. The study showed that patients taking relacorilant were much less likely to lose control over their blood pressure compared to those on placebo, with an odds ratio of 0.17 and a p-value of 0.02.
These results are important as they show that relacorilant can provide rapid and sustained improvements in symptoms like hypertension and hyperglycemia without significant safety issues. The data from GRACE supports the continued development of relacorilant and moves it one step closer to a New Drug Application in the third quarter.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- April 22, 2024
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated announced positive results from the open-label portion of the pivotal Phase 3 GRACE trial of its proprietary selective cortisol modulator relacorilant in patients with all etiologies of endogenous Cushing's syndrome (hypercortisolism).
AI Summary
Corcept Therapeutics announced positive results from the open-label phase of its pivotal Phase 3 GRACE trial. In this study, 152 patients with endogenous Cushing’s syndrome—including those with hypertension, hyperglycemia, or both—received the selective cortisol modulator relacorilant for 22 weeks. The trial showed clinically meaningful and statistically significant improvements in key symptoms of hypercortisolism, such as blood pressure and blood sugar levels, as well as other related endpoints.
The data demonstrated that relacorilant was well tolerated with no increases in cortisol levels or severe side effects like hypokalemia. These promising results suggest that relacorilant could become a valuable treatment option and potentially set a new standard of care for patients suffering from all forms of endogenous Cushing’s syndrome. Future updates, including data from the randomized withdrawal phase, are expected to further build on these positive findings.
Read Announcement
