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, Relacorilant, and Korlym. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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:
- April 30, 2026
- Indication:
- In patients with ALS along with cortisol's proinflammatory effects
Announcement
Corcept Therapeutics Incorporated announced two-year overall survival data from the Phase 2 DAZALS study of its proprietary, selective cortisol modulator dazucorilant in patients with amyotrophic lateral sclerosis (ALS).
AI Summary
Corcept Therapeutics reported two-year overall survival results from the Phase 2 DAZALS study of dazucorilant in patients with amyotrophic lateral sclerosis (ALS). Patients treated with dazucorilant had an 87% reduction in the risk of death compared to placebo (hazard ratio 0.13, p < 0.0001). Corcept said the drug markedly reduces mortality in the first years after diagnosis, when patients often retain meaningful function and quality of life, and plans to work with regulators to move the program forward toward a pivotal Phase 3 study later this year.
Dazucorilant’s safety profile was described as acceptable. The most common adverse effect was mild to moderate, dose-related, transient abdominal pain. Corcept is running a dose-titration study to improve gastrointestinal tolerability and to inform next steps for the program.
The DAZALS trial’s primary endpoint was change in ALSFRS-R score over 24 weeks; key secondary endpoints included overall survival and quality of life. The study enrolled sites in Europe, the United States and Canada.
Read Announcement- 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
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:
- April 21, 2026
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated will present new data from its pivotal Phase 3 ROSELLA trial of Lifyorli™ (relacorilant) plus nab-paclitaxel in platinum-resistant ovarian cancer at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting.
AI Summary
Corcept Therapeutics will present new data from the pivotal Phase 3 ROSELLA trial of Lifyorli™ (relacorilant) plus nab‑paclitaxel at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. The planned presentation focuses on overall survival subgroup analyses by prior taxane use, comparing the combination against nab‑paclitaxel alone in patients with platinum‑resistant ovarian cancer. The ROSELLA trial carries identifiers GOG‑3073, ENGOT‑ov72, APGOT‑Ov10, LACOG‑0223, and ANZGOG‑2221/2023 and was conducted with GOG Foundation, ENGOT, APGOT, LACOG, and ANZGOG.
Lifyorli is approved in combination with nab‑paclitaxel for adults with platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had 1–3 prior systemic regimens, at least one including bevacizumab, and is listed as a preferred regimen in NCCN guidelines. The ASCO presentation should help clinicians understand how prior taxane treatment may affect overall survival with the relacorilant combination.Read Announcement
- Drug:
- Relacorilant
- Announced Date:
- April 10, 2026
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated today presented final overall survival data from its pivotal Phase 3 ROSELLA trial of Lifyorli™ (relacorilant) combined with the chemotherapeutic agent nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the Society of Gynecologic Oncology (SGO) 2026 Annual Meeting on Women's Cancer.
AI Summary
Corcept Therapeutics presented final overall survival data from the pivotal Phase 3 ROSELLA trial in a late-breaking oral presentation at the SGO 2026 Annual Meeting on Women’s Cancer. The trial tested Lifyorli™ (relacorilant) combined with the chemotherapy drug nab‑paclitaxel in patients with platinum‑resistant ovarian cancer.
The results showed a 35 percent reduction in the risk of death for patients receiving Lifyorli plus nab‑paclitaxel compared with the control arm. These final overall survival findings were highlighted as a key outcome of the study.
Following the trial data, the combination of Lifyorli and nab‑paclitaxel was added to the NCCN Guidelines® as a preferred regimen. The indication covers adults with platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have had 1–3 prior systemic regimens, with at least one including bevacizumab.
The ROSELLA results suggest a meaningful survival benefit for a difficult‑to‑treat patient group and were presented as a major clinical update at SGO 2026. More detailed data were provided during the presentation.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- March 25, 2026
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA) has approved Lifyorli™ (relacorilant) in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab.
AI Summary
Corcept Therapeutics announced FDA approval of Lifyorli™ (relacorilant) in combination with nab‑paclitaxel for adults with platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic regimens, at least one of which included bevacizumab. The approval was based on the pivotal ROSELLA trial, which randomized 381 patients 1:1 to Lifyorli plus nab‑paclitaxel or nab‑paclitaxel alone; no biomarker selection was required.
Important safety notes: Lifyorli plus nab‑paclitaxel can cause neutropenia, febrile neutropenia, and serious infections; 35% of patients experienced serious adverse reactions. Reported serious events included neutropenia, pneumonia, pleural effusion, febrile neutropenia, and fatigue; some fatal events occurred. Common side effects (>20%) include decreased hemoglobin and neutrophils, fatigue, nausea, diarrhea, low platelets, rash, and decreased appetite. Lifyorli is contraindicated with systemic glucocorticoids used for lifesaving purposes and may cause adrenal insufficiency and embryo‑fetal toxicity. For product availability, contact Lifyorli Support at 1‑855‑439‑6754.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- January 22, 2026
- 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 to treat patients with platinum-resistant ovarian cancer, met its overall survival (OS) primary endpoint.
AI Summary
Corcept Therapeutics announced that ROSELLA, its pivotal Phase 3 trial of relacorilant plus nab‑paclitaxel in platinum‑resistant ovarian cancer, met the overall survival (OS) primary endpoint. Patients receiving relacorilant plus nab‑paclitaxel had a 35% lower risk of death versus nab‑paclitaxel alone (hazard ratio 0.65, p=0.0004). Median OS was 16.0 months with relacorilant versus 11.9 months with chemotherapy alone, a 4.1‑month improvement.
The combination was well tolerated, with similar types, frequency and severity of adverse events compared to nab‑paclitaxel monotherapy. ROSELLA also met its progression‑free survival endpoint, showing a 30% reduction in the risk of disease progression (hazard ratio 0.70, p=0.008), and benefits were seen without selecting patients by biomarkers.
ROSELLA enrolled 381 patients across multiple regions. Investigators say the results support evaluating relacorilant plus nab‑paclitaxel as a new treatment option for platinum‑resistant ovarian cancer and exploring relacorilant in other GR‑expressing tumors.Read Announcement
- Drug:
- Relacorilant
- Announced Date:
- December 31, 2025
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA or the Agency) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for relacorilant as a treatment for patients with hypertension secondary to hypercortisolism.
AI Summary
Corcept Therapeutics said the U.S. Food and Drug Administration issued a Complete Response Letter for its New Drug Application for relacorilant as a treatment for hypertension secondary to hypercortisolism. The agency told the company it could not reach a favorable benefit–risk assessment without additional evidence of effectiveness.
The FDA noted the company’s pivotal trial met its primary endpoint and that another trial offered supporting data, but still concluded more proof of benefit is needed. Corcept described the decision as surprising and disappointing and said it will meet with the FDA as soon as possible to discuss the best path forward.
Relacorilant is an oral selective glucocorticoid receptor antagonist designed to block harmful effects of excess cortisol. Corcept said it remains committed to patients with hypercortisolism, may provide new analyses or further clinical data to address the FDA’s concerns, and gave no timeline for next steps.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- October 19, 2025
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated today shared new late-breaking data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the European Society for Medical Oncology (ESMO) 2025 Annual Meeting.
AI Summary
At the ESMO 2025 Annual Meeting, Corcept Therapeutics presented late-breaking results from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer. The combination improved progression-free survival (PFS) and overall survival without the need for biomarker selection, marking a major advance in this hard-to-treat group.
In patients who had progressed while on or after a PARP inhibitor, relacorilant plus nab-paclitaxel showed a PFS benefit (hazard ratio 0.60, p=0.0035) and in those whose disease progressed during PARPi therapy (hazard ratio 0.56, p=0.0046), with a median PFS of 7.36 months for both subgroups. Safety was consistent with prior studies, and adverse events were similar to nab-paclitaxel alone.
Investigators noted these findings are especially promising for patients with poor prognosis and support further research in earlier treatment lines of gynecologic cancers.
Corcept also announced expansion of its Phase 2 BELLA trial into three study arms: platinum-resistant ovarian cancer, platinum-sensitive ovarian cancer after PARPi, and relacorilant plus nab-paclitaxel in endometrial cancer. Initial BELLA results are expected in late 2026.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- September 22, 2025
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated will present new data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting.
AI Summary
Corcept Therapeutics announced it will share new data from its pivotal Phase 3 ROSELLA trial at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting. This trial tests relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer.
The data will be presented in a late-breaking oral session on Sunday, October 19, 2025. It highlights participants who received prior PARP inhibitors, a group with limited treatment options and a particularly poor prognosis.
The ROSELLA trial is conducted in collaboration with The GOG Foundation, ENGOT, APGOT, LACOG and ANZGOG across North America, Europe, Asia-Pacific, Latin America and Australia/New Zealand.
Platinum-resistant ovarian cancer recurs within six months after platinum therapy and has a median survival of about 12 months with standard chemotherapy. Relacorilant is a selective glucocorticoid receptor antagonist that may boost chemotherapy by blocking cortisol’s tumor-protective effects.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- September 10, 2025
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted Corcept's New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer. The FDA has assigned a PDUFA date of July 11, 2026 for the application.
AI Summary
Corcept Therapeutics has an FDA NDA accepted for relacorilant to treat platinum-resistant ovarian cancer. The FDA set a PDUFA date of July 11, 2026. Corcept based the application on positive results from its Phase 3 ROSELLA and Phase 2 trials, which showed that combining relacorilant with nab-paclitaxel improved progression-free and overall survival versus nab-paclitaxel alone, without extra safety risks. Adverse events were similar in both groups. Relacorilant is an oral selective glucocorticoid receptor antagonist that blocks cortisol’s support of tumor growth and resistance.
Over 20,000 U.S. women with platinum-resistant disease need new options each year. If approved, relacorilant could offer a much-needed therapy for this aggressive form of ovarian cancer. Corcept’s CEO said the FDA’s acceptance brings patients closer to a new treatment choice.
Read Announcement- Drug:
- Relacorilant
- Announced Date:
- July 14, 2025
- Indication:
- Recurrent Platinum-Resistant Ovarian Cancer
Announcement
Corcept Therapeutics Incorporated announced that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for its proprietary, selective cortisol modulator, relacorilant, to treat patients with platinum-resistant ovarian cancer.
AI Summary
Corcept Therapeutics recently submitted a new drug application (NDA) to the U.S. Food and Drug Administration for relacorilant, its proprietary and selective cortisol modulator designed to treat platinum-resistant ovarian cancer. This decision comes after positive results in both Phase 3 ROSELLA and Phase 2 clinical trials, where patients receiving relacorilant with nab-paclitaxel showed improved progression-free and overall survival compared to those receiving nab-paclitaxel alone. Importantly, the combination therapy maintained a safety profile similar to the monotherapy, underscoring relacorilant’s tolerability.
By targeting cortisol—a hormone known to help tumors resist chemotherapy—relacorilant aims to overcome treatment challenges in ovarian cancer. This application represents a significant step toward providing new hope and additional treatment options for women with platinum-resistant ovarian cancer, a condition that currently has limited effective therapies.
Read Announcement- 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
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
