Relacorilant for Cushing syndrome (endogenous hypercortisolism)
One email when the decision is public, with what it means in plain language. You'll also get new trials and FDA news for Cushing Disease. Unsubscribe anytime.
You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Cushing Disease. Turn any of these off from the link in every email.
The FDA is expected to decide on Relacorilant for Cushing syndrome (endogenous hypercortisolism) by December 17, 2026, under an NDA resubmission from Corcept Therapeutics.
What is being decided
Corcept Therapeutics has an NDA resubmission under FDA review for Relacorilant in Cushing syndrome (endogenous hypercortisolism). Oral pill that blocks cortisol at the glucocorticoid receptor, which Corcept says avoids side effects seen with current Cushing medicines such as pregnancy termination, low potassium and thickening of the uterine lining. The FDA issued a complete response letter dated December 30, 2025 on the original application. In its published letter the FDA said the GRACE trial met its primary endpoint on blood pressure but in a highly enriched group that likely overstates the effect, and the GRADIENT trial did not meet its primary endpoint, so substantial evidence of effectiveness was not shown. Corcept resubmitted on June 17, 2026 with additional analyses of the existing data that the FDA requested, and gave the December 17 decision date in its second quarter release. Relacorilant is already approved, as Lifyorli, for platinum-resistant ovarian cancer.
Who this decision matters to
Cushing Disease is a rare endocrine disorder caused by an ACTH-secreting pituitary adenoma that leads to excessive cortisol production. It causes distinctive changes including central obesity with purple stretch marks, hypertension, diabetes, psychiatric changes, and osteoporosis. Diagnosis is complex and requires specialized testing.
Prevalence: Estimated 2-8 new cases per million people per year, though recent population studies suggest the true incidence may be higher. Cushing disease (pituitary-dependent) accounts for about 70% of endogenous Cushing syndrome cases. More common in women (3:1 female-to-male ratio). See our full Cushing Disease page for current treatments, recruiting trials, and community resources.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Where Cushing Disease treatment stands today
Read our full Cushing Disease treatment summary
Transsphenoidal surgery by an experienced pituitary neurosurgeon remains the first-line treatment for Cushing disease. When surgery doesn't fully normalize cortisol, 4 FDA-approved medications are now available: pasireotide (Signifor) suppresses ACTH secretion from the pituitary, osilodrostat (Isturisa) and levoketoconazole (Recorlev) block cortisol production in the adrenal glands, and mifepristone (Korlym) blocks cortisol's effects at the receptor level.
Clinical trials are testing next-generation approaches including selective ACTH receptor antagonists, combination medical therapy protocols, and refined surgical and radiation techniques. Off-label agents like ketoconazole, metyrapone, and cabergoline continue to play important roles.
Trial Friend's medication conflict checker can help you identify whether your current treatment might affect eligibility for specific trials.
The Cushing Disease page has every treatment and trial →Meanwhile, 28 Cushing Disease studies are enrolling
Whatever the FDA decides here, research on Cushing Disease does not stop. Of these, 14 test a treatment; the others follow patients over time. The most recently updated:
We'll email you when the decision is public, with what it means in plain language, and when new trials open for Cushing Disease. Unsubscribe anytime.
You'll get new recruiting trials, changes to trials, FDA decisions and condition news for Cushing Disease. Turn any of these off from the link in every email.
Frequently asked questions
When will the FDA decide on Relacorilant?
The FDA's target date (PDUFA date) for Relacorilant in Cushing syndrome (endogenous hypercortisolism) is December 17, 2026.
Who disclosed it: Corcept Therapeutics. The FDA does not publish these dates.
Can it move: the FDA can act early, and a major amendment to the application can push the date back 3 months.
What is Relacorilant being reviewed for?
Corcept Therapeutics submitted an NDA resubmission for Relacorilant in Cushing syndrome (endogenous hypercortisolism).
What to know: Oral pill that blocks cortisol at the glucocorticoid receptor, which Corcept says avoids side effects seen with current Cushing medicines such as pregnancy termination, low potassium and thickening of the uterine lining. The FDA issued a complete response letter dated December 30, 2025 on the original application. In its published letter the FDA said the GRACE trial met its primary endpoint on blood pressure but in a highly enriched group that likely overstates the effect, and the GRADIENT trial did not meet its primary endpoint, so substantial evidence of effectiveness was not shown. Corcept resubmitted on June 17, 2026 with additional analyses of the existing data that the FDA requested, and gave the December 17 decision date in its second quarter release. Relacorilant is already approved, as Lifyorli, for platinum-resistant ovarian cancer.
Is there already an FDA-approved treatment for Cushing Disease?
Yes. Trial Friend's drug list includes 4 FDA-approved drugs for Cushing Disease.
Approved: Korlym (mifepristone), Signifor (pasireotide), Isturisa (osilodrostat), Recorlev (levoketoconazole).
Check: the Cushing Disease page also searches FDA drug labels for approved treatments.
Can I get Relacorilant before the FDA decides?
Usually only through a clinical trial or an expanded access program, and the company decides whether to offer one.
Trials: 28 Cushing Disease studies are enrolling now, 14 of them testing a treatment. See them.
Check your fit: Match Me compares your details with every open trial.
Expanded access: your doctor can ask Corcept Therapeutics directly. Registered programs are listed on ClinicalTrials.gov.
How much will Relacorilant cost?
Corcept Therapeutics has not announced a price. Drugmakers usually set it around approval.
Help paying: drugmaker programs and charity funds usually open at launch.
Find help: the patient assistance finder lists programs by insurance type.
What happens after the Relacorilant decision?
This page updates with the outcome the day it is announced.
If approved: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.
If not approved: a complete response letter means the FDA declined the application in its current form. Many are about manufacturing or how data were presented, and companies often resubmit.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Corcept press release, Jul 29 2026. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.