Relacorilant
An investigational treatment for Cushing Disease.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Relacorilant wherever you encounter it, plus the key facts at a glance.
- Generic name
- Relacorilant
- Development code
- CORT125134
- Drug class
- Selective glucocorticoid receptor antagonist
- Manufacturer
- Corcept Therapeutics
- How it's taken
- Capsule by mouth; in the Cushing's trial, once a day
An oral pill from Corcept Therapeutics under FDA review for Cushing's syndrome, with a decision expected by December 17, 2026. It is not approved for Cushing's. The FDA turned down the first application on December 30, 2025, and relacorilant is approved separately as Lifyorli for platinum-resistant ovarian cancer.
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Where Relacorilant fits
If approved for Cushing's, relacorilant would be the second glucocorticoid receptor blocker after Korlym. Korlym's approval covers high blood sugar from Cushing's in adults with type 2 diabetes or glucose intolerance, while Isturisa and Recorlev lower cortisol production and Signifor treats only Cushing disease.
How Relacorilant works
Cortisol acts on cells by attaching to the glucocorticoid receptor. Relacorilant sits on that receptor and blocks cortisol from attaching, which is the same approach as Korlym (mifepristone), also from Corcept. Mifepristone also blocks the progesterone receptor, which is why Korlym can end a pregnancy. Corcept describes relacorilant as selective, binding the glucocorticoid receptor but not the body's other hormone receptors[3]. Because it works at the receptor, relacorilant does not lower cortisol levels in the blood.
Clinical trial results
GRACE (NCT03697109) enrolled 152 adults with Cushing's syndrome and high blood pressure, high blood sugar or both at 77 centers in 11 countries. Everyone started on relacorilant for up to 22 weeks, and the 62 who met response criteria were randomly assigned to stay on it or switch to placebo for 12 weeks. More people switched to placebo lost blood pressure control, a difference of 34 percentage points (p=0.022)[2].
The FDA wrote that this group was highly enriched, since only 46 of the 102 people with high blood pressure at the start reached the comparison. GRADIENT (NCT04308590), in people with cortisol-secreting adrenal growths, missed its main goal, with systolic blood pressure falling 5.8 mmHg on relacorilant and 5 mmHg on placebo (p=0.77)[1]. A long-term extension study (NCT03604198) with 125 participants is active but not recruiting.
Main registered trial: NCT03697109 on ClinicalTrials.gov. Check it for the current status, sites and contacts before asking about enrollment.
Side effects and safety
- Liver injury. The FDA judged 4 cases of drug-induced liver injury probable in the Cushing's application and asked Corcept for a plan with label warnings and routine monitoring.
- Adrenal insufficiency. The Lifyorli label for ovarian cancer warns it can cause too little cortisol effect, especially during illness, infection or surgery.
- Pregnancy. The Lifyorli label says it can harm a developing baby and advises effective contraception.
In the 12-week placebo-controlled part of the GRACE trial, the most common side effects on relacorilant were back pain (17%, against 19% on placebo), acne (10% against 0%), joint pain (10% against 9%), bursitis (10% against 0%) and headache (10% against 13%). The published paper reported no cases of adrenal insufficiency, drug-induced low potassium or drug-induced QT prolongation[2].
In its December 2025 letter, the FDA concluded after a safety review that relacorilant is associated with drug-induced liver injury. It judged 4 cases probable among 303 people exposed, including one in which the liver enzyme ALT rose to more than 50 times the upper limit of normal, and none met Hy's law[1]. The Lifyorli label for ovarian cancer warns about adrenal insufficiency, harm to a developing baby, and low white blood cell counts when given with chemotherapy[5].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Relacorilant
Taken by mouth. In the GRACE trial for Cushing's syndrome, people took relacorilant once a day, starting at 100mg and rising up to 400mg[2]. The approved Lifyorli dose for ovarian cancer is different, 150mg on the day before, the day of and the day after each nab-paclitaxel infusion, taken with food[5]. No Cushing's dose has been approved.
Development history
Corcept developed relacorilant after Korlym, its 2012 Cushing's medicine. On December 30, 2025, the FDA issued a complete response letter on the Cushing's application saying the trials did not provide substantial evidence of effectiveness. It corrected the letter on January 28, 2026 and later posted it publicly[1]. In March 2026 the FDA approved relacorilant as Lifyorli, with nab-paclitaxel, for platinum-resistant ovarian cancer[5].
Corcept said on May 27, 2026 that the FDA had asked for more analyses of its data, and it resubmitted on June 17, 2026[3]. Its July 29, 2026 release gave a target date of December 17, 2026[4].
Access and eligibility
A doctor can ask Corcept for investigational relacorilant for a patient with a serious condition who has tried standard treatments and cannot join a trial. Corcept does not guarantee access, and requests go to access@corcept.com.
Visit Corcept compassionate use programAccess program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Explore Cushing Disease trials
Other Cushing Disease treatments
Surgery to remove the tumor causing excess cortisol is the first treatment for most people with Cushing's syndrome. When surgery is not possible or does not work, the FDA-approved medicines are Korlym (mifepristone), Isturisa (osilodrostat), Recorlev (levoketoconazole) and Signifor (pasireotide, for Cushing disease only). Their labels ask for different checks: Recorlev and Signifor require liver tests, and Korlym requires a pregnancy test in women who could become pregnant.
Common questions about Relacorilant
▸What is Relacorilant?
An oral pill from Corcept Therapeutics under FDA review for Cushing's syndrome, with a decision expected by December 17, 2026. It is not approved for Cushing's. The FDA turned down the first application on December 30, 2025, and relacorilant is approved separately as Lifyorli for platinum-resistant ovarian cancer.
▸How does Relacorilant work?
Cortisol acts on cells by attaching to the glucocorticoid receptor. Relacorilant sits on that receptor and blocks cortisol from attaching, which is the same approach as Korlym (mifepristone), also from Corcept. Mifepristone also blocks the progesterone receptor, which is why Korlym can end a pregnancy. Corcept describes relacorilant as selective, binding the glucocorticoid receptor but not the body's other hormone receptors[3]. Because it works at the receptor, relacorilant does not lower cortisol levels in the blood.
▸What are the side effects of Relacorilant?
In the 12-week placebo-controlled part of the GRACE trial, the most common side effects on relacorilant were back pain (17%, against 19% on placebo), acne (10% against 0%), joint pain (10% against 9%), bursitis (10% against 0%) and headache (10% against 13%). The published paper reported no cases of adrenal insufficiency, drug-induced low potassium or drug-induced QT prolongation[2]. In its December 2025 letter, the FDA concluded after a safety review that relacorilant is associated with drug-induced liver injury. It judged 4 cases probable among 303 people exposed, including one in which the liver enzyme ALT rose to more than 50 times the upper limit of normal, and none met Hy's law[1]. The Lifyorli label for ovarian cancer warns about adrenal insufficiency, harm to a developing baby, and low white blood cell counts when given with chemotherapy[5].
▸How is Relacorilant taken?
Taken by mouth. In the GRACE trial for Cushing's syndrome, people took relacorilant once a day, starting at 100mg and rising up to 400mg[2]. The approved Lifyorli dose for ovarian cancer is different, 150mg on the day before, the day of and the day after each nab-paclitaxel infusion, taken with food[5]. No Cushing's dose has been approved.
▸Is Relacorilant FDA approved?
Not yet. Relacorilant is under FDA review for Cushing Disease; Corcept Therapeutics has filed an application and a decision is due December 17, 2026. The FDA calendar page tracks the outcome.
▸When will the FDA decide on relacorilant for Cushing's syndrome?
Corcept expects an FDA decision by December 17, 2026, the target date set after its June 17, 2026 resubmission. Trial Friend's FDA calendar page for relacorilant shows the outcome once it is public.
▸Is relacorilant the same as Lifyorli?
Yes, Lifyorli is relacorilant's brand name for platinum-resistant ovarian cancer, approved in March 2026 at a dose of 150mg on 3 days around each chemotherapy infusion. It is not approved for Cushing's syndrome.
▸How is relacorilant different from Korlym?
Both block cortisol at the glucocorticoid receptor. Korlym's mifepristone also blocks the progesterone receptor, which is why its label has a boxed pregnancy warning and reports low potassium in 44% of patients in its Cushing's study. No trial has compared the 2 drugs directly.
▸Why did the FDA reject relacorilant in 2025?
The FDA said GRACE's result came from a highly enriched group and GRADIENT missed its main goal, so the evidence did not show the drug works for the proposed use. It also concluded relacorilant is associated with drug-induced liver injury, based on its safety review.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration · January 28, 2026. Corrected complete response letter, NDA 219398, relacorilant capsules. https://download.open.fda.gov/crl/CRL_NDA219398_20260128.pdf
- Lancet Diabetes & Endocrinology (Pivonello et al.) · 2026-02-20. Efficacy and safety of relacorilant for the treatment of patients with Cushing's syndrome (GRACE): a multicentre, phase 3, double-blind, placebo-controlled, randomised-withdrawal study. https://pubmed.ncbi.nlm.nih.gov/41730814/
- Corcept Therapeutics · 2026-06-17. Corcept resubmits New Drug Application for relacorilant as a treatment for patients with Cushing's syndrome. https://ir.corcept.com/news-releases/news-release-details/corcept-resubmits-new-drug-application-relacorilant-treatment
- Corcept Therapeutics · 2026-07-29. Corcept Therapeutics announces second quarter financial results and provides corporate update. https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-second-quarter-financial-4
- Corcept Therapeutics, via DailyMed · 2026-03. LIFYORLI (relacorilant) prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6fcebfb5-19d6-4f63-b852-999d68a13729
- ClinicalTrials.gov. GRACE, relacorilant in endogenous Cushing syndrome. https://clinicaltrials.gov/study/NCT03697109
- ClinicalTrials.gov. Long-term extension study of relacorilant in Cushing syndrome. https://clinicaltrials.gov/study/NCT03604198