Relacorilant

Relacorilant is a reversible glucocorticoid receptor (GR) antagonist. In functional in vitro assays with the mineralocorticoid receptor, relacorilant showed no agonist or antagonist activity.

• LIFYORLI is indicated 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 [see Clinical Studies ( 14 )] . LIFYORLI is a glucocorticoid receptor antagonist indicated 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.

• LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids [see Warnings and Precautions ( 5.3 )] . Concurrent systemic glucocorticoid therapy for a lifesaving indication.contraindicated

The recommended dosage of LIFYORLI is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion. ( 2 ) 2.1 Important Dosage and Administration Information LIFYORLI Follow LIFYORLI dosing instructions provided on the blister card. Take LIFYORLI with food. Swallow capsules whole. Do not crush, chew, dissolve, or split the capsules. If a dose of LIFYORLI is missed by less than 12 hours, take the missed dose. If a dose of LIFYORLI is missed by 12 hours or more, skip the missed dose and take the next dose at the regularly scheduled time. Do not take 2 doses at the same time to make up for a missed dose. If vomiting occurs after taking LIFYORLI, do not take an additional dose. Nab-Paclitaxel The recommended dosage and dosage modifications for nab-paclitaxel when administered in combination with LIFYORLI differ from those for other nab-paclitaxel indications [see Dosage and Administration ( 2.2 and 2.3 ) and Clinical Studies ( 14 )] . Do not substitute with other paclitaxel formulations. 2.2 Recommended Dosage and Administration The recommended dosage of LIFYORLI is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion until disease progression or unacceptable toxicity. The recommended dosage for nab-paclitaxel is 80 mg/m 2 administered as an intravenous infusion on Days 1, 8 and 15 of each 28-day cycle until disease progression or unacceptable toxicity [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14 )]. Refer to the Prescribing Information for nab-paclitaxel for administration.

Neutropenia and Severe Infections : Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Withhold, reduce the dose, or permanently discontinue LIFYORLI based on severity. ( 2.3 , 5.1 ) Adrenal insufficiency: Monitor for signs and symptoms of adrenal insufficiency. ( 5.2 ) Exacerbation of Conditions Treated with Glucocorticoids: LIFYORLI makes systemic glucocorticoids less effective in patients who have an ongoing requirement for systemic glucocorticoids. ( 5.3 ) Embryo-Fetal Toxicity : LIFYORLI can cause fetal harm. Advise females of reproductive potential of the risk to a fetus and to use effective contraception. ( 5.4 ) 5.1 Neutropenia and Severe Infections LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. In ROSELLA, decreased neutrophil count occurred in 74% of patients treated with LIFYORLI in combination with nab-paclitaxel, 30% Grade 3, 15% Grade 4, and 3.7% febrile neutropenia. The median time to onset of neutropenia was 15 days (range: 8 to 329). Instances of neutropenia were temporally associated with infection in 16% of patients. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy. Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated.

The following adverse reactions are discussed in more detail in other sections of the labeling: Neutropenia and Severe Infections [see Warnings and Precautions ( 5.1 )] . Adrenal Insufficiency [see Warnings and Precautions ( 5.2 )] Exacerbation of Conditions Treated with Glucocorticoids [see Warnings and Precautions ( 5.3 )]. Most common adverse reactions (incidence > 20%), including laboratory abnormalities, that occurred in patients treated with LIFYORLI in combination with nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Corcept Therapeutics at 1-855-844-3270 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LIFYORLI in combination with nab-paclitaxel was evaluated in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in ROSELLA [see Clinical Studies ( 14 )] . Patients received LIFYORLI (150 mg orally on the day before, the day of, and the day after each administration of nab-paclitaxel 80 mg/m 2 intravenous infusion on Days 1, 8 and 15 of each 28-day cycle (n=188) or nab-paclitaxel 100 mg/m 2 intravenous infusion (n=190) until disease progression or unacceptable toxicity.

Lactation : Advise not to breastfeed. ( 8.2 ) Hepatic Impairment : Avoid use in patients with moderate or severe hepatic impairment. ( 8.6 ) 8.1 Pregnancy Risk Summary LIFYORLI is used in combination with nab-paclitaxel. Refer to the Prescribing Information of nab-paclitaxel for pregnancy information. Based on findings in animals, LIFYORLI can cause fetal harm when administered to a pregnant woman. There are no available data on relacorilant use in pregnant women to inform drug-associated risk. In animal embryo-fetal development studies, oral administration of relacorilant to pregnant rabbits during the period of organogenesis resulted in embryo-fetal mortality and structural abnormalities at maternal doses of ≥ 10 mg/kg/day (0.6 times the human exposure based on area under the curve (AUC) at the recommended dose). Oral administration of relacorilant to pregnant rats during the period of organogenesis did not result in fetal malformations [see Data ] . Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is between 2 to 4% and 15 to 20%, respectively. Data Animal Data Relacorilant is a partial agonist of the glucocorticoid receptor in rats.

Metabolism

Relacorilant pharmacokinetics were observed in adult patients at the approved recommended dosage and are presented as mean (CV%), unless otherwise specified. Relacorilant maximum concentration (C max ) is 720 (68%) ng/mL and systemic exposure (AUC) is 5,686 (84%) ng*h/mL following the third consecutive daily dose.

• Mar 25, 2026NDANDA220641Corcept Therap

1. 1Abdominal Discomfort133%
2. 2Breath Odour133%
3. 3Eructation133%
4. 4Hernia133%
5. 5Nausea133%
6. 6Nephrolithiasis133%
7. 7Product Odour Abnormal133%
8. 8Product Use In Unapproved Indication133%
9. 9Therapy Interrupted133%

The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Relacorilant as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
  Recruiting · Phase 2 · Interventional · 60 enrolled · Corcept Therapeutics
  NCT07259317updated 2026-04-23
• Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
  Active not recruiting · Phase 2 · Interventional · 125 enrolled · Corcept Therapeutics
  NCT03604198updated 2026-04-21
• Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
  Recruiting · Phase 2 · Interventional · 270 enrolled · Corcept Therapeutics
  NCT06906341updated 2026-04-14
• Study of Drug 1 (Enzalutamide) Plus Drug 2 (Relacorilant) for Patients With Prostate Cancer
  Completed · Phase 1 · Interventional · 42 enrolled · University of Chicago
  NCT03674814updated 2026-03-31
• A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer
  Recruiting · Phase 2 · Interventional · 90 enrolled · University of Chicago
  NCT05726292updated 2026-03-04
• Study of Relacorilant in Combination With Nab-Paclitaxel for Patients With Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
  Completed · Phase 2 · Interventional · 178 enrolled · Corcept Therapeutics
  NCT03776812updated 2025-10-07
• A Study of the Efficacy and Safety of Relacorilant in Patients With Cortisol-Secreting Adrenal Adenomas
  Completed · Phase 3 · Interventional · 137 enrolled · Corcept Therapeutics
  NCT04308590updated 2025-09-04
• A Study of the Efficacy and Safety of Relacorilant in Patients With Endogenous Cushing Syndrome
  Completed · Phase 3 · Interventional · 152 enrolled · Corcept Therapeutics
  NCT03697109updated 2025-07-16
• Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
  Active not recruiting · Phase 3 · Interventional · 381 enrolled · Corcept Therapeutics
  NCT05257408updated 2025-04-16
• Study of Relacorilant in Combination With Pembrolizumab for Patients With Adrenocortical Carcinoma Which Produces Too Much Stress Hormone (Cortisol)
  Completed · Phase 1 · Interventional · 15 enrolled · Corcept Therapeutics
  NCT04373265updated 2024-02-23

Frequently asked questions

How does Relacorilant work?

Relacorilant is a reversible glucocorticoid receptor (GR) antagonist. In functional in vitro assays with the mineralocorticoid receptor, relacorilant showed no agonist or antagonist activity.

What is Relacorilant used for?

According to FDA labeling, Relacorilant carries indications including: LIFYORLI is indicated 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 [see Clinical Studies ( 14 )] . LIFYORLI is a glucocorticoid receptor antagonist indicated 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Relacorilant?

Relacorilant is marketed under brand names including Lifyorli.

What are the contraindications for Relacorilant?

Relacorilant labeling lists contraindications including: LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids [see Warnings and Precautions ( 5.3 )] . Concurrent systemic glucocorticoid therapy for a lifesaving indication.. Always consult the full prescribing information and a clinician.