Relacorilant, a reversible glucocorticoid receptor antagonist, is an antineoplastic agent.1
Relacorilant is used in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens, at least one of which included bevacizumab.1
Efficacy and safety of relacorilant in combination with nab-paclitaxel for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer have been established in a multicenter, open-label, randomized, active-controlled, 2-arm study (ROSELLA).1, 2, 4 The study included patients who had received 1 to 3 prior lines of systemic therapy, including prior bevacizumab therapy.1 Patients who required chronic or frequent use of glucocorticoids were excluded.1 A total of 188 patients received relacorilant 150 mg orally the day before, the day of, and the day after administration of nab-paclitaxel 80 mg/m2 IV infusion on days 1, 8, and 15 of each 28-day cycle and 193 patients received nab-paclitaxel 100 mg/m2 IV infusion on days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.1 Assessment of tumor response occurred every 8 weeks for the first 40 weeks and every 12 weeks thereafter.1 The major efficacy outcome measures were progression free survival (PFS) assessed by blinded independent central review (BICR) and overall survival (OS).1 PFS was evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.1
The median age of patients was 62 years (range, 26‒86 years); 71% were White, 13% were Asian, 1.3% were Black or African American, 9% were Hispanic or Latino, and 76% were non-Hispanic.1 Most patients had an Eastern Cooperative Oncology Group performance status (ECOG) of 0 (69%) or 1 (30%).1 Prior systemic therapy included 1 line in 9% of patients, 2 lines in 48%, and 3 lines in 44%; 39% received prior systemic therapy for platinum-resistant disease.1 All patients had previously received bevacizumab, 99.5% had received a taxane (19% in the most recent line of therapy and 4% in the platinum-resistant setting), and 61% had received a poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor.1 Among patients previously treated with a PARP inhibitor, 78% experienced radiographic disease progression during treatment.1 Relacorilant plus nab-paclitaxel significantly improved PFS and OS compared with nab-paclitaxel alone.1 Median PFS was 6.5 months with relacorilant plus nab-paclitaxel compared to 5.5 months with nab-paclitaxel alone.1 Median OS was 16 months with relacorilant plus nab-paclitaxel compared to 11.9 months with nab-paclitaxel alone.1
Approximately 80% of patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer will relapse after first-line treatment with platinum- and taxane-based chemotherapy.124 If disease recurs <6 months after completion of a platinum-containing regimen, it is generally considered platinum-resistant; if it recurs >6 months after platinum therapy cessation, it is generally considered platinum-sensitive.124 For platinum-sensitive recurrence, re-treatment with a platinum-containing regimen should be considered.124 The American Society of Clinical Oncoloty (ASCO) recommends combination chemotherapy with carboplatin, with or without bevacizumab, for the treatment of platinum-sensitive recurrent epithelial ovarian cancer.125 Maintenance therapy with a PARP inhibitor may be appropriate for some patients with platinum-sensitive recurrent disease.126, 127 For platinum-resistant recurrence, platinum therapy is generally not useful.124 ASCO recommends single-agent non-platinum chemotherapy, with or without bevacizumab, for the treatment of platinum-resistant or platinum-refractory epithelial ovarian cancer.125 Relacorilant was approved after guideline publication, and therefore is not addressed.1
Relacorilant is administered orally as capsules, with food.1
Swallow capsules whole; do not crush, chew, dissolve, or split.1
If a dose is missed by less than 12 hours, take the missed dose.1 If a dose is missed by 12 hours or more, skip the missed dose and take the next dose at the regularly scheduled time.1 Do not take 2 doses at the same time to make up for a missed dose.1
If vomiting occurs after taking relacorilant, do not take an additional dose.1
Store relacorilant capsules at 20‒25°C (excursions permitted between 15‒30°C) in the original container.1
Do not substitute nab-paclitaxel with other paclitaxel formulations.1
The recommended dosage of relacorilant for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer is 150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion.1
The recommended dosage of nab-paclitaxel is 80 mg/m2 administered as an IV infusion on days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.1
The recommended dosage and dosage modifications for nab-paclitaxel when administered in combination with relacorilant differ from those for other nab-paclitaxel indications.1
Dosage Modification for Adverse Reactions
If adverse events occur during therapy, dosage reduction, and/or discontinuation of relacorilant and nab-paclitaxel may be necessary.1
Recommended dosage reductions for relacorilant for adverse reactions : If dosage reduction is required, reduce dosage to 125 mg orally once the day before, the day of, and the day after the nab-paclitaxel infusion.1 If the patient is unable to tolerate the drug after one dose reduction, permanently discontinue therapy.1
Recommended dosage reductions for nab-paclitaxel for adverse reactions: If dosage reduction is required, reduce dosage to 60 mg/m2 administered as an IV infusion on days 1, 8, and 15 of each 28-day cycle.1 If a second dosage reduction is necessary, the dosage should be reduced to 60 mg/m2 on days 1 and 15 of each 28-day cycle.1 If the patient is unable to tolerate the drug after 2 dose reductions, permanently discontinue therapy.1
The recommended dosage modifications for nab-paclitaxel and relacorilant based on adverse reactions are presented in Tables 1 and 2.1
Adverse Reaction | Dosage Modification Based on Severity |
|---|---|
Neutropenia (ANC 1,000 to <1,500/mm3) on Day 1 | Nab-paclitaxel: Withhold until ≥1,500/mm3; resume at same dose Relacorilant: Withhold; resume at the same dose once nab-paclitaxel resumes |
Neutropenia (ANC <1,000/mm3) on Day 1 | Nab-paclitaxel: Withhold until ≥1,500/mm3; resume at reduced dose. Relacorilant: Withhold; resume at the same dose once nab-paclitaxel resumes |
Neutropenia (ANC <1,000/mm3) on Day 8 or 15 | Nab-paclitaxel: Omit dose; resume at reduced dose or continue at same dose with supportive short acting G-CSF (administered 24 hours after nab-paclitaxel for 2 days in accordance with clinical practice). If the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose. Relacorilant: Withhold; resume at the same dose once nab-paclitaxel resumes |
Febrile neutropenia (Grade 3 or 4) | Nab-paclitaxel: Withhold until fever resolves and ANC ≥1,500/mm3; resume at reduced dose. If the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose. Relacorilant: Withhold; resume at the same dose once nab-paclitaxel resumes |
Thrombocytopenia (Platelets <100,000/mm3 ) on Day 1 | Nab-paclitaxel: Withhold until ≥100,000/mm3; resume at the same dose Relacorilant: Withhold; resume at the same dose once nab-paclitaxel resumes |
Thrombocytopenia (Platelets <50,000/mm3) on Day 8 or 15 | Nab-paclitaxel: Omit dose; resume at reduced dose Relacorilant: Withhold; resume at the same dose once nab-paclitaxel resumes |
Other Grade 3 or 4 hematologic adverse reactions (excluding laboratory abnormalities that are not clinically relevant) | Nab-paclitaxel: Withhold until Grade ≤1; resume at reduced dose; if the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose Relacorilant: Withhold until Grade ≤1; resume at reduced dose |
Adverse Reaction | Dosage Modification Based on Severity |
|---|---|
Peripheral neuropathy (Intolerable Grade 2) | Nab-paclitaxel: Reduce dose Relacorilant: No change |
Peripheral neuropathy (Grade 3) | Nab-paclitaxel: Withhold until Grade ≤2 and resume at reduced dose; if the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose Relacorilant: Withhold; resume at the same dose once nab-paclitaxel resumes |
Peripheral neuropathy (Grade 4) | Nab-paclitaxel: Permanently discontinue Relacorilant: Permanently discontinue |
Cutaneous toxicity (Grade 3) | Nab-paclitaxel: Withhold until Grade ≤1 and resume at reduced dose; if the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose Relacorilant: Resume at the same dose once nab-paclitaxel resumes |
Cutaneous toxicity (Grade 4) | Nab-paclitaxel: Permanently discontinue Relacorilant: Permanently discontinue |
Mucositis or Diarrhea (Grade 3 or 4) | Nab-paclitaxel: Withhold until Grade ≤1 and resume at reduced dose; if the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose Relacorilant: Resume at the same dose once nab-paclitaxel resumes |
Other Grade 3 non-hematologic adverse reactions (excluding laboratory abnormalities that are not clinically relevant) | Nab-paclitaxel: Withhold until Grade ≤1 and resume at reduced dose; if the delay in nab-paclitaxel dosing exceeds 7 days, omit the nab-paclitaxel dose Relacorilant: Withhold until Grade ≤1; resume at reduced dose |
Other Grade 4 non-hematologic adverse reactions (excluding laboratory abnormalities that are not clinically relevant) | Nab-paclitaxel: Permanently discontinue Relacorilant: Permanently discontinue |
Avoid relacorilant in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment.1
The manufacturer recommends no specific dosage adjustments for patients with renal impairment.1, 2
The manufacturer recommends no specific dosage adjustments for geriatric patients.1
Neutropenia and Severe Infections
Relacorilant in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections.1 In clinical studies, decreased neutrophil count occurred in 74% of patients (Grade 3 in 30% and Grade 4 in 15%) and febrile neutropenia occurred in 3.7% of patients.1 The median time to onset was 15 days (range, 8‒329 days).1 Neutropenia was associated with infection in 16% of patients, including one fatal case of septic shock with febrile neutropenia.1 Granulocyte colony-stimulating factor (G-CSF) was initiated during the first or second treatment cycle in 38% of patients.1
Monitor complete blood count (CBC) before each weekly treatment with relacorilant plus nab-paclitaxel and as clinically indicated.1 Based on the severity of neutropenia, delay, reduce the dose, or permanently discontinue relacorilant in combination with nab-paclitaxel.1 Consider short-acting G-CSF administration as needed.1 Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.1 Inform patients to promptly report any episodes of fever to their healthcare provider.1
Relacorilant can cause adrenal insufficiency at any time during treatment, with increased risk during periods of stress (e.g., acute illness, infection, or surgery).1 Consider perioperative supplemental glucocorticoids in patients who received relacorilant within 30 days before surgery.1
Monitor patients for signs and symptoms of adrenal insufficiency; serum cortisol levels are not reliable for diagnosis during treatment.1 If adrenal insufficiency is suspected, withhold relacorilant and administer glucocorticoids.1 Higher glucocorticoid doses may be required because of glucocorticoid receptor antagonism, which can persist for up to 6 days after the last dose of relacorilant .1 After resolution, resume prior dose, reduce dose, or permanently discontinue relacorilant based on severity.1 Counsel patients on the symptoms of adrenal insufficiency and instruct them to contact their healthcare provider if they occur.1
Exacerbation of Conditions Treated with Glucocorticoids
Relacorilant, a glucocorticoid receptor antagonist, may reduce the effectiveness of systemic glucocorticoids and vice versa.1 In patients receiving systemic glucocorticoids for other conditions (e.g., autoimmune disorders), concomitant use may exacerbate the underlying condition.1 Monitor patients receiving both therapies for reduced effectiveness of relacorilant and glucocorticoids.1 Patients requiring chronic or frequent glucocorticoid use were excluded from clinical trials.1 Relacorilant is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes.1
Fetal/Neonatal Morbidity and Mortality
Based on findings from animal reproductive studies, relacorilant can cause fetal harm when administered to a pregnant woman.1 Oral administration of relacorilant to pregnant rabbits resulted in adverse developmental outcomes, including embryo-fetal mortality.1
Advise pregnant women of the potential risk to a fetus.1 Verify pregnancy status of females of reproductive potential prior to initiating relacorilant.1 Advise such patients to use effective contraception during treatment with relacorilant and for 1 week after the last dose.1 Advise male patients with female partners of reproductive potential to use effective contraception during treatment with relacorilant and for 1 week after the last dose.1
Based on animal findings, relacorilant can cause fetal harm when administered to a pregnant woman.1 In animal embryo-fetal development studies, oral administration of relacorilant to pregnant rabbits resulted in embryo-fetal mortality and structural abnormalities at maternal doses of ≥10 mg/kg/day (0.6 times the human exposure based on AUC at the recommended dose).1 Oral administration of relacorilant to pregnant rats during organogenesis did not result in fetal malformations.1 Advise pregnant women and females of reproductive potential of the potential risk to a fetus.1
It is not known whether relacorilant or its metabolites are distributed into human milk, or if the drug has any effects on the breastfed infant or on milk production.1 Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with relacorilant and for 1 week after the last dose.1
Females and Males of Reproductive Potential
Relacorilant can cause fetal harm when administered to a pregnant woman.1
Verify pregnancy status in women of reproductive potential prior to initiating relacorilant.1 Advise females of reproductive potential to use effective contraception during treatment and for 1 week after the last dose.1 Advise male patients with female partners of reproductive potential to use effective contraception during treatment with relacorilant and for 1 week after the last dose.1
The safety and effectiveness of relacorilant have not been established in pediatric patients.1
Of the 188 patients with platinum-resistant epithelial ovarian cancer who received relacorilant in clinical studies, 38% were ≥65 years of age and 9.6% were ≥75 years of age.1 A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients ≥65 years of age compared to younger adult patients.1 No overall differences in effectiveness were observed between patients ≥65 years of age and younger patients.1
No clinically significant differences in the pharmacokinetics of relacorilant were observed in patients with mild hepatic impairment.1 Relacorilant AUC increased 1.3-fold in patients with moderate hepatic impairment.1 The effects of severe hepatic impairment on relacorilant pharmacokinetics are unknown.1
No clinically significant differences in the pharmacokinetics of relacorilant were observed based on creatinine clearance (Clcr) 30 to <90 mL/minute.1 The effects of severe renal impairment (Clcr<30 mL/minute) or end-stage renal disease requiring hemodialysis on relacorilant pharmacokinetics are unknown.1
The most common adverse reactions (>20%) reported with relacorilant in combination with nab-paclitaxel in clinical studies, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.1
Relacorilant is a cytochrome P-450 (CYP) 3A substrate.1
In vitro, relacorilant and its metabolite, CORT125295, are inducers of CYP1A2.1 Relacorilant is a weak CYP2C8 inducer and a strong CYP3A inhibitor.1
Relacorilant and CORT125295 are inhibitors of breast cancer resistance protein (BCRP).1
Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes
Concomitant use of strong CYP3A inducers with relacorilant plus nab-paclitaxel can decrease concentrations of both drugs, which may reduce their effectiveness.1 Avoid such concomitant use with strong CYP3A inducers.1
Steady-state peak plasma concentrations of relacorilant (administered at a dosage of 300 mg once daily for 10 days under fasted conditions) increased 1.2-fold and AUC increased 1.5-fold following coadministration of itraconazole, a strong CYP3A inhibitor, at a dosage of 200 mg once daily for 10 days.1
CYP2C8 Inducers and Moderate CYP3A Inducers
Concomitant use of CYP2C8 inducers and moderate CYP3A inducers with relacorilant plus nab-paclitaxel can decrease concentrations of both drugs, which may reduce their effectiveness.1
Monitor for reduced effectiveness of relacorilant plus nab-paclitaxel when coadministered with CYP2C8 inducers and moderate CYP3A inducers.1
Concomitant use of CYP2C8 inhibitors with relacorilant plus nab-paclitaxel may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.1 Monitor for increased adverse reactions and modify the dosage as recommended.1
Relacorilant increases exposure of CYP3A substrates, which may increase the risk for adverse reactions related to these substrates.1
Peak plasma concentration and AUC of midazolam (a CYP3A substrate) increased 3.1- and 8.9-fold, respectively, following coadministration of relacorilant 350 mg under fasted conditions once daily for 10 days.1
Avoid concomitant use of relacorilant with CYP3A substrates unless otherwise recommended in the Prescribing Information for the CYP3A substrate.1
Relacorilant decreases exposure of CYP2C8 substrates, which may decrease the effectiveness of these substrates.1
Peak plasma concentration and AUC of pioglitazone ( CYP2C8 substrate) decreased to 78% and 75%, respectively, following coadministration of relacorilant 350 mg under fasted conditions once daily for 11 days.1
Avoid concomitant use of relacorilant with certain CYP2C8 substrates unless otherwise recommended in the Prescribing Information for the CYP2C8 substrate where minimal concentration changes may lead to reduced effectiveness.1
Relacorilant is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation).1
Avoid concomitant use with systemic glucocorticoids when possible because relacorilant, a glucocorticoid receptor antagonist, may reduce glucocorticoid effectiveness, and systemic glucocorticoids may reduce the effectiveness of relacorilant.1 If coadministration cannot be avoided, monitor patients for reduced effectiveness of both therapies.1
Peak plasma concentrations of dose-normalized paclitaxel (CYP2C8 and CYP3A4 substrate) increased 2-fold and AUC increased 1.7-fold following coadministration of nab-paclitaxel with relacorilant 150 mg.1
No clinically significant differences in the pharmacokinetics of relacorilant were observed when administered concomitantly with nab-paclitaxel.1
Glucocorticoid receptor (GR) signaling in ovarian cancer promotes chemotherapy resistance by increasing antiapoptotic protein expression, and increased GR expression or elevated cortisol levels have been associated with poor prognosis.4 Relacorilant is a selective, reversible GR antagonist that enhances apoptosis and antitumor activity when administered with paclitaxel.1 By blocking cortisol-mediated GR signaling, relacorilant also enhances antitumor immune responses by reversing cortisol-induced suppression of proinflammatory cytokines.1
The median time to peak plasma concentrations of relacorilant is 2.5 hours.1 Relacorilant exposure increases with food; a 1.7-fold increase in peak plasma concentrations and a 2-fold increase in AUC was observed after a low-fat meal, and a 1.9-fold increase in peak plasma concentrations and a 2.4-fold increase in AUC was observed after a high-fat meal.1 Relacorilant is more than 99% protein bound and the half-life is 27 hours.1 The drug is primarily metabolized by cytosolic reductases and cytochrome P-450 (CYP) 3A.1 An active metabolite, CORT125295, with functional activity approximately 5-fold lower than relacorilant, represents 75% of the parent AUC.1 After a single oral dose of radiolabeled relacorilant 250 mg administered to healthy participants, about 73% (<1% unchanged) of the dose was recovered in feces and 17% (<2% unchanged) in urine.1
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Relacorilant is available only from designated specialty pharmacies.3 Contact the manufacturer or consult the relacorilant website ([Web]) for more information.3
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Capsules | 25 mg | Lifyorli® | Corcept Therapeutics |
100 mg | Lifyorli® | Corcept Therapeutics |
AHFS® Drug Information. © Copyright, 1959-2026, Selected Revisions September 10, 2026. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
Only references cited for selected revisions after 1984 are available electronically.
1. Corcept Therapeutics Incorporated. Lifyorli® (Relacorilant) ORAL prescribing information. 2026 Mar. [Web]
2. US Food and Drug Administration. Center for Drug Evaluations and Research Application Number: 220641Orig1s000 Multi-Discipline Review. From the FDA website. Accessed 2026 Jun 21.
3. Savings & Support. From Lifyorli website. [Web]
4. Olawaiye AB, Gladieff L, O'Malley DM, et al. Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial. Lancet. 2025;405(10496):2205-2216. doi:10.1016/S0140-6736(25)01040-2
124. National Cancer Institute. Ovarian epithelial, fallopian tube, and primary peritoneal cancer treatment - health professional version. Revised May 14, 2025. Accessed 2026 Jul 4.
125. Vanderpuye VD, Clemenceau JRV, Temin S, Aziz Z, Burke WM, Cevallos NL, Chuang LT, Colgan TJ, Del Carmen MG, Fujiwara K, Kohn EC, Gonzáles Nogales JE, Konney TO, Mukhopadhyay A, Paudel BD, Tóth I, Wilailak S, Ghebre RG. Assessment of Adult Women With Ovarian Masses and Treatment of Epithelial Ovarian Cancer: ASCO Resource-Stratified Guideline. JCO Glob Oncol. 2021 Jun;7:1032-1066.
126. Tew WP, Lacchetti C, Ellis A, Maxian K, Banerjee S, Bookman M, Jones MB, Lee JM, Lheureux S, Liu JF, Moore KN, Muller C, Rodriguez P, Walsh C, Westin SN, Kohn EC. PARP Inhibitors in the Management of Ovarian Cancer: ASCO Guideline. J Clin Oncol. 2020 Oct 20;38(30):3468-3493.
127. Tew WP, Lacchetti C, Kohn EC; PARP Inhibitors in the Management of Ovarian Cancer Guideline Expert Panel. Poly(ADP-Ribose) Polymerase Inhibitors in the Management of Ovarian Cancer: ASCO Guideline Rapid Recommendation Update. J Clin Oncol. 2022 Nov 20;40(33):3878-3881.