Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company pioneering the modulation of cortisol to treat severe disorders, today announced that the U.S. Food and Drug Administration (FDA) has approved Lifyorli™ (relacorilant).
The drug is indicated for use 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, including at least one containing bevacizumab.
Lifyorli represents a therapeutic milestone as the first FDA-approved selective glucocorticoid receptor antagonist (SGRA).
By modulating the effects of the hormone cortisol, Lifyorli is designed to enhance the efficacy of chemotherapy in tumors where cortisol activity traditionally promotes treatment resistance.
The approval is supported by data from the pivotal ROSELLA trial, a global study involving 381 patients.
The trial demonstrated that adding Lifyorli to nab-paclitaxel resulted in a statistically significant 35% reduction in the risk of death compared to nab-paclitaxel monotherapy (hazard ratio: 0.65; p-value: 0.0004).
Patients in the Lifyorli arm achieved a median overall survival (OS) of 16 months, a 4.1-month improvement over the 11.9 months seen in the control group.
Furthermore, the combination reduced the risk of disease progression by 30% as assessed by blinded independent central review.
Meanwhile, the safety profile was characterized as manageable, with the most common adverse reactions including decreased hemoglobin, neutrophils, and fatigue.
The prescribing information includes warnings regarding neutropenia, adrenal insufficiency, and embryo-fetal toxicity.
Corcept plans to present complete results from the ROSELLA study at the Society of Gynecologic Oncology (SGO) meeting in April 2026.