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FDA approval · Corcept Therapeutics · Oncology

Lifyorlirelacorilant

FDA approves relacorilant with nab-paclitaxel for platinum-resistant ovarian cancer.

CompareFDA press release
FDA approval · New molecule40-second read

Lifyorlirelacorilant

Corcept Therapeutics · Glucocorticoid receptor antagonist · Oncology

Bottom line for your patients

Adding relacorilant to nab-paclitaxel lengthened both progression-free and overall survival in previously treated platinum-resistant disease. Patients who need chronic or frequent glucocorticoids were excluded from the trial.

Drug brief
Drug IQ
Who it is for
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, in combination with nab-paclitaxel.
What changes
ROSELLA compared relacorilant plus nab-paclitaxel with nab-paclitaxel alone.
The evidence
Median PFS was 6.5 months versus 5.5 months (hazard ratio 0.70; two-sided p-value 0.0076). Median OS was 16 months versus 11.9 months (hazard ratio 0.65; two-sided p-value 0.0004).Open-label randomized trialROSELLA · 381 participantsRandomized, but patients and clinicians knew the assignment, so subjective outcomes are more open to bias.
Watch for
Contraindicated in patients who require corticosteroids for a lifesaving indication; warnings for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity. Most common adverse reactions (20% or more) include decreased hemoglobin, decreased neutrophils, fatigue, nausea, and diarrhea.
How it is given
Oral150 mg orally once on the day before, the day of, and the day after each nab-paclitaxel infusion
What the approval tells you
New molecule. An active ingredient the FDA had not approved before.

Clinical summary

Lifyorli is an oral glucocorticoid receptor antagonist given with nab-paclitaxel to adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic regimens, at least one including bevacizumab. In the ROSELLA trial of 381 patients, median overall survival was 16 months with the combination and 11.9 months with nab-paclitaxel alone (hazard ratio 0.65). It is contraindicated in patients who require corticosteroids for a lifesaving indication.

From the source 9

FDA press release

The FDA press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. On March 25, 2026, the Food and Drug Administration approved relacorilant (Lifyorli, Corcept Therapeutics Inc.), a glucocorticoid receptor antagonist, 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.

    Backs · FDA action date 2026-03-25; class; approved population (one to three prior regimens)

  2. Efficacy was evaluated in ROSELLA (NCT05257408), a multicenter, open-label, trial in 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.

    Backs · ROSELLA, open-label, 381 patients

  3. Patients were randomized (1:1) to receive relacorilant in combination with nab-paclitaxel or nab-paclitaxel alone.

    Backs · Randomized against nab-paclitaxel alone

View all 9 lines

  1. Median PFS was 6.5 months (95% CI: 5.6, 7.4) in the relacorilant in combination with nab-paclitaxel arm and 5.5 months (95% CI: 3.9, 5.9) in the nab-paclitaxel arm (Hazard ratio 0.70 [95% CI: 0.54, 0.91]; two-sided p-value 0.0076).

    Backs · Median PFS 6.5 vs 5.5 months, HR 0.70, p 0.0076

  2. Median OS was 16 months (95% CI: 13, 18.3) in the relacorilant in combination with nab-paclitaxel arm and 11.9 months (95% CI: 10, 13.8) in the nab-paclitaxel arm (Hazard ratio 0.65 [95% CI: 0.51, 0.83]; two-sided p-value 0.0004).

    Backs · Median OS 16 vs 11.9 months, HR 0.65, p 0.0004

  3. The trial excluded patients who required chronic or frequent use of glucocorticoids.

    Backs · Glucocorticoid users excluded

  4. The prescribing information includes a contraindication for patients who require corticosteroids for a lifesaving indication as well as warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity.

    Backs · Contraindication and warnings

  5. The most common adverse reactions (incidence ≥ 20%), including laboratory abnormalities, that occurred in patients treated with relacorilant in combination with nab-paclitaxel were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

    Backs · Most common adverse reactions, incidence 20% or more

  6. The recommended dosage of relacorilant 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.

    Backs · Dosing 150 mg

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