Corcept Therapeutics has secured US approval for its selective glucocorticoid receptor agonist, Lifyorli (relacorilant), in ovarian cancer more than three months before its Prescription Drug User Fee Act (PDUFA) date of 11 July.
This means that the drug will soon be available alongside nab-paclitaxel to American patients with platinum chemotherapy-resistant ovarian, fallopian tube or primary peritoneal cancer. Lifyorli is specifically indicated for patients who have received one-to-three prior treatments, including at least one course of Roche’s VEGF-A blocker, Avastin (bevacizumab).
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The FDA greenlit Lifyorli based on the results of the Phase III ROSELLA study (NCT05257408), which found that the drug plus nab-paclitaxel significantly boosted both progression-free survival (PFS) and overall survival (OS) over nab-paclitaxel alone in patients with refractory, platinum-resistant disease.
Lifyorli’s approval will be welcome news for Corcept, which ran into a regulatory roadblock back in December 2025 when the FDA refused to give the drug the OK in hypertension linked to Cushing’s syndrome.
The news looks to have pleased investors too, as Corcept’s stock value climbed more than 18.5% on the Nasdaq exchange from $34.15 at market open on 25 March pre-news debut to $40.47 at close the same day following the approval announcement.
Now, with one indication under Lifyorli’s belt, Corcept is hoping to expand the drug’s utility to several other indications, including endometrial, cervical, prostate and pancreatic cancer. Lifyorli is currently the only selective glucocorticoid receptor agonist on the US market.
Lifyorli’s market potential
Now that Lifyorli is approved for use in the ovarian cancer setting, Rob Coleman, gynaecologic oncologist at Texas Oncology, notes that the drug is poised to become “a new standard of care (SoC) treatment”.
Jasminemay Barcelon, senior oncology analyst at GlobalData, echoed this sentiment, noting that Lifyorli’s potential to resensitise tumours to platinum-based chemotherapy could prolong the drug’s duration of benefit and drive its potential as a SoC choice.
Barcelon added that its mechanism of action does not require a level of glucocorticoid receptor (GR) tumour expression, so the drug may capture uptake in patients lacking established ovarian cancer biomarkers like folate receptor alpha.
Currently, there are few options for patients with refractory, platinum-resistant ovarian cancer, as the SoC revolves around non-platinum-based chemotherapy such as nab-paclitaxel or topotecan. While targeted therapies like Avastin and antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) are available, patients are left with few options when they relapse following treatment with these therapies – leaving a treatment gap, which Corcept hopes Lifyorli will fill.
GlobalData, parent company of Pharmaceutical Technology, currently forecasts a blockbuster future for Lifyorli, with the drug expected to generate $2bn in 2031.
