Lifyorli

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Opinion

EMA has issued an opinion on this medicine

relacorilant
MedicineHumanOpinion

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 17 September 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lifyorli, intended for the treatment of adults with epithelial ovarian, fallopian tube or primary peritoneal cancer.

The applicant for this medicinal product is Corcept Therapeutics Netherlands B.V.

Lifyorli will be available as 25 mg and 100 mg soft capsules. The active substance of Lifyorli is relacorilant, an antineoplastic and immunomodulating, other hormone antagonist agent (ATC code: L02BX05). Relacorilant is a selective, reversible glucocorticoid receptor (GR) antagonist. Activation of the GR pathway increases expression of anti-apoptotic proteins. In human cell-line derived xenograft models, relacorilant enhanced sensitivity to chemotherapy.

The benefits of Lifyorli in combination with nab-paclitaxel are an improved progression-free survival (PFS) and overall survival (OS) compared to nab-paclitaxel alone in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatments. The most common side effects with Lifyorli are anaemia, nausea, diarrhoea, neutropenia, constipation, asthenia, abdominal pain, fatigue and decreased appetite.

The full indication is:

Lifyorli in combination with nab-paclitaxel is indicated for the treatment of adult patients with platinum-resistant high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

Treatment with Lifyorli in combination with nab-paclitaxel should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.


Note: This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

Product details

Name of medicine
Lifyorli
Active substance
relacorilant
International non-proprietary name (INN) or common name
relacorilant
Therapeutic area (MeSH)
  • Fallopian Tube Neoplasms
  • Peritoneal Neoplasms
  • Carcinoma, Ovarian Epithelial
EMA product number
EMEA/H/C/006731

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Marketing authorisation applicant
Corcept Therapeutics Netherlands B.V.
Opinion adopted
17/09/2026
Opinion status
Positive
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