Lifyorli (relacorilant)

Where it stands

Lifyorli (relacorilant), from Corcept Therapeutics Netherlands B.V., received a positive CHMP opinion on 2026-09-17. The records show its status as "Opinion" and give no approval date, so no European Commission (EC) marketing authorisation is recorded yet.

The indication in the opinion is treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The therapeutic areas listed are fallopian tube neoplasms, peritoneal neoplasms and epithelial ovarian carcinoma.

The records list the same substance as Lifyorli (Copackaged) in the US, with status Approved. They give no US approval date, indication or label details, and they do not say what the product is co-packaged with. This analysis therefore draws no comparison between the US and EU positions.

Regulatory pathway and designations

The product carries an Orphan designation. The CHMP opinion is a scientific recommendation. The EC then issues the legally binding decision, which, once granted, covers the EU market. The records estimate the EC decision for 2026-11-23, calculated as the CHMP opinion date plus 67 days, the standard Commission decision period. This is an internal estimate, not an official date.

In general EU procedure, orphan status is re-checked at the time of marketing authorisation to confirm the orphan criteria are still met. If it is maintained, the product can benefit from orphan market exclusivity. The records do not say whether this review has taken place or what its outcome is.

The records also do not state the type of authorisation (for example standard or conditional), any accelerated assessment, or the pivotal data behind the opinion. None of these are assumed here.

Safety and pharmacovigilance

The records contain no safety, risk management or pharmacovigilance information for this product, so no assessment can be made here.

What to watch

The key event is the EC decision. The 2026-11-23 date is only an estimate, and the actual timing may differ. Confirmation would come through the Union Register of medicinal products and the CHMP/EMA publications that follow, including the product information and assessment report.

Two points will only become clear after the decision: whether the orphan designation is maintained at authorisation, and the exact wording of the final EU indication compared with the CHMP opinion.

The records do not cover launch timing, pricing, reimbursement or national access in EU member states. These are separate processes that follow authorisation and cannot be inferred from the current data.