# Relugolix

Relugolix (Orgovyx, Accord Healthcare S.L.U.) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Prostate cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Advanced | Hormone-sensitive |

## Products

### Orgovyx

- Company: Accord Healthcare S.L.U.
- Target: GnRH receptor antagonist
- Class: Other hormone antagonists and related agents
- ATC: L02BX
- EU approval: 29 Apr 2022
- Label revised: 2 Oct 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/orgovyx-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/orgovyx-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/orgovyx

Mechanism (SmPC section 5.1): Competitively binds pituitary GnRH receptors, blocking GnRH signalling so LH and FSH fall and testosterone is suppressed, without the initial flare seen with GnRH analogues.

## Label wording

- **Relugolix** (Orgovyx), Prostate cancer, advanced: “Orgovyx is indicated for the treatment of adult patients with advanced hormone-sensitive prostate cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/orgovyx-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/relugolix