Nubeqa

darolutamide · Bayer AG
AUTHORISED IN THE EU

What Nubeqa is used for

NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).

Approved use, as published by the European Medicines Agency.

Key facts

Brand
Nubeqa
Active substance
darolutamide
Disease area
Prostatic Neoplasms, Castration-Resistant
Medicine group
Endocrine therapy
ATC code
L02BB
Marketing authorisation holder
Bayer AG
Authorised in the EU since
2020

Official information

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Nubeqa used for?

NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).

What is the active substance in Nubeqa?

Nubeqa contains darolutamide.

Who makes Nubeqa?

The EU marketing authorisation holder is Bayer AG.

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

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