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Darolutamide

Generic Name
Darolutamide
Brand Names
Nubeqa
Drug Type
Small Molecule
Chemical Formula
C19H19ClN6O2
CAS Number
1297538-32-9
Unique Ingredient Identifier
X05U0N2RCO

Overview

Darolutamide is a nonsteroidal androgen receptor antagonist for the treatment of castrate-resistant, non-metastatic prostate cancer (nmCRPC). This condition occurs in the majority of patients with advanced prostate cancer who have been treated with androgen receptor antagonists. Though prior treatment for prostate cancer has been successful for these patients, the cancer eventually progresses to become resistant to existing therapies. This warrants further treatment. The goal of treatment with darolutamide is to delay the progression of prostate cancer to metastatic disease, increasing quality of life and life expectancy for those with advanced prostate cancer. Darolutamide was developed by Bayer HealthCare Pharmaceuticals Inc. and approved by the FDA on July 30th, 2019.

Background

Darolutamide is a nonsteroidal androgen receptor antagonist for the treatment of castrate-resistant, non-metastatic prostate cancer (nmCRPC). This condition occurs in the majority of patients with advanced prostate cancer who have been treated with androgen receptor antagonists. Though prior treatment for prostate cancer has been successful for these patients, the cancer eventually progresses to become resistant to existing therapies. This warrants further treatment. The goal of treatment with darolutamide is to delay the progression of prostate cancer to metastatic disease, increasing quality of life and life expectancy for those with advanced prostate cancer. Darolutamide was developed by Bayer HealthCare Pharmaceuticals Inc. and approved by the FDA on July 30th, 2019.

Indication

Darolutamide is indicated for the treatment of adults with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.

Associated Conditions

  • Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
  • Non-Metastatic Castration-Resistant Prostate Cancer

FDA Approved Products

NUBEQA
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:ORAL
Strength:300 mg in 1 1
Approved: 2021/01/07
NDC:50419-395

Singapore Approved Products

NUBEQA FILM-COATED TABLET 300MG
Manufacturer:Orion Oyj / Orion Corporation / Orion Pharma, Orion Oyj / Orion Corporation / Orion Pharma (Primary and secondary packaging)
Form:TABLET, FILM COATED
Strength:300mg
Online:Yes
Approved: 2021/02/11
Approval:SIN16103P

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