Darolutamide

ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

Key facts

Darolutamide is an onp drug catalogued in DrugCentral. It was first approved by the FDA in 2019. DrugCentral lists 3 molecular targets, including Ar, AR and PGR. Recorded indications include Hormone refractory prostate cancer and Metastatic prostate cancer.

• Approval status: onp (first approved 2019 by the FDA).
• Molecular targets: Ar, AR and PGR (3 listed in DrugCentral).
• Indications: Hormone refractory prostate cancer and Metastatic prostate cancer.
• ATC code: L02BB06 (Anti-androgens).
• Molecular formula: C19H19ClN6O2; molecular weight 398.85 g/mol.

Indications & contraindications

Drug–disease relationships curated by DrugCentral (OMOP / SNOMED concepts).

Indications (2)

• Hormone refractory prostate cancer
• Metastatic prostate cancer

Mechanism & targets

Molecular targets (3)

Target	Gene	Action	Activity
Androgen receptor	Ar	antagonist	Ki 7.96
Androgen receptor	AR	inhibitor	IC50 7.19
Progesterone receptor	PGR	antagonist	—

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2020-03-27	EMA	—	Bayer AG
2020-01-23	PMDA	—	Bayer Yakuhin, Ltd
2019-07-30	FDA	—	BAYER HEALTHCARE PHARMACEUTICALS INC

ATC classification

ATC code	Therapeutic hierarchy
L02BB06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ENDOCRINE THERAPY › HORMONE ANTAGONISTS AND RELATED AGENTS › Anti-androgens

Reported adverse-event signals

Strongest FDA FAERS disproportionality signals (log-likelihood ratio). A signal is a statistical association in spontaneous reports, not proof that the drug causes the event.

MedDRA term	LLR
Prostatic specific antigen increased	544.6
Metastases to bone	261.1
Hormone-refractory prostate cancer	142.7
Interstitial lung disease	122.1
Hot flush	112.9
Neuropathy peripheral	109.0
Neutrophil count decreased	100.1
Death	92.8
Prostate cancer	74.6
Myelosuppression	74.2
Vasogenic cerebral oedema	52.9
Fatigue	48.0

Chemical structure

• Molecular formula: C₁₉H₁₉ClN₆O₂
• Molecular weight: 398.85 g/mol
• CAS number: 1297538-32-9
• InChIKey: BLIJXOOIHRSQRB-NWDGAFQWSA-N
• PubChem CID: 67171867

C[C@@H](CN1C=CC(=N1)C1=CC=C(C#N)C(Cl)=C1)NC(=O)C1=NNC(=C1)[C@@H](C)O

Frequently asked questions

Answers are generated from the structured data on this page, not written by hand.

What is Darolutamide used for?

DrugCentral lists the following indications for Darolutamide: Hormone refractory prostate cancer and Metastatic prostate cancer.

How does Darolutamide work?

Its molecular targets in DrugCentral include Ar (antagonist), AR (inhibitor) and PGR (antagonist).

When was Darolutamide first approved?

Darolutamide was first approved by the FDA in 2019.

What is the chemical formula of Darolutamide?

Darolutamide has the molecular formula C19H19ClN6O2 and a molecular weight of 398.85 g/mol.

Sources

• DrugCentral drug card 5334 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL4297185 — compound record and bioactivity
• PubChem CID 67171867 — chemical identifiers
• DrugBank DB12941 — drug record
• FDA UNII X05U0N2RCO — substance identity
• DailyMed: FDA labels for Darolutamide — current prescribing information (label search)
• UniProt P10275 (AR) — target protein
• UniProt P06401 (PGR) — target protein
• FDA Adverse Event Reporting System (openFDA FAERS) — adverse-event signals, as aggregated by DrugCentral

How this page is built: methodology · editorial policy & corrections.