Romosozumab

MUSCULO-SKELETAL SYSTEM

Key facts

Romosozumab is a drug catalogued in DrugCentral. It was first approved by the FDA in 2019. DrugCentral lists 1 molecular target, including SOST. Recorded indications include Postmenopausal osteoporosis.

• Molecular targets: SOST (1 listed in DrugCentral).
• Indications: Postmenopausal osteoporosis.
• ATC code: M05BX06 (Other drugs affecting bone structure and mineralization).

Indications & contraindications

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

Indications (1)

• Postmenopausal osteoporosis

Contraindications (1)

• Hypocalcemia

Mechanism & targets

Molecular targets (1)

Target	Gene	Action	Activity
Sclerostin	SOST	other	Kd 11.70

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2019-12-09	EMA	—	UCB PHARMA S.A.
2019-08-01	PMDA	—	AMGEN ASTELLAS BIOPHARMA K.K.
2019-04-09	FDA	—	AMGEN INC

ATC classification

ATC code	Therapeutic hierarchy
M05BX06	MUSCULO-SKELETAL SYSTEM › DRUGS FOR TREATMENT OF BONE DISEASES › DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION › Other drugs affecting bone structure and mineralization

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
Fracture	1044.3
Spinal fracture	869.7
Fall	750.7
Hospitalisation	728.6
Femur fracture	641.5
Product storage error	525.4
Injection site pain	515.4
Compression fracture	461.0
Spinal compression fracture	455.2
Femoral neck fracture	382.6
Intercepted product administration error	378.2
Injection site swelling	338.8

Chemical structure

• Molecular formula: —
• Molecular weight: —
• CAS number: 909395-70-6
• InChIKey: —
• PubChem CID: —

Frequently asked questions

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

What is Romosozumab used for?

DrugCentral lists the following indications for Romosozumab: Postmenopausal osteoporosis.

How does Romosozumab work?

Its molecular targets in DrugCentral include SOST.

When was Romosozumab first approved?

Romosozumab was first approved by the FDA in 2019.

Sources

• DrugCentral drug card 5362 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL2107874 — compound record and bioactivity
• DrugBank DB11866 — drug record
• FDA UNII 3VHF2ZD92J — substance identity
• DailyMed: FDA labels for Romosozumab — current prescribing information (label search)
• UniProt Q9BQB4 (SOST) — 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.