Burosumab

MUSCULO-SKELETAL SYSTEM

Key facts

Burosumab is a drug catalogued in DrugCentral. It was first approved by the EMA in 2018. DrugCentral lists 1 molecular target, including FGF23. Recorded indications include Familial x-linked hypophosphatemic vitamin D refractory rickets and Osteomalacia.

• Molecular targets: FGF23 (1 listed in DrugCentral).
• Indications: Familial x-linked hypophosphatemic vitamin D refractory rickets and Osteomalacia.
• ATC code: M05BX05 (Other drugs affecting bone structure and mineralization).

Indications & contraindications

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

Indications (2)

• Familial x-linked hypophosphatemic vitamin D refractory rickets
• Osteomalacia

Contraindications (1)

• Renal impairment

Mechanism & targets

Molecular targets (1)

Target	Gene	Action	Activity
Fibroblast growth factor 23	FGF23	other	—

Regulatory approvals (3)

Date	Agency	Marketed as	Applicant	Orphan
2019-09-20	PMDA	—	Kyowa Kirin Co., Ltd.	Yes
2018-04-17	FDA	—	ULTRAGENYX PHARM INC	Yes
2018-02-02	EMA	—	KYOWA KIRIN LIMITED	Yes

ATC classification

ATC code	Therapeutic hierarchy
M05BX05	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
Blood phosphorus decreased	2594.4
Inappropriate schedule of product administration	1404.4
Product dose omission issue	1287.1
Restless legs syndrome	789.8
Incorrect dose administered	398.8
Bone pain	358.0
Knee deformity	330.2
Injection site pruritus	313.3
Tooth abscess	291.0
Injection site pain	290.7
Therapy interrupted	257.8
Pain in extremity	255.9

Chemical structure

• Molecular formula: —
• Molecular weight: —
• CAS number: —
• InChIKey: —
• PubChem CID: —

Frequently asked questions

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

What is Burosumab used for?

DrugCentral lists the following indications for Burosumab: Familial x-linked hypophosphatemic vitamin D refractory rickets and Osteomalacia.

How does Burosumab work?

Its molecular targets in DrugCentral include FGF23.

When was Burosumab first approved?

Burosumab was first approved by the EMA in 2018.

Sources

• DrugCentral drug card 5282 — structure, indications, targets, approvals, pharmacologic classes (CC BY-SA 4.0)
• ChEMBL CHEMBL3707326 — compound record and bioactivity
• DrugBank DB14012 — drug record
• FDA UNII G9WJT6RD29 — substance identity
• DailyMed: FDA labels for Burosumab — current prescribing information (label search)
• UniProt Q9GZV9 (FGF23) — 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.