Drug Search Results
More Filters [+]

Burosumab

Alternative Names: burosumab, krn23, crysvita, burosumab-twza
Latest Update: 2024-07-23
Latest Update Note: Clinical Trial Update

Product Description

Burosumab-twza injection is used to treat X-linked hypophosphatemia (XLH; an inherited disease where the body doesn't maintain phosphorus and that leads to weak bones) in adults and children 6 months of age and older. It is also used to treat tumor-induced osteomalacia (a tumor that causes a loss of phosphorus in the body that leads to weak bones) that cannot be surgically removed in adults and children 2 years of age and older, Burosumab-twza injection is in a class of medications called fibroblast growth factor 23 (FGF23) blocking antibodies. It works by blocking the action of a certain natural substance in the body which causes the symptoms of XLH. (Sourced from: https://medlineplus.gov/druginfo/meds/a618034.html)

Mechanisms of Action: FGF23 Inhibitor

Novel Mechanism: No

Modality: Antibody

Route of Administration: Subcutaneous

FDA Designation: None *

Approval Status: Approved

Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | Norway | Peru | Poland | Portugal | Romania | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States | Uruguay

Approved Indications: Hypophosphatemia

Known Adverse Events: Back Pain | Dizziness | Headache | Pain Unspecified | Restless Legs Syndrome | Constipation

Company: Kyowa Hakko Kirin
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Burosumab

Countries in Clinic: Austria, France, Germany, Ireland, Italy, Japan, Spain, Sweden, United Kingdom

Active Clinical Trial Count: 7

Highest Development Phases

Phase 3: Familial Hypophosphatemic Rickets|Hypophosphatemia, Familial|Osteomalacia|Rickets|Rickets, Hypophosphatemic|Tic Disorders

Phase 2: Hypophosphatemia

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

2019-000469-19

P2

Unknown status

Tic Disorders|Rickets

2025-03-03

BUR-CL207

P2

Completed

Familial Hypophosphatemic Rickets|Rickets, Hypophosphatemic|Hypophosphatemia, Familial

2023-10-04

24%

2018-001983-49

P2

Active, not recruiting

Osteomalacia|Rickets|Hypophosphatemia

2023-04-08

BurGER

P3

Completed

Hypophosphatemia, Familial|Rickets, Hypophosphatemic|Familial Hypophosphatemic Rickets

2023-03-17

Recent News Events