Product Description
Velaglucerase alfa injection is used to treat type 1 Gaucher's disease. This disease is caused by the lack of a certain enzyme, glucocerebrosidase, in the body. This enzyme is necessary for the body to use fats correctly, and fats will build up in certain areas of the body if the enzyme is not present. Velaglucerase alfa replaces the missing enzyme to help the body process fats. (Sourced from: https://www.mayoclinic.org/drugs-supplements/velaglucerase-alfa-intravenous-route/description/drg-20073970)
Mechanisms of Action: Glucocerebroside Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela
Approved Indications: None
Known Adverse Events: None
Company: Takeda
Company Location: TOKYO M0 103-8668
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Gaucher Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| TAK-669-3001 | P3 |
Completed |
Gaucher Disease |
2024-08-05 |
16% |
2024-11-23 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 2012-003427-38 | P2 |
Active, not recruiting |
Gaucher Disease |
2018-04-22 |
2025-06-29 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |