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: None *
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:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Gaucher Disease
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| TAK-669-3001 | P3 |
Completed |
Gaucher Disease |
2024-08-05 |
|
| 2022-002323-35 | P3 |
Active, not recruiting |
Gaucher Disease |
2022-11-23 |
|
| 2012-003427-38 | P2 |
Active, not recruiting |
Gaucher Disease |
2021-02-14 |
|
| CTR20222758 | P3 |
Not yet recruiting |
Gaucher Disease |
None |