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Research Report
Vilanterol: A Comprehensive Pharmacological and Clinical Review
1. Introduction to Vilanterol
1.1. Background and Development
Vilanterol is a selective long-acting β2-adrenergic agonist (LABA) distinguished by its inherent 24-hour activity, permitting once-daily administration for the management of Chronic Obstructive Pulmonary Disease (COPD) and asthma.[1] The impetus for its development stemmed from a clinical need to enhance patient compliance, which is often suboptimal with regimens requiring more frequent dosing or complex administration techniques.[1] This focus on simplifying treatment regimens addresses a significant barrier in chronic respiratory disease management, potentially leading to improved disease control and patient outcomes. This approach is further supported by pharmacoeconomic analyses suggesting adherence benefits for once-daily therapies.[2]
The molecular design of Vilanterol is rooted in the salmeterol scaffold. It was specifically engineered as an antedrug analog of salmeterol, involving modifications to produce homochiral compounds with the (R)-configuration at the chiral benzylic alcohol carbon.[1] This targeted chemical modification aimed to optimize the pharmacological profile, particularly to achieve a duration of action suitable for once-daily dosing, a characteristic that differentiates it from some earlier LABAs like salmeterol, which typically requires twice-daily administration.[1] The development of Vilanterol, particularly the active substance, involved a collaboration between Innoviva (formerly Theravance) and GlaxoSmithKline (GSK). GSK is the primary manufacturer of Vilanterol-containing products, and Innoviva receives royalties from their sales.[3]
1.2. Drug Class and Therapeutic Significance
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/15 | Not Applicable | Recruiting | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | ||
2025/04/23 | Not Applicable | Recruiting | Affiliated Hospital of Guangdong Medical University | ||
2025/03/30 | Not Applicable | Not yet recruiting | He Huang | ||
2025/03/21 | Not Applicable | Recruiting | Shenzhen Genocury Biotech Co., Ltd. | ||
2025/03/21 | Not Applicable | Not yet recruiting | He Huang | ||
2025/03/17 | Not Applicable | Not yet recruiting | He Huang | ||
2025/01/28 | Not Applicable | Recruiting | |||
2024/11/15 | Not Applicable | Recruiting | |||
2024/11/07 | Not Applicable | Recruiting | Shenzhen Genocury Biotech Co., Ltd. | ||
2024/11/05 | Phase 1 | Recruiting | 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
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No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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