Overview
A 4-aminoquinoquinoline compound with anti-inflammatory properties.
Indication
For treatment of acute malarial attacks in non-immune subjects.
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Monograph on Amodiaquine (DB00613): Pharmacology, Clinical Utility, and Risk Profile
Executive Summary
Amodiaquine (CAS Number: 86-42-0; DrugBank ID: DB00613) is a 4-aminoquinoline antimalarial agent first synthesized in 1948. Over seven decades, it has evolved from a standalone therapy into a cornerstone of modern malaria treatment, particularly in high-burden regions. Its enduring clinical relevance is primarily due to its efficacy against chloroquine-resistant strains of Plasmodium falciparum and its critical role as a partner drug in Artemisinin-based Combination Therapy (ACT), the global standard of care for uncomplicated malaria. The most widely used combination, artesunate-amodiaquine (AS-AQ), is a World Health Organization (WHO) Essential Medicine and has been instrumental in reducing malaria-related mortality.
This monograph provides an exhaustive analysis of Amodiaquine, synthesizing data on its chemical properties, pharmacology, pharmacokinetics, clinical applications, and safety profile. The central theme that emerges is the inherent paradox of Amodiaquine: its high therapeutic value is inextricably linked to a risk of rare but life-threatening idiosyncratic toxicities, namely severe hepatotoxicity and agranulocytosis. These risks, identified during its use for long-term prophylaxis, led to a strategic re-evaluation of its clinical role, shifting its application to short-course treatment regimens where the risk-benefit profile is overwhelmingly positive.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/29 | Phase 4 | Not yet recruiting | |||
2023/12/26 | Not Applicable | Not yet recruiting | |||
2023/03/13 | Phase 2 | Recruiting | |||
2022/09/22 | Phase 2 | Completed | |||
2022/07/28 | Phase 4 | Active, not recruiting | |||
2022/07/25 | Phase 3 | Active, not recruiting | |||
2022/04/29 | Not Applicable | UNKNOWN | |||
2021/10/18 | Phase 2 | Completed | |||
2021/03/25 | Phase 4 | Completed | Institut de Recherche en Sciences de la Sante, Burkina Faso | ||
2019/09/06 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| 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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