Overview
No overview information available.
Indication
用于防治耐氯喹的恶性疟原虫所致的疟疾。
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Clinical and Pharmacological Review of Sulfadoxine-Pyrimethamine
Section 1: Introduction and Pharmacological Profile
1.1. Overview and Drug Classification
Sulfadoxine-Pyrimethamine (SP) is a fixed-dose combination medication that has played a pivotal and evolving role in the global fight against malaria and other protozoal infections.[1] It is broadly classified as an anti-infective and antiprotozoal agent, with its primary application being the treatment and, more significantly in the modern era, the prevention of malaria caused by the parasite
Plasmodium falciparum.[2] The combination consists of two distinct active pharmaceutical ingredients, each with a specific mechanism of action that contributes to a potent synergistic effect.
The first component, Sulfadoxine, is a long-acting sulfonamide antibiotic.[1] As a member of the sulfonamide class, its primary pharmacological roles are as an antibacterial and antimalarial drug.[2] The United States Food and Drug Administration (FDA) formally categorizes sulfadoxine within the Established Pharmacologic Class [EPC] of Sulfonamides.[2] Its prolonged duration of action is a key feature that makes it suitable for intermittent preventive therapies.
The second component, Pyrimethamine, is an antiprotozoal agent belonging to the diaminopyrimidine class of drugs.[1] It functions as an antifolate compound, with a structure and mechanism of action similar to that of another antimalarial, proguanil.[3] Pyrimethamine is also indicated for the treatment of other parasitic diseases, including toxoplasmosis and cystoisosporiasis, often in combination with other agents.[6]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/10/20 | N/A | Active, not recruiting | |||
2020/04/07 | Phase 3 | Completed | Grant Dorsey, M.D, Ph.D. | ||
2020/02/21 | Phase 1 | Suspended | |||
2019/11/12 | Phase 4 | Completed | |||
2017/01/04 | Phase 3 | Completed | |||
2016/09/21 | Phase 2 | Completed | |||
2016/07/18 | Phase 1 | Completed | |||
2015/10/15 | Phase 4 | UNKNOWN | |||
2015/01/30 | Not Applicable | Completed | |||
2014/06/13 | Phase 3 | Completed | Grant Dorsey, M.D, Ph.D. |
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 |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| 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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