MedPath

Sulfadoxine-Pyrimethamine

Generic Name
Sulfadoxine-Pyrimethamine

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

Published: Aug 15, 2025

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]

Continue reading the full research report

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.

Help Us Improve

Your feedback helps us provide better drug information and insights.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.