Overview
One of the folic acid antagonists that is used as an antimalarial or with a sulfonamide to treat toxoplasmosis.
Indication
For the treatment of toxoplasmosis and acute malaria; For the prevention of malaria in areas non-resistant to pyrimethamine
Associated Conditions
- Toxoplasmosis
Research Report
A Comprehensive Monograph on Pyrimethamine (DB00205)
Introduction and Drug Profile
Overview of Pyrimethamine: Class, Primary Use, and Clinical Significance
Pyrimethamine is a synthetic diaminopyrimidine derivative, pharmacologically classified as an antiprotozoal agent and a folic acid antagonist.[1] Its primary clinical application is in the treatment of toxoplasmosis, an infection caused by the protozoan parasite
Toxoplasma gondii. This therapeutic role is particularly critical in immunocompromised patient populations, such as individuals with Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS), where toxoplasmic encephalitis represents a life-threatening opportunistic infection.[4] Historically, pyrimethamine was a cornerstone in the global management of malaria, although its utility for this indication has been significantly curtailed by the widespread emergence of drug-resistant
Plasmodium strains.[6]
The enduring clinical importance of pyrimethamine is underscored by its inclusion on the World Health Organization's List of Essential Medicines, a designation reserved for medications considered most effective and safe to meet the most important needs in a health system.[9] Despite its long history of use and established efficacy, the drug has a dual identity in modern medicine. It is both a vital, often life-saving, therapeutic agent for a serious parasitic disease and, simultaneously, a prominent symbol of the complex and often contentious issues surrounding pharmaceutical pricing, access, and market ethics in the 21st century. This report provides a comprehensive monograph on pyrimethamine, detailing its chemical properties, pharmacology, clinical applications, safety profile, and the socio-economic context that has defined its recent history.
Chemical Identity and Physicochemical Properties
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/02/05 | Phase 1 | Not yet recruiting | |||
2023/12/07 | Phase 1 | Recruiting | |||
2023/01/10 | Early Phase 1 | Completed | |||
2022/08/11 | Phase 1 | UNKNOWN | Emzor Pharmaceutical Industries Limited | ||
2022/03/16 | Phase 1 | Completed | |||
2020/11/13 | Early Phase 1 | UNKNOWN | Hebei Senlang Biotechnology Inc., Ltd. | ||
2019/09/12 | Phase 1 | Completed | |||
2019/05/16 | Phase 1 | Completed | |||
2018/05/16 | Phase 1 | Completed | |||
2017/08/23 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
South Coast Specialty Compounding, Inc. d/b/a Park Compounding | 70260-430 | ORAL | 12.5 mg in 1 1 | 11/25/2015 | |
TILDE Sciences LLC | 83649-330 | ORAL | 25 mg in 1 1 | 12/7/2023 | |
Vyera Pharmaceuticals LLC | 69413-330 | ORAL | 25 mg in 1 1 | 11/24/2021 | |
South Coast Specialty Compounding, Inc. d/b/a Park Compounding | 70260-426 | ORAL | 25 mg in 1 1 | 11/25/2015 | |
ImprimisRx PA, Inc. d/b/a ImprimisRx | 70271-429 | ORAL | 50 mg in 1 1 | 11/27/2015 | |
ImprimisRx PA, Inc. d/b/a ImprimisRx | 70271-480 | ORAL | 50 mg in 1 1 | 11/27/2015 | |
OAKRUM PHARMA, LLC | 72647-330 | ORAL | 25 mg in 1 1 | 3/18/2020 | |
DR.REDDYS LABORATORIES INC | 43598-672 | ORAL | 25 mg in 1 1 | 3/20/2023 | |
ImprimisRx PA, Inc. d/b/a ImprimisRx | 70271-428 | ORAL | 50 mg in 1 1 | 11/27/2015 | |
ImprimisRx PA, Inc. d/b/a ImprimisRx | 70271-426 | ORAL | 25 mg in 1 1 | 11/27/2015 |
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 |
---|---|---|---|---|---|
Daraprim Tablets | 97531 | Medicine | A | 11/11/2003 | |
Daraprim Tablets | 97456 | Medicine | A | 11/11/2003 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
DARAPRIM | amedra pharmaceuticals llc | 00004774 | Tablet - Oral | 25 MG | 12/31/1952 |
FANSIDAR TABLETS | Hoffmann-La Roche Limited | 00692719 | Tablet - Oral | 25 MG | 12/31/1989 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
DARAPRIM 25 mg COMPRIMIDOS | Smithkline Beecham Farma S.A. | 19625 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
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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