PYRIMETHAMINE

Post-LOE

Alvogen

ANDAORALTABLET

Approved

Jul 2021

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

PYRIMETHAMINE by Alvogen is clinical pharmacology pyrimethamine is well absorbed with peak levels occurring between 2 to 6 hours following administration. Approved for toxoplasmosis, since synergism exists with this combination. First approved in 2021.

Drug data last refreshed 18h ago

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Mechanism of Action

CLINICAL PHARMACOLOGY Pyrimethamine is well absorbed with peak levels occurring between 2 to 6 hours following administration. It is eliminated slowly and has a plasma half-life of approximately 96 hours. Pyrimethamine is 87% bound to human plasma proteins. Microbiology: Pyrimethamine is a folic…

Indications (2)

toxoplasmosis

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (17)

NCT03952650Phase 1/2Completed

Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...

Started May 2019

252 enrolled

Malaria

NCT03258762Phase 1Completed

Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects

Started Sep 2017

14 enrolled

Toxoplasmosis

NCT02511054Phase 1Completed

Sanaria PfSPZ Challenge With Pyrimethamine Chemoprophylaxis (PfSPZ-CVac Approach): Phase 1 Trial to Determine Safety and Protective Efficacy of Sanaria PfSPZ Challenge With Concurrent Pyrimethamine Treatment That Inhibits Development of Asexual B...

Started Jul 2015

57 enrolled

Malaria

NCT01103063Phase 3Terminated

Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

Started Oct 2010

2,891 enrolled

Intermittent Preventive Treatment In Pregnancy (IPTp)

NCT00125489Phase 4Completed

CQSP in Malawi: Chloroquine and Sulfadoxine-pyrimethamine Efficacy for the Treatment of Malaria in Malawi

Started May 2005

210 enrolled

MalariaPlasmodium Falciparum Malaria