NDAORALTABLETPriority Review
Approved
Jan 1953
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
6/8 — Strong
Priority Review
DARAPRIM (pyrimethamine) by Aurobindo Pharma is dihydrofolate reductase inhibitors [moa]. Approved for malaria, toxoplasmosis. First approved in 1953.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DARAPRIM (pyrimethamine) is an oral dihydrofolate reductase inhibitor antimalarial approved in 1953 for treating malaria, toxoplasmosis, and opportunistic infections in immunocompromised patients including those with HIV. The drug inhibits parasitic dihydrofolate reductase, blocking nucleotide synthesis essential for parasite survival. It is indicated across ten conditions ranging from malaria to autoimmune diseases and anemia.
$0.001BPart D
LOE ApproachingWith LOE approaching and minimal Part D spending ($1M in 2023), the brand team is likely small and focused on defending market position against generic competition rather than growth initiatives.
Mechanism of Action
Dihydrofolate Reductase Inhibitors
Pharmacologic Class:
Dihydrofolate Reductase Inhibitor Antimalarial
Indications (2)
Clinical Trials (17)
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
Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects
Started Sep 2017
14 enrolled
Toxoplasmosis
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
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)
CQSP in Malawi: Chloroquine and Sulfadoxine-pyrimethamine Efficacy for the Treatment of Malaria in Malawi
Started May 2005
210 enrolled
MalariaPlasmodium Falciparum Malaria
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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.