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AboutPricing
Drug ReportsProguanil
Proguanil
Atovaquone / Proguanil, Malarone (proguanil) is a small molecule pharmaceutical. Proguanil was first approved as Malarone on 2000-07-14. It is used to treat falciparum malaria and malaria in the USA.
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FDA approval date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Combinations
Atovaquone proguanil, Malarone
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Atovaquone
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Proguanil hydrochloride
Tradename
Company
Number
Date
Products
MALARONEGSKN-021078 RX2000-07-14
1 products, RLD, RS
MALARONE PEDIATRICGSKN-021078 RX2000-07-14
1 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
atovaquone and proguanil hclNDA authorized generic2023-10-23
atovaquone and proguanil hydrochlorideANDA2024-10-10
atovaquone and proguanil hydrochloride atovaquone and proguanil hydrochloride pediatricANDA2019-12-31
malaroneNew Drug Application2023-11-14
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
P: Antiparasitic products, insecticides and repellents
P01: Antiprotozoals
P01B: Antimalarials
P01BB: Biguanide antimalarials
P01BB01: Proguanil
P01BB51: Proguanil and atovaquone
P01BB52: Chloroquine and proguanil
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameProguanil
INNproguanil
Description
Proguanil is a biguanide compound which has isopropyl and p-chlorophenyl substituents on the terminal N atoms. A prophylactic antimalarial drug, it works by inhibiting the enzyme dihydrofolate reductase, which is involved in the reproduction of the malaria parasites Plasmodium falciparum and P. vivax within the red blood cells. It has a role as an antimalarial, an antiprotozoal drug and an EC 1.5.1.3 (dihydrofolate reductase) inhibitor. It is a member of biguanides and a member of monochlorobenzenes.
Classification
Small molecule
Drug class
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Structure (InChI/SMILES or Protein Sequence)
CC(C)NC(=N)NC(=N)Nc1ccc(Cl)cc1
Identifiers
PDB
CAS-ID500-92-5
RxCUI
ChEMBL IDCHEMBL1377
ChEBI ID8455
PubChem CID6178111
DrugBankDB01131
UNII IDS61K3P7B2V (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Proguanil
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Atovaquone
Total medical expenditures per year (USD, in millions)
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Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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