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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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Drug
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Variants
Financial
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Events Timeline
5D
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YTD
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
atovaquone and proguanil hclNDA authorized generic2023-10-23
atovaquone and proguanil hydrochlorideANDA2024-07-01
atovaquone and proguanil hydrochloride atovaquone and proguanil hydrochloride pediatricANDA2019-12-31
malaroneNew Drug Application2023-11-14
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
malariaEFO_0001068D008288B54
falciparum malariaEFO_0007444D016778B50
cerebral toxoplasmosisEFO_0007200D016781B58.2
pneumocystis pneumoniaEFO_0007448D011020B59
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
Clinical Trials
49 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalariaD008288EFO_0001068B541010581037
Falciparum malariaD016778EFO_0007444B503344718
Sickle cell anemiaD000755EFO_0000697D5733—115
Hiv infectionsD015658EFO_0000764B20———1—1
RabiesD011818—A82———1—1
PharmacokineticsD010599—————1—1
ExerciseD015444EFO_0000483————1—1
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544——1——34
Communicable diseasesD003141———1——23
AnemiaD000740HP_0001903D64.911———1
Healthy volunteers/patients———11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Gastroesophageal refluxD005764EFO_0003948K211————1
CarcinomaD002277—C80.01————1
Non-small-cell lung carcinomaD002289——1————1
HypoxiaD000860HP_0012418R09.021————1
Biological availabilityD001682——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug-related side effects and adverse reactionsD064420—T88.7————11
Drug interactionsD004347——————11
Yin deficiencyD016710——————11
Epidemiology
Epidemiological information for investigational and approved indications
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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
$
€
£
â‚£
No data
Estimated US medical usage
Proguanil
+
Atovaquone
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,461 adverse events reported
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