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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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)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| atovaquone and proguanil hcl | NDA authorized generic | 2023-10-23 |
| atovaquone and proguanil hydrochloride | ANDA | 2024-10-10 |
| atovaquone and proguanil hydrochloride atovaquone and proguanil hydrochloride pediatric | ANDA | 2019-12-31 |
| malarone | New Drug Application | 2023-11-14 |
Indications
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Agency Specific
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Patent Expiration
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HCPCS
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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 |
|---|---|---|---|---|---|---|---|---|---|
| Malaria | D008288 | EFO_0001068 | B54 | 10 | 10 | 5 | 8 | 10 | 37 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | 3 | 3 | 4 | 4 | 7 | 18 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 3 | 3 | — | 1 | 1 | 5 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | — | 1 | — | 1 |
| Rabies | D011818 | — | A82 | — | — | — | 1 | — | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | — | 1 | — | 1 |
| Exercise | D015444 | EFO_0000483 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 3 | 4 |
| Communicable diseases | D003141 | — | — | — | 1 | — | — | 2 | 3 |
| Anemia | D000740 | HP_0001903 | D64.9 | 1 | 1 | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 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 reactions | D064420 | — | T88.7 | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Yin deficiency | D016710 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Proguanil |
| INN | proguanil |
| 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 | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)NC(=N)NC(=N)Nc1ccc(Cl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 500-92-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1377 |
| ChEBI ID | 8455 |
| PubChem CID | 6178111 |
| DrugBank | DB01131 |
| UNII ID | S61K3P7B2V (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Proguanil
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Atovaquone
Total medical expenditures per year (USD, in millions)
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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2,461 adverse events reported
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