Atovaquone
Atovaquone, Malarone, Mepron (atovaquone) is a small molecule pharmaceutical. Atovaquone was first approved as Mepron on 1992-11-25. It is used to treat cerebral toxoplasmosis, malaria, and pneumocystis pneumonia in the USA. It is known to target Cytochrome b.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| respiratory tract diseases | D012140 |
| nervous system diseases | D009422 |
Trade Name
FDA
EMA
Atovaquone, Mepron (discontinued: Atovaquone, Mepron)
CombinationsAtovaquone 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 | ANDA | 2025-10-01 |
| 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 |
| atovaquone oral suspension | ANDA | 2024-02-15 |
| malarone | New Drug Application | 2023-11-14 |
| mepron | New Drug Application | 2023-07-20 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
P: Antiparasitic products, insecticides and repellents
— P01: Antiprotozoals
— P01A: Agents against amoebiasis and other protozoal diseases
— P01AX: Other agents against amoebiasis and other protozoal diseases in atc
— P01AX06: Atovaquone
— P01B: Antimalarials
— P01BB: Biguanide antimalarials
— P01BB51: Proguanil and atovaquone
HCPCS
No data
Clinical
Clinical Trials
57 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 | 11 | 8 | 2 | 7 | 7 | 31 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | 5 | 4 | 2 | 3 | 5 | 16 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 4 | 2 | 1 | 3 | 11 |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | 1 | 3 | 2 | 1 | 2 | 9 |
| Pneumonia | D011014 | EFO_0003106 | J18 | 1 | 2 | 1 | 1 | 3 | 8 |
| Rabies | D011818 | — | A82 | — | — | — | 1 | — | 1 |
| Pharmacokinetics | D010599 | — | — | — | — | — | 1 | — | 1 |
| Exercise | D015444 | EFO_0000483 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 2 | 2 | — | 1 | 5 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | 2 | 4 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Toxoplasmosis | D014123 | EFO_0007517 | B58 | 1 | 1 | — | — | 1 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 2 | — | — | 1 | 3 |
| Communicable diseases | D003141 | — | — | — | 1 | — | — | 1 | 2 |
| Cerebral toxoplasmosis | D016781 | EFO_0007200 | B58.2 | — | 1 | — | — | 1 | 2 |
| Encephalitis | D004660 | — | — | — | 1 | — | — | 1 | 2 |
| Bacterial infections | D001424 | — | A49 | — | 1 | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | 1 | — | — | — | 1 |
| Aids-related opportunistic infections | D017088 | — | — | — | 1 | — | — | — | 1 |
| Asymptomatic infections | D058345 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | — | — | — | — | 2 |
| Parasitemia | D018512 | — | — | 1 | — | — | — | — | 1 |
| Hiv | D006678 | — | O98.7 | 1 | — | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Hypoxia | D000860 | — | R09.02 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory insufficiency | D012131 | — | J96.9 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Atovaquone |
| INN | atovaquone |
| Description | Atovaquone is a naphthoquinone compound having a 4-(4-chlorophenyl)cyclohexyl group at the 2-position and a hydroxy substituent at the 3-position. It has a role as an antimalarial, an antifungal agent, an EC 1.3.5.2 [dihydroorotate dehydrogenase (quinone)] inhibitor, an EC 1.6.5.3 [NADH:ubiquinone reductase (H(+)-translocating)] inhibitor and an EC 1.10.2.2 (quinol--cytochrome-c reductase) inhibitor. It is a member of monochlorobenzenes and a hydroxy-1,4-naphthoquinone. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1C(O)=C([C@H]2CC[C@H](c3ccc(Cl)cc3)CC2)C(=O)c2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 95233-18-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1450 |
| ChEBI ID | 575568 |
| PubChem CID | 74989 |
| DrugBank | DB01117 |
| UNII ID | Y883P1Z2LT (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
MT-CYB
MT-CYB
Organism
Plasmodium falciparum
Gene name
MT-CYB
Gene synonyms
COB, CYTB, MTCYB
NCBI Gene ID
—
Protein name
Cytochrome b
Protein synonyms
Complex III subunit 3, Complex III subunit III, Cytochrome b-c1 complex subunit 3, Ubiquinol-cytochrome-c reductase complex cytochrome b subunit
Uniprot ID
Mouse ortholog
—
—
Variants
No data
Financial
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Atovaquone – Amneal Pharmaceuticals
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Estimated US medical usage
Atovaquone
+
Proguanil
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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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,846 adverse events reported
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