Hydroxychloroquine
Hydroxychloroquine, Plaquenil, Sovuna (hydroxychloroquine) is a small molecule pharmaceutical. Hydroxychloroquine was first approved as Plaquenil on 1982-01-01. It is used to treat malaria, photosensitivity disorders, porphyria cutanea tarda, rheumatic diseases, and rheumatoid arthritis amongst others in the USA. The pharmaceutical is active against toll-like receptor 9 and toll-like receptor 7.
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Commercial
Trade Name
FDA
EMA
Hydroxychloroquine, Plaquenil, Sovuna (discontinued: Hydroxychloroquine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Hydroxychloroquine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PLAQUENIL | ADVANZ PHARMA | N-009768 RX | 1982-01-01 | 1 products, RLD, RS |
| SOVUNA | Novitium Pharma | N-214581 RX | 2022-01-14 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| hydroxychloroquine | ANDA | 2024-06-03 |
| hydroxychloroquine sulfate | ANDA | 2025-01-07 |
| hydroxychloroquinesulfate | ANDA | 2018-07-06 |
| plaquenil | New Drug Application | 2024-12-05 |
| sovuna | New Drug Application | 2024-09-11 |
Agency Specific
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Clinical
Clinical Trials
588 clinical trials
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Indications Phases 4
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatic diseases | D012216 | — | M79.0 | 1 | — | — | — | — | 1 |
| Immunosuppression therapy | D007165 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hydroxychloroquine |
| INN | hydroxychloroquine |
| Description | Hydroxychloroquine is an aminoquinoline that is chloroquine in which one of the N-ethyl groups is hydroxylated at position 2. An antimalarial with properties similar to chloroquine that acts against erythrocytic forms of malarial parasites, it is mainly used as the sulfate salt for the treatment of lupus erythematosus, rheumatoid arthritis, and light-sensitive skin eruptions. It has a role as an antimalarial, an antirheumatic drug, a dermatologic drug and an anticoronaviral agent. It is an aminoquinoline, an organochlorine compound, a primary alcohol, a secondary amino compound and a tertiary amino compound. It is functionally related to a chloroquine. It is a conjugate base of a hydroxychloroquine(2+). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12 |
Identifiers
| PDB | — |
| CAS-ID | 118-42-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1535 |
| ChEBI ID | 5801 |
| PubChem CID | 3652 |
| DrugBank | DB01611 |
| UNII ID | 4QWG6N8QKH (ChemIDplus, GSRS) |
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Estimated US medical usage
Hydroxychloroquine
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Safety
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66,689 adverse events reported
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