Hydroxychloroquine
Plaquenil (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 7 and toll-like receptor 9.
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COVID-19
Case Study: COVID-19
Commercial
Trade Name
FDA
EMA
Plaquenil (generic drugs available since 1994-09-30)
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 |
|---|---|---|
| hydroxychloroquine sulfate | ANDA | 2023-05-31 |
| plaquenil | New Drug Application | 2023-03-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| malaria | EFO_0001068 | D008288 | B54 |
| photosensitivity disorders | — | D010787 | L57.1 |
| porphyria cutanea tarda | — | D017119 | E80.1 |
| rheumatic diseases | — | D012216 | M79.0 |
| rheumatoid arthritis | EFO_0000685 | D001172 | M06.9 |
| systemic lupus erythematosus | EFO_0002690 | D008180 | M32 |
Agency Specific
FDA
EMA
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Patent Expiration
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HCPCS
No data
Clinical
Clinical Trials
413 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | 8 | 59 | 69 | 22 | 17 | 153 | |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | 8 | 12 | 8 | 29 |
| Sars-cov-2 | D000086402 | 1 | 13 | 11 | 2 | 1 | 25 | ||
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | 1 | 7 | 12 | 3 | 3 | 23 |
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | — | 5 | 8 | 1 | — | 13 | |
| Antiphospholipid syndrome | D016736 | EFO_0002689 | D68.61 | — | 2 | 2 | 1 | 2 | 7 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | 3 | 1 | 3 | — | 7 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | 1 | 1 | 1 | 2 | 5 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | — | 2 | — | 4 |
| Spontaneous abortion | D000022 | EFO_1001255 | O00.1 | — | 1 | 1 | 1 | — | 3 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Coronavirus | D017934 | — | 3 | 8 | — | 1 | 12 | ||
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | 4 | 7 | — | — | 9 |
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | 3 | 3 | — | 2 | 6 |
| Pregnancy rate | D018873 | — | — | 1 | — | 3 | 4 | ||
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | 2 | 2 | — | 1 | 4 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | 1 | 1 | 2 | — | — | 3 |
| Virus diseases | D014777 | B34 | — | 1 | 2 | — | — | 3 | |
| Respiratory tract infections | D012141 | J06.9 | — | — | 2 | — | — | 2 | |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | 1 | 2 | — | — | 2 |
| Hiv | D006678 | O98.7 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 6 | 11 | — | — | — | 15 |
| Neoplasms | D009369 | C80 | 9 | 4 | — | — | — | 12 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 6 | — | — | — | 8 |
| Prostatic neoplasms | D011471 | C61 | 4 | 6 | — | — | — | 8 | |
| Colorectal neoplasms | D015179 | 2 | 5 | — | — | — | 6 | ||
| Non-small-cell lung carcinoma | D002289 | 2 | 4 | — | — | — | 5 | ||
| Melanoma | D008545 | 4 | 2 | — | — | — | 4 | ||
| Renal cell carcinoma | D002292 | 4 | 2 | — | — | — | 4 | ||
| Gastrointestinal neoplasms | D005770 | C26.9 | 2 | 2 | — | — | — | 3 | |
| Lung neoplasms | D008175 | C34.90 | 1 | 3 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | C90.0 | 2 | — | — | — | — | 2 | |
| Plasma cell neoplasms | D054219 | 1 | — | — | — | — | 1 | ||
| Myeloid leukemia acute | D015470 | C92.0 | 1 | — | — | — | — | 1 | |
| Lymphangioleiomyomatosis | D018192 | J84.81 | 1 | — | — | — | — | 1 | |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | — | — | — | — | 1 |
| Muscle cramp | D009120 | HP_0003394 | 1 | — | — | — | — | 1 | |
| Rheumatic diseases | D012216 | M79.0 | 1 | — | — | — | — | 1 | |
| Immunosuppression therapy | D007165 | 1 | — | — | — | — | 1 | ||
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | — | 1 |
| Pancreatic ductal carcinoma | D021441 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | — | — | 2 | 2 |
| Hashimoto disease | D050031 | EFO_0003779 | E06.3 | — | — | — | — | 2 | 2 |
| Immunotherapy | D007167 | — | — | — | — | 1 | 1 | ||
| Cytokine release syndrome | D000080424 | D89.83 | — | — | — | — | 1 | 1 | |
| Undifferentiated connective tissue diseases | D000074079 | — | — | — | — | 1 | 1 | ||
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | — | — | — | — | 1 | 1 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | — | — | 1 | 1 | |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | — | — | — | 1 | 1 |
| Chronic urticaria | D000080223 | L50.8 | — | — | — | — | 1 | 1 | |
| Xerostomia | D014987 | K11.7 | — | — | — | — | 1 | 1 |
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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 | 5521 |
| ChEMBL ID | CHEMBL1535 |
| ChEBI ID | 5801 |
| PubChem CID | 3652 |
| DrugBank | DB01611 |
| UNII ID | 4QWG6N8QKH (ChemIDplus, GSRS) |
Target
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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5,801 adverse events reported
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