Dapsone
Aczone, Dapsone (dapsone) is a small molecule pharmaceutical. Dapsone was first approved as Dapsone on 1982-01-01. It is used to treat aids-related opportunistic infections, dermatitis herpetiformis, lepromatous leprosy, and relapsing polychondritis in the USA. It is known to target hydroxymethyldihydropterin pyrophosphokinase-dihydropteroate synthase.
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Aczone, Dapsone (discontinued: Dapsone)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 011503 dapsone 6% / niacinamide 2% / spironolactone 5% | unapproved drug other | 2020-07-02 |
| 011504 dapsone 8.5% / niacinamide 4% | unapproved drug other | 2020-07-02 |
| aczone | New Drug Application | 2024-03-25 |
| dapsone | ANDA | 2024-11-04 |
| dapsone 100 mg dapsone 25 mg | ANDA | 2024-07-11 |
| dapsone 6% / niacinamide 2% / spironolactone 5% | unapproved drug other | 2019-05-10 |
| dapsone 6% / niacinamide 2% / tretinoin 0.025% | unapproved drug other | 2019-05-03 |
| dapsone 6% / niacinamide 4% | unapproved drug other | 2019-04-23 |
| dapsone 8.5% / niacinamide 2% / spironolactone 5% | unapproved drug other | 2019-05-09 |
| dapsone 8.5% / niacinamide 2% / tretinoin 0.025% | unapproved drug other | 2019-05-02 |
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Indications
FDA
EMA
Agency Specific
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EMA
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ATC Codes
D: Dermatologicals
— D10: Anti-acne preparations
— D10A: Anti-acne preparations for topical use
— D10AX: Other anti-acne preparations for topical use in atc
— D10AX05: Dapsone
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04B: Drugs for treatment of lepra
— J04BA: Drugs for treatment of lepra
— J04BA02: Dapsone
— J04BA50: Dapsone and rifampicin
— J04BA51: Dapsone, rifampicin and clofazimine
HCPCS
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Clinical
Clinical Trials
79 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acne vulgaris | D000152 | EFO_0003894 | L70 | 5 | 2 | 5 | 13 | — | 25 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | 2 | 8 | 2 | 3 | 15 |
| Pneumocystis pneumonia | D011020 | EFO_0007448 | B59 | 2 | — | 4 | 2 | 2 | 10 |
| Pneumonia | D011014 | EFO_0003106 | — | 2 | — | 4 | 1 | 2 | 9 |
| Falciparum malaria | D016778 | EFO_0007444 | B50 | — | — | 2 | 2 | 1 | 5 |
| Leprosy | D007918 | EFO_0001054 | A30 | 1 | 1 | — | 3 | — | 4 |
| Vasculitis | D014657 | HP_0002633 | — | — | 1 | — | 1 | — | 2 |
| Vascular skin diseases | D017445 | HP_0011276 | — | — | 1 | — | 1 | — | 2 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 1 | 1 | 1 | — | 2 |
| Skin diseases | D012871 | — | L00-L99 | 1 | — | — | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | — | 4 | — | 3 | 10 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | 1 | — | 1 | 4 |
| Communicable diseases | D003141 | — | — | 2 | — | 1 | — | 1 | 4 |
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | 2 | — | — | 2 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | — | 1 | — | — | 2 |
| Fever | D005334 | HP_0001945 | R50.9 | — | — | 1 | — | — | 1 |
| Vivax malaria | D016780 | EFO_0007445 | B51 | — | — | 1 | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | — | — | 1 | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | — | — | 1 | — | — | 1 |
| Benign mucous membrane pemphigoid | D010390 | — | L12.1 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | 1 | 2 |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | — | 1 | — | — | — | 1 |
| Polyarteritis nodosa | D010488 | EFO_0009012 | M30.0 | — | 1 | — | — | — | 1 |
| Purpura | D011693 | HP_0000979 | D69.2 | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | — | — | — | 1 |
| Exanthema | D005076 | HP_0000988 | — | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 1 |
| Kidney transplantation | D016030 | — | — | 1 | 1 | — | — | — | 1 |
| Pemphigus | D010392 | EFO_1000749 | L10 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | 1 | 4 |
| Methemoglobinemia | D008708 | — | D74 | 1 | — | — | — | 1 | 2 |
| Linear iga bullous dermatosis | D062027 | EFO_0009313 | L12.2 | 1 | — | — | — | — | 1 |
| Mycoses | D009181 | — | B35-B49 | 1 | — | — | — | — | 1 |
| Bacterial infections | D001424 | — | A49 | 1 | — | — | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | 1 | — | — | — | — | 1 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | HP_0001903 | D64.9 | — | — | — | — | 2 | 2 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
| Prurigo | D011536 | — | L28.2 | — | — | — | — | 1 | 1 |
| Leukemia | D007938 | — | C95 | — | — | — | — | 1 | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | — | — | — | 1 | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | — | — | — | 1 | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | — | — | — | 1 | 1 |
| Lymphoma | D008223 | — | C85.9 | — | — | — | — | 1 | 1 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | — | — | — | — | 1 | 1 |
| Lymphoproliferative disorders | D008232 | Orphanet_2442 | D47.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Dapsone |
| INN | dapsone |
| Description | Dapsone is a sulfone that is diphenylsulfone in which the hydrogen atom at the 4 position of each of the phenyl groups is substituted by an amino group. It is active against a wide range of bacteria, but is mainly employed for its actions against Mycobacterium leprae, being used as part of multidrug regimens in the treatment of all forms of leprosy. It has a role as an antimalarial, a leprostatic drug, an antiinfective agent and an anti-inflammatory drug. It is a sulfone and a substituted aniline. It is functionally related to a diphenyl sulfone. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 80-08-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1043 |
| ChEBI ID | 4325 |
| PubChem CID | 2955 |
| DrugBank | DB00250 |
| UNII ID | 8W5C518302 (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
Organism
Plasmodium falciparum 3D7
Gene name
Gene synonyms
NCBI Gene ID
Protein name
hydroxymethyldihydropterin pyrophosphokinase-dihydropteroate synthase
Protein synonyms
Uniprot ID
Mouse ortholog
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Aczone – Allergan
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Aczone – Warner Chilcott
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Estimated US medical usage
Dapsone
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 10,975 documents
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Safety
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Adverse Events
Top Adverse Reactions
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3,406 adverse events reported
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