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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
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 | 2024-12-06 |
| 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
FDA
EMA
No data
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
No data
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 | 3 | — | 3 | 6 | — | 12 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | 1 | — | — | — | 1 |
| Exanthema | D005076 | HP_0000988 | — | — | 1 | — | — | — | 1 |
| Rosacea | D012393 | — | L71 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
Indications Without Phase
No data
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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Variants
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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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Number of persons purchased
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Trends
PubMed Central
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Additional graphs summarizing 11,151 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,693 adverse events reported
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