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Drug ReportsDapsone
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
Therapeutic Area
MeSH
infectionsD007239
musculoskeletal diseasesD009140
skin and connective tissue diseasesD017437
immune system diseasesD007154
Trade Name
FDA
EMA
Aczone (generic drugs available since 1982-01-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dapsone
Tradename
Company
Number
Date
Products
ACZONEAbbVieN-021794 RX2005-07-07
1 products, RLD, RS
ACZONEAlmirallN-207154 RX2016-02-24
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
011503 dapsone 6% / niacinamide 2% / spironolactone 5%unapproved drug other2020-07-02
011504 dapsone 8.5% / niacinamide 4%unapproved drug other2020-07-02
aczoneNew Drug Application2023-06-12
dapsoneANDA2024-01-31
dapsone 6% / niacinamide 2% / spironolactone 5%unapproved drug other2019-05-10
dapsone 6% / niacinamide 2% / tretinoin 0.025%unapproved drug other2019-05-03
dapsone 6% / niacinamide 4%unapproved drug other2019-04-23
dapsone 8.5% / niacinamide 2% / spironolactone 5%unapproved drug other2019-05-09
dapsone 8.5% / niacinamide 2% / tretinoin 0.025%unapproved drug other2019-05-02
dapsone 8.5% / niacinamide 4%unapproved drug other2019-04-23
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Dapsone, Aczone, Almirall
91619262033-11-18DP
95172192033-11-18U-1033
112731322033-11-18DP
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 vulgarisD000152EFO_0003894L705251325
Pneumocystis pneumoniaD011020EFO_0007448B59242210
Falciparum malariaD016778EFO_0007444B50224
LeprosyD007918EFO_0001054A301134
Dermatitis herpetiformisD003874L13.0112
PsoriasisD011565EFO_0000676L4011
UrticariaD014581EFO_0005531L5011
Vesiculobullous skin diseasesD012872EFO_1000774L10-L1411
Leukocytoclastic vasculitis cutaneousD018366EFO_1000974D69.011
ObesityD009765EFO_0001073E66.911
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8011
Iga vasculitisD011695EFO_1000965D69.011
Non-small-cell lung carcinomaD00228911
ExanthemaD005076HP_000098811
Kidney diseasesD007674EFO_0003086N08111
Kidney transplantationD016030111
PemphigusD010392EFO_1000749L1011
RosaceaD012393L7111
SarcoidosisD012507EFO_0000690D80-D8911
Lung diseasesD008171HP_0002088J98.411
Show 1 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients314
MethemoglobinemiaD008708D74112
Linear iga bullous dermatosisD062027EFO_0009313L12.211
MycosesD009181B35-B4911
Bacterial infectionsD001424A4911
Sars-cov-2D00008640211
HypoxiaD000860HP_0012418R09.0211
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AnemiaD000740HP_0001903D64.922
PrurigoD011536L28.211
LeukemiaD007938C9511
Myelodysplastic syndromesD009190D4611
Myeloproliferative disordersD009196D47.111
LymphomaD008223C85.911
Lymphoproliferative disordersD008232Orphanet_2442D47.911
Plasma cell neoplasmsD05421911
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDapsone
INNdapsone
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)Loading
Structure (InChI/SMILES or Protein Sequence)
Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Identifiers
PDB
CAS-ID80-08-0
RxCUI
ChEMBL IDCHEMBL1043
ChEBI ID4325
PubChem CID2955
DrugBankDB00250
UNII ID8W5C518302 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
Organism
Plasmodium falciparum 3D7
Gene name
Gene synonyms
NCBI Gene ID
Protein name
hydroxymethyldihydropterin pyrophosphokinase-dihydropteroate synthase
Protein synonyms
Uniprot ID
Mouse ortholog
Variants
No data
Financial
Revenue by drug
$
£
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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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 10,623 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,577 adverse events reported
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