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dapsone

Trade name: aczone

Small moleculeapproved

Approved

Jul 3, 1979

Dapsone was synthesized in 1908 by Fromm and Wittmann. The drug was approved by FDA for the treatment of such conditions as acne vulgaris, leprosy and dermatitis herpetiformis, also the drug is used off-label for many skin diseases. Although the exact mechanism of dapsone action is unknown, it is speculated that it acts as both anti-inflammatory and antimicrobial agent. It was demonstrated that dapsone suppresses ROS generation, inhibits neutrophil myeloperoxidase and eosinophil peroxidase and also inhibits bacterial dihydropteroate synthase. — NCATS

Clinical trial activity

80 trials · 105 clinical orgs · 27 marketing orgs

Phase 1
15
Phase 2
31
Phase 3
24
Phase 4
21

Earliest trial started Jun 1, 1978 (NCT00000596)

Timeline

1970s

  1. Jan 1, 1978

    Earliest Phase 2 Sponsor(trial)

  2. Jul 3, 1979

    Jacobus Pharmaceutical — Earliest FDA Approval

  3. Jul 3, 1979

    Jacobus Pharmaceutical — Marketing Organization

  4. Jul 3, 1979

    Jacobus Pharmaceutical — NDA Organization

  5. Jul 3, 1979

    Everest Medicines — Marketing Organization

1990s

  1. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jul 7, 2005

    Allergan — NDA Secondary Org

  2. Jul 7, 2005

    AbbVie — Marketing Organization

  3. Jul 7, 2005

    AbbVie — NDA Secondary Org

2010s

  1. Jan 7, 2016

    Alvogen — Marketing Organization

  2. Feb 24, 2016

    Almirall — NDA Secondary Org

  3. May 6, 2016

    Nostrum Laboratories — Marketing Organization

  4. May 10, 2016

    Virtus Pharms — Marketing Organization

  5. May 10, 2016

    ANDA Repository — Marketing Organization

  6. May 10, 2016

    Chartwell Pharmaceuticals — Marketing Organization

  7. Dec 1, 2016

    Novitium Pharma — Marketing Organization

  8. Mar 23, 2017

    Actavis — Marketing Organization

  9. Mar 23, 2017

    Allergan PLC (2015) — Marketing Organization

  10. Oct 16, 2017

    Taro Pharmaceuticals — Marketing Organization

  11. Oct 16, 2017

    Sun Pharmaceuticals — Marketing Organization

  12. May 8, 2019

    Sai Life Sciences — Marketing Organization

  13. May 8, 2019

    Rising Pharmaceuticals — Marketing Organization

2020s

  1. Apr 23, 2021

    Torrent Pharmaceuticals Limited — Marketing Organization

  2. Feb 4, 2022

    Mylan — Marketing Organization

  3. Mar 31, 2022

    Cosette — Marketing Organization

  4. May 31, 2023

    Amneal Pharmaceuticals — Marketing Organization

  5. Jun 6, 2023

    Acrux Ltd — Marketing Organization

  6. Jun 6, 2023

    TRUPHARMA — Marketing Organization

  7. Oct 13, 2023

    Encube Ethicals Pvt. Ltd. — Marketing Organization

  8. Oct 27, 2023

    Alembic — Marketing Organization

  9. Oct 31, 2023

    Padagis Us — Marketing Organization

  10. May 8, 2024

    Zydus Discovery DMCC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJul 3, 1979

Chemistry & pharmacology

Loading structure…

SMILES

NC1=CC=C(C=C1)S(=O)(=O)C2=CC=C(N)C=C2
Mol. weight
248.301 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Sources

Also known as

  • 1,1'-sulfonylbis(4-aminobenzene)
  • 1,1'-sulfonylbis(4-aminobenzene)
  • 1,1'-sulfonylbis[4-aminobenzene]
  • 1,1'-sulfonylbis[4-aminobenzene]
  • 4-(4-amino-benzenesulfonyl)-phenylamine
  • 4-(4-amino-benzenesulfonyl)-phenylamine
  • 4-(4-aminophenylsulfonyl)aniline
  • 4-(4-aminophenylsulfonyl)aniline
  • 4-(4-aminophenylsulfonyl)benzenamine
  • 4-(4-aminophenylsulfonyl)benzenamine
  • 4,4'-dapsone
  • 4,4'-dapsone
  • 4,4'-diaminodiphenylsulfone
  • 4,4'-diaminodiphenylsulfone
  • 4,4'-diaminodiphenyl sulfone
  • 4,4'-diaminodiphenyl sulfone
  • 4,4'-diaminodiphenyl sulphone
  • 4,4'-diaminodiphenyl sulphone
  • 4,4'-sulfonylbisaniline
  • 4,4'-sulfonylbisaniline
  • 4,4'-sulfonylbisbenzenamine
  • 4,4'-sulfonylbisbenzenamine
  • 4,4'-sulfonylbisbenzeneamine
  • 4,4'-sulfonylbisbenzeneamine
  • 4,4'-sulfonyldianilin
  • 4,4'-sulfonyldianilin
  • 4,4'-sulfonyldianiline
  • 4,4'-sulfonyldianiline
  • 4-aminophenyl sulfone
  • 4-aminophenyl sulfone
  • aczone
  • aczone
  • aczone
  • bis(4-aminophenyl)sulfone
  • bis(4-aminophenyl)sulfone
  • bis(p-aminophenyl) sulfone
  • bis(p-aminophenyl) sulfone
  • dadps
  • dadps
  • dapson
  • dapsona
  • dapsona
  • dapsone
  • dapsone
  • dapsone
  • dapsone
  • dapsone
  • dapsone
  • dapsone
  • dapsone
  • dapsone
  • dapsone
  • dapsone
  • dapsone mixture with pyrimethamine
  • dapsonum
  • dapsonum
  • dds
  • dds
  • diaminodiphenylsulfone
  • diaminodiphenylsulfone
  • diaphenylsulfon
  • diaphenylsulfone
  • diaphenylsulfone
  • diaphenylsulfone
  • diaphenylsulfone
  • p-aminophenyl sulfone
  • p-aminophenyl sulfone
  • p,p'-diaminodiphenyl sulfone
  • p,p'-diaminodiphenyl sulfone
  • p,p-sulphonylbisbenzamine
  • p,p-sulphonylbisbenzamine
  • p,p-sulphonylbisbenzenamine
  • p,p-sulphonylbisbenzenamine
  • sulphadione

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07244887Phase 4Jun 17, 2025Istanbul University
NCT06819449N/ADec 20, 2024South Valley University
NCT05984381Phase 4Aug 1, 2023All India Institute of Medical Sciences
NCT05899699Phase 2Jun 5, 2023Mansoura University
NCT05296460Phase 4Sep 1, 2022Assiut University
NCT05926869Phase 2Aug 1, 2022Jinnah Postgraduate Medical Centre, University of Karachi
NCT04935476Phase 3Nov 22, 2021McGill University, Pulmonem Inc.
NCT04918914Early Phase 1 (Phase 1)Oct 18, 2020Hunt Regional Medical Center
NCT04744623Phase 2/Phase 3 (Phase 3)Sep 30, 2020Tanta University
NCT04015375Phase 3Jul 31, 2019Catawba Clinical Research, Torrent Pharmaceuticals Limited
NCT03681470Phase 4Oct 1, 2018Icahn School of Medicine at Mount Sinai
NCT02939573Phase 2Jan 1, 2017National Center for Advancing Translational Science (NCATS), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH), University of Pennsylvania, University of Toronto
NCT02959970Phase 4Oct 31, 2016Allergan
NCT02944461Phase 4Oct 1, 2016Derm Research Incorporated, Derm Research, PLLC
NCT03132194Phase 1Aug 8, 2016Catawba Clinical Research, Taro Pharmaceuticals
NCT02730117N/AMar 1, 2016Chulalongkorn University
NCT02865005Phase 3Feb 1, 2016Catawba Clinical Research, Seegpharm S.A.
NCT02627417Phase 3Dec 1, 2015University of Paris
NCT02550080Phase 4Jul 1, 2015Dezhou People's Hospital,Shandong, Dongying People's Hospital, Shandong, Jinan University, Jining City Dermatology Hospital Prevention and Treatment, Laiwu City Dermatology Hospital Prevention and Treatment, Liaocheng People's Hospital, Linyi City Dermatology Hospital Prevention and Treatment, People's Liberation Army of China, Qingdao Center Medical Group, Rizhao City Dermatology Hospital Prevention and Treatment, Shandong Jining No. 1 People's Hospital, Shandong Province Qianfoshan Hospital, Shandong Provincial Hospital, Shandong Provincial Institute of Dermatology and Venereology, Weifang City Dermatology Hospital Prevention and Treatment
NCT02929719Phase 1Apr 1, 2014Catawba Clinical Research, Taro Pharmaceuticals
Showing 20 of 80 trials
Page 1 / 4

Organizations

Research & Development (105)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit171742005
Jacobus PharmaceuticalFor profit7341996
University of LondonAcademic/Hospital7732004
National Institute of Allergy and Infectious Diseases (NIAID)Government6621999
Catawba Clinical ResearchFor profit4022014
Centers for Disease Control and Prevention (CDC)Government4432004
GlaxoSmithKlineFor profit4332003
Novelion TherapeuticsFor profit4032005
National Institute for Medical Research, TanzaniaGovernment3012004
Derm Research, PLLCFor profit2212013
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezAcademic/Hospital2112007
Government of MalawiGovernment2012005
Institute of Tropical Medicine, BelgiumAcademic/Hospital2122005
Kilimanjaro Christian Medical College, TanzaniaAcademic/Hospital2012005
Rush UniversityAcademic/Hospital2121996
Taro PharmaceuticalsFor profit2212014
University of AntwerpAcademic/Hospital2022005
University of BarcelonaAcademic/Hospital2121995
University of LiverpoolAcademic/Hospital2022005
University of PennsylvaniaAcademic/Hospital2111996
105 organizations
Page 1 / 6

Marketing (32)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGMay 10, 2016
AbbVieFor profitMKTGJul 7, 2005
AbbVieFor profitNDA2Jul 7, 2005
Acrux LtdFor profitMKTGJun 6, 2023
ActavisFor profitMKTGMar 23, 2017
AlembicFor profitMKTGOct 27, 2023
AllerganFor profitNDA2Jul 7, 2005
Allergan PLC (2015)For profitMKTGMar 23, 2017
AlmirallFor profitNDA2Feb 24, 2016
AlvogenFor profitMKTGJan 7, 2016
Amneal PharmaceuticalsFor profitMKTGMay 31, 2023
Chartwell PharmaceuticalsFor profitMKTGMay 10, 2016
CosetteFor profitMKTGMar 31, 2022
Encube Ethicals Pvt. Ltd.For profitMKTGOct 13, 2023
Everest MedicinesFor profitMKTGJul 3, 1979
Jacobus PharmaceuticalFor profitMKTGJul 3, 1979
Jacobus PharmaceuticalFor profitNDAJul 3, 1979
MylanFor profitMKTGFeb 4, 2022
Nostrum LaboratoriesFor profitMKTGMay 6, 2016
Novitium PharmaFor profitMKTGDec 1, 2016
Padagis UsFor profitMKTGOct 31, 2023
Rising PharmaceuticalsFor profitMKTGMay 8, 2019
Sai Life SciencesFor profitMKTGMay 8, 2019
Sun PharmaceuticalsFor profitMKTGOct 16, 2017
TRUPHARMAFor profitMKTGJun 6, 2023
Taro PharmaceuticalsFor profitMKTGOct 16, 2017
Taro PharmaceuticalsFor profitSYNMar 1, 2019
Taro PharmaceuticalsFor profitSYNJun 26, 2019
Torrent Pharmaceuticals LimitedFor profitMKTGApr 23, 2021
Torrent Pharmaceuticals LimitedFor profitSYNFeb 10, 2022
Virtus PharmsFor profitMKTGMay 10, 2016
Zydus Discovery DMCCFor profitMKTGMay 8, 2024