Drug

Dapsone

Approved · FDA

ClassDihydropteroate synthase 1 inhibitorEmerging researchLate-stage development

Also known as 4-(4-amino-benzenesulfonyl)-phenylamine, 4-(4-aminophenylsulfonyl)aniline, 4-(4-aminophenylsulfonyl)benzenamine, 4-aminophenyl sulfone+25 more

4-(4-amino-benzenesulfonyl)-phenylamine, 4-(4-aminophenylsulfonyl)aniline, 4-(4-aminophenylsulfonyl)benzenamine, 4-aminophenyl sulfone, Aczone, Bis(p-aminophenyl) sulfone, DADPS, DDS, Dapsone Topical, Diaminodiphenylsulfone, Diaminodiphenylsulphone, Diaphenylsulfone, bis(4-aminophenyl)sulfone, p,p'-diaminodiphenyl sulfone, p,p-sulphonylbisbenzamine, p,p-sulphonylbisbenzenamine, p-aminophenyl sulfone, Dapsona, 1,1'-sulfonylbis(4-aminobenzene), 4,4'-Diaminodiphenyl sulphone, 4,4'-Diaminodiphenylsulfone, 4,4'-Sulfonylbisbenzenamine, 4,4'-Sulfonylbisbenzeneamine, 4,4'-Sulfonyldianilin, 4,4'-dapsone, 4,4'-diaminodiphenyl sulfone, 4,4'-sulfonylbisaniline, 4,4'-sulfonyldianiline, Dapsonum.

RxNorm3108 ChEMBLCHEMBL1043 ATCJ04BA02 ATCD10AX05UNII8W5C518302

Research papers

Active clinical trials

Dihydropteroate synthase

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: DAPSONE (ANDA218335)

Regulatory2026-07-08FDA

Approval: DAPSONE (ANDA213414)

Regulatory2026-06-25FDA

A Randomized Multicenter Study for Isolated Skin Vasculitis

Clinical trial2026-01-23Results expected Q4 2028 · ClinicalTrials.gov

Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients and Its Relation to Multiple Drug Therapy: Randomized Clinical Trial

Clinical trial2025-12-10Primary completion · ClinicalTrials.gov

Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial

Clinical trial2025-04-01Completed · ClinicalTrials.gov

Recall (Class II): DAPSONE

Regulatory2024-10-29FDA

Off Label Use of Dapsone in SARS-CoV-2 Hospitalized Patients

Clinical trial2021-12-31Primary completion · ClinicalTrials.gov

Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition

Clinical trial2020-12-01Primary completion · ClinicalTrials.gov

Dermatitis Herpetiformis: Novel Perspectives.

Research2019-06-11Frontiers in immunology

Prospective Multicenter Randomized Open-label Controlled Trial Assessing Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia

Clinical trial2019-05-01Primary completion · ClinicalTrials.gov

A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*1301) for Susceptibility to Dapsone Hypersensitivity Syndrome

Clinical trial2018-12-01Primary completion · ClinicalTrials.gov

A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris

Clinical trial2017-01-30Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Dapsone

Aliases & brands

4-(4-amino-benzenesulfonyl)-phenylamine4-(4-aminophenylsulfonyl)aniline4-(4-aminophenylsulfonyl)benzenamine4-aminophenyl sulfoneAczoneBis(p-aminophenyl) sulfoneDADPSDDSDapsone TopicalDiaminodiphenylsulfoneDiaminodiphenylsulphoneDiaphenylsulfonebis(4-aminophenyl)sulfonep,p'-diaminodiphenyl sulfonep,p-sulphonylbisbenzaminep,p-sulphonylbisbenzenaminep-aminophenyl sulfoneDapsona1,1'-sulfonylbis(4-aminobenzene)4,4'-Diaminodiphenyl sulphone4,4'-Diaminodiphenylsulfone4,4'-Sulfonylbisbenzenamine4,4'-Sulfonylbisbenzeneamine4,4'-Sulfonyldianilin4,4'-dapsone4,4'-diaminodiphenyl sulfone4,4'-sulfonylbisaniline4,4'-sulfonyldianilineDapsonum

RxNorm CUI

3108

ChEMBL ID

CHEMBL1043

ATC codes

J04BA02D10AX05

UNII

8W5C518302

Primary mechanism

Dihydropteroate synthase 1 inhibitor

Regulatory jurisdictions

fda

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Dihydropteroate synthase

folP1 · P0C0X1

INHIBITORDihydropteroate synthase 1 inhibitor

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2026-06-25

Latest approval

2026-07-08

Authorities

FDA

Total events

fdaU.S. Food and Drug Administration· 3 events

2026-07-08Approval

Approval: DAPSONE (ANDA218335)

Evidence ↗

2026-06-25Approval

Approval: DAPSONE (ANDA213414)

Evidence ↗

2024-10-29RecallSafety

Recall (Class II): DAPSONE

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Clinical trials

23 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 23

Early Phase 11Phase 14Phase 23Phase 2 / 31Phase 36Phase 44Phase N / A4

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial

CompletedPH IVAll India Institute of Medical Sciences, Bhubaneswarn=622025

A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*1301) for Susceptibility to Dapsone Hypersensitivity Syndrome

Unknown statusPH IVKey trialShandong Provincial Institute of Dermatology and Venereologyn=3,1302019

Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers

CompletedPH IVTexas Tech University Health Sciences Centern=372012

Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

CompletedPH IVAllergann=1712009

Prospective Multicenter Randomized Open-label Controlled Trial Assessing Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia

Unknown statusPH IIIAssistance Publique - Hôpitaux de Parisn=2162019

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid: A Randomized Controlled Trial

CompletedPH IVAll India Institute of Medical Sciences, Bhubaneswarn=622025

A Single-center, Double-blind, Randomized, Parallel-group Study, Comparing DPSG to a Placebo Control in the Treatment of Acne Vulgaris

CompletedPH ISun Pharmaceutical Industries, Inc.n=1,1252017

Population Pharmacokinetic Analysis of Dapsone in Normal, Overweight and Obese Volunteers

CompletedPH IVTexas Tech University Health Sciences Centern=372012

Dapsone Gel 5% and Tazarotene Cream 0.1% Versus Tazarotene Cream 0.1% Monotherapy for Facial Acne Vulgaris

CompletedPH IVAllergann=1712009

Neuroprotective Effect of Dapsone in Patients With Aneurysmal Subarachnoid Hemorrhage: Prospective, Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial

CompletedPH IIIEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarezn=492009

Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole and Dapsone and Their Hydroxylamine Metabolites

CompletedPH INational Institute of Allergy and Infectious Diseases (NIAID)n=481999

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Dermatitis Herpetiformis: Novel Perspectives.

Frontiers in immunology · 2019 · 51 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Clobetasol

Studied across 2 of the same disease areas as Dapsone in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.