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Priya Life Science Compound trial record
Compound · clinical trials

Dapsone clinical trials

Also listed in trial records as Diaminodiphenylsulfone, Rifampcin
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our Canada, Japan and Egypt registers that name Dapsone as an intervention. Synced 10 Nov 2026
2Current trials
2Recruiting now
2Lead sponsors
3Country registers
At a glance

Dapsone is named as an intervention in 2 current clinical trials in our Canada, Japan and Egypt registers. 2 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is University of Pennsylvania (1). The most-studied condition is Primary Cutaneous Vasculitis.

Where Dapsone is approved

All regulators →

Of the three regulators tracked here, the first to approve Dapsone was the US, on 7 Jul 2005. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
7 Jul 2005
Aczone
NDA021794 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
15 Jun 2006
Aczone
Notice of Compliance 8028
First new-drug NOC
  • 1 EU orphan designation, most recently for treatment of acute uncomplicated plasmodium falciparum malaria (26 Jul 2002, negative)

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Dapsone patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Dapsone, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Aczone
  • 1 listed patent; the last listed expires 18 Nov 2033 (US 11273132).
See the Orange Book listing for NDA 021794
Patents and exclusivities above are pooled across 2 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Dapsone

All medicines →
ENNHS England
£225k
21,738 items dispensed, Sep 2025 to Aug 2026
-17% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$4.4m
54,610 prescriptions in 2025 · Dapsone, Dapsone, dapsone
-10% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Dapsone works

All drug targets →
  • Dihydropteroate synthase 1 inhibitor Inhibitor
    ChEMBL only
Diseases it has been tested for in clinical trials, by furthest phase
  • COVID-19Phase 3
  • Plasmodium falciparum malariaPhase 3
  • Plasmodium vivax malariaPhase 3
  • Autoimmune thrombocytopenic purpuraPhase 3
  • MalariaPhase 3
  • Subarachnoid hemorrhagePhase 3
  • Ischemic strokePhase 2/3
  • Mucous membrane pemphigoidPhase 2/3
  • Cutaneous polyarteritis nodosaPhase 2
  • ExanthemPhase 2
15 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1043, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10934, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Dapsone

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Dapsone

ATC codes
J04BA02, D10AX05
ChEMBL
CHEMBL1043
DrugBank
DB00250
PubChem CID
2955
CAS number
80-08-0
FDA UNII
8W5C518302
Wikidata
Q422226
Wikipedia
Dapsone

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting2100%

Trials by phase

  • Phase 2150%
  • Not applicable150%
01

Clinical trials of Dapsone

2 trials
StudyPhaseStatusLead sponsorRegisters
A Randomized Multicenter Study for Isolated Skin Vasculitis
NCT02939573 · ClinicalTrials.gov ↗ · Primary Cutaneous Vasculitis, Cutaneous Polyarteritis Nodosa, IgA Vasculitis
Phase 2 Recruiting University of Pennsylvania Canada, Japan
Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients
NCT06819449 · ClinicalTrials.gov ↗ · Leprosy, Mycobacterium Leprae Infection
Not applicable Recruiting South Valley University Egypt

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied with Dapsone

6 conditions
Primary Cutaneous Vasculitis1Cutaneous Polyarteritis Nodosa1IgA Vasculitis1Henoch-Schönlein Purpura1Leprosy1Mycobacterium Leprae Infection1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
University of Pennsylvania1
South Valley University1
04

By country register

RegisterTrialsRecruiting
Clinical trials in Canada11
Clinical trials in Japan11
Clinical trials in Egypt11

A trial with sites in more than one country appears in each of those registers.

05

Related compounds

06

Questions about Dapsone trials

How many clinical trials are testing Dapsone?

2 current trials in our Canada, Japan and Egypt registers name Dapsone as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Dapsone trials recruiting patients?

Yes. 2 of the 2 trials are recruiting: 1 with sites in Canada, 1 with sites in Japan and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Dapsone clinical trials?

University of Pennsylvania (1) and South Valley University (1). The number in brackets is how many trials each organisation leads.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Dapsone works or whether it is effective, and it is not medical advice.

Approvals, shortages and trials, every Friday

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Dapsone works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Dapsone (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.