Dapsone
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | ACZONE | — | 2008-03-14 – 2019-09-10 | fda.gov ↗ |
| Approved | US (FDA) | DAPSONE | — | 1979-07-03 | fda.gov ↗ |
Trials 57 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 20 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03132194 Comparator | Aug 2016 → Jan 2017 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02929719 Comparator | Apr 2014 → Jun 2016 | acne | Sun Pharmaceutical Industries, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01773122 Comparator | Jan → May 2013 | acne | Allergan | Completed | No outcome recorded |
| Phase 1 | NCT01425320 Comparator | Jan → Jun 2013 | acne | Allergan | Withdrawn | No outcome recorded |
| Phase 1 | NCT02493283 Comparator | Sep 2011 → Jun 2012 | linear IgA Dermatosis, methemoglobinemia | University Medicine Greifswald | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00519467 Background | Jun 2003 → Feb 2005 | Plasmodium falciparum malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT05894954 Background | Jul 2023 → Oct 2025 | cognitive impairment with or without cerebellar ataxia, dementia | Alzheimer's Prevention and Reversal Project, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT04935476 Comparator | Nov 2021 → Mar 2022 | COVID-19 | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| Phase 3 | NCT02865005 Comparator | Feb → Nov 2016 | acne | Seegpharm S.A. | Completed | No outcome recorded |
| Phase 3 | NCT00371735 Background | Apr 2006 → May 2007 | Plasmodium falciparum malaria | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT02550080 Background | Jul 2015 → Dec 2018 | acne, allergic cutaneous vasculitis, leprosy, pneumocystosis +3 | Shandong Provincial Institute of Dermatology and Venereology | Unknown | No outcome recorded |
| Phase 4 | NCT01231334 Comparator | Aug 2010 → Jun 2011 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00964366 Comparator | Jul → Aug 2009 | acne | Stiefel, a GSK Company | Completed | No outcome recorded |
| Phase 4 | NCT00834210 Comparator | Dec 2008 → Sep 2009 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00835198 Comparator | Dec 2008 → Aug 2009 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00636935 Background | Feb 2008 → Aug 2013 | pneumocystosis | George Washington University | Withdrawn | No outcome recorded |
| Phase 4 | NCT00669643 Comparator | Feb 2007 → Sep 2012 | leprosy | University of Brasilia | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06819449 Comparator | Dec 2024 → Dec 2025 overdue | leprosy | South Valley University | Recruiting | No outcome recorded |
| — | NCT01870050 Comparator | Sep 2013 → Nov 2019 | prurigo | Cook County Health | Unknown | No outcome recorded |
| — | NCT00162383 Background | Jul 1995 → Dec 2020 | — | Hadassah Medical Organization | Unknown | No outcome recorded |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 79 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dapsone | “Bacterial or Viral infection treatment may include: Doxycycline, Minocycline, Nitazoxanide, Hydroxychloroquine, Rifampin, Dapsone, Azithromycin, Tetracycline, Benzathine...” NCT05894954 ↗76“Combination therapy of topical anti-inflammatory agent (Dapsone 5%) and anti-androgenic agent (Flutamide 2.5%) with anti-bacterial agent of micro-emulsion component (tea tree oil 5%)” NCT05899699 ↗ “Artesunate+chlorproguanil-dapsone (AS+CD) was a potential alternative for treatment of uncomplicated malaria.” PMID 18575626 ↗ Jun 2008 “antibiotics (Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone)” NCT00636935 ↗ “Doxycycline, Paramomycin, Clarithromycin, Clindamycin, Dapsone, Miltefosine” NCT02366884 ↗ “The active drug ingredient in ACZONE Gel, 5% is dapsone.” NCT00243542 ↗ “dapsone 7.5” NCT03132194 ↗ “Dapsone” NCT01885910 ↗ “Dapsone” NCT03681470 ↗ “dapsone” NCT02929719 ↗ |
| Known as | 4,4'-diaminodiphenylsulfone | “In 2 clinical trials of antimalarial preparations containing dapsone (4,4'-diaminodiphenylsulfone; 2.5 mg/kg once daily for 3 days), 95 G6PD-deficient hemizygous boys, 24...” PMID 22993389 ↗ Sep 2012 |
| Known as | ACZONE | “Research has demonstrated that Aczone ® (dapsone) gel, 7.5% used once daily is effective, safe, and well-tolerated for the treatment of acne” NCT03681470 ↗4“Dapsone (ACZONE) 7.5% gel topically once daily.” NCT02959970 ↗ “ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)” NCT04015375 ↗ “ACZONE (dapsone) Gel, 5%, 2x/day” NCT00249782 ↗ “ACZONE (dapsone) Gel, 5%” NCT00343187 ↗ |
| Known as | ACZONE (dapsone) Gel | “ACZONE® (dapsone) Gel” NCT00964366 ↗ |
| Known as | ACZONE (dapsone) Gel, 5% | “ACZONE™ (dapsone) Gel, 5%” NCT01115244 ↗ |
| Known as | Dapson-Fatol | “Administration of two tablets Dapson-Fatol 50 mg Tabletten (= 100 mg dapsone)” NCT02493283 ↗ |
| Known as | Dapsone Topical Gel | “Dapsone Topical Gel + adapalene gel 0.1%” NCT00151541 ↗ |
| Known as | DDS | “The combination of chlorproguanil HCl (CPG) and dapsone (DDS) as chlorproguanil-dapsone has already been shown to be efficacious against P.falciparum in adults and children in...” NCT00371735 ↗4“With minimal bactericidal activity, sulfone (diaminodiphenyl sulfone, or DDS), commonly referred to as dapsone, primarily acts as a bacteriostatic agent.” NCT06819449 ↗ “Chlorproguanil (CPG)-dapsone (DDS)-artesunate was in development for the treatment of uncomplicated Plasmodium falciparum malaria.” PMID 19517101 ↗ Jun 2009 “Dapsone (diamino diphenyl sulphone, DDS) was synthesized by Emil Fromm and Jakob Wittmann in Freiburg (Germany) in 1908.” NCT02493283 ↗ “Dapsone(DDS)-naive patients” NCT02550080 ↗ |
| Known as | diamino diphenyl sulphone | “Dapsone (diamino diphenyl sulphone, DDS) was synthesized by Emil Fromm and Jakob Wittmann in Freiburg (Germany) in 1908.” NCT02493283 ↗ |
| Known as | diaminodiphenyl sulfone | “With minimal bactericidal activity, sulfone (diaminodiphenyl sulfone, or DDS), commonly referred to as dapsone, primarily acts as a bacteriostatic agent.” NCT06819449 ↗ |
| Known as | Disulone | “Dapsone (Disulone®)” NCT02627417 ↗ |
| Known as | DTG | “5% Dapsone Topical Gel, (DTG)” NCT00151541 ↗ |
| Known as | rifampcin | “( dapsone \_ clofazimine \_ rifampcin) then to assess the role of Rab 32 gene.” NCT06819449 ↗ |
| Known as | rifampicin | “The primary bactericidal effect of rifampicin (RMP), a semi-synthetic derivative of rifamycin B, is observed.” NCT06819449 ↗ |
| Known as | RMP | “The primary bactericidal effect of rifampicin (RMP), a semi-synthetic derivative of rifamycin B, is observed.” NCT06819449 ↗ |
| Action | Inhibit | “its glutamate receptors antagonistic effect” NCT05131295 ↗ |
| Modality | Small molecule | “Dapsone is a "4,40-diamino diphenyl sulfone" compound” NCT05296460 ↗ |
| Route | Oral | “two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of...” NCT00000640 ↗ |