Drugs / Dapsone
Dapsone
also known as
ACZONE · DDS · 4,4'-diaminodiphenylsulfone · ACZONE (dapsone) Gel · ACZONE (dapsone) Gel, 5% · Dapson-Fatol · Dapsona · Dapsone Topical Gel · +11 more
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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04918914 | Oct 2020 → Dec 2021 | COVID-19, acute respiratory distress syndrome | Hunt Regional Medical Center | Unknown | No outcome recorded |
| Phase 18 trials | ||||||
| Phase 1 | NCT02117739 | Apr → Jul 2014 | — | Almirall, S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02117752 | Apr → Jul 2014 | — | Almirall, S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02108483 | Apr → May 2014 | — | Almirall, S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01785836 | Mar → Oct 2013 | acne | Allergan | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00126971 | Jul 2005 → ? | Plasmodium falciparum malaria | Centers for Disease Control and Prevention | Terminated | No outcome recorded |
| Phase 1 | NCT00002120 | — | HIV infectious disease, pneumocystosis | U.S. Bioscience | Completed | No outcome recorded |
| Phase 1 | NCT00000826 | ? → May 1999 | HIV infectious disease, bacterial infectious disease, fungal infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00000739 | ? → Jun 1998 | HIV infectious disease, pneumocystosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 28 trials · 1 missed | ||||||
| Phase 2 | NCT05899699 | Jun → Sep 2023 | acne | Mansoura University | Unknown | No outcome recorded |
| Phase 2 | NCT05926869 | Aug → Dec 2022 | acne | Jinnah Postgraduate Medical Centre | Completed | No outcome recorded |
| Phase 2 | NCT02939573 | Jan 2017 → Dec 2028 expected | cutaneous polyarteritis nodosa, cutaneous vasculitis, immunoglobulin A vasculitis | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT02366884 | Jul 2011 → Dec 2022 | neoplasm | Dr. Frank Arguello Cancer Clinic | Unknown | No outcome recorded |
| Phase 2 | NCT00343187 | Jun 2006 → Jul 2007 | exanthem, non-small cell lung carcinoma | Allergan | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00249782 | Nov 2005 → May 2006 | rosacea | Allergan | Completed | No outcome recorded |
| Phase 2 | NCT00429533 | Nov 1996 → Feb 2004 | pemphigus vulgaris | Jacobus Pharmaceutical | Terminated | Missed primary |
| Phase 2 | NCT00000596 | Jun 1978 → Jan 1983 | pulmonary fibrosis, sarcoidosis | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2/33 trials · 2 met primary | ||||||
| Phase 2/3 | NCT04744623 | Sep → Dec 2020 | mucous membrane pemphigoid | Tanta University | Unknown | No outcome recorded |
| Phase 2/3 | NCT01144650 | Jul 2009 → Aug 2010 | stroke disorder | Cidat, S.A. de C.V. | Unknown | Met primary |
| Phase 2/3 | NCT00158574 | Jan 2005 → Apr 2008 | malaria | London School of Hygiene and Tropical Medicine | Completed | Met primary |
| Phase 317 trials · 1 met primary · 2 missed | ||||||
| Phase 3 | NCT04015375 | Jul 2019 → Feb 2020 | acne | Torrent Pharmaceuticals Limited | Completed | No outcome recorded |
| Phase 3 | NCT02627417 | Dec 2015 → May 2019 | autoimmune thrombocytopenia | Assistance Publique - Hôpitaux de Paris | Unknown | Missed primary |
| Phase 3 | NCT01974323 | Nov 2013 → Oct 2014 | acne | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01974141 | Nov 2013 → Oct 2014 | acne | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01931150 | Aug 2013 → Sep 2015 | acneiform dermatitis, cancer | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT05131295 | Sep 2007 → Dec 2008 | acquired aneurysmal subarachnoid hemorrhage, brain ischemia, intracranial vasospasm | El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez | Completed | No outcome recorded |
| Phase 3 | NCT00393679 | Jul 2007 → Dec 2009 | malaria | Institute of Tropical Medicine, Belgium | Completed | Mixed |
| Phase 3 | NCT00361114 | Jul 2006 → Aug 2007 | malaria | London School of Hygiene and Tropical Medicine | Terminated | No outcome recorded |
| Phase 3 | NCT00344006 | Jun 2006 → Aug 2007 | Plasmodium falciparum malaria | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00151541 | Feb → Jul 2005 | acne | Allergan | Completed | No outcome recorded |
| Phase 3 | NCT00118794 | Sep 2004 → Jun 2005 | malaria | London School of Hygiene and Tropical Medicine | Completed | Missed primary |
| Phase 3 | NCT00158561 | Feb 2004 → Mar 2006 | Plasmodium vivax malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 3 | NCT00146731 | Jan 2004 → Sep 2007 | malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 3 | NCT00000640 | ? → Sep 1994 | HIV infectious disease, pneumocystosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00000991 | ? → Apr 1994 | HIV infectious disease, pneumocystosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00001028 | ? → Jun 1994 | HIV infectious disease, pneumocystosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 3 | NCT00000802 | ? → Jul 1997 | HIV infectious disease, pneumocystosis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT07244887 | Jun 2025 → Feb 2026 | acne | Oya Helin Dundar | Completed | No outcome recorded |
| Phase 4 | NCT05984381 | Aug 2023 → Jan 2025 | bullous pemphigoid | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT05296460 | Sep 2022 → Oct 2023 | acne | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT03681470 | Apr 2019 → May 2021 | acne | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 4 | NCT02959970 | Oct 2016 → Mar 2018 | acne | Almirall, S.A. | Completed | No outcome recorded |
| Phase 4 | NCT02944461 | Oct 2016 → Sep 2017 | acne | Derm Research, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT02032407 | Dec 2013 → Jun 2014 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT01885910 | Jul 2013 → Jul 2014 | acne | Derm Research, PLLC | Completed | No outcome recorded |
| Phase 4 | NCT01313728 | Dec 2010 | acne | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01165840 | Jul 2010 → May 2012 | leprosy, obesity disorder, tuberculosis | Texas Tech University Health Sciences Center | Completed | No outcome recorded |
| Phase 4 | NCT01115244 | Jul 2010 → Mar 2012 | dermatitis herpetiformis | Vanderbilt University Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00243542 | Nov 2005 → Oct 2006 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00119145 | Jun 2005 → May 2006 | malaria | London School of Hygiene and Tropical Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00164359 | Apr → Sep 2005 | Plasmodium falciparum malaria | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase 4 | NCT00164710 | Apr → Sep 2005 | Plasmodium falciparum malaria | Centers for Disease Control and Prevention | Completed | No outcome recorded |
| Phase not applicable5 trials · 1 missed | ||||||
| — | NCT00461578 | Apr 2005 → Oct 2006 | malaria | London School of Hygiene and Tropical Medicine | Completed | Missed primary |
| — | NCT00111163 | Mar 2004 → Mar 2006 | anemia, malaria | Centers for Disease Control and Prevention | Completed | Mixed |
| — | NCT00497471 | Feb 1995 → Jul 1999 | Plasmodium falciparum malaria, iron deficiency anemia | Hospital Clinic of Barcelona | Terminated | No outcome recorded |
| — | NCT00002043 | — | HIV infectious disease, pneumocystosis | Jacobus Pharmaceutical | Completed | No outcome recorded |
| — | NCT00002283 | — | HIV infectious disease, pneumocystosis | Jacobus Pharmaceutical | Completed | No outcome recorded |
| Comparator or background therapy20 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 Stop: Enrollment |
| Phase 1 | NCT02493283 Comparator | Sep 2011 → Jun 2012 | linear IgA Dermatosis, methemoglobinemia | University Medicine Greifswald | Completed | No outcome recorded |
| Phase 2 | NCT00519467 Background | Jun 2003 → Feb 2005 | Plasmodium falciparum malaria | GlaxoSmithKline | Completed | Met primary |
| 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 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 | Missed primary |
| Phase 4 | NCT00835198 Comparator | Dec 2008 → Aug 2009 | acne | Allergan | Completed | No outcome recorded |
| Phase 4 | NCT00834210 Comparator | Dec 2008 → Sep 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-06-23 | AbbVie | Regulatory AbbVie Announces European Commission Approval of MAVIRET® (Glecaprevir/Pibrentasvir) for People with Acute Hepatitis C Virus Infection abbvie.com ↗
MAVIRET ® (glecaprevir/pibrentasvir) is now approved in the European Union for the treatment of acute hepatitis C virus (HCV) infection with compensated liver disease (with or without cirrhosis) in adults and children aged 3 years and older. |
| 2026-06-01 | Alembic Pharmaceuticals Ltd. | Regulatory 26th June, 2026 Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5%. |
| 2026-05-22 | AbbVie | Regulatory AbbVie Announces Positive CHMP Opinion for MAVIRET® (glecaprevir/pibrentasvir) for the Treatment of Acute Hepatitis C Infection abbvie.com ↗ |
| 2024-05-09 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Dapsone Gel, 7.5% zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) to market Dapsone Gel, 7.5%, (USRLD: Aczone® Gel 7.5%). |
| 2024-01-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release USFDA Products Approvals For the Qtr ended 31st Dec, 2023 alembicpharmaceuticals.com ↗ |
| 2023-07-03 | Impax Laboratories, LLC | Regulatory Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter amneal.com ↗
In addition, the Company announced it has received Abbreviated New Drug Application (ANDA) approvals from the U.S. Food and Drug Administration (“FDA”) for five complex generics products. |
| 2020-01-15 | GlaxoSmithKline | Regulatory Dovato (dolutegravir/lamivudine), the once-daily, single-pill, 2-drug regimen for the treatment of HIV-1 infection, granted marketing approval by Japan Ministry of Health, Labour and Welfare gsk.com ↗
Japan and UK ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that it has obtained approval of Dovato (dolutegravir 50 mg/lamivudine 300 mg) from the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, to be administered orally, with or without food. |
| 2019-08-02 | AbbVie | Regulatory AbbVie's MAVIRET™ (glecaprevir/pibrentasvir) Approved by European Commission to Shorten Treatment Duration to Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis abbvie.com ↗ |
| 2017-07-28 | AbbVie | Regulatory European Commission Grants AbbVie's MAVIRET® (glecaprevir/pibrentasvir) Marketing Authorization for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6) abbvie.com ↗
AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the European Commission has granted marketing authorization for MAVIRET® (glecaprevir/pibrentasvir), a once-daily, ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major genotypes (GT1-6). |
All press releases naming this drug 9 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 80 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” NCT02929719 ↗ “Dapsone” NCT01885910 ↗ “Dapsone” NCT03681470 ↗ |
| 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 | Dapsona | ChEMBL registry synonym — accepted as the source's own label CHEMBL1043 ↗ |
| Known as | Dapsone Topical Gel | “Dapsone Topical Gel + adapalene gel 0.1%” NCT00151541 ↗ |
| Known as | Dapsonum | ChEMBL registry synonym — accepted as the source's own label CHEMBL1043 ↗ |
| 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 | Diaphenylsulfone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1043 ↗ |
| Known as | Disulone | “Dapsone (Disulone®)” NCT02627417 ↗ |
| Known as | DTG | “5% Dapsone Topical Gel, (DTG)” NCT00151541 ↗ |
| Known as | J04BA02 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1043 ↗ |
| Known as | Novophone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1043 ↗ |
| Known as | NSC-6091 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1043 ↗ |
| Known as | NSC-6091D | ChEMBL registry synonym — accepted as the source's own label CHEMBL1043 ↗ |
| Known as | Servidapson | ChEMBL registry synonym — accepted as the source's own label CHEMBL1043 ↗ |
| 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 ↗ |