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Avlosulfon

(Dapsone)

ApprovedSmall molecule

AAlmirall, S.A.

Dapsone is used to treat certain skin infections like leprosy and a skin condition called dermatitis herpetiformis. It's also used to prevent and treat a type of pneumonia in people with weakened immune systems.[2] Avlosulfon is currently approved and in use across 23 indications[4].[1]

Avlosulfon is one of 535 small molecule programs targeting HIV infection. It is currently in Approved.

23

Indications

32

Total Trials

2

Active Trials

534

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

AllergyActive, not recruiting

Bullous PemphigoidActive, not recruiting

Pemphigus VulgarisActive, not recruiting

Aplastic AnemiaActive, not recruiting

IschemiaActive, not recruiting

VasculitisActive, not recruiting

StrokeApproved

PneumocystosisActive, not recruiting

RosaceaApproved

HIV InfectionPhase 1

Active, not recruiting

AllergyPhase 1

Active, not recruiting

Bullous PemphigoidApproved

Active, not recruiting

Pemphigus VulgarisPhase 2

Active, not recruiting

Aplastic AnemiaPreclinical

Active, not recruiting

IschemiaPhase 2/Phase 3

Active, not recruiting

VasculitisPhase 2

Active, not recruiting

StrokeApproved

Approved

PneumocystosisApproved

Active, not recruiting

RosaceaApproved

Approved

Showing 10 of 22 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Avlosulfon

AAlmirall, S.A.

Bnt162b2

Proventil

Mylan Pharmaceuticals Inc

Glucocorticoid

Nadroparin

HB-Admscs

HHope Biosciences Research Foundation

Antihypertensive Agents

NNational Heart, Lung, and Blood Institute (NHLBI)

Exoflo

DDirect Biologics, LLC

Sivelestat Sodium

TThe First Hospital of Jilin University

COVID-19 Vaccines

UUniversity of British Columbia

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 2Recruiting

Vasculitis

NCT02939573

Clinical

Trials by Indication[1]

Pneumonia4 trials

A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

Completed·JJacobus Pharmaceutical·N/A·NCT00002283

Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia

Completed·UU.S. Bioscience·Phase 1·NCT00002120·20 enrolled

Dapsone 100 Mg Versus 50 as Primary Prophylaxis for Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS-Related Complex (ARC)

Completed·JJacobus Pharmaceutical·N/A·NCT00002043

Show 1 more trial

A Study of Pentamidine Plus Dapsone in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients Who Cannot Take Trimethoprim or Sulfonamides

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001028·400 enrolled

Safety and Efficacy3 trials

Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

Completed·AAlmirall, S.A.·Phase 3·NCT01974323·2,238 enrolled

Safety and Efficacy Trial of ACZONE (Dapsone) Gel, 7.5% in 9 to 11 Year-Old Patients With Acne Vulgaris

Completed·AAlmirall, S.A.·Phase 4·NCT02959970·100 enrolled

A Safety and Efficacy Study of Dapsone Gel in Patients With Acne Vulgaris

Completed·AAlmirall, S.A.·Phase 3·NCT01974141·2,102 enrolled

Acne Vulgaris2 trials

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

Completed· AbbVie logo

AbbVie·Phase 4·NCT00834210·171 enrolled

A Study of Dapsone Gel in Females With Skin of Color and Acne Vulgaris

Completed· AbbVie logo

AbbVie·Phase 4·NCT02032407·68 enrolled

Hypersensitivity1 trial

Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome

Unknown status·SShandong Provincial Institute of Dermatology and Venereology·Phase 4·NCT02550080·3,130 enrolled

Aplastic Anemia1 trial

Methemoglobinemia in Young Patients With Hematologic Cancer or Aplastic Anemia Treated With Dapsone

Completed·VVanderbilt University··NCT00993694·41 enrolled

20 more indications

Prevention1 trial

A Study of Three Drugs Plus Zidovudine in the Prevention of Infections in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000991·600 enrolled

Prophylaxis1 trial

A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000802·700 enrolled

Immune Thrombocytopenia1 trial

Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia

Unknown status·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02627417·216 enrolled

Trichloroacetic Acid1 trial

DAPSONE GEL7.5%Versus Trichloroacetic Acid 20% ON ACNE VULGARIS

Unknown status·—·Phase 4·NCT05296460·30 enrolled

Allergy1 trial

Photoallergy Potential of Dapsone Gel in Healthy Volunteers

Completed·AAlmirall, S.A.·Phase 1·NCT02117739·58 enrolled

Ototoxicity1 trial

Phototoxicity Test of Dapsone Gel in Healthy Volunteers

Completed·AAlmirall, S.A.·Phase 1·NCT02108483·33 enrolled

Medication1 trial

Study to Determine and Compare the Tolerance and Irritation Potential of Topical Acne Medications

Completed· GSK logo

GSK·Phase 4·NCT00964366·53 enrolled

COVID-191 trial

Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment

Unknown status·HHunt Regional Medical Center·Phase 1·NCT04918914·100 enrolled

Pemphigus Vulgaris1 trial

Efficacy of Dapsone as a Steroid Sparing Agent in Pemphigus Vulgaris

Terminated·JJacobus Pharmaceutical·Phase 2·NCT00429533·48 enrolled

Vasculitis1 trial

A Randomized Multicenter Study for Isolated Skin Vasculitis

Recruiting·UUniversity of Pennsylvania·Phase 2·NCT02939573·90 enrolled

Subarachnoid Hemorrhage1 trial

Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.

Completed·EEl Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez·Phase 3·NCT05131295·49 enrolled

Lung Disease1 trial

Diffuse Fibrotic Lung Disease

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000596

Bullous Pemphigoid1 trial

Efficacy and Safety of add-on Dapsone Versus add-on Methotrexate in Patients With Bullous Pemphigoid

Completed·—·Phase 4·NCT05984381·62 enrolled

Leprosy1 trial

Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients

Recruiting·SSouth Valley University·N/A·NCT06819449·50 enrolled

Obesity1 trial

Effect of Weight and/or Obesity on Dapsone Drug Concentrations

Completed·TTexas Tech University Health Sciences Center·Phase 4·NCT01165840·37 enrolled

Ischemia1 trial

Dapsone for Acute Ischemia Stroke Study

Unknown status·CCidat, S.A. de C.V.·Phase 2/3·NCT01144650·300 enrolled

Tics1 trial

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

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000826·48 enrolled

Treatment1 trial

A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000640·290 enrolled

HIV infection1 trial

Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000739·96 enrolled

Unspecified2 trials

Dermal Tolerability of Dapsone Gel in Healthy Volunteers

Completed·AAlmirall, S.A.·Phase 1·NCT02117752·237 enrolled

Metabolic Capacity of Israeli Populations

Unknown status·HHadassah Medical Organization·N/A·NCT00162383·1,200 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 7, 2005

ACZONE

NDA NDA021794

Feb 24, 2016

ACZONE

NDA NDA207154

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Dapsone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Avlosulfon drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dapsone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dapsone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA207154). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Avlosulfon. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Almirall, S.A. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dihydropteroate Synthase 1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAlmirall, S.A.

Patent Landscape[6]

Patent Cliff

Nov 18, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11273132Nov 18, 2033

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