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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 14 indications[4].[1]

Avlosulfon is one of 227 small molecule programs targeting Acne. It is currently in Approved.

14

Indications

32

Total Trials

2

Active Trials

226

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

AcneActive, not recruiting

Dermatitis HerpetiformisActive, not recruiting

PneumocystosisActive, not recruiting

LeprosyActive, not recruiting

MalariaApproved

Mucous Membrane PemphigoidApproved

StrokeApproved

RosaceaApproved

Aplastic AnemiaActive, not recruiting

PneumoniaActive, not recruiting

AcneApproved

Active, not recruiting

Dermatitis HerpetiformisApproved

Active, not recruiting

PneumocystosisApproved

Active, not recruiting

LeprosyApproved

Active, not recruiting

MalariaApproved

Approved

Mucous Membrane PemphigoidApproved

Approved

StrokeApproved

Approved

RosaceaApproved

Approved

Aplastic AnemiaPreclinical

Active, not recruiting

PneumoniaPreclinical

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Avlosulfon

AAlmirall, S.A.

Cagrilintide

Retatrutide

Decadron

AAspen Global Incorporated

Revlimid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Gemtesa

Sumitomo Pharma America, Inc.

Berobenatide

Mibavademab

Elecoglipron

Survodutide

Boehringer Ingelheim

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

Timeline

Expected Milestones

Q4 2028

Phase 2Recruiting

Primary Cutaneous Vasculitis

NCT02939573

Clinical

Trials by Indication[1]

Pneumonia4 trials

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

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

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

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

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

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

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

Acne Vulgaris2 trials

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

Completed· AbbVie logo

AbbVie·Phase 4·NCT02032407·68 enrolled

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

Lung Disease1 trial

Diffuse Fibrotic Lung Disease

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

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

20 more indications

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

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

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

Ischemia1 trial

Dapsone for Acute Ischemia Stroke Study

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

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

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

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

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

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

Ototoxicity1 trial

Phototoxicity Test of Dapsone Gel in Healthy Volunteers

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

Obesity1 trial

Effect of Weight and/or Obesity on Dapsone Drug Concentrations

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

Aplastic Anemia1 trial

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

Completed·VVanderbilt University··NCT00993694·41 enrolled

Leprosy1 trial

Rab 32 Gene Polymorphisms as a Prognostic Factor in Leprosy Patients

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

Primary Cutaneous Vasculitis1 trial

A Randomized Multicenter Study for Isolated Skin Vasculitis

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