CLINICAL TRIALS PROFILE FOR DAPSONE

All Clinical Trials for DAPSONE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000596 ↗	Diffuse Fibrotic Lung Disease	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1978-06-01	To determine the effects of cyclophosphamide compared with prednisone, dapsone, or high-dose intermittent 'pulse' therapy with methylprednisolone in patients with idiopathic pulmonary fibrosis. Also, to evaluate the use of intermittent, short-term, high-dose intravenous corticosteroids in patients with sarcoidosis. There were actually four separate clinical trials.
NCT00000640 ↗	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	Glaxo Wellcome	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	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	Jacobus Pharmaceutical	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	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	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000666 ↗	A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).
NCT00000739 ↗	Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection	Completed	Jacobus Pharmaceutical	Phase 1	1969-12-31	Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children. Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthrough in children receiving two different dose regimens of dapsone. Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.

Clinical Trial Conditions for DAPSONE

Condition Name

Condition Name for DAPSONE
Intervention	Trials
Acne Vulgaris	22
Malaria	13
HIV Infections	11
Pneumonia, Pneumocystis Carinii	8

Condition MeSH

Condition MeSH for DAPSONE
Intervention	Trials
Acne Vulgaris	23
Malaria	17
HIV Infections	11
Pneumonia, Pneumocystis	10

Clinical Trial Locations for DAPSONE

Trials by Country

Trials by Country for DAPSONE
Location	Trials
United States	225
Malawi	8
Tanzania	7
Canada	7
Burkina Faso	3

Trials by US State

Trials by US State for DAPSONE
Location	Trials
California	21
Pennsylvania	15
New York	15
Florida	11
North Carolina	11

Clinical Trial Progress for DAPSONE

Clinical Trial Phase

Clinical Trial Phase for DAPSONE
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	1
Phase 4	22

Clinical Trial Status

Clinical Trial Status for DAPSONE
Clinical Trial Phase	Trials
Completed	60
Recruiting	8
Unknown status	7

Clinical Trial Sponsors for DAPSONE

Sponsor Name

Sponsor Name for DAPSONE
Sponsor	Trials
Allergan	23
National Institute of Allergy and Infectious Diseases (NIAID)	9
Jacobus Pharmaceutical	7

Sponsor Type

Sponsor Type for DAPSONE
Sponsor	Trials
Other	140
Industry	64
NIH	15

Clinical Trials Update, Market Analysis, and Projection for DAPSONE

Last updated: October 26, 2025

Introduction

Dapsone, also known by its chemical name 4,4'-Diaminodiphenylsulfone, is a well-established antimicrobial agent primarily used to treat leprosy, dermatitis herpetiformis, and certain pneumocystis infections. With a longstanding history in medicine, recent developments and ongoing clinical trials suggest expanding indications and new formulations. This article provides a comprehensive update on Dapsone’s clinical trials, analyzes its current market landscape, and offers projections based on emerging trends.

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Clinical Trials Update

Current Status and Focus Areas

Over the past year, multiple clinical trials have addressed Dapsone's expanding therapeutic potential. The most notable themes include its application in dermatology, infectious diseases, and emerging indications such as autoimmune disorders.

1. Dermatitis Herpetiformis and Enigmatic Skin Conditions
   Several studies focus on Dapsone’s efficacy and safety profile in managing dermatitis herpetiformis (DH), a gluten-sensitive blistering skin disease. Recent phase III trials affirm its continued role as the first-line therapy, showcasing manageable side effects with improved patient compliance through optimized dosing regimens [1].

2. Leprosy and Multidrug Therapy (MDT)
   Although Dapsone remains a core component of WHO-recommended multidrug therapy for leprosy, multiple ongoing trials seek to streamline dosing, mitigate resistance development, and evaluate safety in pediatric populations. A notable recent trial reported no significant adverse events over prolonged therapy (up to 24 months), supporting its continued use [2].

3. Autoimmune and Inflammatory Disorders
   Emerging research explores Dapsone's immunomodulatory effects in conditions such as vasculitis, rheumatic diseases, and perhaps, COVID-19 related inflammatory syndromes. An ongoing phase II trial investigates its role as an adjunct in autoimmune blistering disorders, with preliminary data suggesting reduced disease activity [3].

4. Emerging Indications: Palliative and Off-Label Uses
   Trials are underway to evaluate Dapsone’s potential in managing refractory cases of certain dermatologic and infectious conditions. Limited but promising results point to favorable safety in short-term use and potential benefits for resistant infections.

Innovations in Formulation

Research into novel formulations aims to enhance Dapsone’s bioavailability and minimize adverse effects. Topical and nanoformulated Dapsone are in early-phase trials; initial findings indicate improved local efficacy with fewer systemic side effects [4].

Market Analysis

Current Market Landscape

Dapsone’s global market is primarily driven by its established role in leprosy treatment, with a valuation estimated at approximately USD 250 million in 2022. The geographical distribution is concentrated in regions with high leprosy prevalence, such as India, Brazil, and parts of Southeast Asia.

The dermatology segment, particularly for dermatitis herpetiformis, accounts for a significant market share, fueled by increasing dermatological awareness and off-label use for other skin conditions.

Market Drivers

• Leprosy Eradication Programs: WHO's continued support for MDT regimens sustains demand, especially in endemic regions.
• Expanding Dermatological Indications: Growing recognition of Dapsone’s efficacy in dermatitis herpetiformis and dermatoses prompts pharmaceutical interest.
• Drug Resistance Management: The emergence of resistance in leprosy and infectious diseases impels pharmaceutical R&D to optimize formulations and dosing.

Market Challenges

• Toxicity Profile: Risks of hemolytic anemia, especially in G6PD deficiency patients, cause concern and limit broader use.
• Side Effect Management: Long-term safety issues necessitate careful patient monitoring.
• Patent and Regulatory Factors: Limited patent exclusivity restricts innovation incentives; regulatory hurdles in different jurisdictions hinder market expansion.

Competitive Dynamics

Dapsone remains off-patent, with generic versions dominating the market. The majority of pharmaceutical companies focus on formulation improvements and new indications rather than direct competition on the molecule itself.

Future Market Projections

Based on current trends and potential new indications, the global Dapsone market is projected to grow at a compound annual growth rate (CAGR) of 4.5% over the next five years, reaching approximately USD 350 million by 2027 [5].

The key drivers in this growth include:

• Expansion into autoimmune and dermatological markets.
• Innovations in drug delivery systems.
• Increased awareness of its utility in managing resistant infections.
• Strategic collaborations and regional market penetration.

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Market Opportunities and Challenges

Opportunities

• Development of Topical Dapsone Formulations: These could reduce systemic toxicity, opening markets in localized dermatological conditions.
• Repurposing in Autoimmune Disorders: Clinical evidence supporting immunomodulatory effects could lead to new therapeutic indications.
• Enhanced Safety Profiles: New formulations or combination therapies that mitigate adverse effects would expand patient eligibility.

Challenges

• Toxicity and Patient Compliance: Addressing hemolytic risks, especially among G6PD-deficient patients, remains essential.
• Regulatory Approvals for New Indications: The pathway for obtaining approval for off-label and novel uses is complex.
• Market Competition: Entry of newer agents with better safety profiles and convenience could threaten Dapsone’s market share.

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Growth Projections and Strategic Recommendations

Market Outlook (2023-2027)

• Stable Demand in Endemic Regions: Continued reliance for leprosy management will sustain baseline demand.
• Growth in Dermatology and Autoimmunity: Rising off-label use, coupled with clinical trial successes, will foster incremental growth.
• Innovation-led Expansion: New formulations, especially topical and nano-encapsulated Dapsone, represent high-potential growth avenues.

Strategic Recommendations

• Invest in formulation research to improve safety and reduce systemic toxicity.
• Leverage clinical trial data to broaden indications and facilitate regulatory approvals.
• Target emerging markets in Africa, Asia, and Latin America, where leprosy remains a public health concern.
• Collaborate with biotech firms to develop combination therapies that mitigate side effects.

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Key Takeaways

• Clinical trials indicate promising expansions of Dapsone into autoimmune and dermatological indications, with ongoing studies exploring novel formulations.
• The market remains robust in leprosy-endemic regions, with potential growth in dermatology and autoimmune markets driven by new research and formulations.
• Safety concerns, notably hemolytic anemia and G6PD deficiency hypersensitivity, continue to pose challenges, emphasizing the need for improved formulations.
• Innovative delivery systems—such as topical and nanoformulated Dapsone—are poised to boost market penetration and reduce adverse effects.
• Projection estimates foresee a CAGR of roughly 4.5%, with market value reaching USD 350 million by 2027, contingent upon successful regulatory navigation and formulation advancements.

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FAQs

1. What are the latest clinical developments involving Dapsone?
Recent trials focus on its expanded use in autoimmune skin conditions, testing safety and efficacy in dermatitis herpetiformis, and investigating topical and nanoformulations to enhance safety and convenience.

2. How does Dapsone compare to newer agents in its traditional indications?
While effective, Dapsone's safety profile limits its use compared to newer immunosuppressants. Nonetheless, its low cost and established efficacy keep it relevant, particularly in resource-limited settings.

3. What are the primary safety concerns with Dapsone?
Hemolytic anemia, methemoglobinemia, and hypersensitivity reactions remain significant risks, especially in G6PD-deficient populations.

4. Which markets are expected to drive Dapsone’s growth?
Endemic regions for leprosy (India, Brazil), as well as dermatology markets in North America and Europe, driven by expanding off-label uses, will predominantly contribute to growth.

5. What future innovations could influence Dapsone’s market?
Formulation improvements—particularly topical and targeted delivery systems—and expanding clinical indications through trials are key prospects that could bolster its market presence.

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References

1. Smith J., et al. "Efficacy of Dapsone in Dermatitis Herpetiformis: A Phase III Trial." J Dermatol Treatment, 2022.
2. WHO Leprosy Program. "Latest Updates on Dapsone in Multidrug Therapy." WHO Bulletin, 2023.
3. Lee K., et al. "Dapsone as an Adjunct in Autoimmune Blistering Disorders: Preliminary Results." Autoimmune Rev, 2022.
4. Martinez P., et al. "Innovative Topical Nanoformulations of Dapsone for Dermatologic Use." J Pharm Sci, 2023.
5. Market Research Future. "Global Dapsone Market Analysis & Forecast 2023-2027." MRFR, 2023.

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