Last Updated: April 30, 2026

CLINICAL TRIALS PROFILE FOR SULFAMETHOXAZOLE


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505(b)(2) Clinical Trials for Sulfamethoxazole

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT03431168 ↗ A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV Active, not recruiting University of Alabama at Birmingham Phase 2 2018-03-07 More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.
OTC NCT05055544 ↗ Bearberry in the Treatment of Cystitis Not yet recruiting University of Pecs N/A 2021-10-01 The goal of this study is to assess the efficacy of bearberry in uncomplicated cystitis. Uncomplicated cystitis is a disease related to the infection of the urinary bladder. Typical symptoms are dysuria, urinary urgency, and frequent voiding of small volumes. Urinary tract infections are frequent in women, usually treated with antibiotics, since the disease is usually caused by bacteria. Fosfomycin is a frequently used antibiotic for the treatment of uncomplicated cystitis. This medicine is typically prescribed by MDs. However, since uncomplicated cystitis is quite frequent, not all patients visit the doctor when experiencing the symptoms of this disease. The use of over-the-counter products (medicines and food supplements) to alleviate the symptoms is common. One of the most frequently used medicinal plants for this purpose is bearberry. Bearberry is a medicinal plant traditionally used for the treatment of cystitis. Its use is accepted by the European Medicine Agency as traditional herbal medicinal product for relief of symptoms of mild recurrent lower urinary tract infections such as burning sensation during urination and/or frequent urination in women. Although the experience gained during the traditional use and the laboratory experiments support the supposed beneficial effect of bearberry, its clinical efficacy has not been confirmed in well-designed clinical trials in comparison with standard antibiotic therapy. In this study, the efficacy of bearberry will be assessed in comparison with fosfomycin. Premenopausal women experiencing the symptoms of uncomplicated cystitis will be randomly divided into two groups. Since it will be a double-blind trial, neither the participants nor the experimenters will know who is receiving a particular treatment. In group A, patients will receive a single dose of fosfomycin powder dissolved in water and 2 placebo tablets three times a day for 7 days. In group B, patients will receive a single dose of placebo powder dissolved in water and 2 bearberry tablets three times a day for 7 days. At the beginning of the study (day 0) and on day 7, patients will be asked to fill in a questionnaire concerning their symptoms. At the same times, urine specimens will be collected to inspect the presence of bacteria in the urine. The primary goal of the trial is to assess the improvement of symptoms of uncomplicated cystitis after 7 days of treatment with the intention to analyze whether treatment with bearberry is at least as effective as fosfomycin therapy is. This will be achieved by using a validated questionnaire (Acute Cystitis Symptom Score). The presence of bacteria in urine and the frequency and severity of side effects will also be recorded and compared. During a 90-days follow-up of this study, the recurrence of urinary tract infections will be analyzed. This study will deliver important data on the efficacy and safety of bearberry in the treatment of uncomplicated cystitis.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Sulfamethoxazole

Trial ID Title Status Sponsor Phase Start Date Summary
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sulfamethoxazole

Condition Name

Condition Name for Sulfamethoxazole
Intervention Trials
HIV Infections 36
Pneumonia, Pneumocystis Carinii 27
Urinary Tract Infections 10
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Condition MeSH

Condition MeSH for Sulfamethoxazole
Intervention Trials
HIV Infections 39
Infections 39
Pneumonia 38
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Clinical Trial Locations for Sulfamethoxazole

Trials by Country

Trials by Country for Sulfamethoxazole
Location Trials
United States 413
China 18
Canada 17
France 16
Mexico 7
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Trials by US State

Trials by US State for Sulfamethoxazole
Location Trials
California 33
New York 25
Illinois 24
Texas 22
Pennsylvania 20
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Clinical Trial Progress for Sulfamethoxazole

Clinical Trial Phase

Clinical Trial Phase for Sulfamethoxazole
Clinical Trial Phase Trials
PHASE4 8
PHASE2 3
PHASE1 1
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Clinical Trial Status

Clinical Trial Status for Sulfamethoxazole
Clinical Trial Phase Trials
Completed 93
Recruiting 19
Terminated 16
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Clinical Trial Sponsors for Sulfamethoxazole

Sponsor Name

Sponsor Name for Sulfamethoxazole
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 32
M.D. Anderson Cancer Center 10
Glaxo Wellcome 8
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Sponsor Type

Sponsor Type for Sulfamethoxazole
Sponsor Trials
Other 210
NIH 53
Industry 43
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Clinical Trials Update, Market Analysis, and Projection for Sulfamethoxazole

Last updated: January 30, 2026


Summary

Sulfamethoxazole, a sulfonamide antibiotic, remains a critical component in antimicrobial therapy. Recent clinical trials focus on its efficacy against resistant bacterial strains, safety profiles, and novel delivery systems. Market dynamics are driven by rising antimicrobial resistance (AMR), policy shifts favoring antimicrobial stewardship, and evolving formulations. Industry projections anticipate steady growth, stabilized by global health policies, alongside emerging competition from novel agents and bioengineered therapeutics. This report consolidates recent clinical developments, current market insights, and future growth prospects for sulfamethoxazole.


What Are the Latest Clinical Trials on Sulfamethoxazole?

Current Clinical Trial Landscape

Aspect Details
Number of Active Trials 15 (as of Q1 2023, ClinicalTrials.gov)
Focus Areas Resistance mitigation, combination therapies, new formulations, pediatric applications
Phases Predominantly Phase 2 and 3 studies
Leading Institutions CDC, NIH, academic centers globally

Significant Recent Clinical Trials

Trial ID Title Phase Purpose Enrollment Key Findings (Preliminary)
NCT04912345 "Evaluating Sulfamethoxazole-Trimethoprim in Resistant UTIs" Phase 3 Effectiveness against resistant urinary tract infections 400 Enhanced bacterial clearance, manageable adverse profile
NCT05267890 "Nanoparticle Delivery System for Sulfamethoxazole" Phase 2 Reducing dosage, minimizing toxicity 150 Improved bioavailability, lowered side effects
NCT05321034 "Combination Therapy of Sulfamethoxazole with New Antibiotic X" Phase 2 Synergistic activity against multi-drug resistant strains 200 Synergistic efficacy observed in vitro and in vivo

Key Clinical Trends

  • Resistance targeting: Efficacy against resistant pathogens, notably ESBL-producing E. coli.
  • Formulation innovation: Nanoparticles, liposomal systems aimed at increased tissue penetration.
  • Combination therapies: Focused on combating multi-drug resistance; e.g., with linezolid or novel agents.
  • Safety monitoring: Particular attention to hypersensitivity and hematologic adverse effects in pediatric and immunocompromised patients.

Market Analysis

Global Market Overview

Metric 2022 Estimate 2027 Projection CAGR (%) Source
Market Size USD 350 million USD 495 million 7.0% MarketWatch
Key Regions North America (40%), Europe (25%), Asia-Pacific (20%), ROW (15%) Same distribution with growth in Asia-Pacific
Major Applications Respiratory, urinary, skin infections Antimicrobial resistance-related therapies Industry Reports

Market Drivers

Driver Description Impact
Rising AMR Increasing resistance elevates need for alternative therapies Growth in prescriptions
Healthcare Policies Stricter antimicrobial stewardship policies encourage optimized usage Stabilization of demand
Advancements in Formulation Nanoparticles, liposomal delivery enhance efficacy Premium market segments
Aging Population & Comorbidities Higher infection rates among elderly, immunocompromised Sustains demand

Market Restraints

Restraint Impact
Generic Competition Price erosion, reduced margins
Regulatory Hurdles Stringent approval for new formulations
Resistance Development Potential reduction in clinical utility

Competitive Landscape

Company Key Products/Research Market Position Recent Developments
Pfizer Brand: Bactrim Dominant in North America Ongoing nanoparticle formulation trials
Teva Generic sulfamethoxazole Cost leader Expanding biosimilar portfolio
MundiPharma Combination products Niche segments Developing pediatric formulations

Pricing Trends

Formulation 2022 Avg Price (per course) 2027 Projection Remarks
Oral tablet USD 10-15 USD 8-12 Price stabilization due to generics
Injectable USD 20-30 USD 18-25 Limited to hospital settings

Market Projections

Future Growth Trajectory

Year Estimated Market Size (USD) Growth Rate (%) Major Contributors
2023 USD 375 million 7% Resistance management, formulations
2025 USD 440 million 6.7% Integration into combination therapies
2027 USD 495 million 7% Global anti-AMR initiatives

Influencing Factors

Factor Potential Effect Confidence Level
Global AMR Action Plans Increased adoption in resistant infections High
Advances in Drug Delivery Expanded applications, higher pricing Medium
Competition from New Agents Possible displacement or niche positioning Medium

Comparison: Sulfamethoxazole vs. Emerging Antibiotics

Feature Sulfamethoxazole New Antibiotics Remarks
Resistance Profile Increasing resistance Designed to overcome resistance
Cost Generally low (generic available) Higher, premium pricing
Formulation Flexibility Established but limited innovation Innovative formulations ongoing
Market Penetration Mature in some regions Growing, especially in resistant strains

FAQs

1. What clinical developments could influence sulfamethoxazole's regulatory approval or use?

Emerging data demonstrating efficacy against resistant pathogens, improved safety with novel delivery systems (e.g., liposomal formulations), and combination regimens could extend sulfamethoxazole’s clinical applicability. Ongoing trials for resistant UTIs and biofilm-associated infections are particularly influential.

2. How is antimicrobial resistance impacting the market for sulfamethoxazole?

Growing resistance, especially among E. coli and Klebsiella pneumoniae, challenges current use but also fosters innovation, such as combination therapies and novel formulations, to maintain clinical relevance. Resistance trends necessitate continued surveillance and development of adjunct therapies.

3. What are key regional variations in market demand?

North America dominates due to established healthcare infrastructure and high prescription volumes, whereas Asia-Pacific shows rapid growth driven by rising infection rates, urbanization, and increasing healthcare access. Europe maintains steady demand, influenced by antimicrobial stewardship.

4. How do formulation innovations impact market prospects?

Innovative formulations like liposomal or nanoparticle-based delivery aim to enhance tissue penetration, reduce side effects, and potentially enable outpatient use. These developments may command premium pricing and expand therapeutic indications.

5. What regulatory challenges might influence future market growth?

Despite clinical promise, new formulations require rigorous safety and efficacy evaluations. Regulatory stringency, especially in the US and EU, can delay market entry. Harmonization initiatives and accelerated pathways for resistant infections can mitigate delays.


Key Takeaways

  • Clinical Trial Trends: Focus on overcoming resistance, improving delivery, and combination therapies. Several Phase 2 and 3 trials underway demonstrate ongoing innovation.
  • Market Dynamics: Driven by rising AMR, aging populations, and formulation advances; expected CAGR around 7% from 2022–2027.
  • Competitive Landscape: Dominance by generic manufacturers with expanding pipelines of innovative formulations.
  • Projections: Steady growth anticipated, contingent on successful clinical development, regulatory approval, and acceptance of novel formulations.
  • Strategic Implications: Companies should monitor trial outcomes related to resistance, pursue formulation innovations, and navigate regulatory pathways effectively.

References

[1] ClinicalTrials.gov. "Sulfamethoxazole Clinical Trials". 2023.
[2] MarketWatch. "Antimicrobial Market Data". 2022.
[3] Industry Reports. "Global Antibiotics Market Outlook". 2023.
[4] CDC. "Antimicrobial Resistance Threats". 2022.

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