CLINICAL TRIALS PROFILE FOR SULFAMETHOXAZOLE; TRIMETHOPRIM

505(b)(2) Clinical Trials for SULFAMETHOXAZOLE; TRIMETHOPRIM

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.

All Clinical Trials for SULFAMETHOXAZOLE; TRIMETHOPRIM

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.
NCT00000655 ↗	A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients	Completed	Glaxo Wellcome	Phase 2	1969-12-31	To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

Clinical Trial Conditions for SULFAMETHOXAZOLE; TRIMETHOPRIM

Condition Name

Condition Name for SULFAMETHOXAZOLE; TRIMETHOPRIM
Intervention	Trials
HIV Infections	36
Pneumonia, Pneumocystis Carinii	27
Urinary Tract Infections	10
Urinary Tract Infection	8

Condition MeSH

Condition MeSH for SULFAMETHOXAZOLE; TRIMETHOPRIM
Intervention	Trials
HIV Infections	39
Infections	38
Pneumonia	36
Infection	34

Clinical Trial Locations for SULFAMETHOXAZOLE; TRIMETHOPRIM

Trials by Country

Trials by Country for SULFAMETHOXAZOLE; TRIMETHOPRIM
Location	Trials
United States	402
China	16
France	16
Canada	15
Mexico	7

Trials by US State

Trials by US State for SULFAMETHOXAZOLE; TRIMETHOPRIM
Location	Trials
California	33
New York	25
Illinois	24
Pennsylvania	20
Ohio	20

Clinical Trial Progress for SULFAMETHOXAZOLE; TRIMETHOPRIM

Clinical Trial Phase

Clinical Trial Phase for SULFAMETHOXAZOLE; TRIMETHOPRIM
Clinical Trial Phase	Trials
PHASE4	7
PHASE2	1
Phase 4	28

Clinical Trial Status

Clinical Trial Status for SULFAMETHOXAZOLE; TRIMETHOPRIM
Clinical Trial Phase	Trials
Completed	87
Recruiting	19
Terminated	14

Clinical Trial Sponsors for SULFAMETHOXAZOLE; TRIMETHOPRIM

Sponsor Name

Sponsor Name for SULFAMETHOXAZOLE; TRIMETHOPRIM
Sponsor	Trials
National Institute of Allergy and Infectious Diseases (NIAID)	31
Glaxo Wellcome	8
National Cancer Institute (NCI)	7

Sponsor Type

Sponsor Type for SULFAMETHOXAZOLE; TRIMETHOPRIM
Sponsor	Trials
Other	186
NIH	52
Industry	41

Clinical Trials Update, Market Analysis, and Projection for Sulfamethoxazole; Trimethoprim

Last updated: October 28, 2025

Introduction

Sulfamethoxazole and trimethoprim are a combination antibiotic widely used to treat bacterial infections, notably urinary tract infections, respiratory infections, and certain gastrointestinal infections. This combination, commercially known as co-trimoxazole or Bactrim, has a long-standing presence in clinical practice. Recent developments in clinical research, coupled with evolving resistance patterns and market dynamics, warrant a detailed analysis of current status, future prospects, and strategic insights into the drug's market trajectory.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have seen renewed clinical interest in sulfamethoxazole and trimethoprim, particularly in the context of antimicrobial resistance, prophylaxis, and investigational uses.

• Antimicrobial Resistance Studies: Multiple trials focus on resistance patterns against co-trimoxazole, especially concerning MRSA (methicillin-resistant Staphylococcus aureus). A notable trial (NCT04576854) assesses the efficacy of co-trimoxazole against resistant strains, reaffirming its ongoing relevance, albeit with concerns over declining susceptibility.

• Adjunctive Therapies and New Indications: Clinical trials explore combination therapies with other antimicrobials to combat multidrug-resistant pathogens. For instance, NCT03854337 investigates co-trimoxazole's role in eradicating Mycobacterium avium complex, especially in immunocompromised patients.

• Preventive and Prophylactic Uses: Studies such as NCT04694972 evaluate co-trimoxazole's efficacy in preventing Pneumocystis pneumonia (PCP) among HIV-positive individuals. These trials reinforce the drug's prophylactic importance and its potential extension into broader immunosuppressed populations.

Regulatory Developments and Post-Market Data

While no recent filings for novel formulations have emerged, regulatory agencies like the FDA have issued updates emphasizing prudent use amidst rising resistance. Post-market surveillance data indicate consistent efficacy but highlight the need for stewardship to prevent resistance escalation.

Research Gaps and Future Directions

• Resistance Mitigation: Current trials aim to unravel mechanisms of resistance and develop stewardship strategies.

• Novel Formulations: Limited ongoing development for fixed-dose combinations or formulations with enhanced pharmacokinetics, signaling potential areas for innovation.

• Special Populations: A focus on pediatric and geriatric populations remains, given differing pharmacodynamics and safety profiles.

Market Analysis

Global Market Size and Trends

The co-trimoxazole market is valued approximately at USD 0.8 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 3.5% through 2030, driven by factors such as persistent bacterial infections, increased prevalence of immunosuppressed conditions, and the ongoing need for cost-effective antibiotics.

Key Market Drivers

• Prevalence of Bacterial Infections: Continual demand owing to high incidence of urinary tract and respiratory bacterial infections.

• Prophylactic Use in Immunocompromised Patients: Particularly in HIV/AIDS care and transplant recipients, boosting demand for prophylactic formulations.

• Cost-Effective Treatment Option: Its inexpensive profile sustains its use in developing nations with limited healthcare budgets.

Segment Analysis

• By Formulation: Oral tablets dominate, accounting for roughly 70% of sales, with injectable forms holding minor shares, mostly in hospital settings.

• By Application: Urinary tract infections comprise the largest segment, followed by respiratory infections and HIV/AIDS prophylaxis.

• Regional Insights: North America and Europe lead in adoption, driven by established healthcare infrastructure and antimicrobial stewardship programs. Emerging markets in Asia-Pacific and Latin America register growing demand, propelled by increasing infectious disease burden.

Competitive Landscape

Major pharmaceutical companies like Pfizer and Teva dominate the market with established formulations. Generic manufacturers significantly influence pricing, making co-trimoxazole widely accessible. Innovation remains limited, with no recent novel formulations entering the market.

Market Challenges

• Antimicrobial Resistance: Rising resistance threatens long-term efficacy, potentially limiting future market size.

• Regulatory Scrutiny: Increased focus on antimicrobial stewardship could restrict use, affecting sales.

• Patent Expiry and Generic Competition: While this enhances accessibility, it pressures profit margins for branded formulations.

Market Projection

Considering current trends, the market is expected to sustain moderate growth over the next decade. Factors such as rising antimicrobial resistance may slightly constrain growth but simultaneously prompt innovation and new indications. Strategic collaborations for stewardship and formulation development could unlock further market opportunities, particularly targeting resistant infections and prophylactic applications.

Future Opportunities

• Innovative Formulations: Development of sustained-release, combination, or targeted delivery systems.

• Expanded Indications: Exploring use in multidrug-resistant tuberculosis, uncomplicated infections, and anti-infective prophylaxis.

• Global Expansion: Penetration into underserved markets, especially in Asia, Africa, and Latin America.

Conclusion

Sulfamethoxazole and trimethoprim remain cornerstone antibiotics with enduring relevance, especially in prophylaxis and treatment of common bacterial infections. While resistance patterns pose a significant threat, ongoing clinical trials focusing on resistance management and new formulations could revitalise its market. Stakeholders should prioritize antimicrobial stewardship, innovation, and expanding indications to sustain growth and address emerging healthcare needs.

Key Takeaways

• The clinical landscape reflects ongoing research into resistance mitigation, new indications, and combination therapies; however, no groundbreaking new formulations are imminent.
• The global market remains stable with moderate growth prospects, driven by high demand for cost-effective antibiotics and prophylactic applications.
• Resistance development and regulatory considerations are critical risks; proactive stewardship and innovation are vital.
• Emerging markets offer significant growth potential due to increasing infectious disease burden and unmet healthcare needs.
• Strategic investments in formulation innovation and expanding indications will be pivotal for future market success.

FAQs

1. What are the primary clinical uses of sulfamethoxazole and trimethoprim?
   The combination is primarily used for urinary tract infections, respiratory infections, skin infections, and prophylaxis against Pneumocystis pneumonia in immunocompromised patients.

2. How has antimicrobial resistance impacted the effectiveness of co-trimoxazole?
   Resistance particularly among Staphylococcus aureus and Enterobacteriaceae strains has increased, leading to reduced efficacy in certain infections, prompting a call for prudent use and research into new strategies.

3. Are there any new formulations or indications in development for sulfamethoxazole and trimethoprim?
   Currently, no significant novel formulations are in late-stage development; most efforts focus on stewardship, resistance management, and exploring expanded prophylactic and treatment indications.

4. What is the outlook for the co-trimoxazole market over the next decade?
   The market is expected to grow modestly, influenced by ongoing demand, resistance challenges, and opportunities in emerging markets and prophylactic use.

5. How can stakeholders mitigate resistance concerns related to co-trimoxazole?
   By implementing antimicrobial stewardship programs, adhering to prescribing guidelines, investing in research for resistance mechanisms, and developing new formulations or combination therapies.

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Sources:
[1] Market research reports (e.g., Fortune Business Insights, GlobalData)
[2] ClinicalTrials.gov database
[3] FDA and EMA regulatory updates
[4] Relevant peer-reviewed publications and key industry press releases