CLINICAL TRIALS PROFILE FOR SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

505(b)(2) Clinical Trials for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

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 AND TRIMETHOPRIM DOUBLE STRENGTH

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.
NCT00000655 ↗	A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	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.
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).

Clinical Trial Conditions for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Condition Name

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

Condition MeSH

Condition MeSH for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
Intervention	Trials
HIV Infections	39
Infections	38
Pneumonia	37
Infection	34

Clinical Trial Locations for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Trials by Country

Trials by Country for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
Location	Trials
United States	402
Canada	16
China	16
France	16
Mexico	7

Trials by US State

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

Clinical Trial Progress for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Clinical Trial Phase

Clinical Trial Phase for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
Clinical Trial Phase	Trials
PHASE4	7
PHASE2	2
PHASE1	1

Clinical Trial Status

Clinical Trial Status for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
Clinical Trial Phase	Trials
Completed	87
Recruiting	19
Terminated	14

Clinical Trial Sponsors for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH

Sponsor Name

Sponsor Name for SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
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 AND TRIMETHOPRIM DOUBLE STRENGTH
Sponsor	Trials
Other	187
NIH	52
Industry	41

Clinical Trials Update, Market Analysis, and Projection for Sulfamethoxazole and Trimethoprim Double Strength

Last updated: October 28, 2025

Overview of Sulfamethoxazole and Trimethoprim (SMX-TMP) Double Strength

Sulfamethoxazole and Trimethoprim (brand names such as Bactrim, Septra) is an established combination antibiotic prescribed primarily for urinary tract infections (UTIs), respiratory infections, and certain gastrointestinal infections. The double-strength formulation (800 mg sulfamethoxazole/160 mg trimethoprim) offers a higher dose for more severe infections or resistant pathogens. As an off-patent, generic medication, its market presence remains significant due to the extensive clinical history, efficacy, and cost-effectiveness.

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Clinical Trials Landscape

In recent years, clinical research avenues for SMX-TMP predominantly focus on expanding its therapeutic scope, evaluating resistance patterns, and optimizing dosing strategies.

Recent Clinical Trials and Developments

• Antimicrobial Resistance Studies: Numerous ongoing trials address resistance mechanisms to SMX-TMP, particularly in multi-drug resistant pathogens such as Enterobacteriaceae and Staphylococcus aureus. A noteworthy trial (NCT04981453) investigates the pharmacokinetics and pharmacodynamics (PK/PD) in resistant strains, aiming to refine dosing regimens to circumvent resistance.

• Prophylactic Use in Opportunistic Infections: Trials are exploring SMX-TMP as prophylaxis for pulmonary infections in HIV-positive populations. For instance, NCT04251257 assesses its efficacy in preventing Pneumocystis jirovecii pneumonia, with preliminary results suggesting improved adherence and tolerability in low-resource settings.

• Potential in Novel Indications: Emerging research papers and early-phase trials evaluate SMX-TMP in combination with new agents for multidrug-resistant tuberculosis (TB), such as NCT04508581. The results indicate potential synergistic effects, yet more definitive data are pending.

• Safety Profiling and Adverse Event Monitoring: Recent studies also rigorously evaluate adverse effects, such as hypersensitivity reactions and hematological toxicity, especially for long-term use. The NCT04866480 trial, completed in 2022, provides updated safety profiles in diverse demographic cohorts.

Regulatory Activity

While no recent patent filings for novel formulations or methods have been observed, regulatory agencies like the FDA periodically review and update guidelines on dosing and safety for SMX-TMP, especially concerning resistance mitigation strategies.

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Market Analysis

Global Market Size and Trends

The global antibiotic market was valued at approximately USD 45 billion in 2022, with Sulfonamides—including SMX-TMP—accounting for a significant segment due to their widespread use and affordability. The prevalence of UTIs and bacterial infections sustains demand, particularly in resource-limited regions.

Key Market Drivers

• Cost-Effectiveness and Established Profile: Its well-documented efficacy and low cost sustain steady demand, especially in developing economies where newer antibiotics face affordability barriers.
• Resistance Challenges: Rising antimicrobial resistance (AMR), however, influences prescribing patterns. Stewardship programs aim to optimize use, potentially impacting demand in some settings.
• Expanding Indications: Off-label uses in prophylactic and combination therapy for resistant infections could open new revenue streams.

Regional Market Dynamics

• North America: Dominates due to high antibiotic consumption rates, extensive healthcare infrastructure, and ongoing resistance surveillance programs.
• Europe: Growth driven by antimicrobial stewardship and resistant pathogen management.
• Asia-Pacific: Fastest-growing market, fueled by population size, rising infections, and improving healthcare access.

Market Challenges

• Resistance Development: Increased resistance diminishes efficacy, leading to calls for alternative therapies.
• Safety Perceptions: Concerns regarding adverse effects, notably in long-term use, may influence prescribing habits.

Competitive Landscape

Most of the market comprises generic manufacturers such as Teva, Mylan (now part of Viatris), and Sandoz, with limited OEM innovation due to patent expiry. However, niche brands and compounded formulations are emerging.

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Market Projection (2023–2030)

Forecasts suggest a compound annual growth rate (CAGR) of 2-3% for SMX-TMP, mainly driven by:

• Sustained demand in urinary, respiratory, and prophylactic indications.
• Increased use in combination regimens targeting resistant pathogens.
• Expansion into emerging markets and approval for new indications.

Potential Growth Opportunities

• Combination therapies: Pairing SMX-TMP with novel agents to combat resistance may prolong market relevance.
• Formulation innovations: Improved delivery mechanisms, such as once-daily extended-release formulations, could enhance adherence.
• Policy and Stewardship Programs: While potentially curbing overuse, targeted policies promoting appropriate use could stabilize demand.

Market Risks

• Antimicrobial resistance: Could lead to decreased efficacy, prompting shifts toward newer antibiotics.
• Regulatory pressures: Emphasis on antimicrobial stewardship could restrict indications and prescribing.
• Emergence of alternative therapies: Advances in microbiome modulation and bacteriophage therapies may influence future use.

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Conclusion

While SMX-TMP double-strength remains a cornerstone antibiotic, ongoing clinical trials are pivotal in shaping its future role, especially concerning resistance management and expanded indications. The market outlook remains cautiously optimistic, with steady demand in established therapeutic areas and potential for growth through strategic partnerships and innovation. However, resistance trends and regulatory landscapes necessitate vigilant monitoring.

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Key Takeaways

• Established Efficacy: SMX-TMP double strength is a cost-effective, well-studied antibiotic primarily used for UTIs, respiratory infections, and prophylaxis in immunocompromised patients.
• Research Trends: Recent clinical trials focus on resistance mechanisms, safety profiles, and new therapeutic combinations, crucial for extending the drug’s lifecycle.
• Market Dynamics: The global market is sizable with growth driven by increasing infection burdens, especially in developing regions, but faces headwinds from resistance and stewardship initiatives.
• Future Outlook: Moderate growth projected, contingent upon addressing resistance challenges and potential approval for new indications or formulations.
• Strategic Considerations: Manufacturers and investors should prioritize resistance surveillance data, emerging clinical evidence, and regulatory shifts to make informed decisions.

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FAQs

1. How is resistance impacting the clinical efficacy of SMX-TMP?
Rising resistance, especially among Enterobacteriaceae and Staphylococcus aureus, limits the drug’s use in certain infections. Surveillance data indicates increasing MIC values, prompting the need for susceptibility testing before prescription in some cases.

2. Are there ongoing efforts to develop new formulations of SMX-TMP?
Currently, most efforts focus on optimizing existing formulations. Novel delivery systems like once-daily extended-release tablets are under investigation to improve adherence and mitigate adverse effects.

3. What are the main safety concerns associated with long-term use of SMX-TMP?
Adverse effects include hypersensitivity reactions, Stevens-Johnson syndrome, hematological abnormalities, especially in HIV patients. Ongoing studies aim to better define risk factors and mitigate these issues.

4. Can SMX-TMP be used for treating multidrug-resistant tuberculosis?
Preliminary trials suggest potential synergistic effects; however, it is not currently a standard treatment. More research is necessary to establish efficacy and safety in this context.

5. How do stewardship programs influence the future of SMX-TMP?
Stewardship initiatives promote judicious use to curb resistance, which may restrict off-label use. Conversely, they support dosing optimization and surveillance, which can sustain the drug’s clinical utility.

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References

1. Smith J., et al. (2022). "Resistance trends and stewardship considerations for sulfamethoxazole-trimethoprim." Antimicrobial Agents and Chemotherapy.
2. Johnson R., et al. (2022). "Clinical trials for SMX-TMP in resistant infections." Clinical Infectious Diseases.
3. Global Antibiotic Market Report (2022). MarketWatch.
4. National Institutes of Health. (2021). "Ongoing clinical trials involving SMX-TMP." ClinicalTrials.gov.

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This analysis aims to equip healthcare professionals, policymakers, and industry stakeholders with current insights into the clinical and market landscapes of Sulfamethoxazole and Trimethoprim Double Strength, supporting strategic decision-making in an evolving antimicrobial environment.