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.

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

Condition MeSH

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

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
France	16
Canada	16
China	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	9
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	189
NIH	52
Industry	41

Last updated: May 25, 2026

Sulfamethoxazole and Trimethoprim Double Strength Clinical Trials Update, Market Analysis, and 2026–2036 Forecast

Sulfamethoxazole and trimethoprim (SMX-TMP) double strength (DS) is a long-established, off-patent oral antibiotic product with minimal formal patent-driven exclusivity tail risk and no material, drug-specific clinical development cycle that can be cleanly mapped to an identifiable Phase 3 readout or NDA/BLA milestone under a single, branded product. Market dynamics are dominated by (1) broad generic supply, (2) formulary access and reimbursement, and (3) FDA/antimicrobial stewardship constraints rather than by new clinical-trial-driven demand expansion.

What is the clinical trial pipeline for sulfamethoxazole and trimethoprim double strength?

No drug-specific, currently active Phase 3 (or registrational Phase 2/3) development program tied to “double strength” SMX-TMP can be established from the available information. SMX-TMP DS is used across multiple indications that are addressed by older trials, published literature, and guideline-based practice rather than by a single sponsor-driven late-stage program.

Are there new Phase 3 trials replacing older evidence for SMX-TMP DS?

No identifiable, current Phase 3 trial set can be validated here for SMX-TMP DS as a distinct dosage form or label expansion.

What trial updates most affect SMX-TMP DS use in practice?

Use patterns are driven by:

• Antimicrobial resistance trends affecting empiric therapy selection.
• Stewardship restrictions for uncomplicated infections depending on local susceptibility.
• Safety monitoring signals (class effects) such as hypersensitivity and hematologic adverse events.

What endpoints matter for future SMX-TMP DS trials?

In practice, trial designs typically hinge on cure/response rates, microbiologic eradication, and safety tolerability in outpatient settings. For DS dosing, adherence and tolerability in ambulatory populations are key.

Which indications drive demand for sulfamethoxazole and trimethoprim double strength?

SMX-TMP DS demand is typically concentrated in community and outpatient settings, with usage skewing toward infection categories where SMX-TMP is guideline-supported and where susceptibility patterns remain favorable.

Common commercial indication buckets

SMX-TMP DS is generally used for:

• Uncomplicated urinary tract infection (UTI) and other susceptible uropathogen infections
• Skin and soft tissue infections in susceptible cases
• Pneumocystis jirovecii prophylaxis/treatment contexts (label and population dependent)
• Off-label use patterns in practice where clinician-established protocols rely on susceptibility

How does resistance change prescribing volume for SMX-TMP DS?

Where resistance to trimethoprim-sulfamethoxazole increases, prescribers shift toward alternatives. That shift tends to affect DS volume even when the drug remains accessible and affordable.

What is the Orange Book status of sulfamethoxazole and trimethoprim double strength?

No product-specific Orange Book exclusivity or patent term data can be validated from the information provided here.

Does SMX-TMP DS have meaningful regulatory exclusivity left?

SMX-TMP is widely available as generic and is not associated with a current, defensible, drug-specific patent or exclusivity barrier in the way newer specialty antibiotics can be.

How many patents protect sulfamethoxazole and trimethoprim double strength in the US?

No robust, countable patent estate for a specific SMX-TMP DS marketed NDA can be compiled from the information available here.

Are there formulation or method-of-use patents that can block generics?

For older antibiotic actives like SMX-TMP, the market is typically not held by formulation patents for DS tablets/suspension-equivalent strength unless a specific branded product has a unique, later-granted formulation. That type of product-specific patent mapping cannot be produced from the present input constraints.

What is the market size and competitive landscape for SMX-TMP DS?

SMX-TMP DS operates in a competitive, low-margin generics environment characterized by:

• Many authorized generic and generic manufacturers
• High price competition
• Frequent substitutions at the pharmacy and health-system formulary level

Who are the commercial competitors?

Competitors include multiple generic manufacturers of SMX-TMP DS tablets and equivalent dosage-strength products. A validated, current list of manufacturers cannot be produced here from the provided information.

What substitution and channel dynamics matter most?

• Wholesale acquisition cost (WAC) compression due to multi-source supply
• Rebates and formulary position for payers
• Pharmacy substitution rules and inventory availability
• Smaller share shifts driven by payer restrictions tied to resistance or stewardship policy

What is the 2026–2036 sales projection for sulfamethoxazole and trimethoprim double strength?

A defensible forecast cannot be computed from the available information because no baseline market revenue, unit volume, payer mix, channel inventory, or geography-level sales data is provided here.

What drives growth or decline in SMX-TMP DS sales?

• Growth drivers
  • Stable outpatient infection incidence
  • Retention on formularies where susceptibility supports use
  • Cost containment preferences for affordable generics
• Decline drivers
  • Rising resistance reducing empiric appropriateness
  • Substitution to fluoroquinolones, beta-lactams, or newer agents where clinically preferred
  • Stewardship limits on broad-spectrum alternatives and specific classes in some settings, which can either increase or decrease SMX-TMP use depending on local guidance

When does sulfamethoxazole and trimethoprim double strength lose exclusivity?

No actionable exclusivity timeline can be stated here because the necessary product-level Orange Book and exclusivity data is not available.

What generic entry risks exist for SMX-TMP DS?

Risk is low for new entrants because the active ingredient is long off-patent and the regulatory path for generics is mature. The limiting factors are typically manufacturing capacity, quality systems, and pharmacovigilance rather than exclusivity.

What patent litigation affects sulfamethoxazole and trimethoprim double strength?

No SMX-TMP DS patent litigation can be validated from the information provided here.

Are there any known Paragraph IV challenges for SMX-TMP DS?

No validated Paragraph IV dataset is available in the provided input.

How does SMX-TMP DS compare with doxycycline, nitrofurantoin, and fluoroquinolones for outpatient UTIs?

A comparative clinical and commercial view generally shows:

• SMX-TMP efficacy is highly dependent on local susceptibility.
• Nitrofurantoin use tends to be favored for uncomplicated cystitis where appropriate.
• Doxycycline is used for specific pathogen profiles, not a direct substitute in standard UTI algorithms.
• Fluoroquinolones are effective but face tighter stewardship constraints in many indications, shifting usage toward older narrow options.

A quantified comparison tied specifically to “double strength” DS dosing and reimbursement patterns cannot be completed from the available information.

What manufacturing and IP barriers affect new entrants for SMX-TMP DS?

For older small-molecule oral antibiotics, the barriers are usually operational:

• cGMP manufacturing capability
• bioequivalence and quality consistency
• supply chain reliability for active ingredient sourcing

IP barriers are typically limited unless a specific product form or strength has unique, later-granted protectable subject matter, which cannot be mapped here.

Key Takeaways

• SMX-TMP DS market performance is dominated by multi-source generic competition and antimicrobial prescribing dynamics, not by a late-stage, drug-specific clinical trial pipeline.
• No product-level patent/exclusivity and litigation dataset can be established from the available information, so there is no actionable IP-driven timing or risk timeline to report.
• A 2026–2036 sales forecast cannot be quantified without baseline market and channel data; the qualitative direction depends on resistance trends, guideline positioning, and payer formulary access.

FAQs

1) What are the most common reasons clinicians switch off SMX-TMP DS for suspected UTIs?
Local resistance, prior treatment failure, intolerance, and guideline restrictions where susceptibility rates are low.

2) Does SMX-TMP DS have risks that limit use in certain patient populations?
Class effects include hypersensitivity reactions and hematologic adverse events, which can narrow prescribing in higher-risk groups.

3) Are there biosimilar or biologics risks for SMX-TMP DS?
No. SMX-TMP DS is a small-molecule antibiotic, not a biologic.

4) How do stewardship programs affect SMX-TMP DS prescribing?
Stewardship changes empiric therapy recommendations based on susceptibility and severity, influencing volume.

5) What is the most likely commercial leverage for a manufacturer of SMX-TMP DS in a generics market?
Supply reliability, formulary placement via contracting, and cost competitiveness driven by manufacturing scale and quality.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via tool-dependent availability not provided in the input.)
2. ClinicalTrials.gov. Search results for sulfamethoxazole and trimethoprim clinical trials. (Accessed via tool-dependent availability not provided in the input.)
3. IDSA. Clinical practice guidelines for urinary tract infections and related infectious diseases. Infectious Diseases Society of America. (Specific guideline versions not provided in the input.)