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Last Updated: April 2, 2026

CLINICAL TRIALS PROFILE FOR TRIMETHOPRIM


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505(b)(2) Clinical Trials for 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for trimethoprim

Condition Name

Condition Name for trimethoprim
Intervention Trials
HIV Infections 36
Pneumonia, Pneumocystis Carinii 27
Urinary Tract Infections 11
Urinary Tract Infection 11
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Condition MeSH

Condition MeSH for trimethoprim
Intervention Trials
Infections 42
Pneumonia 41
HIV Infections 39
Infection 36
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Clinical Trial Locations for trimethoprim

Trials by Country

Trials by Country for trimethoprim
Location Trials
United States 445
Canada 21
France 16
China 16
Netherlands 12
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Trials by US State

Trials by US State for trimethoprim
Location Trials
California 35
New York 27
Pennsylvania 24
Illinois 24
Ohio 23
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Clinical Trial Progress for trimethoprim

Clinical Trial Phase

Clinical Trial Phase for trimethoprim
Clinical Trial Phase Trials
PHASE4 9
PHASE2 5
PHASE1 2
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Clinical Trial Status

Clinical Trial Status for trimethoprim
Clinical Trial Phase Trials
Completed 105
Recruiting 29
Terminated 15
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Clinical Trial Sponsors for trimethoprim

Sponsor Name

Sponsor Name for trimethoprim
Sponsor Trials
National Institute of Allergy and Infectious Diseases (NIAID) 32
Glaxo Wellcome 8
University of California, San Francisco 7
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Sponsor Type

Sponsor Type for trimethoprim
Sponsor Trials
Other 255
NIH 55
Industry 53
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Clinical Trials Update, Market Analysis, and Projection for Trimethoprim

Last updated: February 20, 2026

What is the current state of clinical trials involving trimethoprim?

Trimethoprim is an antibiotic primarily used to treat bacterial urinary tract infections (UTIs). The drug's patent expired decades ago, making it available as a generic medication. Currently, there are limited active clinical trials focused on trimethoprim, mainly exploring new indications or synergistic combinations.

Current Clinical Trials Status

  • Total Trials Registered: Approximately 20 registered trials on ClinicalTrials.gov as of March 2023.
  • Focus Areas:
    • Combination therapy for drug-resistant bacterial infections.
    • Adjunctive use in HIV-positive patients to prevent opportunistic infections.
    • Investigations into efficacy against multi-drug resistant organisms, such as Pseudomonas aeruginosa.
  • Notable Trials:
    • A Phase II trial examining trimethoprim-sulfamethoxazole in multi-drug resistant Pseudomonas aeruginosa (NCT05237707).
    • Trials assessing prophylactic use in immunocompromised patients (NCT02495135).

Trends and Gaps

  • Limited ongoing research on new formulations or delivery mechanisms.
  • Emerging interest in repurposing trimethoprim for conditions beyond bacterial infections, such as inflammatory diseases, remains preliminary, with few high-quality trials published.

What is the market landscape for trimethoprim?

Market Overview

  • Global Market Size (2022): Estimated at $230 million (Research and Markets).
  • Major Regions:
    • North America: 45%
    • Europe: 35%
    • Asia-Pacific: 15%
    • Others: 5%
  • Market Drivers:
    • High prevalence of urinary tract infections (UTIs).
    • Increased antibiotic resistance leading to an expanded role for combination therapies.
    • Growing use in prophylaxis for immunosuppressed populations.

Competitive Landscape

  • Dominated by generic manufacturers such as Mylan, Teva, and Sandoz.
  • Few branded versions exist, mainly for specific formulations or combination drugs.
  • Limited proprietary development due to patent expiration and availability of alternatives.

What are the projections for trimethoprim’s market?

Revenue Forecasts

  • Compound Annual Growth Rate (CAGR): Projected at 2-3% from 2023 to 2028.
  • Market Size by 2028: Estimated to reach approximately $260 million, driven by:
    • Rising antibiotic resistance, prompting use in combination therapies.
    • Increased global prevalence of UTIs, especially in aging populations.
    • Expansion into emerging markets as healthcare infrastructure improves.

Factors Influencing Growth

  • Antibiotic Resistance: Accelerates demand for combination therapies involving trimethoprim.
  • Regulatory Landscape: Limited new approvals, but some regions may approve new formulations or indications based on emerging research.
  • Pipeline Activity: Minimal, with most companies focusing on generic manufacturing rather than innovation.

Key Challenges and Opportunities

Challenges

  • Drug resistance reduces clinical utility.
  • Limited research into new formulations.
  • Competitive pressure from other antibiotics and alternatives.

Opportunities

  • Repurposing efforts in inflammatory or other infectious diseases.
  • Developing combination therapies to counter resistance.
  • Growing demand in developing nations with high infection rates.

Conclusion

Trimethoprim’s clinical trial activity remains subdued, mainly focusing on repurposing or combination strategies amid rising antibiotic resistance. Market growth prospects are steady but limited by existing generic status and resistance challenges. The market is expected to expand modestly over the next five years, driven by increased infection rates and resistance issues.

Key Takeaways

  • Clinical trials for trimethoprim are few, mainly targeting resistant infections or combination therapies.
  • The market is mature, with global sales around $230 million in 2022.
  • Growth projections remain modest, with a CAGR of 2-3% through 2028.
  • Resistance trends and regulatory changes could influence future development.
  • Opportunities exist in drug repurposing and combination therapy development.

FAQs

Q1: Are there new formulations of trimethoprim in development?
A1: No significant new formulations are currently in advanced clinical stages. Most efforts focus on existing generic versions.

Q2: What indications beyond bacterial infections are being studied?
A2: Early-stage research explores use in inflammatory diseases and prophylaxis for immunocompromised patients, but clinical evidence remains limited.

Q3: How does resistance affect trimethoprim’s market?
A3: Resistance diminishes efficacy, prompting reliance on combination therapies or alternative antibiotics, which could suppress demand.

Q4: What regions have the highest potential for growth?
A4: Emerging markets where infection prevalence is high and healthcare infrastructure improves may see increased trimethoprim use.

Q5: Is there ongoing research exploring alternative delivery methods?
A5: Current research is limited; most studies focus on efficacy and resistance rather than new delivery systems.


References

  1. ClinicalTrials.gov. (2023). Trimethoprim-related clinical trials. Retrieved from https://clinicaltrials.gov.
  2. MarketWatch. (2023). Global antibiotics market size and forecasts. Retrieved from https://www.marketwatch.com.
  3. Research and Markets. (2022). Global trimethoprim market report. Retrieved from https://www.researchandmarkets.com.

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