Sulfamethoxazole-Trimethoprim

Phase 3Small molecule

NNational Institute of Allergy and Infectious Diseases (NIAID)

Sulfamethoxazole-Trimethoprim is one of 63 small molecule programs targeting Otitis media. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Otitis MediaActive, not recruiting

Diabetic FootActive, not recruiting

AntibioticsCompleted

Antibiotic ProphylaxisRecruiting

Otitis MediaPreclinical

Active, not recruiting

Diabetic FootPreclinical

Active, not recruiting

AntibioticsPhase 3

Completed

Antibiotic ProphylaxisPhase 3

Recruiting

Competition

Competitive Landscape

49 competitors in Diabetic Foot

#DrugCompanyPhaseTrials

Desferal

Remodulin

Vancocin

HHikma Pharmaceuticals LLC

Approved

3 4

Januvia

ZZydus Therapeutics Inc.

Approved

1 5

Mozobil

GGenzyme, a Sanofi Company

Approved

—6

Nydrazid

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Levaquin

Glucophage

Xylocaine

Caverject

VViatris Specialty LLC

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Clinical

Trials by Indication[1]

Pneumonia6 trials

Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00000816·370 enrolled

Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001013·364 enrolled

Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001014·302 enrolled

Show 3 more trials

A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral/Oral Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis Carinii Pneumonia in AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000715·240 enrolled

Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000730·240 enrolled

A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000655·300 enrolled

Antibiotics2 trials

Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome

Recruiting·—·Phase 1·NCT05302531·10 enrolled

Prophylactic Antibiotics in Measles

Completed·BBandim Health Project·Phase 3·NCT00168532·218 enrolled

7 more indications

Treatment1 trial

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·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000640·290 enrolled

Diabetic Foot1 trial

Efficacy of Surgical Treatment of Osteomyelitis in Diabetic Foot Ulcers

Unknown status·UUniversidad Complutense de Madrid·N/A·NCT01137903·88 enrolled

Antibiotic Prophylaxis1 trial

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

Recruiting·RRigshospitalet, Denmark·Phase 4·NCT06709196·248 enrolled

Otitis media1 trial

Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media

Completed·UUMC Utrecht·N/A·NCT00189098·101 enrolled

Prospective1 trial

A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000748·2,500 enrolled

Bacterial Infections1 trial

A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000811·690 enrolled

Urinary Tract Infection1 trial

Efficacy of Fosfomycin-Trometamol in Urinary Tract Infection Prophylaxis After Kidney Transplantation

Completed·JJOSE MANUEL ARREOLA GUERRA·Phase 4·NCT01820897·130 enrolled

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Sulfamethoxazole-Trimethoprim. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sulfamethoxazole-Trimethoprim compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sulfamethoxazole-Trimethoprim. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — National Institute of Allergy and Infectious Diseases (NIAID) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNational Institute of Allergy and Infectious Diseases (NIAID)

Sulfamethoxazole-Trimethoprim

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Trials by Indication[1]

Pneumonia6 trials

Antibiotics2 trials

Interaction2 trials

Tics1 trial

Prevention1 trial

Treatment1 trial

Diabetic Foot1 trial

Antibiotic Prophylaxis1 trial

Otitis media1 trial

Prospective1 trial

Bacterial Infections1 trial

Urinary Tract Infection1 trial

References

Drug Info

Quick Facts

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