Trimethoprim-sulfamethoxazole

Phase 3Small molecule

Astellas

Trimethoprim-sulfamethoxazole is one of 140 small molecule programs targeting Cellulitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

139

Competitors

Pipeline

Status by Indication[3][1]

Indication

CellulitisActive, not recruiting

AbscessActive, not recruiting

Granulomatosis With PolyangiitisActive, not recruiting

Cystic FibrosisNot yet recruiting

Chronic Obstructive Pulmonary Disease (COPD)Not yet recruiting

Staphylococcus AureusRecruiting

KidneyNot yet recruiting

HypospadiasActive, not recruiting

CellulitisPreclinical

Active, not recruiting

AbscessPreclinical

Active, not recruiting

Granulomatosis With PolyangiitisPhase 2

Active, not recruiting

Cystic FibrosisPhase 2

Not yet recruiting

Chronic Obstructive Pulmonary Disease (COPD)Preclinical

Not yet recruiting

Staphylococcus AureusPhase 3

Recruiting

KidneyPhase 3

Not yet recruiting

Age-Related Macular DegenerationPhase 1

Recruiting

HypospadiasPreclinical

Active, not recruiting

Competition

Competitive Landscape

105 competitors in Cystic Fibrosis

#DrugCompanyPhaseTrials

Ibsrela

AArdelyx

Phase 3

1 2

Zyvox

Pfizer

Phase 2

2 3

HSK31858

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

2 4

Trimethoprim-sulfamethoxazole

Astellas

Phase 3

1 5

Amoxil

GGlobal Antibiotics Research and Development Partnership

Phase 2

1 6

ELX/TEZ/IVA

Vertex Pharmaceuticals

Phase 3

19 7

Trikafta

NNottingham University Hospitals NHS Trust

Phase 3

4 8

VNZ/TEZ/D-IVA

Vertex Pharmaceuticals

Phase 3

1 9

VX-121/TEZ/D-IVA

Vertex Pharmaceuticals

Phase 3

4 10

Verapamil Hydrochloride

Mylan Pharmaceuticals Inc

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Small Intestine Bacterial Overgrowth

NCT07451171

Q1 2027

Phase 2/3Recruiting

Antibiotic Therapy

NCT07202078

Phase 2/3Recruiting

Antibiotic Therapy

NCT07202091

Phase 2/3Recruiting

Antibiotic Therapy

NCT07202052

Q2 2027

Phase 2/3Recruiting

Antibiotic Therapy

NCT05678621

ApprovedRecruiting

Staphylococcus Aureus

NCT06982105

Clinical

Trials by Indication[1]

Antibiotic Therapy4 trials

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)

Recruiting·MMonash University·Phase 2/3·NCT07202078·900 enrolled

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)

Recruiting·MMonash University·Phase 2/3·NCT07202091·900 enrolled

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)

Recruiting·MMonash University·Phase 2/3·NCT07202052·900 enrolled

Show 1 more trial

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension

Recruiting·MMonash University·Phase 2/3·NCT05678621·300 enrolled

Abscess3 trials

Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management

Completed·SSt. Louis University·Phase 4·NCT00679302·161 enrolled

Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department

Terminated·—·N/A·NCT00867789·140 enrolled

Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage

Completed·—·N/A·NCT02024867·249 enrolled

Lymphoma2 trials

Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00002524·46 enrolled

SWOG-9320 Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma

Completed·SSWOG Cancer Research Network·Phase 2·NCT00002571·52 enrolled

Antibiotics2 trials

Prophylactic Antibiotics on Urethral Catheter Withdrawal

Completed·SSt. Antonius Hospital·Phase 4·NCT00126698·100 enrolled

Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2/3·NCT00729937·2,265 enrolled

Methicillin-resistant Staphylococcus Aureus2 trials

Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00730028·1,310 enrolled

Randomized Clinical Trial to Compare a Regimen of Trimethoprim-sulfamethoxazole Plus Rifampicin With a Regimen of Linezolid in the Treatment of Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

Completed·UUniversity Hospital, Geneva·Phase 4·NCT00711854·150 enrolled

27 more indications

Pneumonia2 trials

Low Dose Trimethoprim-Sulfamethoxazole for the Treatment of Pneumocystis Jirovecii Pneumonia

Recruiting·—·Phase 3·NCT04851015·416 enrolled

DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)

Terminated·IImmtech Pharmaceuticals, Inc·Phase 3·NCT00302341·48 enrolled

Malaria2 trials

Interactions Between HIV and Malaria in African Children

Completed·UUniversity of California, San Francisco·Phase 3·NCT00527800·351 enrolled

Chemopreventive Therapy for Malaria in Ugandan Children

Completed·UUniversity of California, San Francisco·Phase 3·NCT00948896·600 enrolled

Hypospadias1 trial

Prophylactic Antibiotics or Placebo After Hypospadias Repair

Active, not recruiting·—·N/A·NCT02096159·93 enrolled

Children1 trial

PK of Clindamycin and Trimethoprim-sulfamethoxazole in Infants and Children

Completed·MMichael Cohen-Wolkowiez·Phase 1·NCT02475876·51 enrolled

Pyelonephritis1 trial

Antibiotic Prophylaxis in Children With Pyelonephritis

Withdrawn·UUniversity of Alberta·Phase 3·NCT00752375

Staphylococcus Aureus Bacteremia1 trial

Staphylococcus Aureus Bacteremia Antibiotic Treatment Options

Completed·HHeinrich-Heine University, Duesseldorf·Phase 3·NCT01792804·215 enrolled

Malignancies1 trial

Antimicrobial Solution or Saline Solution in Maintaining Catheter Patency and Preventing Catheter-Related Blood Infections in Patients With Malignancies

Withdrawn·MM.D. Anderson Cancer Center·Phase 1/2·NCT01101412

Toxoplasmosis1 trial

Influence of Trimethoprim-Sulfamethoxazole for the Recurrence of Ocular Toxoplasmosis

Completed·UUniversity of Campinas, Brazil·Phase 3·NCT01449877·141 enrolled

Osteomyelitis1 trial

Vancomycin Or Trimethoprim/Sulfamethoxazole for Methicillin-resistant Staphylococcus Aureus Osteomyelitis

Completed·UUniversity of Washington·Phase 3·NCT00324922·2 enrolled

Urinary Tract Infection1 trial

Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients

Completed·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 4·NCT03235947·82 enrolled

Cellulitis1 trial

Study of New Antibiotic Regimen for the Treatment of Uncomplicated Cellulitis in Emergency Department Patients

Completed·—·N/A·NCT00676130·153 enrolled

Cystic Fibrosis1 trial

Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

Acute Lymphoblastic Leukemia1 trial

Alemtuzumab and Combination Chemotherapy in Treating Patients With Untreated Acute Lymphoblastic Leukemia

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT00061945·302 enrolled

Completed·VVion Pharmaceuticals·Phase 1·NCT00004216

Chronic Obstructive Pulmonary Disease1 trial

Antibiotic/COPD in Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) Requiring Mechanical Ventilation

Completed·UUniversity of Monastir·Phase 3·NCT00791505·170 enrolled

Antibiotic Prophylaxis1 trial

Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Completed·NNorthwestern University·Phase 4·NCT01659866·563 enrolled

Erythema1 trial

Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous

Unknown status·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 4·NCT03042260·310 enrolled

Pneumocystis1 trial

Treatment of Pneumocystis in COPD (the TOPIC Study)

Terminated·CCorewell Health East·Phase 1/2·NCT05418777·1 enrolled

Small Intestine Bacterial Overgrowth1 trial

A Phase II Trial to Prevent Linear Growth Stunting and Malnutrition in Impoverished Children From a Low-Income Country by Treating Small Intestine Bacterial Overgrowth

Active, not recruiting·UUniversity of Virginia·Phase 2·NCT07451171·60 enrolled

Bladder Carcinoma1 trial

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy

Completed·RRoswell Park Cancer Institute·Approved·NCT04502095·89 enrolled

Granulomatosis with Polyangiitis1 trial

Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis With Polyangiitis

Active, not recruiting·UUniversity of Pennsylvania·Preclinical·NCT03919435·8 enrolled

Kidney1 trial

Trial of Antibiotic Strategies for Kidney Transplant Recipients

Not yet recruiting·UUniversity of California, San Francisco·Approved·NCT07106125·50 enrolled

Age-Related Macular Degeneration1 trial

A Phase 1b, Multicenter, Dose Escalation, Evaluation of Safety and Tolerability of ASP7317 for Geographic Atrophy Secondary to Age-related Macular Degeneration

Recruiting· Astellas logo

Astellas·Phase 1·NCT03178149·42 enrolled

Staphylococcus Aureus1 trial

Comparing Optimal Step-down Therapy for Children With Invasive MRSA Trimethoprim-Sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections

Recruiting·IIndiana University·Approved·NCT06982105·100 enrolled

Chronic Obstructive Pulmonary Disease (COPD)1 trial

A Multicenter, Prospective, Double-blind, Randomized Controlled Study on the Impact of Decolonization Treatment on the Frequency of Acute Exacerbation in Patients With Chronic Obstructive Pulmonary Disease Colonized With Pneumocystis Jirovecii

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Preclinical·NCT07665359·630 enrolled

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Trimethoprim-sulfamethoxazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trimethoprim-sulfamethoxazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Trimethoprim-sulfamethoxazole. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Astellas

Trimethoprim-sulfamethoxazole

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Antibiotic Therapy4 trials

Abscess3 trials

Lymphoma2 trials

Antibiotics2 trials

Methicillin-resistant Staphylococcus Aureus2 trials

Pneumonia2 trials

Malaria2 trials

Hypospadias1 trial

Children1 trial

Pyelonephritis1 trial

Staphylococcus Aureus Bacteremia1 trial

Malignancies1 trial

Toxoplasmosis1 trial

Osteomyelitis1 trial

Urinary Tract Infection1 trial

Cellulitis1 trial

Cystic Fibrosis1 trial

Acute Lymphoblastic Leukemia1 trial

Stenotrophomonas Maltophilia Infection1 trial

Vesicoureteral Reflux1 trial

Advanced or Metastatic Solid Tumors1 trial

Chronic Obstructive Pulmonary Disease1 trial

Antibiotic Prophylaxis1 trial

Erythema1 trial

Pneumocystis1 trial

Small Intestine Bacterial Overgrowth1 trial

Bladder Carcinoma1 trial

Granulomatosis with Polyangiitis1 trial

Kidney1 trial

Age-Related Macular Degeneration1 trial

Staphylococcus Aureus1 trial

Chronic Obstructive Pulmonary Disease (COPD)1 trial

References

Drug Info

Quick Facts

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