Primsol

(Trimethoprim)

Phase 2Small molecule

CConrado Roberto Hoffmann Filho

Primsol is one of 182 small molecule programs targeting Recurrent urinary tract infections. It is currently in Phase 2.

Indications

Total Trials

Active Trials

181

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Recurrent Urinary Tract InfectionsActive, not recruiting

PneumoniaActive, not recruiting

Acute BronchitisActive, not recruiting

Oxidative StressActive, not recruiting

ImmunodeficiencyActive, not recruiting

Prostate CancerActive, not recruiting

Type 1 DiabetesActive, not recruiting

Epidermolysis BullosaActive, not recruiting

Recurrent Urinary Tract InfectionsPreclinical

Active, not recruiting

PneumoniaPreclinical

Active, not recruiting

Acute BronchitisPreclinical

Active, not recruiting

Oxidative StressPhase 1

Active, not recruiting

ImmunodeficiencyPreclinical

Active, not recruiting

Prostate CancerPhase 2

Active, not recruiting

Type 1 DiabetesPhase 2

Active, not recruiting

Epidermolysis BullosaPhase 2

Active, not recruiting

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Primsol

CConrado Roberto Hoffmann Filho

Phase 2

1 2

Novantrone

Pfizer

Preclinical

5 3

Mekinist

Novartis

Preclinical

3 4

Trexall

Alnylam Pharmaceuticals

Preclinical

—5

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 6

Viagra

VViatris Specialty LLC

Preclinical

1 7

Duragesic

CCephalon

Preclinical

1 8

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 9

Prednisone/prednisolone

Roche

Preclinical

3 10

Osmitrol

BB. Braun Medical Inc.

Preclinical

—

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalRecruiting

Antibiotic Prophylaxis

NCT06709196

Q4 2027

Phase 2Not yet recruiting

Prostate Cancer

NCT06536374

Clinical

Trials by Indication[1]

Pneumonia2 trials

A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

Completed·JJacobus Pharmaceutical·N/A·NCT00002283

Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia

Completed·UU.S. Bioscience·Phase 1·NCT00002120·20 enrolled

Recurrent urinary tract infections1 trial

Effect of Nanotechnology Structured Water Magnalife for the Prevention of Recurrent Urinary Tract Infections.

Completed·UUniversity of Sulaimani·N/A·NCT04306731·437 enrolled

Acute bronchitis1 trial

A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis

Completed· Roche logo

Roche··NCT02879981·51 enrolled

Colonization1 trial

S. Aureus Decolonization in HPN Patients.

Terminated·RRadboud University Medical Center·N/A·NCT03173053·63 enrolled

ALS1 trial

A Non-Interventional Safety Study of Balsamic Bactrim

Completed· Roche logo

Roche··NCT02902640·52 enrolled

10 more indications

Tics1 trial

The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine

Completed·UUniversity of California, San Francisco·Phase 4·NCT03746106·7 enrolled

Epidermolysis Bullosa1 trial

The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa

Completed·TThe Hospital for Sick Children·Phase 2·NCT00380640·10 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

Type 1 Diabetes1 trial

Islet Transplantation for Type 1 Diabetes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00014911·36 enrolled

Oxidative Stress1 trial

Pentriox - Induction of Oxidative Stress

Completed·HHenrik Enghusen Poulsen·Phase 1·NCT02188472·90 enrolled

Immunodeficiency1 trial

A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome

Completed·LLederle Laboratories·N/A·NCT00002002

Recurrent UTIs1 trial

Methenamine Hippurate Versus Trimethoprim in the Prevention of Recurrent UTIs

Completed·EEndeavor Health·Phase 4·NCT03077711·92 enrolled

Hydronephrosis1 trial

Effectiveness of Antibiotics Versus Placebo to Treat Antenatal Hydronephrosis

Unknown status·MMcMaster University·N/A·NCT01140516·160 enrolled

Prostate Cancer1 trial

Folate Study in Men With Advanced Prostate Cancer

Not yet recruiting·UUniversity of California, San Diego·Phase 2·NCT06536374·50 enrolled

Interaction1 trial

Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers

Completed· GSK logo

GSK·Phase 1·NCT02371603·70 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

PROLOPRIM

NDA NDA017943

Jan 1, 1982

TRIMPEX

NDA NDA017952

Jul 30, 1982

TRIMETHOPRIM

NDA NDA018679

Jun 23, 1995

PRIMSOL

NDA NDA074374

Jan 24, 2000

PRIMSOL

NDA NDA074973

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Trimethoprim. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trimethoprim compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Trimethoprim. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA074973). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Conrado Roberto Hoffmann Filho company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: CConrado Roberto Hoffmann Filho

Primsol

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Trials by Indication[1]

Pneumonia2 trials

Recurrent urinary tract infections1 trial

Acute bronchitis1 trial

Colonization1 trial

ALS1 trial

Tics1 trial

Epidermolysis Bullosa1 trial

Antibiotic Prophylaxis1 trial

Type 1 Diabetes1 trial

Oxidative Stress1 trial

Immunodeficiency1 trial

Recurrent UTIs1 trial

Hydronephrosis1 trial

Prostate Cancer1 trial

Interaction1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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