Benznidazole

ApprovedSmall molecule

CCorestemchemon, Inc.

Benznidazole is one of 33 small molecule programs targeting Women of Reproductive Age. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Women of Reproductive AgeActive, not recruiting

Phase 1Active, not recruiting

Chagas DiseaseActive, not recruiting

Women of Reproductive AgePhase 3

Active, not recruiting

Phase 1Phase 1

Active, not recruiting

Chagas DiseaseApproved

Active, not recruiting

Competition

Competitive Landscape

59 competitors in Phase 1

#DrugCompanyPhaseTrials

Benznidazole

CCorestemchemon, Inc.

Approved

1 2

Rituxan

Roche

Phase 2

4 3

Fludara

Sanofi

Phase 2

4 4

Venclexta

AbbVie

Phase 2

2 5

Cytoxan

BBaxter Healthcare Corporation

Phase 2

5 6

Erbitux

IImclone

Phase 2

3 7

Rayos

RRoxane Laboratories

Phase 2

1 8

Navitoclax

AbbVie

Phase 2

1 9

Yervoy

Bristol-Myers Squibb

Phase 1

1 10

VX-407

Vertex Pharmaceuticals

Phase 1

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

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Phase 1

NCT05523596

Q1 2028

Phase 3Active, not recruiting

Chagas Disease

NCT04024163

Q1 2031

Phase 2Recruiting

Chagas Disease

NCT06632600

Clinical

Trials by Indication[1]

Chagas disease11 trials

Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial

Completed·IInstituto Nacional de Parasitologia Dr. Mario Fatala Chaben·Phase 3·NCT02386358·910 enrolled

Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease

Completed·DDrugs for Neglected Diseases·Phase 4·NCT01678599·220 enrolled

New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease

Completed·BBarcelona Centre for International Health Research··NCT01755377·63 enrolled

Show 8 more trials

Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 2·NCT01162967·78 enrolled

Population Pharmacokinetics of Benznidazole in Children With Chagas Disease

Completed·—·N/A·NCT00699387·37 enrolled

Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease

Unknown status·DDrugs for Neglected Diseases·Phase 2·NCT01489228·230 enrolled

A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01377480·120 enrolled

Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 2·NCT03191162·238 enrolled

Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease

Active, not recruiting·IInsud Pharma·Phase 3·NCT04024163·178 enrolled

Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease

Completed·BBarcelona Centre for International Health Research·Phase 4·NCT01755403·52 enrolled

A Randomized, Participant- and Investigator-blinded, Controlled, Parallel Group Study to Assess the Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LXE408 in Participants With Chronic Chagas Disease Without Severe Organ Dysfunction.

Recruiting· Novartis logo

Novartis·Phase 2·NCT06632600·130 enrolled

Treatment2 trials

BENDITA BEnznidazole New Doses Improved Treatment and Associations

Unknown status·DDrugs for Neglected Diseases·Phase 2·NCT03378661·210 enrolled

BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease

Completed·PPopulation Health Research Institute·Phase 3·NCT00123916·2,854 enrolled

Women of Reproductive Age1 trial

Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age

Active, not recruiting·—·Phase 3·NCT03672487·273 enrolled

Phase 11 trial

A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults

Active, not recruiting·IIC-MedTech Corporation·Phase 1·NCT05523596·13 enrolled

Interaction1 trial

Pharmacokinetic Drug-Drug Interaction Study

Completed·DDrugs for Neglected Diseases·Phase 1·NCT03892213·28 enrolled

2 more indications

Trypanosomiasis1 trial

CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)

Unknown status·UUniversidad Autónoma de Bucaramanga·Phase 2/3·NCT02369978·500 enrolled

Biomarkers1 trial

New Therapies and Biomarkers for Chagas Infection

Completed·—·Phase 2·NCT03981523·450 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 29, 2017

BENZNIDAZOLE

NDA NDA209570

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Benznidazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Benznidazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Benznidazole. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209570). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Corestemchemon, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: CCorestemchemon, Inc.

Benznidazole

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2028

Q1 2031

Trials by Indication[1]

Chagas disease11 trials

Treatment2 trials

Women of Reproductive Age1 trial

Phase 11 trial

Interaction1 trial

Trypanosomiasis1 trial

Biomarkers1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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