Fexinidazole

Phase 2Small molecule

Sanofi

Fexinidazole is one of 11 small molecule programs targeting Chagas disease. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Chagas DiseaseActive, not recruiting

Human African TrypanosomiasisActive, not recruiting

Chagas DiseasePhase 2

Active, not recruiting

Human African TrypanosomiasisPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

13 competitors in Chagas Disease

#DrugCompanyPhaseTrials

Bayer Aspirin

Bayer

Approved

1 2

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

—3

Benznidazole

CCorestemchemon, Inc.

Approved

11 4

Noxafil

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 2

2 5

Selenium

SSWOG Cancer Research Network

LXE408

1 7

Fexinidazole

Sanofi

Phase 2

2 8

E1224

DDrugs for Neglected Diseases

Phase 2

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

Clinical

Trials by Indication[1]

Human African Trypanosomiasis6 trials

Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

Completed·DDrugs for Neglected Diseases·Phase 3·NCT03025789·174 enrolled

Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study

Completed·DDrugs for Neglected Diseases·Phase 2/3·NCT02184689·125 enrolled

Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

Completed·DDrugs for Neglected Diseases·Phase 2/3·NCT01685827·394 enrolled

Show 3 more trials

Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense

Completed·DDrugs for Neglected Diseases·Phase 2/3·NCT03974178·45 enrolled

Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study

Completed·DDrugs for Neglected Diseases·Phase 2/3·NCT02169557·230 enrolled

Multiple Dose Study to Evaluate Security, Tolerance and Pharmacokinetic of Fexinidazole (Drug Candidate for Human African Trypanosomiasis) Administered With a Loading Dose and With Food

Terminated·DDrugs for Neglected Diseases·Phase 1·NCT01483170·30 enrolled

Chagas disease2 trials

Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease

Unknown status·DDrugs for Neglected Diseases·Phase 2·NCT02498782·140 enrolled

Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease

Completed·DDrugs for Neglected Diseases·Phase 2·NCT03587766·45 enrolled

Efficacy1 trial

Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan

Terminated·DDrugs for Neglected Diseases·Phase 2·NCT01980199·14 enrolled

Moderate Hepatic Impairment1 trial

A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment

Completed· Sanofi logo

Sanofi·Phase 1·NCT05607173·21 enrolled

Unspecified2 trials

Fexinidazole (1200mg) Bioavailability Under Different Food Intake Conditions

Completed·DDrugs for Neglected Diseases·Phase 1·NCT01340157·12 enrolled

Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation

Completed·DDrugs for Neglected Diseases·Phase 1·NCT02571062·30 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 16, 2021

FEXINIDAZOLE

NDA NDA214429

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Fexinidazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fexinidazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fexinidazole. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214429). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: Sanofi

Fexinidazole

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Human African Trypanosomiasis6 trials

Chagas disease2 trials

Efficacy1 trial

Moderate Hepatic Impairment1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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