Substance / Medication

Fexinidazole

Overview

Active Ingredient
fexinidazole
RxNorm CUI
2564146

Indications

Trypanosoma brucei gambiense Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due toin patients 6 years of age and older and weighing at least 20 kg.

Labeler: Sanofi-Aventis U.S. LLCUpdated: 2025-05-02T00:00:00.000ZFull label on DailyMed

Contraindications

When this intervention should not be used

Fexinidazole Tablets are contraindicated in: Patients with known hypersensitivity to Fexinidazole Tablets and/or any nitroimidazole-class drugs (e.g., metronidazole, tinidazole). Warnings and Precautions (5.5) Adverse Reactions (6.1) Use in Specific Populations (8.7) [see,, and] Patients with severe

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
New WHO guidelines for treating rhodesiense human African trypanosomiasis: expanded indications for fexinidazole and pentamidine.
Lindner Andreas K, Lejon Veerle, Barrett Michael P et al. · Lancet Infect Dis · 2025
PMID: 39389073Meta-Analysis
Safety and efficacy of oral fexinidazole in children with gambiense human African trypanosomiasis: a multicentre, single-arm, open-label, phase 2-3 trial.
Kande Betu Kumesu Victor, Mutombo Kalonji Wilfried, Bardonneau Clélia et al. · Lancet Glob Health · 2022
PMID: 36179736TrialFull text (PMC)
Oral fexinidazole for late-stage African Trypanosoma brucei gambiense trypanosomiasis: a pivotal multicentre, randomised, non-inferiority trial.
Mesu Victor Kande Betu Ku, Kalonji Wilfried Mutombo, Bardonneau Clélia et al. · Lancet · 2018
PMID: 29113731Trial

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Fexinidazole (substance)
SNOMED CT
890462007
UMLS CUI
C0060304
RxNorm CUI
2564146
Labeler
Sanofi-Aventis U.S. LLC

Clinical Data

This intervention maps to 1 entities in the Ltrl knowledge graph.

1
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.