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Molecule

Fexinidazole

Nitroimidazole Antimicrobial
Available on requestOrphan
Presentations
1
Brands
0
Manufacturers
0
Available from stock
0

Fexinidazole is a nitroimidazole antimicrobial. It is available as tablets for oral use. MedsAcross supplies Fexinidazole for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Nitroimidazole Antimicrobial, Cytochrome P450 1A2 Inducers, Cytochrome P450 1A2 Inhibitors, Cytochrome P450 2B6 Inducers, Cytochrome P450 2B6 Inhibitors, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A4 Inhibitors, Cytochrome P450 3A5 Inhibitors, Multidrug and Toxin Extrusion Transporter 1 Inhibitors, Multidrug and Toxin Extrusion Transporter 2 K Inhibitors, Organic Anion Transporter 1 Inhibitors
ATC classification
P01CA03 Fexinidazole · Antiprotozoals, including antimalarials, subgroup P01C, subgroup P01CA
US FDA first approval
16 July 2021
EU status
Not recorded
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 306ERL82IRCAS 59729-37-2DrugBank DB12265Q5446115

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. Fexinidazole Tablets is a nitroimidazole antimicrobial, indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. Limitations of Use Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/µL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options.

Source: US FDA prescribing information

Dosing overview

Administer Fexinidazole Tablets once daily with food each day at about the same time of the day. Do not break or crush tablets. Recommended Dosage of Fexinidazole Tablets in Patients 6 years of age and older and weighing at least 20 kg. Body Weight Type of Dose Daily Dose Number of Tablets Duration of Treatment Greater than or equal to 35 kg Loading dose 1,800 mg 3 4 days Maintenance dose 1,200 mg 2 6 days Greater than or equal to 20 kg to less than 35 kg Loading dose 1,200 mg 2 4 days Maintenance dose 600 mg 1 6 days

Source: US FDA prescribing information

Contraindications

Fexinidazole Tablets are contraindicated in: Patients with known hypersensitivity to Fexinidazole Tablets and/or any nitroimidazole-class drugs (e.g., metronidazole, tinidazole). Patients with severe hepatic impairment. Patients with Cockayne syndrome. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to fexinidazole, in patients with Cockayne syndrome. Known hypersensitivity to fexinidazole, and/or nitroimidazole drugs.

Source: US FDA prescribing information

Warnings and precautions

Decreased Efficacy in Severe Human African Trypanosomiasis caused by Trypanosoma brucei gambiense. QT Interval Prolongation: Prolongation of the QT interval due to Fexinidazole Tablets occurs in a concentration-dependent manner. Avoid use in patients with known prolongation, proarrhythmic conditions, and concomitant use with drugs that prolong the QT interval, those that block cardiac potassium channels, and/or those that induce bradycardia, or are inducers of hepatic CYP450. Neuropsychiatric Adverse Reactions: Adverse reactions such as agitation, anxiety, abnormal behavior, depression, suicidal ideation, nightmares, hallucination, and personality change have been observed during therapy. Inform patients and their caregivers of the risk.

Source: US FDA prescribing information

Side effects

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Decreased Efficacy in Severe Human African Trypanosomiasis Caused by Trypanosoma brucei gambiense QT Interval Prolongation Neuropsychiatric Adverse Reactions Neutropenia Potential for Hepatotoxicity Most common adverse reactions (incidence >10%) are headache, vomiting, insomnia, nausea, asthenia, tremor, decreased appetite, dizziness, hypocalcemia, dyspepsia, back pain, upper abdominal pain, and hyperkalemia.

Source: US FDA prescribing information

Interactions

Avoid use of herbal medicines and supplements. See full prescribing information for complete list of clinically significant drug interactions.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Fexinidazole, sorted by availability.

MedicineManufacturerRegisterAvailability
Fexinidazole 600 mg tabletOralGeneric name—US FDAAvailable on request

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 16 July 2021Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Fexinidazole available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Fexinidazole and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Fexinidazole approved by the US FDA?

Yes. The US FDA first approved Fexinidazole on 16 July 2021, according to Drugs@FDA.

Does Fexinidazole need cold chain shipping?

No listed presentation of Fexinidazole is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Fexinidazole in?

Fexinidazole is classified under ATC code P01CA03 (Fexinidazole).

References

  1. Fexinidazole prescribing information (Sanofi-Aventis). U.S. National Library of Medicine, DailyMed. Retrieved 2 May 2025

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