Molecule

Tiopronin

Reducing and Complexing Thiol

Available on requestOrphanNephrology and urology

Presentations: 8
Brands: 3
Manufacturers: 2
Available from stock: 0

Tiopronin is a reducing and complexing thiol indicated , in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults, among other approved uses. MedsAcross supplies Tiopronin 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: Reducing and Complexing Thiol, Cystine Disulfide Reduction
ATC classification: G04BX16 Tiopronin · Urology medicines, subgroup G04B, subgroup G04BX
US FDA first approval: 11 August 1988
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: Delayed-release tablet, Tablet
Identifiers: UNII C5W04GO61SRxCUI 6765CAS 1953-02-2DrugBank DB06823Q414456

Clinical information

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

Uses

THIOLA is indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone. --------------------------------------------INDICATIONS AND USAGE----------------------------------------- THIOLA is a reducing and complexing thiol indicated, in combination with high fluid intake, alkali, and diet modification, for the prevention of cystine stone formation in adults and pediatric patients 20 kg and greater with severe homozygous cystinuria, who are not responsive to these measures alone.

Source: US FDA prescribing information

Dosing overview

Recommended Dosage Monitoring Recommended Dosage Adults: The recommended initial dosage in adult patients is 800 mg/day. In clinical studies, the average dosage was about 1,000 mg/day. Pediatrics: The recommended initial dosage in pediatric patients weighing 20 kg and greater is 15 mg/kg/day. Avoid dosages greater than 50 mg/kg per day in pediatric patients. Administer THIOLA in 3 divided doses at the same times each day at least one hour before or 2 hours after meals. Consider starting THIOLA at a lower dosage in patients with history of severe toxicity to d-penicillamine.

Source: US FDA prescribing information

Contraindications

THIOLA is contraindicated in patients with hypersensitivity to tiopronin or any other components of THIOLA. ----------------------------------------------CONTRAINDICATIONS------------------------------------------ • Hypersensitivity to tiopronin or any component of THIOLA

Source: US FDA prescribing information

Warnings and precautions

Proteinuria Hypersensitivity Reactions Proteinuria Proteinuria, including nephrotic syndrome, and membranous nephropathy, have been reported with tiopronin use. Pediatric patients receiving greater than 50 mg/kg of tiopronin per day may be at increased risk for proteinuria. Monitor patients for the development of proteinuria and discontinue therapy in patients who develop proteinuria.

Source: US FDA prescribing information

Side effects

Clinical Trials Experience Postmarketing Experience The following adverse reactions are discussed in greater detail in other sections of the labeling: • Proteinuria • Hypersensitivity

Source: US FDA prescribing information

Storage

Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).

Source: US FDA prescribing information

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

All presentations

8 presentations of Tiopronin, sorted by availability.

Medicine	Manufacturer	Register	Availability
Tiopronin 300 mg delayed-release tabletOralGeneric name	—	US FDA	Available on request
Tiopronin 100 mg delayed-release tabletOralGeneric name	—	US FDA	Available on request
Tiopronin 100 mg tabletOralGeneric name	—	US FDA	Available on request
Thiola 100 mg tabletOral	Mission Pharmacal	US FDA	Available on request
Thiola EC 100 mg delayed-release tabletOral	Mission Pharmacal	US FDA	Available on request
Thiola EC 300 mg delayed-release tabletOral	Mission Pharmacal	US FDA	Available on request
Venxxiva 100 mg delayed-release tabletOral	Cycle Pharmaceuticals	US FDA	Available on request
Venxxiva 300 mg delayed-release tabletOral	Cycle Pharmaceuticals	US FDA	Available on request

Brands by market

3 brand names across 1 markets.

Brand names by country

United States

Thiola Thiola EC Venxxiva

Manufacturers

Regulatory status

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

Register	Status	Source
US FDA	First approved 11 August 1988	Drugs@FDA
EU (EMA)	Not recorded	—
India (CDSCO)	Not yet confirmed against CDSCO approval lists	—
United States	Registered	US FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Tiopronin available for export from India?

Yes, on request. MedsAcross lists 8 presentations of Tiopronin and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Tiopronin have?

The catalogue lists 3 brand names for Tiopronin, including Thiola, Thiola EC, Venxxiva.

Is Tiopronin approved by the US FDA?

Yes. The US FDA first approved Tiopronin on 11 August 1988, according to Drugs@FDA.

Does Tiopronin need cold chain shipping?

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

Which ATC class is Tiopronin in?

Tiopronin is classified under ATC code G04BX16 (Tiopronin).

References

Thiola prescribing information (Mission Pharmacal). U.S. National Library of Medicine, DailyMed. Retrieved 27 August 2026

Request Tiopronin for export supply

Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.

Request a quote Read the import guides