Regulatory PathRegulatory requirements compared

Active substance

Mercaptamine

Open in the medicines table

EMA European Union — centrally authorised medicines

Cystagon Recordati Rare Diseases · Authorised · authorised 23 Jun 1997 · ATC A16AA04

Therapeutic indication (EMA)

Cystagon is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.

Procysbi Chiesi Farmaceutici S.p.A · Authorised · authorised 5 Sep 2013 · ATC A16AA04

Therapeutic indication (EMA)

Procysbi is indicated for the treatment of proven nephropathic cystinosis. Cysteamine reduces cystine accumulation in some cells (e.g. leukocytes, muscle and liver cells) of nephropathic cystinosis patients and, when treatment is started early, it delays the development of renal failure.

Cystadrops Recordati Rare Diseases · Authorised · authorised 18 Jan 2017 · ATC S01XA21

Therapeutic indication (EMA)

Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months of age with cystinosis.

Dropcys Lucane Pharma · Refused · ATC S01XA21

Therapeutic indication (EMA)

Treatment of corneal cystine deposits

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
CYSTADROPS 3.8 MG/ML EYE DROPS SOLUTIONPLGB 15266/0021RECORDATI RARE DISEASESPOM
CYSTAGON 150 MG HARD CAPSULESPLGB 15266/0022RECORDATI RARE DISEASESPOM
CYSTAGON 50 MG HARD CAPSULESPLGB 15266/0023RECORDATI RARE DISEASESPOM
PROCYSBI 25 MG GASTRO-RESISTANT HARD CAPSULESPLGB 08829/0190CHIESI LIMITEDPOM
PROCYSBI 300MG GASTRO-RESISTANT GRANULESPLGB 08829/0206CHIESI LIMITEDPOM
PROCYSBI 75 MG GASTRO-RESISTANT HARD CAPSULESPLGB 08829/0191CHIESI LIMITEDPOM
PROCYSBI 75MG GASTRO-RESISTANT GRANULESPLGB 08829/0205CHIESI LIMITEDPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffMercaptamine 150mg capsules£190.00100 capsule1 Oct 2026
NHS Drug TariffMercaptamine 25mg gastro-resistant capsules£335.9760 capsule1 Oct 2026
NHS Drug TariffMercaptamine 3.8mg/ml eye drops£865.005 ml1 Oct 2026
NHS Drug TariffMercaptamine 50mg capsules£70.00100 capsule1 Oct 2026
NHS Drug TariffMercaptamine 75mg gastro-resistant capsules£4199.65250 capsule1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.