Cysteamine hydrochloride is under clinical development by Orphan Europe and currently in Phase III for Cystinosis. According to GlobalData, Phase III drugs for Cystinosis does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Cysteamine hydrochloride LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Cysteamine hydrochloride overview

Cysteamine chlorhydrate/mercaptamine hydrochloride (Cystadrops) is a radiation protective agent that oxidizes in air to form cystamine. It is formulated as solution for ophthalmic route of administration. It is indicated for treatment of corneal cysteine deposits in cystinosis (ocular cystinosis).  It is under development for the treatment of nephropathic cystinosis.

Orphan Europe overview

Orphan Europe, a subsidiary of Recordati SpA, is a healthcare products provider that develops, produces and distributes orphan medicinal products. The company offers orphan drug products for treatment in therapeutic areas of metabolic disorders, hepatology, cardiology neonatology, oncology, anticoagulant, nephropathic cystinosis, patent ductus arteriosus and others. Orphan Europe holds interest in producing, packaging, and distributing Carbaglu, Cystadane, Cystagon, Normosang, and Wilzin. The company distributes Novastan, an anticoagulant. It operates in France, Belgium, the UK, Switzerland, Italy, Sweden, Germany, the UAE, the US and others. Orphan Europe is headquartered in Paris, France.

For a complete picture of Cysteamine hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.