Product Description
Mercaptamine (cysteamine) bitartrate is used for metabolic conditions (the management of nephropathic cystinosis) and is available in a 50mg or 150mg tablet. (Sourced from: https://www.tga.gov.au/alert/mercaptamine-cysteamine-and-mercaptopurine)
Mechanisms of Action: Autophagy Activator,TG2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Canada | Chile | Colombia | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Slovakia | Slovenia | Spain | Sweden | Switzerland | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: Cystinosis | Cystinosis | Cystinosis | Cystinosis
Known Adverse Events: Eye Pain | Headache | Pain Unspecified | Pruritus | Ocular Discomfort | Abdominal Pain | Dizziness | Anorexia | Diarrhea | Enteritis | Gastroenteritis
Company: Amgen
Company Location: THOUSAND OAKS CA 91320
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Belgium, France, Germany, Italy, Japan, United Kingdom
Active Clinical Trial Count: 3
Highest Development Phases
Phase 3: Cystinosis
Phase 2: Cystic Fibrosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| SCOB2 | P3 |
Completed |
Cystinosis |
2022-12-23 |
68% |
| jRCT2021200029 | P3 |
Not yet recruiting |
Cystinosis |
2021-12-31 |
|
| 2015-004986-99 | P2 |
Active, not recruiting |
Cystic Fibrosis |
2017-07-11 |