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: Australia, Belgium, Canada, Colombia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Nepal, Netherlands, New Zealand, Pakistan, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: COVID-19|Cystinosis|Influenza, Human|Pneumonia
Phase 2: Cystic Fibrosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| REMAP-CAP | P3 |
Recruiting |
Influenza, Human|COVID-19|Pneumonia |
2026-02-01 |
|
| 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 |