Cysteamine
As of the edition of 20 October 2026, Cysteamine is a small molecule: marketed, first approved in 1994 (US); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Cystagon
- First approved
- 15 August 1994 (US)
- Approvals on record
- 15 in 3 regions
- Holder of the most recent approval
- Leadiant Biosciences; 6 holders in all
- Registered trials
- 26, 3 stopped early
- Disease areas
- Inherited and neonatal; Nutrition and metabolism; Nervous system; Lungs and airways; Mental health; Bones, joints and muscles
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Amgen holds a later exclusivity on its own new formulation or combination product, ending 2027; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 3 | 1 | 2 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 8 | 7 | 0 | 1 |
| Phase 3 | 7 | 5 | 1 | 0 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 26 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Viatris | Originator and Lead sponsor of trials | 1994 to now |
| Recordati Rare Diseases | Applicant | 1997 to now |
| Amgen | Applicant, Acquired holder and Lead sponsor of trials | 2009 to now |
| Raptor Pharmaceutical | Later holder | 2013 to now |
| Chiesi Farmaceutici | Later holder | 2013 to now |
| Leadiant Biosciences | Acquired holder | 2017 to now |