Tetradecyl sulfuric acid
As of the edition of 20 October 2026, Tetradecyl sulfuric acid is a small molecule: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1987
- Kind
- Small molecule
- Brand name
- Sotradecol
- First approved
- 1 January 1982 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Omega Pharma; 3 holders in all
- Registered trials
- 8, 2 stopped early
- Disease areas
- Heart and blood vessels; Blood and lymph; Cancer; Digestive system; Ear, nose and throat; Inherited and neonatal
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 0 | 2 |
| Phase 1 | 1 | 0 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 0 |
| Phase 3 | 1 | 0 | 0 | 0 |
| Phase 4 | 1 | 0 | 0 | 0 |
| All trials | 8 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Omega Pharma | Applicant | 1987 to now |
| Elkins Sinn | Acquired holder | 2003 to now |