Aminolevulinic acid
As of the edition of 20 October 2026, Aminolevulinic acid is a small molecule: marketed, first approved in 1999 (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 2013
- Kind
- Small molecule
- Brand name
- Levulan
- First approved
- 3 December 1999 (US)
- Approvals on record
- 9 in 3 regions
- Holder of the most recent approval
- SBI Pharmaceuticals; 7 holders in all
- Registered trials
- 112, 21 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Nervous system; Mouth and teeth; Urinary and reproductive; Pregnancy and women's health
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.
Biofrontera 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 | 21 | 14 | 2 | 2 |
| Phase 1 | 22 | 10 | 4 | 6 |
| Phase 2 | 45 | 24 | 10 | 9 |
| Phase 3 | 12 | 8 | 2 | 2 |
| Phase 4 | 12 | 6 | 0 | 2 |
| All trials | 112 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| DUSA Pharmaceuticals | Originator and Lead sponsor of trials | 1999 to now |
| Biofrontera Bioscience | Later holder and Lead sponsor of trials | 2006 to now |
| photonamic | Applicant and Lead sponsor of trials | 2007 to now |
| Nobelpharma | Later holder and Lead sponsor of trials | 2010 to now |
| SBI Pharmaceuticals | Applicant | 2013 to now |
| Nx | Later holder and Lead sponsor of trials | 2017 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2024 to now |
| Biofrontera | Acquired holder | 2026 to now |