Lisdexamfetamine
As of the edition of 20 October 2026, Lisdexamfetamine is a small molecule: marketed, first approved in 2007 (US); acts on SLC18A2, SLC6A2 and SLC6A3; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Small molecule
- Brand name
- Vyvanse
- First approved
- 23 February 2007 (US)
- Approvals on record
- 30 in 4 regions
- Holder of the most recent approval
- Azurity Pharmaceuticals; 4 holders in all
- Registered trials
- 77, 9 stopped early
- Disease areas
- Mental health; Chemically induced; Nervous system; Nutrition and metabolism; Hormones; Immune system
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.
Companies that need a new molecule because of this drug
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Lisdexamfetamine.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 11 | 9 | 0 | 1 |
| Phase 1 | 8 | 6 | 0 | 2 |
| Phase 2 | 16 | 14 | 0 | 1 |
| Phase 3 | 21 | 17 | 0 | 4 |
| Phase 4 | 21 | 19 | 0 | 1 |
| All trials | 77 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| New River Pharmaceuticals | Earlier holder and Lead sponsor of trials | 2004 to now |
| Takeda | Acquired holder, Later holder and Lead sponsor of trials | 2007 to now |
| Shionogi | Applicant | 2019 to now |
| Azurity Pharmaceuticals | Later holder | 2025 to now |