Modafinil
As of the edition of 20 October 2026, Modafinil is a small molecule: marketed, first approved in 1992 (FR); acts on SLC6A3.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Provigil
- First approved
- 24 June 1992 (FR)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Alfresa Pharma Corporation; 5 holders in all
- Registered trials
- 117, 16 stopped early
- Disease areas
- Mental health; Nervous system; Chemically induced; Lungs and airways; Cancer; Immune system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Modafinil.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC6A3 | Sodium-dependent dopamine transporter | Q01959 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 23 | 12 | 1 | 3 |
| Phase 1 | 24 | 19 | 2 | 0 |
| Phase 2 | 34 | 20 | 3 | 7 |
| Phase 3 | 20 | 15 | 2 | 3 |
| Phase 4 | 16 | 12 | 0 | 3 |
| All trials | 117 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Teva | Originator and Lead sponsor of trials | 1998 to now |
| Libbs Farmacêutica LTDA | Applicant | 2008 to now |
| Nuvo Pharmaceuticals Dac | Acquired holder | 2025 to now |