Fluvoxamine
As of the edition of 20 October 2026, Fluvoxamine is a small molecule: marketed, first approved in 1984 (FR); acts on SLC6A4.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1994
- Kind
- Small molecule
- Brand name
- Luvox
- First approved
- 2 May 1984 (FR)
- Approvals on record
- 16 in 5 regions
- Holder of the most recent approval
- Jazz Pharmaceuticals; 8 holders in all
- Registered trials
- 55, 4 stopped early
- Disease areas
- Mental health; Infections; Lungs and airways; Nervous system; Chemically induced; Digestive 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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Fluvoxamine.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC6A4 | Sodium-dependent serotonin transporter | P31645 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 4 | 1 | 1 |
| Phase 1 | 21 | 20 | 0 | 0 |
| Phase 2 | 5 | 2 | 0 | 1 |
| Phase 3 | 12 | 9 | 2 | 1 |
| Phase 4 | 7 | 3 | 0 | 1 |
| All trials | 55 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Solvay Pharmaceuticals | Applicant and Lead sponsor of trials | 1994 to now |
| Jazz Pharmaceuticals | Later holder | 2007 to now |
| ANI Pharmaceuticals | Acquired holder | 2011 to now |
| AbbVie | Later holder and Lead sponsor of trials | 2013 to now |
| Meiji Seika Pharma | Applicant |