Duloxetine
As of the edition of 20 October 2026, Duloxetine is a small molecule: marketed, first approved in 2004 (US); acts on SLC6A2 and SLC6A4; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Cymbalta
- First approved
- 3 August 2004 (US)
- Approvals on record
- 20 in 4 regions
- Holder of the most recent approval
- Almatica Pharma; 6 holders in all
- Withdrawn from market
- 12 May 2021 (in some regions)
- Registered trials
- 280, 25 stopped early
- Disease areas
- Mental health; Nervous system; Bones, joints and muscles; Urinary and reproductive; Pregnancy and women's health; Hormones
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
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Duloxetine.
See the 2 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 | 54 | 27 | 5 | 6 |
| Phase 1 | 18 | 16 | 0 | 0 |
| Phase 2 | 23 | 9 | 9 | 4 |
| Phase 3 | 95 | 85 | 3 | 5 |
| Phase 4 | 90 | 65 | 8 | 10 |
| All trials | 280 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Eli Lilly | Applicant and Lead sponsor of trials | 2001 to now |
| Shionogi | Applicant and Lead sponsor of trials | 2010 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2022 to now |
| Almatica Pharma | Later holder | 2026 to now |