Mirtazapine
As of the edition of 20 October 2026, Mirtazapine is a small molecule: marketed, first approved in 1996 (US); acts on ADRA2A, ADRA2B and ADRA2C and 2 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Remeron
- First approved
- 14 June 1996 (US)
- Approvals on record
- 13 in 6 regions
- Holder of the most recent approval
- ORGANON FARMACĂUTICA LTDA.; 7 holders in all
- Registered trials
- 62, 12 stopped early
- Disease areas
- Mental health; Chemically induced; Nervous system; Cancer; Digestive system; Lungs and airways
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
10 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product10 company-target rows are on route B because of Mirtazapine.
See the 10 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 | 13 | 5 | 1 | 2 |
| Phase 1 | 10 | 8 | 1 | 0 |
| Phase 2 | 20 | 8 | 5 | 4 |
| Phase 3 | 9 | 4 | 0 | 4 |
| Phase 4 | 10 | 7 | 0 | 2 |
| All trials | 62 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Organon | Originator and Applicant | 1996 to now |
| Merck & Co. | Applicant | 2009 to now |