Imipramine
As of the edition of 20 October 2026, Imipramine is a small molecule: marketed, first approved in 1958 (ES); acts on SLC6A4.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Tofranil-Pm
- First approved
- 1 November 1958 (ES)
- Approvals on record
- 17 in 4 regions
- Holder of the most recent approval
- Jamp Pharma; 6 holders in all
- Registered trials
- 26, 2 stopped early
- Disease areas
- Mental health; Cancer; Nervous system; Skin and connective tissue; Heart and blood vessels; 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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Imipramine.
See the 1 company 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 | 6 | 2 | 3 | 0 |
| Phase 1 | 5 | 3 | 1 | 1 |
| Phase 2 | 7 | 4 | 3 | 0 |
| Phase 3 | 4 | 3 | 0 | 1 |
| Phase 4 | 4 | 3 | 0 | 0 |
| All trials | 26 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Acquired holder and Later holder | 2003 to now |
| Novartis | Acquired holder | 2003 to now |
| Sanofi | Acquired holder | 2006 to now |
| Specgx | Acquired holder | 2018 to now |
| Jamp Pharma | Applicant | 2024 to now |
| GEIGY Pharmaceuticals | Later holder and Lead sponsor of trials |