Imiquimod
As of the edition of 20 October 2026, Imiquimod is a small molecule: marketed, first approved in 1997 (US); acts on TLR7; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Aldara
- First approved
- 27 February 1997 (US)
- Approvals on record
- 13 in 5 regions
- Holder of the most recent approval
- Industrial Farmaceutica Cantabria S.A.; 5 holders in all
- Withdrawn from market
- 11 June 2002 (in some regions)
- Registered trials
- 138, 21 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Urinary and reproductive; Pregnancy and women's health; Infections; Immune system
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 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 Imiquimod.
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 |
|---|---|---|
| TLR7 | Toll-like receptor 7 | Q9NYK1 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 8 | 1 | 4 |
| Phase 1 | 38 | 23 | 5 | 7 |
| Phase 2 | 30 | 20 | 3 | 5 |
| Phase 3 | 30 | 21 | 1 | 3 |
| Phase 4 | 21 | 16 | 1 | 2 |
| All trials | 138 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| 3M | Earlier holder | 1997 to now |
| Viatris | Acquired holder and Lead sponsor of trials | 1998 to now |
| Graceway Pharmaceuticals | Later holder and Lead sponsor of trials | 2001 to now |
| Bausch Health | Acquired holder | 2019 to now |
| Mochida Pharmaceutical | Applicant |