Ivermectin
As of the edition of 20 October 2026, Ivermectin is a drug: marketed, first approved in 1996 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Unknown
- Brand name
- Stromectol
- First approved
- 22 November 1996 (US)
- Approvals on record
- 8 in 5 regions
- Holder of the most recent approval
- Galderma Brasil Ltda; 5 holders in all
- Registered trials
- 154, 11 stopped early
- Disease areas
- Infections; Lungs and airways; Skin and connective tissue; Blood and lymph; Eye; Cancer
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 21 | 14 | 1 | 0 |
| Phase 1 | 16 | 14 | 2 | 0 |
| Phase 2 | 38 | 20 | 7 | 6 |
| Phase 3 | 61 | 42 | 3 | 3 |
| Phase 4 | 18 | 11 | 1 | 2 |
| All trials | 154 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Originator | 1996 to now |
| Sanofi | Later holder | 2012 to now |
| Galderma | Later holder | 2014 to now |
| Arbor Pharmaceuticals | Acquired holder | 2016 to now |
| Galderma Brasil Ltda | Applicant | 2020 to now |