Hydroxychloroquine
As of the edition of 20 October 2026, Hydroxychloroquine is a small molecule: marketed, first approved in 1957 (CA); acts on TLR7 and TLR9.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2015
- Kind
- Small molecule
- Brand name
- Plaquenil
- First approved
- 31 December 1957 (CA)
- Approvals on record
- 7 in 5 regions
- Holder of the most recent approval
- ANI Pharmaceuticals; 5 holders in all
- Registered trials
- 379, 103 stopped early
- Disease areas
- Lungs and airways; Infections; Cancer; Skin and connective tissue; Immune system; 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.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 55 | 24 | 11 | 3 |
| Phase 1 | 50 | 27 | 6 | 12 |
| Phase 2 | 140 | 45 | 29 | 48 |
| Phase 3 | 90 | 34 | 7 | 31 |
| Phase 4 | 44 | 13 | 6 | 9 |
| All trials | 379 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Applicant and Lead sponsor of trials | 1957 to now |
| ANI Pharmaceuticals | Later holder | 2022 to now |
| Advanz Pharma | Acquired holder | 2025 to now |