Quinine
As of the edition of 20 October 2026, Quinine is a small molecule: marketed, first approved in 1991 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Qualaquin
- First approved
- 30 August 1991 (FR)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Similasan AG; 4 holders in all
- Registered trials
- 24, 4 stopped early
- Disease areas
- Infections; Lungs and airways; Immune system; Urinary and reproductive; Blood and lymph; Cancer
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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 2 | 0 | 0 |
| Phase 1 | 11 | 9 | 0 | 1 |
| Phase 2 | 6 | 2 | 0 | 3 |
| Phase 3 | 1 | 1 | 0 | 0 |
| Phase 4 | 3 | 1 | 0 | 0 |
| All trials | 24 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Mutual Pharmaceutical | Applicant and Lead sponsor of trials | 2004 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2016 to now |