Roxithromycin
As of the edition of 20 October 2026, Roxithromycin is a small molecule: marketed, first approved in 1986 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1986
- Kind
- Small molecule
- Brand name
- Rulid
- First approved
- 4 August 1986 (FR)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Amdipharm
- Registered trials
- 5, 0 stopped early
- Disease areas
- Bones, joints and muscles; Infections; Skin and connective tissue; Immune 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 4 | 2 | 1 | 0 | 0 |
| All trials | 5 |