Clarithromycin
As of the edition of 20 October 2026, Clarithromycin 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 1994
- Kind
- Small molecule
- Brand name
- Biaxin
- First approved
- 11 September 1991 (FR)
- Approvals on record
- 26 in 5 regions
- Holder of the most recent approval
- Phathom Pharmaceuticals; 15 holders in all
- Registered trials
- 235, 14 stopped early
- Disease areas
- Immune system; Infections; Cancer; Blood and lymph; Digestive system; Heart and blood vessels
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 | 44 | 35 | 2 | 0 |
| Phase 1 | 59 | 58 | 0 | 0 |
| Phase 2 | 41 | 24 | 7 | 6 |
| Phase 3 | 40 | 27 | 2 | 3 |
| Phase 4 | 51 | 25 | 4 | 5 |
| All trials | 235 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Abbott | Originator, Later holder and Lead sponsor of trials | 1991 to now |
| Takeda | Applicant and Lead sponsor of trials | 2010 to now |
| AbbVie | Acquired holder | 2012 to now |
| Astellas | Later holder | |
| AstraZeneca | Later holder | |
| Eisai | Later holder | |
| Mitsubishi Tanabe Pharma | Later holder | |
| Shionogi | Later holder | |
| Taisho Pharmaceutical | Later holder |