Zidovudine
As of the edition of 20 October 2026, Zidovudine is a small molecule: marketed, first approved in 1987 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1998
- Kind
- Small molecule
- Brand name
- Retrovir
- First approved
- 13 March 1987 (FR)
- Approvals on record
- 21 in 6 regions
- Holder of the most recent approval
- Micro; 8 holders in all
- Registered trials
- 356, 14 stopped early
- Disease areas
- Immune system; Infections; Urinary and reproductive; Blood and lymph; Cancer; Pregnancy and women's health
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 | 91 | 87 | 0 | 4 |
| Phase 1 | 73 | 71 | 0 | 1 |
| Phase 2 | 93 | 83 | 1 | 5 |
| Phase 3 | 70 | 63 | 1 | 3 |
| Phase 4 | 29 | 23 | 0 | 1 |
| All trials | 356 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 1987 to now |
| Aurobindo Pharma | Later holder | 2009 to now |
| Matrix Pharmaceutical | Later holder | 2011 to now |
| Pharmobedient Consulting | Acquired holder | 2025 to now |