Valacyclovir
As of the edition of 20 October 2026, Valacyclovir is a small molecule: marketed, first approved in 1995 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Valtrex
- First approved
- 8 February 1995 (FR)
- Approvals on record
- 9 in 6 regions
- Holder of the most recent approval
- GSK
- Registered trials
- 104, 8 stopped early
- Disease areas
- Infections; Urinary and reproductive; Skin and connective tissue; Immune system; Pregnancy and women's health; 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 | 19 | 15 | 2 | 2 |
| Phase 1 | 26 | 20 | 1 | 1 |
| Phase 2 | 30 | 17 | 9 | 3 |
| Phase 3 | 14 | 11 | 2 | 0 |
| Phase 4 | 15 | 11 | 1 | 2 |
| All trials | 104 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Originator and Lead sponsor of trials | 1995 to now |