Valganciclovir
As of the edition of 20 October 2026, Valganciclovir is a small molecule: marketed, first approved in 2001 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2008
- Kind
- Small molecule
- Brand name
- Valcyte
- First approved
- 29 March 2001 (US)
- Approvals on record
- 10 in 5 regions
- Holder of the most recent approval
- Cheplapharm Arzneimittel; 4 holders in all
- Registered trials
- 83, 16 stopped early
- Disease areas
- Infections; Immune system; Cancer; Nutrition and metabolism; Urinary and reproductive; Inherited and neonatal
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 6 | 2 | 0 |
| Phase 1 | 8 | 5 | 0 | 2 |
| Phase 2 | 26 | 13 | 7 | 6 |
| Phase 3 | 22 | 12 | 2 | 7 |
| Phase 4 | 15 | 10 | 4 | 1 |
| All trials | 83 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Later holder and Lead sponsor of trials | 2004 to now |
| Cheplapharm Arzneimittel | Acquired holder | 2023 to now |
| Mitsubishi Tanabe Pharma | Applicant |