Ganciclovir
As of the edition of 20 October 2026, Ganciclovir is a small molecule: marketed, first approved in 1988 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1995
- Kind
- Small molecule
- Brand name
- Cytovene
- First approved
- 19 August 1988 (FR)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- Thea Pharma; 7 holders in all
- Withdrawn from market
- 2 April 2002 (in some regions)
- Registered trials
- 89, 8 stopped early
- Disease areas
- Infections; Immune system; Inherited and neonatal; Nutrition and metabolism; Urinary and reproductive; Eye
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 | 31 | 23 | 2 | 0 |
| Phase 1 | 19 | 14 | 1 | 3 |
| Phase 2 | 20 | 13 | 3 | 2 |
| Phase 3 | 11 | 9 | 0 | 2 |
| Phase 4 | 8 | 6 | 1 | 1 |
| All trials | 89 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Acquired holder, Earlier holder and Lead sponsor of trials | 1989 to now |
| Bausch Health | Later holder | 1996 to now |
| Sirion Therapeutics | Later holder | 2009 to now |
| Exela Pharma Sciences | Later holder | 2017 to now |
| Cheplapharm Arzneimittel | Acquired holder | 2019 to now |
| Thea Pharma | Applicant | 2020 to now |