Famciclovir
As of the edition of 20 October 2026, Famciclovir is a small molecule: marketed, first approved in 1994 (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
- Famvir
- First approved
- 29 June 1994 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Asahi Kasei Therapeutics; 4 holders in all
- Registered trials
- 18, 0 stopped early
- Disease areas
- Infections; Skin and connective tissue; Pregnancy and women's health; Urinary and reproductive; Mouth and teeth; Nervous system
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 | 3 | 2 | 0 | 0 |
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 2 | 1 | 0 | 0 |
| Phase 3 | 7 | 7 | 0 | 0 |
| Phase 4 | 4 | 4 | 0 | 0 |
| All trials | 18 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Acquired holder and Lead sponsor of trials | 2003 to now |
| Asahi Kasei Therapeutics | Applicant | 2008 to now |
| GSK | Originator | 1994 to 2003 |