TheraRadar
Data updated: May 26, 2026

FAMVIR (famciclovir)

Trial Activity: Stable 1 active trials
Infectious Disease Approved 1994-06-29
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

EMS conducting 2 trials (40%)
4 indications explored (Focused)
→ herpes zoster (2 trials)
→ herpes labialis (1 trials)
→ genital herpes (1 trials)
8
Indications
--
Phase 3 Trials
1
Priority Reviews
31
Years on Market

Details

Status
Discontinued
First Approved
1994-06-29
Routes
ORAL
Dosage Forms
TABLET

Companies

Novartis
Active Ingredient: FAMCICLOVIR

FAMVIR Approval History

1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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2018
2019
2020
2021
2022
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2026
Original
New Indication
New Form
Label Update
108 FDA actions from 1994 to 2018 · 5 indication expansions
Dec 2018 SUPPL
Label · Labeling
FDA Letter Label
Dec 2016 SUPPL
Mfg · Manufacturing (CMC)
Nov 2016 SUPPL
Mfg · Manufacturing (CMC)

What FAMVIR Treats

8 FDA approvals

Originally approved for its first indication in 1994 . Covers 8 distinct patient populations.

  • Other (8)
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Clinical Trial Registry

5 trials
Trial Sponsor ID Phase Status Title
NCT07099157 M20250600 Ph 4 recruiting Efficacy and Safety of Brivudine in the Treatment of Herpes Zoster
NCT00878072 results posted CFAM810B2305 Ph 2, Ph 3 completed Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
NCT01281007 results posted F125EMS1010 Ph 3 completed Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
NCT01526408 Famvir results posted HRI-003 Meniere's Disease Ph 3 terminated Famvir for Treatment of Hearing in Unilateral Meniere's Disease
NCT01327144 F500EMS1010 Ph 3 completed Efficacy of Oral Famciclovir Versus Aciclovir Treatment in Patients With Herpes Zoster
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

FAMVIR FDA Label Details

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Data Sources

FDA Approval: NDA020363 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment