Last Updated: May 25, 2026

CLINICAL TRIALS PROFILE FOR FAMVIR


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for FAMVIR

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00098059 ↗ Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection Completed Novartis Pharmaceuticals Phase 3 2005-02-01 This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.
NCT00306787 ↗ Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes Completed Novartis Pharmaceuticals Phase 3 2006-03-01 This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
NCT00448227 ↗ Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection Completed Novartis Phase 2 2007-10-01 This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FAMVIR

Condition Name

Condition Name for FAMVIR
Intervention Trials
Genital Herpes 2
Healthy 2
Herpes Simplex 2
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for FAMVIR
Intervention Trials
Herpes Simplex 2
Herpes Genitalis 2
Meniere Disease 1
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for FAMVIR

Trials by Country

Trials by Country for FAMVIR
Location Trials
United States 56
Canada 7
Panama 2
Germany 1
South Africa 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for FAMVIR
Location Trials
Missouri 4
Texas 4
Alabama 3
Ohio 3
North Carolina 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for FAMVIR

Clinical Trial Phase

Clinical Trial Phase for FAMVIR
Clinical Trial Phase Trials
Phase 4 1
Phase 3 3
Phase 2 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for FAMVIR
Clinical Trial Phase Trials
Completed 6
Terminated 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for FAMVIR

Sponsor Name

Sponsor Name for FAMVIR
Sponsor Trials
Novartis Pharmaceuticals 2
Novartis 2
Teva Pharmaceuticals USA 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for FAMVIR
Sponsor Trials
Industry 7
Other 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Famvir (famciclovir) Clinical Trials Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is Famvir and what is the current clinical-development context?

Famvir is the brand name for famciclovir (famciclovir; an oral prodrug of penciclovir), a systemic antiviral used for herpes virus indications. Famvir’s clinical evidence base is largely established in prior regulatory eras, and the drug is marketed in multiple geographies as an established product rather than an active, late-stage development program.

Indications (commercially established)

Famvir’s core label across major markets historically covers herpes-family diseases, including:

  • Genital herpes (episodic and suppressive therapy in multiple jurisdictions)
  • Herpes zoster (shingles)
  • Orolabial herpes (cold sores) in certain jurisdictions and label variants
  • Recurrent herpes labialis in certain settings and label formats (Indication specifics vary by country and approval history.)

Clinical trials landscape

Public clinical-trial activity for famciclovir has been comparatively limited in recent years versus newer antiviral classes, with the current observable footprint skewing toward:

  • Comparative/real-world evidence (treatment outcomes, adherence, dosing schedules)
  • Post-marketing pharmacovigilance
  • Special populations and regimen comparisons

Under a “clinical trials update” framing for an established product, the most actionable takeaway is that famciclovir’s clinical program is not defined by ongoing pivotal phase 3 readouts in the way novel antivirals are. Any ongoing studies that do exist tend to be incremental or confirmatory rather than label-expanding.

What does the market look like for famciclovir?

Famciclovir is an antiviral with established usage patterns in herpes management. Market dynamics are shaped by:

  • Generic entry and price erosion
  • Brand-to-generic substitution
  • Channel mix across hospital, retail, and country-specific formularies
  • Ongoing demand driven by recurrent herpes and shingles incidence

Market structure

  • Generic competition is the dominant structural feature in many markets where famciclovir is off-patent.
  • The brand’s commercial performance depends on country-level pricing, reimbursement, and contracting rather than patent-protected exclusivity.
  • Sales typically track incidence and recurrence patterns rather than disease-category growth driven by new indications.

Pricing and demand drivers

Key drivers for demand and revenue include:

  • Epidemiology of genital herpes and shingles
  • Treatment adherence to episodic versus suppressive regimens
  • Physician prescribing habits and guideline alignment
  • Generic pricing and pharmacy tender dynamics

Competitive set

Famciclovir competes primarily with other herpes antivirals in the same clinical space:

  • Valacyclovir
  • Acyclovir
  • Other herpes therapeutics depending on market form and guideline position

In many geographies, valacyclovir’s convenience and broad formulary presence have historically pressured pricing and share, while generic versions of all agents compress margins.

How should revenue and volume be projected for Famvir over the next 5 years?

A credible projection framework for an off-patent established antiviral should model:

  1. Baseline demand (incidence and recurrence)
  2. Share pressure from generics and competing antivirals
  3. Price declines via generic substitution and tender cycles
  4. Brand-specific resilience (where branding remains entrenched by formularies or contracting)

Projection approach (business model)

A common projection pattern for established antivirals with heavy generic penetration:

  • Volume: grows slowly or remains flat, tied to incidence and prescribing behavior.
  • Price: declines due to generic competition.
  • Revenue: tends to be flat to mildly declining unless there is a structural reimbursement advantage for specific products.

5-year directional projection (qualitative, market-typical)

For famciclovir brands like Famvir, absent a brand-protecting exclusivity event, a typical 5-year outcome is:

  • Unit volume: modest growth or stability
  • Net sales: gradual erosion driven by price compression
  • Operating margin: constrained by competitive pricing

A projection with explicit numeric forecasts requires market-close inputs (country sales, current net price, generic mix, tender pricing). Under the constraints here, only directional projection can be supported without fabricating figures.

Where are the clinical opportunities: new uses, combinations, or reformulations?

For established antivirals, clinical value creation generally comes from:

  • Regimen optimization (dosing schedules, adherence models)
  • Population-specific refinements (immunocompromised, renal impairment)
  • Formulation improvements (bioavailability, tolerability)
  • Therapy sequencing aligned with guideline updates

For famciclovir, the most likely incremental route is evidence generation rather than a new phase-3 registration pathway, unless a new indication or combination strategy is adopted by a sponsor.

Key risks for market outlook

Market risk is dominated by competitive and structural factors:

  • Generic substitution risk reduces brand pricing power.
  • Formulary shifts to competitors can reallocate prescribing.
  • Shifts in shingles and genital herpes guideline preferences change default prescribing.
  • Patent and exclusivity events are unlikely to be catalysts for branded-only products once generics are entrenched.

Key performance indicators to monitor

For business and investment decisions, the operational KPIs that typically reveal trajectory for an established antiviral include:

  • Share-of-prescription at formulary level (where measurable)
  • Average net price by channel and quarter
  • Retail/generic mix in key markets
  • Reimbursement policy changes tied to antivirals
  • Evidence updates that alter guideline positioning (even without new clinical endpoints)

Key Takeaways

  • Famvir (famciclovir) is an established oral antiviral with a mature clinical evidence base; the current clinical update picture is mostly incremental and post-marketing rather than label-expanding phase 3 pivots.
  • The market is structurally shaped by generic competition, which drives pricing compression and limits branded revenue durability.
  • A 5-year outlook for Famvir-style branded famciclovir products is typically flat-to-declining net sales with stable-to-slightly rising volume, unless a country-specific reimbursement or contracting advantage offsets generic pressure.
  • Competitive dynamics center on valacyclovir and acyclovir plus generic substitution across all herpes antiviral classes.
  • The most actionable forward indicators are net price, formulary share, and tender-driven channel mix rather than new trial readouts.

FAQs

1) Is Famvir still relevant for herpes management today?

Yes. Famvir (famciclovir) is used in established herpes indications where antiviral efficacy and tolerability profiles support routine prescribing, with real-world use sustained by generic availability and guideline inclusion.

2) What is the biggest commercial driver for Famvir?

Generic competition and reimbursement-driven net pricing. Revenue trends track net price more than new patient discovery.

3) Are there current phase 3 trials that will expand Famvir’s label?

Clinical activity for famciclovir in recent years is not characterized by widely reported label-expanding phase 3 programs in the way newer antivirals are. The observed footprint is primarily incremental.

4) How does Famvir compete against valacyclovir and acyclovir?

It competes as a herpes antiviral across similar clinical scenarios. Competitive share often depends on net pricing, formulary placement, and dosing convenience perceptions rather than distinct mechanism advantage.

5) What should investors monitor for downside or upside?

Quarterly average net price, formulary contracting outcomes in key markets, shifts in preferred antiviral selection for shingles/genital herpes, and any new evidence that changes guideline defaults.


References (APA)

[1] FDA. (n.d.). Famciclovir (Famvir) prescribing information. U.S. Food and Drug Administration.
[2] EMA. (n.d.). Famciclovir (Famvir) summary of product characteristics. European Medicines Agency.
[3] DailyMed. (n.d.). Famvir (famciclovir) label. U.S. National Library of Medicine.
[4] ClinicalTrials.gov. (n.d.). Famciclovir clinical studies. U.S. National Institutes of Health.
[5] WHO. (n.d.). Herpesvirus disease burden and epidemiology resources. World Health Organization.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.