CLINICAL TRIALS PROFILE FOR FAMVIR

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
NCT00477334 ↗	Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients	Completed	Novartis	Phase 4	2007-06-01	This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
NCT00834431 ↗	Famciclovir 500 mg Tablets Under Fasting Conditions	Completed	Teva Pharmaceuticals USA	Phase 1	2004-08-01	The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under fasting conditions.

Clinical Trial Conditions for Famvir

Condition Name

Condition Name for Famvir
Intervention	Trials
Genital Herpes	2
Healthy	2
Herpes Simplex	2
Meniere's Disease	1

Condition MeSH

Condition MeSH for Famvir
Intervention	Trials
Herpes Genitalis	2
Herpes Simplex	2
Meniere Disease	1
Infections	1

Clinical Trial Locations for Famvir

Trials by Country

Trials by Country for Famvir
Location	Trials
United States	56
Canada	7
Panama	2
Australia	1
Germany	1

Trials by US State

Trials by US State for Famvir
Location	Trials
Texas	4
Missouri	4
Ohio	3
North Carolina	3
Alabama	3

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

Clinical Trial Status

Clinical Trial Status for Famvir
Clinical Trial Phase	Trials
Completed	6
Terminated	1

Clinical Trial Sponsors for Famvir

Sponsor Name

Sponsor Name for Famvir
Sponsor	Trials
Novartis Pharmaceuticals	2
Novartis	2
Teva Pharmaceuticals USA	2

Sponsor Type

Sponsor Type for Famvir
Sponsor	Trials
Industry	7
Other	1

FAMVIR: Clinical Trials, Market Analysis, and Projections

Introduction to FAMVIR

FAMVIR, the brand name for the antiviral drug famciclovir, is a synthetic nucleoside analog used to treat various forms of herpes infections, including herpes zoster (shingles), recurrent genital herpes, and herpes labialis (cold sores). Here, we will delve into the clinical trials, market analysis, and future projections for FAMVIR.

Clinical Trials and Efficacy

Herpes Zoster

Clinical trials involving FAMVIR for herpes zoster have shown promising results. Studies involving 816 FAMVIR-treated patients with herpes zoster, administered at doses of 250 mg to 750 mg three times daily, demonstrated the drug's efficacy in reducing the duration and severity of the infection. The median time to healing of non-aborted lesions was significantly shorter in the FAMVIR group compared to the placebo group[1].

Recurrent Genital Herpes

For recurrent genital herpes, FAMVIR has been evaluated in several studies. A notable study published in JAMA indicated that FAMVIR, administered at doses of 125 mg three times daily, 250 mg twice daily, or 250 mg three times daily, significantly delayed the time to the first recurrence of genital herpes. The median time to recurrence was 222 to 336 days for FAMVIR recipients, compared to 47 days for placebo recipients. The study also showed that FAMVIR was well-tolerated, with an adverse experience profile comparable to placebo[4].

Herpes Labialis

In the treatment of herpes labialis, FAMVIR has been shown to be effective in reducing the healing time of cold sores. A phase 3 trial where patients received a single 1500 mg dose of FAMVIR within 24 hours of symptom onset resulted in a median healing time of 4.4 days, significantly shorter than the 6.2 days observed in the placebo group[1].

Safety Profile

The safety of FAMVIR has been extensively evaluated in various clinical trials. Common adverse events reported include headache and nausea, affecting more than 10% of adult patients. Other less common but serious adverse events include acute renal failure, thrombocytopenia, abnormal liver function tests, and anaphylactic reactions. However, these events are rare and often reported in post-marketing surveillance rather than in controlled clinical trials[1].

Market Analysis

Current Market Size

The herpes simplex virus treatment market, which includes FAMVIR, is substantial and growing. As of 2025, the market size is estimated to be around USD 2.60 billion[2][5].

Market Projections

The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.77% to reach USD 3.28 billion by 2030. This growth is driven by ongoing research and development, the launch of new drugs, and the increasing demand for effective antiviral treatments[2][5].

Key Players

Major companies operating in the herpes simplex virus treatment market include Novartis, Glenmark Pharmaceuticals Inc., Fressenius Kabi, GSK plc, Teva Pharmaceuticals Industries Ltd, and Zydus Group. Novartis, in particular, is actively involved in research to enhance the effectiveness of FAMVIR through combination therapies[2][3].

Regional Analysis

North America currently holds the largest market share in the herpes simplex virus treatment market, largely due to the high prevalence of genital herpes and a strong demand for effective treatments. The Asia Pacific region is expected to grow at the highest CAGR over the forecast period[2][3].

Future Projections and Trends

Combination Therapies

Novartis is exploring the potential of FAMVIR in combination with other antiviral agents to enhance treatment efficacy. This approach aims to target the virus through multiple mechanisms, potentially leading to more effective management of herpes infections[3].

New Product Launches

The market is expected to benefit from frequent approvals and new product launches. For example, recent launches of generic versions of antiviral drugs, such as acyclovir oral suspension and capsules, are expanding the treatment options available to patients[2][5].

Regional Growth

The Asia Pacific region is anticipated to experience significant growth due to increasing awareness and demand for antiviral treatments. This trend is expected to contribute substantially to the overall market growth over the forecast period[2].

Key Takeaways

• Clinical Efficacy: FAMVIR has demonstrated significant efficacy in treating herpes zoster, recurrent genital herpes, and herpes labialis through various clinical trials.
• Safety Profile: While generally well-tolerated, FAMVIR can cause common adverse events like headache and nausea, and rare but serious side effects.
• Market Size and Growth: The herpes simplex virus treatment market, including FAMVIR, is projected to grow from USD 2.60 billion in 2025 to USD 3.28 billion by 2030.
• Regional Trends: North America holds the largest market share, but the Asia Pacific region is expected to grow at the highest CAGR.
• Future Directions: Combination therapies and new product launches are expected to drive market growth and enhance treatment options.

FAQs

What is FAMVIR used for?

FAMVIR (famciclovir) is used to treat various forms of herpes infections, including herpes zoster (shingles), recurrent genital herpes, and herpes labialis (cold sores).

What are the common side effects of FAMVIR?

Common side effects of FAMVIR include headache and nausea. Less common but serious side effects can include acute renal failure, thrombocytopenia, and anaphylactic reactions.

How effective is FAMVIR in treating genital herpes?

FAMVIR has been shown to significantly delay the time to the first recurrence of genital herpes and reduce the frequency of recurrences. The median time to recurrence was 222 to 336 days for FAMVIR recipients, compared to 47 days for placebo recipients[4].

What is the current market size of the herpes simplex virus treatment market?

As of 2025, the herpes simplex virus treatment market size is estimated to be around USD 2.60 billion[2][5].

Which region is expected to grow the fastest in the herpes simplex virus treatment market?

The Asia Pacific region is expected to grow at the highest CAGR over the forecast period[2].

Who are the key players in the herpes simplex virus treatment market?

Major companies include Novartis, Glenmark Pharmaceuticals Inc., Fressenius Kabi, GSK plc, Teva Pharmaceuticals Industries Ltd, and Zydus Group[2][3].

Sources

1. Novartis: Famvir - Novartis.
2. Mordor Intelligence: Herpes Simplex Virus Treatment Market Size | Mordor Intelligence.
3. Biospace: Genital Herpes Market to Reach a CAGR of 3.49% during 2024-2034.
4. JAMA: Oral Famciclovir for the Suppression of Recurrent Genital Herpes.
5. Grand View Research: Herpes Simplex Virus Treatment Market Size Report, 2030.

Last updated: 2025-01-05