You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 14, 2025

CLINICAL TRIALS PROFILE FOR TELAVANCIN HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Telavancin Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00061633 ↗ Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) Completed Cumberland Pharmaceuticals Phase 2 2003-06-01 Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
NCT00061633 ↗ Phase 2 Trial of TD 6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI) Completed Theravance Biopharma Antibiotics, Inc. Phase 2 2003-06-01 Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. One of the ways to deal with this problem is to develop new drugs that can control these bacteria. This study will measure how well TD-6424 (Telavancin) can control infections and whether this drug can be safely given to patients.
NCT00062647 ↗ Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia Completed Cumberland Pharmaceuticals Phase 2 2003-08-01 The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Telavancin Hydrochloride

Condition Name

Condition Name for Telavancin Hydrochloride
Intervention Trials
Bacterial Pneumonia 2
Staphylococcal Skin Infection 2
Gram-Positive Bacterial Infections 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Telavancin Hydrochloride
Intervention Trials
Communicable Diseases 5
Infections 5
Infection 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Telavancin Hydrochloride

Trials by Country

Trials by Country for Telavancin Hydrochloride
Location Trials
United States 21
Israel 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 Telavancin Hydrochloride
Location Trials
California 5
Tennessee 2
Ohio 2
Florida 1
Louisiana 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Telavancin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Telavancin Hydrochloride
Clinical Trial Phase Trials
Phase 4 4
Phase 3 5
Phase 2 4
[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 Telavancin Hydrochloride
Clinical Trial Phase Trials
Completed 12
Recruiting 2
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 Telavancin Hydrochloride

Sponsor Name

Sponsor Name for Telavancin Hydrochloride
Sponsor Trials
Theravance Biopharma Antibiotics, Inc. 14
Cumberland Pharmaceuticals 12
Theravance Biopharma 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Telavancin Hydrochloride
Sponsor Trials
Industry 30
Other 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Telavancin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Telavancin hydrochloride, marketed as VIBATIV, is a potent antibacterial agent used in the treatment of complicated skin and skin structure infections, as well as hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Mechanism of Action and Pharmacokinetics

Telavancin is a semi-synthetic derivative of vancomycin, acting as a bactericidal lipoglycopeptide. It inhibits bacterial cell wall synthesis by binding to D-Ala-D-Ala and disrupts cell membrane integrity, setting it apart from vancomycin with its additional lipophilic side chain moiety[2].

Clinical Trials Overview

Phase 3 ATTAIN Trials

The ATTAIN trials were pivotal in evaluating telavancin's efficacy in treating HABP/VABP. These trials compared telavancin to vancomycin and showed comparable clinical cure rates for monomicrobial Staphylococcus aureus infections, including both methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA). Post hoc analyses indicated that telavancin produced numerically higher clinical cure rates in certain patient populations, although the confidence intervals did not cross, suggesting no statistically significant difference[3].

Telavancin Observational Use Registry (TOUR™)

The TOUR™ registry collected data from 45 US sites for 1,063 patients treated with telavancin between January 2015 and March 2017. This real-world data supported the use of telavancin for various infections caused by Gram-positive pathogens, providing valuable insights into its clinical outcomes in real-world settings[1].

Safety and Nephrotoxicity

Initial concerns about increased nephrotoxicity with telavancin were addressed in subsequent analyses, which showed comparable rates of nephrotoxicity between telavancin and vancomycin. However, patients with baseline creatinine clearance (CrCl) < 50 mL/min were found to have a higher risk of mortality, leading to a boxed warning in the package insert[5].

Market Analysis

Current Market Position

Telavancin has established itself as a viable option for treating complicated skin and skin structure infections and HABP/VABP, particularly in cases involving MRSA. Its unique mechanism of action and efficacy profile make it a valuable asset in the fight against Gram-positive bacterial infections.

Competitive Landscape

The antibiotic market is highly competitive, with established drugs like vancomycin and newer agents vying for market share. Telavancin's differentiation lies in its potent bactericidal activity and its ability to disrupt cell membrane integrity, which can be advantageous in treating severe infections.

Regulatory Environment

Telavancin was first approved by the FDA in 2009 for complicated skin and skin structure infections and later received approval for HABP/VABP in 2013. The regulatory journey was marked by careful evaluation of its efficacy and safety, particularly regarding nephrotoxicity concerns[5].

Market Projections

Growth Potential

Given the increasing prevalence of antibiotic-resistant bacteria, the demand for effective antibiotics like telavancin is expected to rise. The drug's performance in real-world settings and its comparative efficacy to vancomycin position it for continued growth in the market.

Target Markets

Hospitals and healthcare facilities treating severe bacterial infections will remain key target markets. The drug's use in intensive care units (ICUs) and among patients with comorbidities is likely to increase, driven by its proven clinical outcomes.

Challenges and Opportunities

Despite its potential, telavancin faces challenges such as the need for careful patient selection due to nephrotoxicity risks and competition from other antibiotics. However, ongoing research and post-marketing surveillance can further solidify its position and expand its indications.

Real-World Impact and Outcomes

Clinical Outcomes

Real-world data from the TOUR™ registry and other studies have consistently shown that telavancin is effective in treating a variety of infections caused by Gram-positive pathogens. This real-world evidence supports its use in clinical practice[1].

Patient Safety

The comparable rates of nephrotoxicity between telavancin and vancomycin, as well as the careful monitoring of patients with renal impairment, have mitigated initial safety concerns. This ensures that telavancin can be used safely in appropriate patient populations[3].

Key Takeaways

  • Efficacy: Telavancin has demonstrated comparable or superior clinical cure rates to vancomycin in treating HABP/VABP and complicated skin infections.
  • Safety: While there are risks of nephrotoxicity, careful patient selection and monitoring can minimize these risks.
  • Market Potential: The drug has significant growth potential due to its unique mechanism of action and the increasing need for effective antibiotics against Gram-positive bacteria.
  • Regulatory Environment: Telavancin has received FDA approval for its indications, with ongoing surveillance to ensure safety and efficacy.

FAQs

What is telavancin hydrochloride used for?

Telavancin hydrochloride is used for the treatment of complicated skin and skin structure infections and hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

How does telavancin work?

Telavancin inhibits bacterial cell wall synthesis and disrupts cell membrane integrity, making it a potent bactericidal agent against Gram-positive bacteria.

What are the safety concerns associated with telavancin?

The primary safety concern is nephrotoxicity, particularly in patients with baseline creatinine clearance (CrCl) < 50 mL/min.

How does telavancin compare to vancomycin?

Telavancin has shown comparable or numerically higher clinical cure rates to vancomycin in certain patient populations, with similar rates of nephrotoxicity.

What is the current market position of telavancin?

Telavancin is a valuable option in the antibiotic market, particularly for treating severe infections caused by Gram-positive bacteria, including MRSA.

Sources

  1. VIBATIV® (telavancin) | Real World Results. Vibativ.com.
  2. Telavancin: Uses, Interactions, Mechanism of Action - DrugBank. DrugBank.
  3. New Data Analyses From Phase 3 ATTAIN Trials Support VIBATIV(R) (Telavancin) as a Treatment for Staphylococcus Aureus HABP/VABP. Theravance Biopharma.
  4. Telavancin Hydrochloride - Drug Targets, Indications, Patents. Synapse.patsnap.com.
  5. 022407Orig1s000 - accessdata.fda.gov. FDA.gov.

More… ↓

⤷  Try for Free

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. 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.