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CLINICAL TRIALS PROFILE FOR DALVANCE

All Clinical Trials for dalvance

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02269644 ↗	A P3 Comparator Trial in Community Acquired Bacterial Pneumonia	Withdrawn	Durata Therapeutics Inc., an affiliate of Allergan plc	Phase 3	2015-11-01	This study will be a double-blind, randomized, multicenter trial to assess the safety and efficacy of a single 1500 mg IV dose of dalbavancin plus a single 500 mg IV dose of azithromycin in comparison to an approved antibiotic regimen of linezolid 600 mg every 12 hours for 10-14 days plus a single 500 mg IV dose of azithromycin for the treatment of Community Acquired Bacterial Pneumonia.
NCT02344511 ↗	Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis	Withdrawn	Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)	Phase 3	2016-03-01	Dalbavancin for Pediatric Osteomyelitis
NCT03372941 ↗	Hospital Avoidance Strategies for ABSSSI	Terminated	Allergan	Phase 4	2019-03-04	More than 40% of patients presenting with acute bacterial skin and skin structure infection (ABSSSI) to the Barnes-Jewish Hospital (BJH) emergency department (ED) are admitted for intravenous antibiotics. There is growing evidence to suggest that many hospital admissions for uncomplicated ABSSSI due to Gram-positive bacteria could be avoided with an alternative treatment strategy employing newer long-acting antibiotics. Coupled with close outpatient follow-up, such an alternative hospital avoidance strategy has the potential to improve quality and value of care for patients with uncomplicated ABSSSI and optimize use of limited inpatient healthcare resources.
NCT03372941 ↗	Hospital Avoidance Strategies for ABSSSI	Terminated	The Foundation for Barnes-Jewish Hospital	Phase 4	2019-03-04	More than 40% of patients presenting with acute bacterial skin and skin structure infection (ABSSSI) to the Barnes-Jewish Hospital (BJH) emergency department (ED) are admitted for intravenous antibiotics. There is growing evidence to suggest that many hospital admissions for uncomplicated ABSSSI due to Gram-positive bacteria could be avoided with an alternative treatment strategy employing newer long-acting antibiotics. Coupled with close outpatient follow-up, such an alternative hospital avoidance strategy has the potential to improve quality and value of care for patients with uncomplicated ABSSSI and optimize use of limited inpatient healthcare resources.
NCT03372941 ↗	Hospital Avoidance Strategies for ABSSSI	Terminated	Washington University School of Medicine	Phase 4	2019-03-04	More than 40% of patients presenting with acute bacterial skin and skin structure infection (ABSSSI) to the Barnes-Jewish Hospital (BJH) emergency department (ED) are admitted for intravenous antibiotics. There is growing evidence to suggest that many hospital admissions for uncomplicated ABSSSI due to Gram-positive bacteria could be avoided with an alternative treatment strategy employing newer long-acting antibiotics. Coupled with close outpatient follow-up, such an alternative hospital avoidance strategy has the potential to improve quality and value of care for patients with uncomplicated ABSSSI and optimize use of limited inpatient healthcare resources.

Clinical Trial Conditions for dalvance

Condition Name

Condition Name for dalvance
Intervention	Trials
Osteomyelitis	2
Gram-Positive Bacterial Infections	2
Joint Infection	1
Prosthetic Joint Infection	1

Condition MeSH

Condition MeSH for dalvance
Intervention	Trials
Infections	4
Infection	4
Communicable Diseases	3
Gram-Positive Bacterial Infections	2

Clinical Trial Locations for dalvance

Trials by Country

Trials by Country for dalvance
Location	Trials
United States	4

Trials by US State

Trials by US State for dalvance
Location	Trials
Colorado	1
Virginia	1
Missouri	1
Montana	1

Clinical Trial Progress for dalvance

Clinical Trial Phase

Clinical Trial Phase for dalvance
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for dalvance
Clinical Trial Phase	Trials
Withdrawn	2
Recruiting	1
Terminated	1

Clinical Trial Sponsors for dalvance

Sponsor Name

Sponsor Name for dalvance
Sponsor	Trials
Durata Therapeutics International BV (an Affiliate of Actavis, Inc.)	1
Allergan	1
The Foundation for Barnes-Jewish Hospital	1

Sponsor Type

Sponsor Type for dalvance
Sponsor	Trials
Other	6
Industry	3

Dalvance Market Analysis and Financial Projection

Dalvance (Dalbavancin): Clinical Trials, Market Analysis, and Projections

Introduction

Dalvance, also known as dalbavancin, is a second-generation lipoglycopeptide antibiotic that has garnered significant attention for its efficacy in treating acute bacterial skin and skin structure infections (ABSSSI). Here, we delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

FDA Approval and Study Design

Dalvance was approved by the FDA based on two clinical trials involving 1,312 adults with ABSSSI. These trials were randomized, double-blind, and compared Dalvance to a combination of Vancomycin and linezolid, the standard therapy at the time. Patients were evaluated at 48 and 72 hours to assess the cessation of infection spread and fever resolution[1].

Pediatric Approval

In 2021, the FDA extended the approval of Dalvance to include pediatric patients from birth to less than 18 years of age. This approval was based on a multicenter, open-label, actively controlled clinical trial and three pharmacokinetic studies. The trial evaluated the safety and efficacy of Dalvance in pediatric patients with ABSSSI, showing a high early clinical response rate similar to that observed in adults[5].

Efficacy and Safety

The clinical trials demonstrated that Dalvance is highly effective in treating ABSSSI, with a significant proportion of patients showing early clinical response. For pediatric patients, the early clinical response rate was 97.3% for the single-dose arm and 93.6% for the two-dose arm, compared to 86.7% for the comparator arm[5].

Market Analysis

Global Market

The global Dalvance market is expected to grow significantly over the next few years. While exact global market sizes for 2023 are not specified, the compound annual growth rate (CAGR) from 2024 to 2031 is anticipated to be substantial, driven by increasing demand for effective treatments for skin and soft tissue infections[3].

European Market

In Europe, the Dalvance market is projected to grow from USD 75.9 million in 2022 to USD 150.2 million by 2032, at a CAGR of 7.2%. The market is segmented by indication, distribution channel, and country, with skin infections and hospital pharmacies expected to dominate the revenue share. Germany is anticipated to be the leading country in this market[2].

Distribution Channels

The market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies are expected to generate the majority of the revenue, reflecting the drug's primary use in clinical settings[2].

Market Drivers and Trends

Increasing Prevalence of Skin Infections

The rising incidence of skin infections, particularly those caused by Gram-positive bacteria such as MRSA, is a significant driver for the Dalvance market. The effectiveness of Dalvance in treating these infections has led to increased adoption rates[2].

COVID-19 Impact

The COVID-19 pandemic has put additional pressure on healthcare systems, highlighting the need for effective and efficient treatments. Dalvance, with its single-dose or two-dose regimen, offers a convenient and time-saving option for healthcare providers, contributing to its market growth[2].

Regulatory Support

Dalvance was the first drug approved under the Generating Antibiotic Incentives Now (GAIN) Act, part of the FDA Safety and Innovation Act. This regulatory support has encouraged further development and use of the drug[2].

Future Projections

Market Growth

The European Dalvance market is expected to continue its growth trajectory, driven by the increasing demand for effective treatments for skin infections. The global market is also anticipated to expand, though specific growth rates and market sizes are subject to ongoing research and updates[2][3].

Expanding Indications

While Dalvance is currently approved for ABSSSI, ongoing research and clinical trials may expand its indications to other types of infections, further boosting its market potential.

Therapeutic Drug Monitoring

Studies emphasize the importance of therapeutic drug monitoring (TDM) for managing inter-individual variability in dalbavancin treatment, especially in patients with renal dysfunction. This could lead to more personalized and effective treatment strategies, enhancing the drug's market appeal[4].

Key Players

Major companies involved in the Dalvance market include AbbVie Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., and Advanz Pharma Corp. Ltd. These companies play a crucial role in the distribution, marketing, and further development of the drug[2].

Key Takeaways

• Clinical Efficacy: Dalvance has shown high efficacy in treating ABSSSI in both adult and pediatric populations.
• Market Growth: The European market is projected to grow at a CAGR of 7.2% from 2022 to 2032, with similar growth anticipated globally.
• Distribution Channels: Hospital pharmacies are expected to dominate the revenue share.
• Regulatory Support: Approval under the GAIN Act has been a significant factor in the drug's market success.
• Future Projections: Expanding indications and the importance of TDM are expected to further boost the market.

FAQs

What is Dalvance used for?

Dalvance (dalbavancin) is used for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA)[5].

How is Dalvance administered?

Dalvance is administered as a single-dose or two-dose regimen via a 30-minute intravenous (IV) infusion. For pediatric patients, the dosage is based on age and weight[5].

What were the key findings of the clinical trials for Dalvance?

The clinical trials showed high early clinical response rates for Dalvance, with significant reductions in lesion size and fever resolution within 48 to 72 hours. The drug was found to be safe and effective in both adult and pediatric populations[1][5].

How does the COVID-19 pandemic impact the Dalvance market?

The COVID-19 pandemic has increased the demand for effective and efficient treatments, which has positively impacted the adoption rate of Dalvance due to its convenient dosing regimen[2].

What is the projected market size for Dalvance in Europe by 2032?

The European Dalvance market is projected to reach USD 150.2 million by 2032, growing at a CAGR of 7.2% from 2022[2].

Sources

1. FDA: Drug Trials Snapshot: DALVANCE (dalbavancin) - FDA
2. Market.US: Europe Dalbavancin Market Size, Share, Trends | Forecast to 2032
3. Cognitive Market Research: Dalbavancin Market Report 2024 (Global Edition)
4. MDPI: The Major Role of Therapeutic Drug Monitoring
5. AbbVie: DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients