This is a single-arm pilot clinical trial evaluating dalbavancin-based prophylaxis in children and adolescents with acute myeloid leukemia or relapsed lymphoblastic leukemia receiving myelosuppressive chemotherapy.
Primary objective:
- To estimate the rate of bacterial bloodstream infection in pediatric patients with AML or relapsed ALL undergoing chemotherapy receiving dalbavancin-based prophylaxis
Secondary objectives:
* To describe the population pharmacokinetics of every 28 days dalbavancin up to 12 weeks in pediatric patients with AML or relapsed ALL undergoing chemotherapy
* To describe the tolerability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy
* To describe the acceptability of every 28 days dalbavancin prophylaxis in pediatric patients with AML or relapsed ALL undergoing chemotherapy
* To estimate the rates of likely bacterial infections, Clostridioides difficile infection, and febrile neutropenia in pediatric patients receiving dalbavancin-based prophylaxis

Start Date01 Mar 2025

Sponsor / Collaborator

St. Jude Children's Research Hospital, Inc.

NCT06266494

/ RecruitingPhase 4IIT

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.

Start Date01 Mar 2024

Sponsor / Collaborator

University of Colorado Denver

NCT05117398

/ RecruitingPhase 3IIT

Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit).
As the secondary objectives, the study aims to evaluate according to treatment group:
Cure rate at DAY 14 and DAY 90 (EOS);
Mortality rate within 90 days of follow-up;
Time to negativation of blood cultures;
Patient's quality of life;
Hospitalization length of stay;
Cost-utility analyses;
Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).

Start Date23 Jun 2023

Sponsor / Collaborator

Assistance Publique des Hôpitaux de Paris SA

[+3]

100 Clinical Results associated with Dalbavancin Hydrochloride

100 Translational Medicine associated with Dalbavancin Hydrochloride

100 Patents (Medical) associated with Dalbavancin Hydrochloride

789

Literatures (Medical) associated with Dalbavancin Hydrochloride

01 Apr 2025·ARCHIVES OF ORAL BIOLOGY

Asiatic acid methyl ester, a new asiaticoside derivative, induces osteogenic differentiation of hPDLCs

Article

Author: Lin, Aye Chan Khine ; Fitri, Atika Resti ; Sumrejkanchanakij, Piyamas ; Chamni, Supakarn ; Chareonvit, Suconta ; Pavasant, Prasit

OBJECTIVE:

Asiaticoside has the capacity to induce osteogenic differentiation of human periodontal ligament cells (hPDLCs) through Wnt (Wingless-related integration site) signaling. A modified chemical structure (by removing glycoside side chain), referred to as asiatic acid methyl ester (AA1), has been constructed and evaluated for its capacity to induce osteogenic differentiation.

DESIGN:

hPDLCs viability was determined by MTT assay. The mRNA expression were analyzed by using quantitative real time PCR. The subcellular localization of β-catenin was demonstrated by immunofluorescence staining. hPDLCs were cultured in osteogenic medium and the deposited calcium was detected by alizarin red staining. The protein expressions were examined by immunofluorescence and western blot.

RESULTS:

AA1 at a concentration 50 µM or below was not toxic to hPDLCs whereas asiaticoside had revealed no impact on cell viability at any concentration tested. The results showed that 2.5 µM of AA1 and 100 µM of asiaticoside significantly induced gene expression of osterix and dentin matrix protein1 (DMP1), concomitant with a formation of mineralized nodules. AA1 activated Wnt signaling as shown by an increase of WNT3A expression and nuclear translocation of β-catenin. This activation was effectively inhibited when cells were pretreated with recombinant human Dickkopf1 (rhDKK1). rhDKK1 significantly attenuated the AA1-induced expression of DMP1 at both mRNA and protein level.

CONCLUSIONS:

These results confirm a common mechanism between asiaticoside and AA1 in fostering osteogenic differentiation of hPDLCs with a higher potency of AA1. In summary, this study has introduced a novel derivative of asiaticoside, which potentially enhance therapeutic effectiveness for periodontal regeneration.

01 Apr 2025·CURRENT OPINION IN INFECTIOUS DISEASES

The future approach for the management of acute bacterial skin and skin structure infections

Review

Author: Falcone, Marco ; Tiseo, Giusy

Purpose of review:

To discuss the new available options for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) and how to implement in the clinical practice innovative approaches for their management.

Recent findings:

The availability of long-acting antibiotics, including dalbavancin and oritavancin, changed the approach to patients with ABSSSI. Direct discharge from the emergency department and early discharge from the hospital should be considered in patients with ABSSSI. Despite limited data about different bactericidal properties, the choice between dalbavancin and oritavacin is usually based on patients’ characteristics and comorbidities. Delafloxacin and omadacycline are other options and have the advantage to be available for both intravenous and oral formulations, allowing a sequential therapy and switch from intravenous to oral treatment in clinically stable patients. Further studies should elucidate the profile of patients who may beneficiate from these drugs.

Summary:

Early discharge from the hospital should be considered in patients with ABSSSI at a high risk of methicillin-resistant Staphylococcus aureus and in vulnerable patients for which hospitalization may have detrimental consequences. In elderly individuals, patients with diabetes mellitus, oncological people who need for continuing their healthcare pathway, this approach may reduce complications and costs related to hospitalization.

01 Apr 2025·JOURNAL OF PHARMACY PRACTICE

One and Done? An Evaluation of the Clinical Outcomes of Single- and Multi-Dose Dalbavancin Use in the Pediatric Population

Article

Author: Dixon, Terry C. ; Morrisette, Taylor ; Thacker, Stephen A. ; Alghamdi, Shahad ; Maree, Megan B.

Staphylococcus aureus is a leading cause of invasive bacterial infections in the pediatric population. In general, data surrounding the use of newly approved antimicrobials within children are lacking. Dalbavancin is a long-acting lipoglycopeptide that shows promise for off-label use in adults given its unique pharmacokinetics and in vitro potency against common Gram-positive isolates; however, evidence to supports its use in children is limited. We report the use of dalbavancin in three pediatric cases in patients aged 17 months of age, 3 years of age, and 11 years of age. All infections were caused by S. aureus (66.7% methicillin-resistant S. aureus) representing varied disease, including an osteoarticular infection and catheter-related bloodstream infection. Furthermore, all patients had pediatric infectious diseases involvement. Following the utilization of DAL, high clinical success and low rates of adverse effects were observed with high patients’ and parents’ satisfaction. While larger, confirmatory real-world studies are needed, our findings support safe off-label DAL use in select pediatric patients.

News (Medical) associated with Dalbavancin Hydrochloride

14 Oct 2022

·www.ema.europa.eu

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022

10 new medicines recommended for approval EMA’s human medicines committee ( CHMP ) recommended 10 medicines for approval at its October 2022 meeting. The CHMP recommended granting a marketing authorisation for Dengue Tetravalent Vaccine (Live, Attenuated) Takeda for the prevention of dengue virus serotypes 1, 2, 3 and 4 in people from four years of age. Dengue is a mosquito-borne tropical disease caused by the dengue virus, leading to mild flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. The global estimated death rate is 20,000 to 25,000 per year, primarily in children. Dengue tetravalent vaccine prevents fever, severe disease and hospitalisation caused by any of the four serotypes of the dengue virus. This vaccine received an EMA recommendation under the EU Medicines for all (EU-M4All) programme, a mechanism that allows the CHMP to assess medicines that are intended for use in low- and middle-income countries outside of the European Union (EU). Simultaneously, the vaccine has also received a positive opinion for use in the EU, under the trade name Qdenga . See more information in the news announcement in the grid below. The committee adopted a positive opinion for a marketing authorisation under exceptional circumstances for the advanced therapy medicinal product (ATMP) Ebvallo * (tabelecleucel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease. This ATMP is intended for adult and paediatric patients who experience a serious complication following solid organ transplantation or bone marrow transplantation. Ebvallo was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. See more information in the news announcement in the grid below. Eladynos (abaloparatide) received a positive opinion for the treatment of osteoporosis in postmenopausal women at increased risk of fractures. The committee recommended granting a marketing authorisation under exceptional circumstances for Livmarli * (maralixibat chloride) intended for the treatment of cholestatic pruritus (itching) in adult and paediatric patients from two months of age with Alagille syndrome, an inherited condition in which bile builds up in the liver. The CHMP gave a positive opinion for Locametz (gozetotide), which is intended for the diagnosis of prostate cancer. The committee adopted a positive opinion for Pluvicto (lutetium ( 177 Lu) vipivotide tetraxetan) for the treatment of prostate cancer. Spevigo (spesolimab) received a positive opinion for a conditional marketing authorisation for the treatment of flares in adult patients with generalised pustular psoriasis, a skin disorder that consists of pus spots surrounded by areas of red skin. The committee adopted positive opinions for three generic medicines : Dimethyl fumarate Teva (dimethyl fumarate), indicated for the treatment of adult and paediatric patients aged 13 years and older with multiple sclerosis, a chronic disease affecting the central nervous system. Pemetrexed Baxter (pemetrexed) for the treatment of malignant pleural mesothelioma, a rare cancer of the lining around the lungs, and non-small cell lung cancer. Plerixafor Accord (plerixafor) for the treatment of adults and children with lymphoma and multiple myeloma, two types of white blood cells cancers. Recommendations on extensions of therapeutic indication for four medicines The committee recommended four extensions of indication for medicines that are already authorised in the EU: Brukinsa , Libtayo , Lyumjev and Xydalba . Withdrawals of initial applications The applications for marketing authorisation for biosimilar medicines Tuznue and Hervelous were withdrawn by the applicant during the re-examination of the negative opinions that the committee adopted at its May 2022 meeting. These medicines were intended for the treatment of certain forms of breast cancer and gastric (stomach) cancer. A question-and-answer document on the withdrawals is available in the grid below. COVID-19 update The committee recommended converting the conditional marketing authorisation of the COVID-19 vaccine Vaxzevria to a standard marketing authorisation . Agenda and minutes The agenda of the October 2022 CHMP meeting is published on EMA's website. Minutes of the September 2022 CHMP meeting will be published in the coming weeks. CHMP statistics Key figures from the October 2022 CHMP meeting are represented in the graphic below. * This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products ( COMP ) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity . Positive recommendations on new medicines Name of medicine Ebvallo International non-proprietary name (INN) tabelecleucel Marketing-authorisation applicant Atara Biotherapeutics Ireland Limited Therapeutic indication Treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease More information Ebvallo: Pending EC decision News announcement: First therapy to treat transplant patients with post-transplant lymphoproliferative disease Name of medicine Eladynos INN abaloparatide Marketing-authorisation applicant Radius Health Ireland Ltd Therapeutic indication Treatment of osteoporosis in postmenopausal women at increased risk of fracture More information Eladynos: Pending EC decision Name of medicine Livmarli INN maralixibat chloride Marketing-authorisation applicant Mirum Pharmaceuticals International B.V. Therapeutic indication Treatment of cholestatic pruritus in patients with Alagille syndrome More information Livmarli: Pending EC decision Name of medicine Locametz INN gozetotide Marketing-authorisation applicant Novartis Europharm Limited Therapeutic indication Diagnosis of prostate cancer More information Locametz: Pending EC decision Name of medicine Qdenga Common name dengue tetravalent vaccine (live, attenuated) Marketing-authorisation applicant Takeda GmbH Therapeutic indication Prevention of dengue disease More information Qdenga: Pending EC decision Name of medicine Pluvicto INN lutetium (177Lu) vipivotide tetraxetan Marketing-authorisation applicant Novartis Europharm Limited Therapeutic indication Treatment of prostate cancer More information Pluvicto: Pending EC decision Name of medicine Spevigo INN spesolimab Marketing-authorisation applicant Boehringer Ingelheim International GmbH Therapeutic indication Treatment of flares in adult patients with generalised pustular psoriasis More information Spevigo: Pending EC decision Positive recommendations on new generic medicines Name of medicine Dimethyl fumarate Teva INN dimethyl fumarate Marketing-authorisation holder TEVA GmbH Therapeutic indication Treatment of multiple sclerosis More information Dimethylfumarate Teva: Pending EC decision Name of medicine Pemetrexed Baxter INN pemetrexed Marketing-authorisation applicant Baxter Holding B.V. Therapeutic indication Treatment of malignant pleural mesothelioma and non-small cell lung cancer More information Pemetrexed Baxter: Pending EC decision Name of medicine Plerixafor Accord INN plerixafor Marketing-authorisation applicant Accord Healthcare S.L.U. Therapeutic indication Treatment of lymphoma and multiple myeloma More information To be published shortly Positive recommendations on extensions of indications Name of medicine Brukinsa INN zanubrutinib Marketing-authorisation holder BeiGene Ireland Ltd More information Brukinsa: Pending EC decision Name of medicine Libtayo INN cemiplimab Marketing-authorisation holder Regeneron Ireland Designated Activity Company (DAC) More information Libtayo: Pending EC decision Name of medicine Lyumjev INN insulin lispro Marketing-authorisation holder Eli Lilly Nederland B.V. More information Lyumjev: Pending EC decision Name of medicine Xydalba INN dalbavancin Marketing-authorisation holder AbbVie Deutschland GmbH & Co. KG More information Xydalba: Pending EC decision Withdrawals of initial marketing authorisation applications Name of medicine Hervelous INN trastuzumab Marketing-authorisationapplicant Prestige Biopharma Belgium More information Hervelous: Withdrawn application Name of medicine Tuznue INN trastuzumab Marketing-authorisationapplicant Prestige Biopharma Belgium More information Tuznue: Withdrawn application Positive recommendations on medicines for use outside the European Union Name of medicine Dengue Tetravalent Vaccine (Live, Attenuated) Takeda Common name dengue tetravalent vaccine (live, attenuated) More information Dengue Tetravalent Vaccine (Live, Attenuated) Takeda News announcement: New vaccine to protect people in the EU and worldwide against dengue Other updates List item Overview of (invented) names reviewed in September 2022 by the Name Review Group (NRG) adopted at the CHMP meeting of 10-13 October 2022 (PDF/142.16 KB) (new) Adopted First published: 14/10/2022 EMA/825713/2022 List item Scientific advice and protocol assistance adopted during the CHMP meeting 10-13 October 2022 (PDF/242.62 KB) (new) Adopted First published: 14/10/2022 EMA/CHMP/SAWP/827118/2022

VaccineBiosimilar

22 Jun 2022

·www.prnewswire.com

Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market to Surpass US$ 20,450.6 Million by 2030 - Coherent Market Insights

SEATTLE, June 22, 2022 /PRNewswire/ -- According to Coherent Market Insights, the global acute bacterial skin and skin structure infections (ABSSSI) market is estimated to be valued at US$ 10,263.5 million in 2022 and is expected to exhibit a CAGR of 9.0% over the forecast period (2022-2030). Key Trends and Analysis of the Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market: Key trends in market include widespread presence of acute bacterial skin and skin structure infections (ABSSSI); increasing approval of novel drugs for acute bacterial skin and skin structure infections (ABSSSI), and increasing collaborations, acquisitions, and partnerships among key players. These key trends are expected to aid in growth of the global acute bacterial skin and skin structure infections (ABSSSI) market. According to an article published in the PLOS One journal, a peer-reviewed open access scientific journal in July 2020, the lifetime prevalence of skin and soft tissue infections (SSTI), a type of ABSSSI in people who inject drugs (PWID) in London was found to be 64% (abscess and/or cellulitis), on the basis of data collected between October 2017 and March 2019. Moreover, rapid research and development in the field of acute bacterial skin and skin structure infections (ABSSSI) for development of novel treatment for the same is expected to fuel market growth over the forecast period. For instance, in January 2022, Paladin Labs Inc., a subsidiary of Endo International plc launched Xydalba (dalbavancin for injection), in Canada. Xydalba is a 30-minute intravenous (IV) therapy, which can be administered as a single- or two-dose regimen for treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Furthermore, key players operating in the global acute bacterial skin and skin structure infections (ABSSSI) market are focusing on adoption of inorganic growth strategies such as partnerships, acquisitions, collaborations, and others in order to expand their market presence in the global market. For instance, in May 2020, Advanz Pharma, a U.K.-based pharmaceutical company, announced that it had completed the acquisition of Correvio Pharma Corp., a Canada-based specialty pharmaceutical company whose product portfolio includes licensed medicines such as XYDALBA (dalbavancin hydrochloride) indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Request Sample Copy of this Report @ Key Market Takeaways: Global acute bacterial skin and skin structure infections (ABSSSI) market is expected to exhibit a CAGR of 9.0% over the forecast period, owing to rising focus of market players on regulatory approvals for novel acute bacterial skin and skin structure infections (ABSSSI) therapeutics. For instance, in July 2021, AbbVie Inc. ., a U.S. based pharmaceutical company announced that it has received the U.S. Food and Drug Administration (USFDA) approval for its drug Dalvance (dalbavancin), administered as an intravenous (IV) infusion for the treatment of pediatric patients with ABSSSI caused by methicillin-resistant Staphylococcus aureus (MRSA) and other gram-positive bacteria. Among infection type, community acquired ABSSSI segment is expected to account for the largest market share in 2022, owing to rising drug launches by market players for treatment of community acquired acute bacterial skin and skin structure infections (ABSSSI). For instance, in February 2021, Paratek Pharmaceuticals, Inc., a U.S.-based pharmaceutical company announced that it is expanding commercial launch of its tetracycline-class oral antibiotic Nuzyra (omadacycline) into the community setting. Nuzyra is indicated for the treatment of adults with acute skin and skin structure infections (ABSSSI). Key players operating in the global acute bacterial skin and skin structure infections (ABSSSI) market include Merck & Co., Inc., Pfizer, Inc., GlaxoSmithKline plc., Teva Pharmaceutical Industries Ltd., Paratek Pharmaceuticals, Inc., Melinta Therapeutics, Inc., Arrevus, Inc., AbbVie, Inc., Aurobindo Pharma Ltd., Amneal Pharmaceuticals LLC, Sun Pharmaceutical Industries Ltd., Accord Healthcare Ltd., Intas Pharmaceuticals Ltd., Fresenius SE & Co. KGaA, Sandoz Inc., Glenmark Pharmaceuticals Ltd, and Cadila Healthcare Ltd. Request for Customization @ Detailed Segmentation: Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Drug Type: Oral & Parenteral Antibiotics Vancomycin Linezolid Clindamycin Ceftaroline Daptomycin Dalbavancin Tedizolid Others (Rifampin, Doxycycline, Minocycline, and Trimethoprim-Sulfa Methoxazol, among others) Topical Antibiotics Hydrogen Peroxide Fusidic Acid Mupirocin Retapamulin Povidone-Iodine Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Infection Type: Hospital Acquired ABSSSI Community Acquired ABSSSI Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Route of Administration: Oral Parenteral Topical Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Distribution Channel: Hospital Pharmacies Retail Pharmacies Online Pharmacies Global Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market, By Region: North America By Country: U.S. Canada Europe By Country: U.K. Germany Italy France Spain Russia Rest of Europe Asia Pacific By Country: China India Japan ASEAN Australia South Korea Rest of Asia Pacific Latin America By Country: Brazil Mexico Argentina Rest of Latin America Middle East & Africa By Country: GCC Countries Israel South Africa Rest of Middle East & Africa Buy this Complete Report Now @ Find related trending report below: North America and Europe Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Market , by Drug Type (Oral & Parenteral Antibiotics (Vancomycin, Linezolid, Clindamycin, Ceftaroline, Daptomycin, Dalbavancin, Tedizolid, and Others) and Topical Antibiotics (Hydrogen Peroxide, Fusidic Acid, Mupirocin, Retapamulin, and Povidone-Iodine)), by Infection Type (Hospital Acquired ABSSSI and Community Acquired ABSSSI), by Route of Administration (Oral, Parenteral, and Topical), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and by Region (North America, and Europe) - Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027 About Us: Coherent Market Insights is a global market intelligence and consulting organization focused on assisting our plethora of clients achieve transformational growth by helping them make critical business decisions. We are headquartered in India, having sales office at global financial capital in the U.S. and sales consultants in United Kingdom and Japan. Our client base includes players from across various business verticals in over 57 countries worldwide. We create value for clients through our highly reliable and accurate reports. We are also committed in playing a leading role in offering insights in various sectors post-COVID-19 and continue to deliver measurable, sustainable results for our clients. Contact Us: Mr. Shah Senior Client Partner – Business Development Coherent Market Insights Phone: US: +1-206-701-6702 UK: +44-020-8133-4027 Japan: +81-050-5539-1737 India: +91-848-285-0837 Email: [email protected] Website: Follow Us: LinkedIn | Twitter Logo: SOURCE Coherent Market Insights

AcquisitionCollaborate

23 Jul 2021

·www.biospace.com

FDA Greenlights AbbVie’s Antibiotic Dalvance for Acute Skin Infections in Children

Smith Collection/Gado/Getty Images The U.S. Food and Drug Administration (FDA) approved AbbVie’s Dalvance (dalbavancin) for acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients as young as newborns. The drug is given in a single-dose as a 30-mintue intravenous infusion. This approval is specifically for the treatment of ABSSSI caused by certain susceptible Gram-positive bacteria in children, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA). This is not the only recent approval for this indication. In March 2021, the FDA approved Melinta Therapeutics’ Kimrysa for that indication, which became available this month. That is a one-hour, single-dose regimen approved for adults. ABSSSI affect about 14 million people in the U.S. annually, resulting in more than 3 million emergency room visits. They cause U.S. hospitals about $4 billion annually, with a 4-day average length of stay. ABSSSI are common, but can be life-threatening, particularly in children. The most common types of skin infections seen by pediatricians are cutaneous abscesses and cellulitis. In the U.S., ABSSSI causes 3 million pediatric visits to doctors or emergency rooms each year. “Serious infections in children can be difficult to treat and the impact of ABSSSI in children is significant, as these infections often require IV antibiotics, resulting in hospitalization,” said Margaret Burroughs, medical director, infectious diseases, AbbVie. “This pediatric approval for Dalvance as a single-dose provides a meaningful contribution to the treatment of children and infants with ABSSSI.” The approval was built on data from a trial that evaluated Dalvance in pediatric patients from newborn to less than 18 years of age with ABSSSI, as well as three pharmacokinetic studies. In the clinical trial, the safety and efficacy were tested along with intravenous vancomycin for methicillin-resistant Gram-positive infections, or intravenous oxacillin or flucloxacillin for methicillin-susceptible Gram-positive infections. The analysis in the pediatric trial was on 183 patients with ABSSSI in the Modified Intent-to-Treat (mITT) population. That included all the patients who had been randomized to receive any dose of the drug who had ABSSSI caused by Gram-positive bacteria. They looked at an early clinical response at 48 to 72 hours based on a greater than or equal to 20% decrease in size of the lesions compared to baseline as well as on the need for rescue antibacterial therapy for children who were three months of age and older. In the study, 97.3% of patients in the Dalvance single-dose arm demonstrated an early clinical response, and 93.6% had an early clinical response in the two-dose arm, while 86.7% did in the comparator arm. The safety data in the children was similar to what was seen in adults. The drug is a second-generation, semi-synthetic lipoglycopeptide. It is made up of a lipophilic side-chain attached to an enhanced glycopeptide backbone. Dalvance is approved for adults with ABSSSI caused by susceptible Gram-positive bacterium, such as Staphylococcus aureus, including MRSA, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group, and Enterococcus faecalis. It was first approved for adults with skin infections in May 2014. At that time it was developed by Durata Therapeutics. Durata was acquired by Actavis in 2014 for $675 million. Actavis acquired Allergan in 2015 and changed the company name to Allergan. AbbVie completed its acquisition of Allergan in May 2020 in a deal worth about $63 billion.

Acquisition

100 Deals associated with Dalbavancin Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
-	Dalbavancin Hydrochloride	J01XA04	DB06219

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Skin and skin structure infections	United States	AbbVie, Inc.	23 May 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Bacteremia	Phase 3	France	Advanz Pharma Corp. Ltd.	23 Jun 2023
Catheter-Related Infections	Phase 3	France	Advanz Pharma Corp. Ltd.	23 Jun 2023
Staphylococcus Aureus Infections	Phase 3	France	Advanz Pharma Corp. Ltd.	23 Jun 2023
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	United States	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	Argentina	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	Belarus	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	Brazil	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	Bulgaria	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	Chile	AbbVie, Inc.	30 Mar 2017
MRSA - Methicillin resistant Staphylococcus aureus infection	Phase 3	Colombia	AbbVie, Inc.	30 Mar 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04775953 (CTgov)	Phase 2	Staphylococcus aureus bacteraemia	200	Dalbavancin (Dalbavancin)	ivohjbzkvb: Pr(Better DOOR in dalbavancin arm) = 47.70 (95% CI, 39.84 - 55.68) View more	-	22 Oct 2024
				cefazolin+penicillin+oxacillin+Nafcillin+daptomycin+Vancomycin (Standard of Care)
NCT04959799 (DALBADIA, Pubmed \| J Glob Antimicrob Resist)	Not Applicable	Diabetes Mellitus \| Infectious Diseases First line Gram-positive bacterial infection \| Enterococcus faecalis	97	Dalbavancin	rhrcvcapln(bhozqiqcaw) = cgqmfiafxa uvkukofqpx (tlgremvglv ) View more	Positive	01 Mar 2024
NCT03372941 (CTgov)	Phase 4	Skin and skin structure infections \| Skin Diseases, Infectious	11	Dalbavancin (Alternative Treatment Strategy)	ojorseelom = gnbpbvazvz mdwgqcimry (xaguiqomvc, crjcdmamhy - tvewftvybb) View more	-	09 Dec 2022
				vancomycin (Usual Care)	ojorseelom = bufuhkxslz mdwgqcimry (xaguiqomvc, jdyenqdimr - ocdbrhokxn) View more
NCT02961764 (Pubmed \| Acad Emerg Med)	Phase 4	Skin Diseases, Infectious	313	Long-Acting Intravenous Antibiotic (Usual care)	vlcvztdmly(xpwfvtiqnl) = bgjbfkzwda zzjrxexsky (yjggqzaapx ) View more	Positive	29 Mar 2021
				Long-Acting Intravenous Antibiotic (Clinical pathway)	vlcvztdmly(xpwfvtiqnl) = ktpdcpytnk zzjrxexsky (yjggqzaapx ) View more
NCT02940730 (CTgov)	Phase 4	Infectious peritonitis	10	Dalbavancin via Intravenous Administration (Dalbavancin Via IV)	hrgjjrxqee(fyamtirlce) = fqqculnjnc myxbhwygak (dqubgrecou, 9800.3) View more	-	19 Mar 2021
				Dalbavancin via Intraperitoneal Administration (Dalbavancin Via IP)	hrgjjrxqee(fyamtirlce) = vntmemqvtd myxbhwygak (dqubgrecou, 4913.4) View more
NCT02961764 (CTgov)	Phase 4	Skin and skin structure infections	313	Usual Care (Usual Care)	ddeimixexp: Odds Ratio (OR) = 0.289 (95% CI, 0.156 - 0.532), P-Value = <0.001 View more	-	10 Apr 2020
				Dalbavancin (New Critical Pathway)
NCT03233438 (ENHANCE ABSSSI, Pubmed \| Infect Dis Ther)	Phase 4	Skin and skin structure infections	91	Dalbavancin	qakoekgqtl(lrnvewgbgn) = 17% (n = 7) were found to have possible causal relation to dalbavancin in the post-period aruiydylrh (oufvcfvdgl ) View more	-	01 Mar 2020
				Dalbavancin (Usual care)
NCT03233438 (ENHANCE ABSSSI, CTgov)	Phase 4	Bacterial Infections \| Skin and skin structure infections	91	Usual Care (Usual Care)	vqqpknhfuy(atbvhgyymu) = bilemyyezn jmxdruakww (xtpjcoimlp, 2.55) View more	-	18 Jan 2020
				Dalbavancin (New Critical Pathway)	vqqpknhfuy(atbvhgyymu) = eldugchpwt jmxdruakww (xtpjcoimlp, 2.48) View more
NCT02685033 (CTgov)	Phase 2	Osteomyelitis	80	Dalbavancin (Dalbavancin)	xmbmvkpyfp = bsdwhooslj acgzrmdurn (gjnqxtsszt, rgtdsdhjlz - grbtrxojlx) View more	-	04 Jan 2019
				Comparator (Standard of Care)	xmbmvkpyfp = gkeeycezlh acgzrmdurn (gjnqxtsszt, nwgcecdpau - prdljpneor) View more
NCT02685033 (Pubmed \| Open Forum Infect Dis) Manual	Phase 2	Osteomyelitis	80	Dalbavancin	xnqezzsoby(rjidbpwycl) = metxkwnpqf fyzsxbkjmo (ufrjiarfzv ) View more	Positive	10 Dec 2018
				SOC	xnqezzsoby(rjidbpwycl) = miyolmtvns fyzsxbkjmo (ufrjiarfzv )

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