Delving into the Latest Updates on Dalbavancin Hydrochloride with Synapse

Overview

Basic Info

Drug Type

Glycopeptide antibiotic, Cyclic Peptide

Synonyms

dalbavancin, dalbavancin hcl, Dalbavancin powder

+ [14]

Target

Peptidoglycan

Action

inhibitors

Mechanism

Peptidoglycan inhibitors, Cell wall inhibitors

Therapeutic Areas

Infectious DiseasesSkin and Musculoskeletal DiseasesOther Diseases

Active Indication

Skin and skin structure infectionsBacteremiaCatheter-Related Infections+ [1]

Inactive Indication

AbscessCellulitisCommunity-acquired bacterial pneumonia+ [8]

Originator Organization

Actavis

Active Organization

AbbVie Deutschland GmbH & Co. KG

Advanz Pharma Corp. Ltd.

AbbVie, Inc.

+ [2]

Inactive Organization

Durata Therapeutics, Inc.

Vicuron Pharmaceuticals LLCDurata Therapeutics International BV

+ [1]

License Organization

Correvio Pharma Corp.Tzamal Pharma Ltd.ENDO VENTURES LTD

+ [1]

Drug Highest PhaseApproved

First Approval Date

United States (23 May 2014),

Skin and skin structure infections

RegulationOrphan Drug (United States), Fast Track (United States)

Login to view timeline

The DALBA-study Introduction of the antibiotic dalbavancin in orthopaedic surgery – an evaluation of: • Health economic costs • Patient-reported outcomes on quality of life • Local bone and soft tissue concentrations • Effect on the gut microbiome A randomised controlled study of dalbavancin versus standard antibiotic treatment of Gram-positive periprosthetic joint infections.

Start Date12 Dec 2025

Sponsor / Collaborator-

NCT06810583

/ RecruitingPhase 1IIT

A Prospective, Single-Arm, Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia

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 Date22 May 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

100 Clinical Results associated with Dalbavancin Hydrochloride

Login to view more data

100 Translational Medicine associated with Dalbavancin Hydrochloride

Login to view more data

100 Patents (Medical) associated with Dalbavancin Hydrochloride

Login to view more data

757

Literatures (Medical) associated with Dalbavancin Hydrochloride

01 Apr 2026·CURRENT OPINION IN INFECTIOUS DISEASES

Recent advances in the management of skin and soft tissue infections

Review

Author: Mantzarlis, Konstantinos ; Dimopoulos, George ; Valsamaki, Asimina

Purpose of review:

Skin and soft tissue infections (SSTIs) are one of the most frequent infections that need management either in outpatient setting or as inpatient. The present review of the literature will present recent developments in the diagnosis and treatment of SSTIs.

Recent findings:

Regarding SSTIs diagnosis, point of care ultrasound (POCUS), PCR, MALDI-TOF mass spectroscopy, along with the usage of novel biomarkers, such as procalcitonin, can help in the accurate and timely diagnosis of SSTIs in a cost-effective manner. Artificial intelligence applications may be the next step in the field. In terms of treatment, the use of newly approved antibiotics, such as oritavalcin and dalbavancin, in combination with innovative methods of their delivery based on nanotechnology applications, can offer targeted and localized action, minimizing the antibiotics’ microbial inhibition concentration.

Summary:

Even if SSTIs remain a difficult condition to treat, causing significant morbidity, mortality and economic burden on healthcare systems, ongoing scientific research is attempting to improve both diagnostic methods and treatment. More developments are expected in the near future in the areas of innovative diagnostic techniques, innovative drugs, nanotechnology applications, and antigen-based therapies.

01 Mar 2026·INFECTIOUS DISEASE CLINICS OF NORTH AMERICA

Antimicrobial Management Strategies for Multidrug-Resistant Gram-Positive Prosthetic Device Infections

Review

Author: Alcorn, Kylie ; Simos, Peter ; Grey, Victoria ; Isler, Burcu

Prosthetic device infections caused by multidrug-resistant (MDR) gram-positive bacteria pose significant therapeutic challenges. This review examines management strategies for methicillin-resistant staphylococci, ampicillin-resistant enterococci, vancomycin-resistant enterococci, and MDR Corynebacterium infections. Success requires coordinated surgical intervention and antimicrobial therapy, with device removal often necessary. Vancomycin remains the cornerstone for most resistant organisms, while newer agents like dalbavancin enable outpatient therapy. Critical considerations include recognizing linezolid toxicity during prolonged therapy, and understanding that surgical approach determines outcomes more than antimicrobial selection.

04 Feb 2026·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Monthly dalbavancin dosing for suppressive therapy: a pharmacokinetic estimation analysis and case series

Article

Author: Rose, Warren ; Mahapatra, Rahul ; Volk, Cecilia ; Hutson, Paul ; Kufel, Wesley D. ; Tudahl, Kristen

ABSTRACT:

Retained hardware/prosthetic infections frequently require antimicrobial suppression therapy. Treatment options are often limited by resistance, allergies, and dosing frequencies. Dalbavancin (DAL) is a potentially attractive option for suppression of gram-positive infections given its potential for infrequent dosing. However, optimal DAL suppression dosing is unknown. An in silico pharmacokinetic/pharmacodynamic simulation was performed to assess the predicted dalbavancin concentration resulting from suppressive regimens. Serum levels were deemed adequate if the f AUC 24 /MIC was above the PK target of 27.1. Patients at a U.S. medical center receiving DAL as suppressive therapy were reviewed. PK simulation of DAL dosed 1,500 mg monthly resulted in free serum concentrations above the PK target. Because many clinicians opt to initiate these regimens with two doses given 1 week apart, the next modeled regimen included this load, before initiating 1,500 mg monthly. This initial load did not significantly alter total drug exposure. The final simulated regimen was 1,000 mg monthly. With this simulation, the lower 95% CI f AUC 24 /MIC fell just below the PK target for an isolate at the breakpoint. Nine patients who received dalbavancin 1,500 mg monthly as suppressive therapy were reviewed. All had retained hardware and received DAL for a median 591 days, with 7 patients still receiving treatment and no reported suppressive therapy failure. Monthly 1500 mg dalbavancin dosing for suppressive therapy is supported by this case series and PK simulation data. An initial weekly loading dose appears unnecessary. Reducing the monthly dose to 1000 mg may also be appropriate for certain patients, though clinical data is needed to support this practice.

18

News (Medical) associated with Dalbavancin Hydrochloride

24 Nov 2025

·www.businesswire.com

Fresenius Kabi Introduces Dalbavancin for Injection (for single-dose regimen use only)

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today it has introduced Dalbavancin for Injection (for single-dose regimen use only), which is indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections caused by designated susceptible strains of Gram-positive microorganisms. It is available in 500 mg vials and approved for single-dose regimen use only. The drug received FDA approval this month. Fresenius Kabi Introduces Dalbavancin for Injection (for single-dose regimen use only) FDA determined Dalbavancin for Injection from Fresenius Kabi is therapeutically equivalent to the reference-listed drug DALVANCE®1 (single-dose regimen use only). “Dalbavancin for Injection is formulated, filled and packaged in the United States,” said Arun Verma, president of Fresenius Kabi Region U.S. and Member of the Executive Leadership Team, Fresenius Kabi AG. “This cost-effective, generic alternative for the single-dose regimen is part of our ‘More in America’ commitment to invest in American manufacturing, improve our supply chain resilience, and bring products closer to our U.S. customers.” Since 2017, Fresenius Kabi has invested nearly $1 billion to expand and modernize advanced U.S. pharmaceutical production and distribution facilities. Learn more at moreinamerica.com. Dalbavancin offers a 24-month shelf life. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS Dalbavancin for Injection is contraindicated in patients with known hypersensitivity to dalbavancin. WARNINGS AND PRECAUTIONS Serious hypersensitivity (anaphylactic) and skin reactions have been reported in patients treated with dalbavancin for injection. If an allergic reaction occurs, discontinue treatment with dalbavancin for injection and institute appropriate therapy for the allergic reaction. Carefully monitor patients with known hypersensitivity to glycopeptides. Rapid intravenous infusion of dalbavancin for injection can cause flushing of the upper body, urticaria, pruritus, rash, and/or back pain. Stopping or slowing the infusion may result in cessation of these reactions. Alanine Aminotransferase (ALT) elevations with dalbavancin for injection treatment were reported in clinical trials. Clostridioides difficile -associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including dalbavancin for injection. Evaluate if diarrhea occurs. ADVERSE REACTIONS The most common adverse reactions occurring in >4% of adult patients treated with dalbavancin for injection were nausea, headache, and diarrhea. The most common adverse reaction that occurred in >1% of pediatric patients was pyrexia. To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176, option 5, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. INDICATIONS AND USAGE Dalbavancin for injection is a lipoglycopeptide antibacterial indicated for the treatment of adult and pediatric patients with acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram- positive microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of dalbavancin for injection and other antibacterial drugs, dalbavancin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This Important Safety Information does not include all the information needed to use Dalbavancin for Injection safely and effectively. About Fresenius Kabi As a global healthcare company, Fresenius Kabi is Committed to Life. The company’s products, technologies, and services are used for the therapy and care of patients with critical and chronic conditions. With more than 41,000 employees and present in more than 100 countries, Fresenius Kabi’s expansive product portfolio focuses on providing access to essential medicines and technologies. In Biopharma, Fresenius Kabi offers cutting-edge biosimilars for autoimmune diseases and oncology. With leading market positions in Clinical Nutrition, a broad portfolio of enteral and parenteral products makes a distinct difference in patients’ nutritional status. In MedTech, the company provides vital infusion pumps, cell and gene therapy devices, disposables, and more. Fresenius Kabi is a global leader in supplying blood collection bags and devices, supporting blood banks and health care facilities worldwide. The company’s I.V. Generics and Fluids for infusion therapy help save millions of lives every year, in emergency medicine, surgery, oncology, and intensive care. Fresenius Kabi takes a holistic approach to health care and uniquely combines experience, expertise, innovation, and dedication – making a difference in the lives of 450 million patients annually. With the #FutureFresenius strategy, the company is developing, producing, and selling new products and technologies and aspires to expand its position as a leading global provider of therapies, improve patient care, generate sustainable value for stakeholders – shaping the future of healthcare. Fresenius Kabi is part of the Fresenius Group, founded in 1912, along with Helios and Quirónsalud. As ONE team, the companies in the Fresenius Group are committed to providing lifesaving and life-changing healthcare solutions on a global scale. For more information, please visit www.fresenius-kabi.com/us. To learn about U.S. career opportunities at Fresenius Kabi, visit us at www.fresenius-kabi.com/us/join-us and follow us on LinkedIn and Facebook. This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release. 1 DALVANCE® is a trademark of Allergan Pharmaceuticals International Limited, an AbbVie company. 2 2023 Data on file; https://www.fda.gov/media/143406/download

Drug Approval

15 Aug 2025

·www.drugs.com

Dalbavancin Noninferior to Standard Therapy for Complicated S. Aureus Bacteremia

FRIDAY, Aug. 15, 2025 -- Dalbavancin is not superior to standard therapy for adults with complicated Staphylococcus aureus bacteremia, but clinical efficacy met the criteria for noninferiority, according to a study published online Aug. 13 in the Journal of the American Medical Association . Nicholas A. Turner, M.D., from Duke University in Durham, North Carolina, and colleagues examined the efficacy and safety of dalbavancin versus standard therapy for completion of treatment of complicated S. aureus bacteremia in a randomized clinical trial conducted from April 2021 to December 2023 at 23 U.S. medical centers. Hospitalized adults with complicated S. aureus bacteremia who achieved blood culture clearance following at least 72 hours but no more than 10 days of initial antibacterial therapy were randomly assigned to receive two doses of intravenous dalbavancin on days 1 and 8 or four to eight weeks of standard intravenous therapy (cefazolin or an antistaphylococcal penicillin if methicillin-susceptible; vancomycin or daptomycin if methicillin-resistant). Two hundred participants were randomly assigned (100 to each group), and of these, 167 survived to day 70 and underwent an efficacy assessment. The researchers found that the probability of a more desirable day 70 outcome was 47.7 percent with dalbavancin versus standard therapy, which did not meet the criterion for superiority. Clinical efficacy was documented in 73 of 100 for dalbavancin and 72 of 100 for standard therapy, meeting the criterion for noninferiority. Serious adverse events were reported in 40 and 34 participants, respectively, who received dalbavancin and standard therapy; in both groups, treatment-related adverse events were uncommon. "Our findings give patients and health care providers the data to support an extra choice when deciding on treatment for complicated S. aureus bacteremia," Turner said in a statement. Several authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text (subscription or payment may be required) Editorial (subscription or payment may be required)

Clinical ResultQualified Infectious Disease ProductClinical Study

14 Aug 2025

·www.drugs.com

New Means Found For Treating Blood Staph Infections with IV Dalbavancin

THURSDAY, Aug. 14, 2025 — A new way to battle bloodborne staph infections could help save lives while combating the rise of antibiotic-resistant bacteria, according to new clinical trial results. Two intravenous doses of the antibiotic dalbavancin delivered seven days apart worked just as well as daily IV doses of conventional antibiotics in quelling Staphylococcus aureus bloodstream infections, researchers reported Aug. 13 in the Journal of the American Medical Association . “Given the small number of antimicrobial drugs available to treat Staphylococcus aureus bloodstream infections and the bacteria’s growing drug resistance, establishing dalbavancin as a beneficial therapy for these severe infections gives us a vital new alternative to treat them,” Dr. John Beigel said in a news release. He’s acting director of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases (NIAID). NIAID sponsored and funded the trial, which involved 200 hospitalized adults with complicated staph blood infections treated at 23 medical centers in the U.S. and Canada. The patients were randomly assigned to receive either two doses of dalbavancin or daily IV antibiotics, with overall treatment lasting four to eight weeks. In all, 100 received dalbavancin and the same number had standard antibiotics. Dalbavancin is a relatively recent antibiotic discovery, approved by the U.S. Food and Drug Administration (FDA) in May 2014, according to Drugs.com. The standard antibiotics used depended on the type of staph a person had. Cefazolin or penicillin were used for regular staph, while vancomycin or daptomycin were implemented against antibiotic-resistant staph, also known as MRSA . Results showed that dalbavancin worked about as well as standard therapy, providing doctors a new option for treating a severe staph infection. “Our findings give patients and health care providers the data to support an extra choice when deciding on treatment for complicated S. aureus bacteremia,” lead researcher Dr. Nicholas Turner , an assistant professor at Duke University School of Medicine in Durham, N.C., said in a news release. What’s more, the dalbavancin was easier to deliver. People receiving daily antibiotics needed an implanted catheter that remained in place for the full duration of their treatment – something that can lead to complications like blood clots and additional infections. By comparison, people receiving dalbavancin only needed a short catheter inserted twice for about an hour each time, researchers said. As a result, side effects like blood clots occurred more often in the standard treatment group compared to the dalbavancin group, researchers found. Serious side effects were about as common with dalbavancin as with standard antibiotics – 40 cases versus 34 cases, results show. However, severe events leading to treatment discontinuation occurred in 12% of the standard treatment patients compared to 3% of those treated with dalbavancin. Researchers next plan to compare the cost-effectiveness of the two approaches. Sources National Institutes of Health, news release, Aug. 13, 2025

Clinical ResultDrug ApprovalClinical StudyPhase 3

100 Deals associated with Dalbavancin Hydrochloride

Login to view more data

External Link

KEGG	Wiki	ATC	Drug Bank
-	Dalbavancin Hydrochloride	J01XA04	DB06219

R&D Status

Approved

10 top approved records.

Login

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.

Login

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
Impetigo	Phase 3	United States	AbbVie, Inc.	30 Mar 2017
Impetigo	Phase 3	Argentina	AbbVie, Inc.	30 Mar 2017
Impetigo	Phase 3	Belarus	AbbVie, Inc.	30 Mar 2017
Impetigo	Phase 3	Brazil	AbbVie, Inc.	30 Mar 2017
Impetigo	Phase 3	Bulgaria	AbbVie, Inc.	30 Mar 2017
Impetigo	Phase 3	Chile	AbbVie, Inc.	30 Mar 2017
Impetigo	Phase 3	Colombia	AbbVie, Inc.	30 Mar 2017

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04775953 (CTgov)	Phase 2	Bacteremia due to Methicillin resistant Staphylococcus aureus \| Staphylococcus aureus bacteraemia	200	Dalbavancin (Dalbavancin)	uwixwdbkew: Pr(Better DOOR in dalbavancin arm) = 47.70 (95% CI, 39.84 - 55.68) View more	-	22 Oct 2024
				cefazolin+oxacillin+penicillin+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	ejhenwrhbf(gdusueucow) = oysxmrmito jelokqyhnx (iqepsezsin ) View more	Positive	01 Mar 2024
NCT03372941 (CTgov)	Phase 4	Erythema Induratum \| Skin Diseases, Infectious	11	Dalbavancin (Alternative Treatment Strategy)	ifqixsonib = chdgxfdrtw zhvzjxpijp (wfxebczals, xbwqadmjkk - hjuxalkykn) View more	-	09 Dec 2022
				vancomycin (Usual Care)	ifqixsonib = khcupkllpo zhvzjxpijp (wfxebczals, omjpuikfnr - ockqfscpvt) View more
NCT02961764 (Pubmed \| Acad Emerg Med)	Phase 4	Skin Diseases, Infectious	313	Long-Acting Intravenous Antibiotic (Usual care)	xislfsokcf(ahokivptng) = enneudwwez tnmebvfcii (wuuljfhdff ) View more	Positive	29 Mar 2021
				Long-Acting Intravenous Antibiotic (Clinical pathway)	xislfsokcf(ahokivptng) = gouyomoojc tnmebvfcii (wuuljfhdff ) View more
NCT02940730 (CTgov)	Phase 4	Infectious peritonitis	10	Dalbavancin via Intravenous Administration (Dalbavancin Via IV)	gucoeoqdhi(jzemdknldm) = tyzqnypbqf rnvkoioeea (ysejucashq, 9800.3) View more	-	19 Mar 2021
				Dalbavancin via Intraperitoneal Administration (Dalbavancin Via IP)	gucoeoqdhi(jzemdknldm) = jcvohljzpa rnvkoioeea (ysejucashq, 4913.4) View more
NCT02961764 (CTgov)	Phase 4	Skin and skin structure infections	313	Usual Care (Usual Care)	onwgerbujp: 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	yacfzedyjm(rcayeagkol) = 17% (n = 7) were found to have possible causal relation to dalbavancin in the post-period jcstukbvfa (fimwqfvxwa ) View more	-	01 Mar 2020
				Dalbavancin (Usual care)
NCT03233438 (ENHANCE ABSSSI, CTgov)	Phase 4	Bacterial Infections \| Gram-Positive Bacterial Infections \| Skin and skin structure infections	91	Usual Care (Usual Care)	yqmlrmiezl(mbtkltmkrj) = ykqnuvvioj joabesyrrd (nejdxwnkfe, 2.55) View more	-	18 Jan 2020
				Dalbavancin (New Critical Pathway)	yqmlrmiezl(mbtkltmkrj) = mfvqhrxwwe joabesyrrd (nejdxwnkfe, 2.48) View more
NCT02685033 (CTgov)	Phase 2	Osteomyelitis	80	Dalbavancin (Dalbavancin)	nhetqisvcl = flamschdlc qirmxhigae (qrizpvysfg, srrczyrwmb - zfaywnnhfg) View more	-	04 Jan 2019
				Comparator (Standard of Care)	nhetqisvcl = vvhxtuvgbe qirmxhigae (qrizpvysfg, jovcutcymv - ajnvfpfbau) View more
NCT02685033 (Pubmed \| Open Forum Infect Dis) Manual	Phase 2	Osteomyelitis	80	Dalbavancin	frsbsmjrnf(nzxjxpjjxp) = zqmittaxgh rwfcohfjof (pwftlxxqiy ) View more	Positive	10 Dec 2018
				SOC	frsbsmjrnf(nzxjxpjjxp) = ejzoeljvzh rwfcohfjof (pwftlxxqiy )