Dalvance

(Dalbavancin)

ApprovedSmall molecule

Dalbavancin is an antibiotic used to treat skin and soft tissue infections caused by bacteria. It works by killing bacteria and is given as an injection.[2] Dalvance is currently approved and in use across 9 indications[4].[1]

Dalvance is one of 87 small molecule programs targeting Skin Disease Caused by Bacterial Infection. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Skin Disease Caused by Bacterial InfectionActive, not recruiting

Bacterial DiseaseActive, not recruiting

Prosthesis-Related InfectionsActive, not recruiting

BacteriemiaApproved

PneumoniaApproved

Staphylococcus Aureus InfectionApproved

PeritonitisActive, not recruiting

FrostbiteRecruiting

Skin Disease Caused by Bacterial InfectionApproved

Active, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

BacteriemiaApproved

Approved

PneumoniaApproved

Approved

Staphylococcus Aureus InfectionApproved

Approved

PeritonitisPreclinical

Active, not recruiting

FrostbiteApproved

Recruiting

Competition

Competitive Landscape

155 competitors in Pneumonia

#DrugCompanyPhaseTrials

Dalvance

AbbVie

Approved

26 2

Primaquine

Sanofi

Preclinical

1 3

Acanya

Pfizer

Preclinical

1 4

Jakafi

Incyte

Preclinical

1 5

Avlosulfon

AAlmirall, S.A.

Preclinical

4 6

Advil

KKenvue Brands

Preclinical

2 7

Retrovir

BBp Consulting, Inc

Preclinical

2 8

Primsol

CConrado Roberto Hoffmann Filho

Preclinical

2 9

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

2 10

Prograf

VVeloxis Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2031

Phase 1Recruiting

Leukemia

NCT06810583

Clinical

Trials by Indication[1]

Infections4 trials

Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)

Completed·AAziende Chimiche Riunite Angelini Francesco S.p.A··NCT04959799·98 enrolled

Evaluation of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Completed· AbbVie logo

AbbVie·Phase 4·NCT02961764·313 enrolled

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Completed· AbbVie logo

AbbVie·Phase 4·NCT03233438·91 enrolled

Show 1 more trial

Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA

Completed· AbbVie logo

AbbVie·Phase 3·NCT02814916·199 enrolled

Osteomyelitis3 trials

Study on the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Participants With Osteomyelitis

Completed· AbbVie logo

AbbVie·Phase 2·NCT02685033·80 enrolled

Dalbavancin vs Comparator in Pediatric Subjects With Acute Hematogenous Osteomyelitis

Withdrawn·AActavis Inc.·Phase 3·NCT02344511

Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis

Terminated· AbbVie logo

AbbVie·Phase 2·NCT03091439·1 enrolled

Efficacy and Safety2 trials

Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections

Completed·TTourcoing Hospital··NCT06089044·15 enrolled

Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Completed· AbbVie logo

AbbVie·Phase 3·NCT01339091·573 enrolled

Single Dose2 trials

A Single Dose Study To Investigate The Pharmacokinetics and Safety Of Dalbavancin In Hospitalized Children Aged 3 Months to 11 Years.

Completed· AbbVie logo

AbbVie·Phase 1·NCT01946568·36 enrolled

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Completed· AbbVie logo

AbbVie·Phase 3·NCT02127970·698 enrolled

Staphylococcus Aureus Bacteremia1 trial

DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04775953·200 enrolled

13 more indications

Bloodstream Infection1 trial

Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections

Unknown status·VVicuron Pharmaceuticals·Phase 2·NCT00057369·88 enrolled

Peritoneal Dialysis1 trial

Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients

Completed·UUniversity of Colorado, Denver·Phase 4·NCT02940730·10 enrolled

Infective Endocarditis1 trial

Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis

Terminated· AbbVie logo

AbbVie·Phase 2·NCT03148756·2 enrolled

Bacterial Infections1 trial

Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections

Completed· Pfizer logo

Pfizer·Phase 1·NCT00678106·10 enrolled

Peritonitis1 trial

Evaluation of Intravenous Dalbavancin for Peritonitis

Terminated·UUniversity of Colorado, Denver··NCT04624451·2 enrolled

Bacterial Pneumonia1 trial

A P3 Comparator Trial in Community Acquired Bacterial Pneumonia

Withdrawn· AbbVie logo

AbbVie·Phase 3·NCT02269644

Bacterial Infection1 trial

Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection

Terminated· AbbVie logo

AbbVie·Phase 1·NCT02688790·8 enrolled

Frostbite1 trial

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Recruiting·UUniversity of Colorado, Denver·Phase 4·NCT06266494·100 enrolled

Substance Use Disorder (SUD)1 trial

Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition

Terminated·UUniversity of Colorado, Denver·Phase 2/3·NCT04847921·11 enrolled

Osteoarticular Infections1 trial

Dalbavancin For The Treatment of Gram Positive Osteoarticular Infections

Completed·IInfectious Diseases Physicians, Inc.·Phase 4·NCT03426761·41 enrolled

Leukemia1 trial

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

Recruiting·SSt. Jude Children's Research Hospital·Phase 1·NCT06810583·29 enrolled

Infection1 trial

Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements

Active, not recruiting·CCentre Hospitalier Universitaire de Nice·Preclinical·NCT05046860·43 enrolled

Unspecified2 trials

Hospital Avoidance Strategies for ABSSSI

Terminated·WWashington University School of Medicine·Phase 4·NCT03372941·11 enrolled

Dalbavancin Outpatient Pilot

Withdrawn·WWake Forest University Health Sciences·Phase 4·NCT03982030

Regulatory

FDA Approval Timeline[5]

May 23, 2014

DALVANCE

NDA NDA021883

Sources

References

[1]
ClinicalTrials.gov — 26 trial records for Dalbavancin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Dalvance drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Dalbavancin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Dalbavancin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021883). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Dalvance. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[6]

Patent Cliff

May 23, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

6900175May 23, 2028

Dalvance

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2031

Trials by Indication[1]

Infections4 trials

Osteomyelitis3 trials

Efficacy and Safety2 trials

Single Dose2 trials

Staphylococcus Aureus Bacteremia1 trial

Bloodstream Infection1 trial

Peritoneal Dialysis1 trial

Infective Endocarditis1 trial

Bacterial Infections1 trial

Peritonitis1 trial

Bacterial Pneumonia1 trial

Bacterial Infection1 trial

Frostbite1 trial

Substance Use Disorder (SUD)1 trial

Osteoarticular Infections1 trial

Leukemia1 trial

Infection1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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