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Dalbavancin

Phase 1

Bacterial Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Oct 12, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00678106Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial InfectionsPHASE1 COMPLETED 10 — — Sep 1, 2008Jul 1, 2009Oct 12, 20093 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetic Plasma - Cmax, Tmax, AUClast, AUCinf, AUC(48) (as data permit), t1/2 (as data permit), CL, Vss. Urine - Ae48, Ae48% and CLR.
56 days
Secondary Endpoints
Safety assessments: adverse event monitoring; clinical laboratory tests (hematology, serum chemistry, and urinalysis); ECGs; blood pressure and pulse rate determinations; weight and physical examination.
56 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
DalbavancinDRUGSubjects weighing \> 60 Kg: 1 gram IV single dose Subjects weighing \< 60 Kg: 15 mg/Kg IV
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Eligibility Criteria
Age Range12 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 12 to 17 year old adolescents hospitalized for the treatment of bacterial infections. Exclusion Criteria: * Patients being treated with vancomycin. * Patients with liver and kidney failure. * Pregnant female subjects.

Countries:United States
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Competitive Landscape -Bacterial Infections 62 trials
CompanyTickerTrialsLead PhaseDrugs
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CorMedix Inc.CRMD2PHASE3catheter lock, Heparin, Vabomere
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60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Moderna, Inc.MRNA1PHASE2mRNA-1982
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 — AIGIV, CYFENDUS, Collection of samples
Abbott LaboratoriesABT1NAUndisclosed
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