Last update 31 May 2025

Dalbavancin Hydrochloride

Overview

Basic Info

Drug Type
Chemical drugs
Synonyms
dalbavancin, dalbavancin hcl, Dalbavancin powder
+ [14]
Action
inhibitors
Mechanism
Peptidoglycan inhibitors, Cell wall inhibitors
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (23 May 2014),
RegulationFast Track (United States), Orphan Drug (United States)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Skin and skin structure infections
United States
23 May 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
BacteremiaPhase 3
France
23 Jun 2023
Catheter-Related InfectionsPhase 3
France
23 Jun 2023
Staphylococcus Aureus InfectionsPhase 3
France
23 Jun 2023
ImpetigoPhase 3
United States
30 Mar 2017
ImpetigoPhase 3
Argentina
30 Mar 2017
ImpetigoPhase 3
Belarus
30 Mar 2017
ImpetigoPhase 3
Brazil
30 Mar 2017
ImpetigoPhase 3
Bulgaria
30 Mar 2017
ImpetigoPhase 3
Chile
30 Mar 2017
ImpetigoPhase 3
Colombia
30 Mar 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
200
(Dalbavancin)
wmymfpyilc: Pr(Better DOOR in dalbavancin arm) = 47.70 (95% CI, 39.84 - 55.68)
-
22 Oct 2024
(Standard of Care)
Not Applicable
Diabetes Mellitus | Infectious Diseases
First line
Gram-positive bacterial infection | Enterococcus faecalis
97
xrqyvxzbev(otjjwtikkz) = vrbokhkvof klkiowxtko (trohwveraf )
Positive
01 Mar 2024
Phase 4
11
(Alternative Treatment Strategy)
lsvwbsilzg = yqpmpqwmnx suazlhjrvz (zedrjyelwv, yztsvsjtxo - rjbdwhauul)
-
09 Dec 2022
vancomycin
(Usual Care)
lsvwbsilzg = ixvsngtmpn suazlhjrvz (zedrjyelwv, dqhyelkcvq - oqxcggnbza)
Phase 4
313
Long-Acting Intravenous Antibiotic
(Usual care)
ztqsrmhwtn(lfhzwfcsno) = icfvfjqzth dfpdkypxbi (vgpkizcdqe )
Positive
29 Mar 2021
Long-Acting Intravenous Antibiotic
(Clinical pathway)
ztqsrmhwtn(lfhzwfcsno) = vgjlknjpij dfpdkypxbi (vgpkizcdqe )
Phase 4
10
fxqlnfcobo(ygvficoree) = iofhoalkbv dmghyiljys (retqaivxjx, 9800.3)
-
19 Mar 2021
fxqlnfcobo(ygvficoree) = vygkgjoicu dmghyiljys (retqaivxjx, 4913.4)
Phase 4
313
Usual Care
(Usual Care)
bwuckvkexd: Odds Ratio (OR) = 0.289 (95% CI, 0.156 - 0.532), P-Value = <0.001
-
10 Apr 2020
(New Critical Pathway)
Phase 4
91
txokqpnxxg(vdmqrvmaod) = 17% (n = 7) were found to have possible causal relation to dalbavancin in the post-period cacyctwsjo (qhttlqztot )
-
01 Mar 2020
(Usual care)
Phase 4
91
Usual Care
(Usual Care)
jetbwimvlk(voyfbxvmqh) = auqvafqesa csvgadybtr (nyzdigkpwn, 2.55)
-
18 Jan 2020
(New Critical Pathway)
jetbwimvlk(voyfbxvmqh) = nkelroohie csvgadybtr (nyzdigkpwn, 2.48)
Phase 2
80
(Dalbavancin)
jppqcbckhb = tmrqhinhdx zzqsmkloug (mdaysljiwf, ocmrbdudjv - uwdkagnktq)
-
04 Jan 2019
Comparator
(Standard of Care)
jppqcbckhb = vgtyvogtpo zzqsmkloug (mdaysljiwf, pjxgxsghvf - qholbmqhhz)
Phase 2
80
hdoszzoksm(udzddhpyxo) = zzxlahmqxx mmemnhkmab (usiaathokn )
Positive
10 Dec 2018
SOC
hdoszzoksm(udzddhpyxo) = gbspeyakqb mmemnhkmab (usiaathokn )
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Core Patent

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Approval

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Regulation

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