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silver sulfadiazine

Trade name: silvadene

Small moleculeapproved

Approved

Nov 26, 1973

Silver sulfadiazine, sold under the brand Silvadene among others, is a topical antibiotic used in partial thickness and full thickness burns to prevent infection. Tentative evidence has found other antibiotics to be more effective, and therefore it is no longer generally recommended for second-degree (partial-thickness) burns, but is still widely used to protect third-degree (full-thickness) burns. — Wikipedia

Clinical trial activity

22 trials · 24 clinical orgs · 4 marketing orgs

Phase 1
1
Phase 2
8
Phase 3
4
Phase 4
7

Earliest trial started Mar 1, 2004 (NCT00156988)

Timeline

1970s

  1. Nov 26, 1973

    King Pharmaceuticals — Earliest FDA Approval

  2. Nov 26, 1973

    King Pharmaceuticals — NDA Secondary Org

  3. Nov 26, 1973

    King Pharmaceuticals — NDA Organization

1980s

  1. Feb 25, 1982

    Dr. Reddy's Laboratories — NDA Secondary Org

  2. Feb 25, 1982

    Dr. Reddy's Laboratories — Marketing Organization

  3. Dec 23, 1985

    Thepharmanetwork Llc — NDA Secondary Org

  4. Nov 30, 1989

    Franklin Pharmaceuticals — NDA Secondary Org

2000s

  1. Jan 1, 2007

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewNov 26, 1973

Chemistry & pharmacology

Loading structure…

SMILES

[Ag+].NC1=CC=C(C=C1)S(=O)(=O)[N-]C2=NC=CC=N2
Mol. weight
357.137 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • flamazine
  • flamazine
  • silvadene
  • silvadene
  • silvadene
  • silvadene
  • silver sulfadiazinate
  • silver sulfadiazinate
  • silver sulfadiazine
  • silver sulfadiazine
  • silver sulfadiazine
  • silver sulfadiazine
  • silver sulfadiazine
  • silver sulfadiazine
  • silver sulfadiazine
  • silver sulfadiazine
  • silver sulphadiazine
  • silver sulphadiazine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05877638N/AMar 27, 2023Louisiana State University, Synedgen
NCT05347654N/ADec 15, 2022University of Lyon
NCT05073172N/ADec 31, 2021OHSU Knight Cancer Institute, Oregon Health and Science University
NCT04601532Phase 4Feb 28, 2021Department of Defense, Synedgen, University of Pittsburgh
NCT03162367Phase 2Nov 10, 2017Tabriz Medical University
NCT04391582Phase 2May 1, 2017Federal University of Ceara
NCT04202289Phase 3Apr 3, 2017Federal University of Ceara
NCT03592498Phase 2Oct 5, 2016Federal University of Ceara
NCT02116010Phase 1/Phase 2 (Phase 2)Jul 1, 2015Pherecydes Pharma
NCT02108535Phase 4Nov 1, 2013University of Sorocaba
NCT01598493N/AMay 1, 2012Bio-medical Carbon Technology Co., Ltd., National Taiwan University
NCT01598480N/AMay 1, 2012Bio-medical Carbon Technology Co., Ltd., National Taiwan University
NCT01701466Phase 2Dec 31, 2011McGill University
NCT01553708Phase 2/Phase 3 (Phase 3)Dec 1, 2011Chulalongkorn University, National Science and Technology Development Agency, Thailand
NCT01439074Phase 4Sep 1, 2011Molnlycke Health Care AB
NCT01926392Phase 4Apr 1, 2011University of Virginia
NCT02109718Phase 3Jan 1, 2009University of the Philippines
NCT01017094Phase 3Sep 1, 2007Prince of Songkla University
NCT00634166Phase 4Sep 1, 2007Mylan
NCT00297752Phase 4Mar 1, 2006Association of Dutch Burn Centres, Dutch Burns Foundation
Showing 20 of 22 trials
Page 1 / 2

Organizations

Research & Development (24)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Federal University of CearaAcademic/Hospital3322016
Association of Dutch Burn CentresAcademic/Hospital2212004
Bio-medical Carbon Technology Co., Ltd.For profit2212012
Dutch Burns FoundationAcademic/Hospital2012004
National Taiwan UniversityAcademic/Hospital2012012
SynedgenFor profit2122021
Chulalongkorn UniversityAcademic/Hospital1112011
Department of DefenseGovernment1012021
Louisiana State UniversityAcademic/Hospital1012023
McGill UniversityAcademic/Hospital1112011
Molnlycke Health Care ABFor profit1112011
MylanFor profit1112007
National Science and Technology Development Agency, ThailandGovernment1012011
OHSU Knight Cancer InstituteAcademic/Hospital1112021
Oregon Health and Science UniversityAcademic/Hospital1012021
Pherecydes PharmaFor profit1112015
Prince of Songkla UniversityAcademic/Hospital1112007
Rosalind Franklin UniversityAcademic/Hospital1112005
Tabriz Medical UniversityAcademic/Hospital1112017
University of LyonAcademic/Hospital1112022
24 organizations
Page 1 / 2

Marketing (6)

OrganizationOrg typeRelationshipDate
Dr. Reddy's LaboratoriesFor profitNDA2Feb 25, 1982
Dr. Reddy's LaboratoriesFor profitMKTGFeb 25, 1982
Franklin PharmaceuticalsFor profitNDA2Nov 30, 1989
King PharmaceuticalsFor profitNDA2Nov 26, 1973
King PharmaceuticalsFor profitNDANov 26, 1973
Thepharmanetwork LlcFor profitNDA2Dec 23, 1985