Drugs / Retapamulin

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Withdrawn EU (EMA) Altargo 2019-02-25 europa.eu
Approved EU (EMA) Altargo 2007-05-24 europa.eu
Approved US (FDA) ALTABAX 2007-04-12 fda.gov

Trials 14 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT01812382 Apr → May 2014 skin disease caused by bacterial infection GlaxoSmithKline Completed No outcome recorded
Phase 22 trials
Phase 2 NCT00903279 Aug 2009 → Dec 2010 methicillin-resistant staphylococcus aureus infectious disease Bay Pines VA Healthcare System Withdrawn No outcome recorded
Phase 2 NCT00539994 Sep 2007 → Jan 2008 bacterial infectious disease GlaxoSmithKline Completed No outcome recorded
Phase 35 trials
Phase 3 NCT03304873 Dec 2017 → Feb 2019 methicillin-resistant staphylococcus aureus infectious disease NYU Langone Health Completed No outcome recorded
Phase 3 NCT00852540 Apr 2009 → Jul 2010 skin disease caused by bacterial infection Stiefel, a GSK Company Completed No outcome recorded
Phase 3 NCT00684177 May 2008 → Oct 2009 skin disease caused by bacterial infection GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00133848 Apr 2005 → Jan 2006 impetigo GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00133874 Apr → Sep 2005 skin disease caused by bacterial infection GlaxoSmithKline Completed No outcome recorded
Phase 46 trials
Phase 4 NCT01461668 Jul 2012 → Dec 2017 methicillin-resistant staphylococcus aureus infectious disease University of California, Irvine Completed No outcome recorded
Phase 4 NCT01126268 Apr 2010 → Nov 2012 folliculitis, impetigo The University of Texas Health Science Center, Houston Completed No outcome recorded
Phase 4 NCT01064947 Feb 2010 → Jan 2012 atopic eczema, bacterial infectious disease Derm Research, PLLC Completed No outcome recorded
Phase 4 NCT00856089 May → Oct 2009 methicillin-resistant staphylococcus aureus infectious disease Ochsner Health System Withdrawn No outcome recorded
Phase 4 NCT00871208 May 2009 → May 2010 atopic eczema St. Luke's-Roosevelt Hospital Center Withdrawn No outcome recorded
Phase 4 NCT00555061 Sep 2007 → Aug 2008 skin disease caused by bacterial infection GlaxoSmithKline Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 31 trial
Phase 3 NCT01397461 Comparator Mar → Dec 2012 impetigo Ferrer Internacional S.A. Completed No outcome recorded
Phase not applicable1 trial
NCT01591785 Comparator Jan → Aug 2012 atopic eczema, hand dermatosis Gary Goldenberg Completed No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Retapamulin “A randomized, double-blind, comparative study to assess the safety and efficacy of topical retapamulin ointment 1% versus oral linezolid in the treatment of secondarily...” PMID 25396674 Dec 2014
13

Retapamulin 1% ointment is to be applied to lesional atopic dermatitis twice-daily in addition to a topical corticosteroid (Locoid lipocream (R))” NCT00871208

“Altabax (retapamulin)” NCT00903279

NCT00684177

NCT00539994

NCT00856089

NCT01064947

NCT03304873

NCT01461668

NCT01812382

NCT01591785

NCT01126268

NCT01397461

NCT00555061

Known as Altabax “The authors disclose they will discuss off-label uses of retapamulin 1% (Altabax, Altargo).” PMID 25396674 Dec 2014
1

NCT00903279

Known as Altargo “The authors disclose they will discuss off-label uses of retapamulin 1% (Altabax, Altargo).” PMID 25396674 Dec 2014
Known as NSC-759885 ChEMBL registry synonym — accepted as the source's own label CHEMBL1658
Known as Retapamulina ChEMBL registry synonym — accepted as the source's own label CHEMBL1658
Known as Retapamuline ChEMBL registry synonym — accepted as the source's own label CHEMBL1658
Known as SB-275833 “Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment” NCT00852540
3

“Topical Retapamulin (SB-275833) Ointment, 1%, Twice Daily for Five Days” NCT00555061

NCT00133874

NCT00133848

Modality Small molecule CHEMBL1658
Route Topical Topical SB-275833 ointment, 1%” NCT00133848