Drugs / Retapamulin
Retapamulin
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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| Withdrawn | EU (EMA) | Altargo | — | 2019-02-25 | europa.eu ↗ |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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01812382 | Apr → May 2014 | skin disease caused by bacterial infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT00903279 | Aug 2009 → Dec 2010 | methicillin-resistant staphylococcus aureus infectious disease | Bay Pines VA Healthcare System | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT00539994 | Sep 2007 → Jan 2008 | bacterial infectious disease | GlaxoSmithKline | Completed | Met primary |
| Phase 35 trials · 2 missed | ||||||
| Phase 3 | NCT03304873 | Dec 2017 → Feb 2019 | methicillin-resistant staphylococcus aureus infectious disease | NYU Langone Health | Completed | Mixed |
| Phase 3 | NCT00852540 | Apr 2009 → Jul 2010 | skin disease caused by bacterial infection | Stiefel, a GSK Company | Completed | Missed primary |
| Phase 3 | NCT00684177 | May 2008 → Oct 2009 | skin disease caused by bacterial infection | GlaxoSmithKline | Completed | Missed primary |
| 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 · 1 missed | ||||||
| Phase 4 | NCT01461668 | Jul 2012 → Dec 2017 | methicillin-resistant staphylococcus aureus infectious disease | University of California, Irvine | Completed | Missed primary |
| 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NCT00856089 | May → Oct 2009 | methicillin-resistant staphylococcus aureus infectious disease | Ochsner Health System | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00871208 | May 2009 → May 2010 | atopic eczema | St. Luke's-Roosevelt Hospital Center | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00555061 | Sep 2007 → Aug 2008 | skin disease caused by bacterial infection | GlaxoSmithKline | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT01397461 Comparator | Mar → Dec 2012 | impetigo | Ferrer Internacional S.A. | Completed | Met primary |
| — | NCT01591785 Comparator | Jan → Aug 2012 | atopic eczema, hand dermatosis | Gary Goldenberg | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2015-11-23 | Almirall, S.A. | Almirall has acquired the rights to Veltin® and Altabax® from Stiefel, a GSK company, in exchange for its distribution rights to Toctino® almirall.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited 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 201413“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 ↗ |
| Known as | Altabax | “The authors disclose they will discuss off-label uses of retapamulin 1% (Altabax, Altargo).” PMID 25396674 ↗ Dec 2014 |
| 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 ↗ |
| Modality | Small molecule | — CHEMBL1658 ↗ |
| Route | Topical | “Topical SB-275833 ointment, 1%” NCT00133848 ↗ |