retapamulin

Trade name: altabax

Small moleculeapproved

Approved

Apr 12, 2007

Retapamulin is a topical antibiotic which was approved by FDA (Altabax brand name) for the treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes. Retapamulin exerts its antibacterial action by binding to 50S subunit of the bacterial ribosome. — NCATS

Clinical trial activity

16 trials · 13 clinical orgs · 3 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Apr 1, 2005 (NCT00133874)

Timeline

2000s

Jan 1, 2005
GlaxoSmithKline — Earliest Phase 3 Sponsor(trial)
Jan 1, 2007
GlaxoSmithKline — Earliest Phase 2 Sponsor(trial)
Apr 12, 2007
GlaxoSmithKline — Earliest FDA Approval
Apr 12, 2007
GlaxoSmithKline — NDA Organization
Apr 12, 2007
Aqua Pharmaceuticals — NDA Secondary Org
Apr 12, 2007
Almirall — NDA Secondary Org

2010s

Jan 1, 2014
GlaxoSmithKline — Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Impetigo

Studied for

Mechanism of action

Approval history

approvedApr 12, 2007

Chemistry & pharmacology

Loading structure…

SMILES

C=C[C@]1(C)C[C@@H](OC(=O)CS[C@@H]2C[C@H]3CC[C@@H](C2)N3C)[C@]2(C)[C@H](C)CC[C@]3(CCC(=O)[C@H]32)[C@@H](C)[C@@H]1O

Mol. weight: 517.78 g/mol
Lipinski Ro5: 2 violation(s)
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Topical
Availability: Discontinued

Oral

Parenteral

Topical

Yes

Sources

Also known as

aitabax
altabax
altabax
altabax
altabax
altabax
altargo
altargo
altargo
mutilin
retapamulin
retapamulin
retapamulin
retapamulin
retapamulin
retapamulin
retapamulin
retapamulin
retapamulin
retapamulin
retapamulin
retapamulin
retpamulin
sb275833
sb275833
sb 275833
sb-275833
sb-275833
sb-275833
sb-275833
sb-275833

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT03304873	Phase 3	Dec 1, 2017	New York University
NCT01812382	Phase 1	Apr 2, 2014	GlaxoSmithKline
NCT01461668	Phase 4	Jul 1, 2012	Department of Health and Human Services, University of California, Irvine
NCT01397461	Phase 3	Mar 1, 2012	Ferrer Internacional S.A.
NCT01591785	N/A	Jan 1, 2012	Icahn School of Medicine at Mount Sinai
NCT01126268	Phase 4	Apr 1, 2010	GlaxoSmithKline, University of Texas at Houston
NCT01064947	Phase 4	Feb 1, 2010	Derm Research, PLLC, GlaxoSmithKline
NCT00903279	Phase 2	Aug 1, 2009	Department of Veteran Affairs
NCT00871208	Phase 4	May 1, 2009	GlaxoSmithKline, St. Luke's-Roosevelt Hospital Center
NCT00856089	Phase 4	May 1, 2009	GlaxoSmithKline, Ochsner Health System, Tulane University
NCT00852540	Phase 3	Apr 1, 2009	GlaxoSmithKline, Stiefel Laboratories
NCT00684177	Phase 3	May 1, 2008	GlaxoSmithKline
NCT00539994	Phase 2	Sep 1, 2007	GlaxoSmithKline
NCT00555061	Phase 4	Sep 1, 2007	GlaxoSmithKline
NCT00133874	Phase 3	Apr 1, 2005	GlaxoSmithKline
NCT00133848	Phase 3	Apr 1, 2005	GlaxoSmithKline

Showing 16 of 16 trials

Page 1 / 1

Organizations

Research & Development (13)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
GlaxoSmithKline	For profit	11	6	4	2005
Department of Health and Human Services	Government	1	0	1	2012
Department of Veteran Affairs	Government	1	1	1	2009
Derm Research, PLLC	For profit	1	1	1	2010
Ferrer Internacional S.A.	For profit	1	1	1	2012
Icahn School of Medicine at Mount Sinai	Academic/Hospital	1	1	1	2012
New York University	Academic/Hospital	1	1	1	2017
Ochsner Health System	Academic/Hospital	1	1	1	2009
Stiefel Laboratories	For profit	1	1	1	2009
St. Luke's-Roosevelt Hospital Center	Academic/Hospital	1	1	1	2009
Tulane University	Academic/Hospital	1	0	1	2009
University of California, Irvine	Academic/Hospital	1	1	1	2012
University of Texas at Houston	Academic/Hospital	1	1	1	2010

13 organizations

Page 1 / 1

Marketing (3)

Organization	Org type	Relationship	Date
Almirall	For profit	NDA2	Apr 12, 2007
Aqua Pharmaceuticals	For profit	NDA2	Apr 12, 2007
GlaxoSmithKline	For profit	NDA	Apr 12, 2007