Overview
Mupirocin, formerly termed pseudomonic acid A, is a novel antibacterial agent with a unique chemical structure and mode of action apart from other antibiotic agents. Produced by fermentation using the organism Pseudomonas fluorescens, mupirocin is a naturally-occurring antibiotic that displays a broad-specturm activity against many gram-positive bacteria and certain gram-negative bacteria in vitro. It primarily works by inhibiting bacterial protein synthesis. Due to its unique mode of action of inhibiting the activity of bacterial isoleucyl-tRNA synthetase, mupirocin does not demonstrate cross-resistance with other classes of antimicrobial agents, giving it a therapeutic advantage. It is available in topical formulations only due to extensive systemic metabolism and is used in the treatment of impetigo caused by Staphylococcus aureus and Streptococcus pyogenes and traumatic skin lesions due to secondary skin infections caused by S. aureus and S. pyogenes. There is also some clinical evidence that suggests the potential role of mupirocin in eradicating nasal carriage of Staphylococci when administered intranasally. Mupirocin is commonly marketed under the brand name Bactroban.
Indication
Indicated for the treatment of impetigo and secondary skin infections, leading to traumatic skin lesions, due to Staphylococcus aureus and Streptococcus pyogenes.
Associated Conditions
- Impetigo
- Impetigo caused by Staphylococcus aureus
- Impetigo caused by streptococcus pyogenes
- Secondary infection Skin infection
- Staphylococcus aurea colonization of the nasal passage
Research Report
Mupirocin (DB00410): A Comprehensive Monograph on its Chemistry, Pharmacology, and Clinical Utility
Executive Summary
Mupirocin is a topical antibiotic with a unique structure and mechanism of action that has established it as a cornerstone therapy for superficial bacterial skin infections and a critical tool in public health infection control strategies. Derived from the fermentation of Pseudomonas fluorescens, Mupirocin is not a single chemical entity but a mixture of related pseudomonic acids, with pseudomonic acid A being the principal active component. Its defining pharmacological feature is the specific inhibition of bacterial isoleucyl-tRNA synthetase (IleRS), a mechanism distinct from all other major antibiotic classes. This distinction confers the significant clinical advantage of no inherent cross-resistance, allowing Mupirocin to remain effective against pathogens that have developed resistance to other antimicrobials, most notably methicillin-resistant Staphylococcus aureus (MRSA).
The clinical utility of Mupirocin is twofold. It is a first-line treatment for primary skin infections such as impetigo and folliculitis, as well as secondarily infected traumatic skin lesions, caused by susceptible strains of S. aureus and Streptococcus pyogenes. Beyond treating active infections, its role in public health has been profound, particularly through the use of a dedicated nasal formulation for the eradication of MRSA carriage. This application is central to infection control programs aimed at reducing transmission and preventing invasive infections in high-risk settings like hospitals and long-term care facilities.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/26 | Not Applicable | Recruiting | |||
2025/07/14 | Not Applicable | Completed | University of Santo Tomas Hospital, Philippines | ||
2024/10/09 | Phase 4 | Recruiting | Swiss Paraplegic Research, Nottwil | ||
2024/08/07 | Not Applicable | Recruiting | |||
2024/04/16 | Phase 1 | Active, not recruiting | |||
2023/09/21 | Early Phase 1 | Completed | Victoriano Luna Medical Center | ||
2023/06/08 | Phase 3 | Recruiting | Jiangxi Provincial Cancer Hospital | ||
2023/05/24 | Phase 2 | Completed | |||
2022/10/19 | Phase 4 | Recruiting | |||
2022/02/22 | Not Applicable | UNKNOWN | Phramongkutklao College of Medicine and Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Rebel Distributors Corp | 42254-137 | TOPICAL | 20 mg in 1 g | 9/17/2009 | |
RPK Pharmaceuticals, Inc. | 53002-9851 | TOPICAL | 20 mg in 1 g | 9/30/2017 | |
Padagis Israel Pharmaceuticals Ltd | 45802-018 | TOPICAL | 20 mg in 1 g | 8/1/2021 | |
NuCare Pharmaceuticals,Inc. | 68071-4111 | TOPICAL | 20 mg in 1 g | 7/19/2022 | |
Encube Ethicals Private Limited | 21922-029 | TOPICAL | 2 g in 100 g | 8/31/2021 | |
Central Texas Community Health Centers | 76413-158 | TOPICAL | 20 mg in 1 g | 7/12/2017 | |
Unit Dose Services | 50436-0112 | TOPICAL | 20 mg in 1 g | 1/2/2018 | |
A-S Medication Solutions | 50090-4349 | TOPICAL | 20 mg in 1 g | 12/9/2019 | |
Rebel Distributors Corp. | 21695-188 | TOPICAL | 20 mg in 1 g | 11/11/2009 | |
Sincerus Florida, LLC | 72934-2137 | TOPICAL | 2 g in 100 g | 5/14/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
MUPIRAX OINTMENT 2% w/w | SIN10760P | OINTMENT | 2% w/w | 2/18/1999 | |
SUPIROCIN OINTMENT 2% w/w | SIN11895P | OINTMENT | 2% w/w | 4/24/2002 | |
BACTROBAN NASAL OINTMENT 2% w/w | SIN05075P | OINTMENT | 2% w/w | 9/17/1990 | |
Mupider Ointment 2%w/w | SIN13712P | OINTMENT | 2.00 % w/w | 10/19/2009 | |
Muprin Ointment 2% w/w | SIN14421P | OINTMENT | 2.00% w/w | 10/30/2013 | |
EPIROZIN OINTMENT 2% W/W | SIN16306P | OINTMENT | 2% w/w | 8/24/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
PIBAKSIN OINTMENT 2% W/W | N/A | N/A | N/A | 12/18/2012 | |
MUPIDER OINTMENT 2% W/W | N/A | N/A | N/A | 3/8/2016 | |
BACTROBAN OINT 2% | N/A | N/A | N/A | 1/15/1987 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Bactroban Ointment | 11145 | Medicine | A | 8/14/1991 | |
BACTROBAN mupirocin (as calcium) 20mg/g cream tube | 63542 | Medicine | A | 4/23/1998 | |
MUPIROCIN LUPIN mupirocin 20 mg/g ointment tube | 276518 | Medicine | A | 4/12/2017 | |
MEDICIANZ MUPIROCIN OINTMENT mupirocin 2%w/w, tube | 279471 | Medicine | A | 7/6/2017 | |
BACTROBAN mupirocin 2% nasal ointment tube | 11199 | Medicine | A | 8/14/1991 | |
MUPIROCIN SCP mupirocin 20mg/g ointment tube | 276519 | Medicine | A | 4/12/2017 | |
MEDICIANZ MUPIROCIN NASAL OINTMENT mupirocin (as calcium) 20 mg/g (2% w/w) ointment tube | 299568 | Medicine | A | 4/5/2019 | |
APO-MUPIROCIN mupirocin 20mg/g ointment tube | 276520 | Medicine | A | 4/12/2017 | |
MEDSURGE MUPIROCIN NASAL OINTMENT mupirocin (as calcium) 20 mg/g (2% w/w) ointment tube | 300228 | Medicine | A | 4/5/2019 | |
SUPIROCIN mupirocin (as calcium) 2% w/w cream tube | 385530 | Medicine | A | 5/24/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
TARO-MUPIROCIN | 02279983 | Ointment - Topical | 2 % | 7/10/2006 | |
BACTROBAN | glaxosmithkline consumer healthcare ulc | 01916947 | Ointment - Topical | 2 % | 12/31/1992 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
BACTROBAN 20 mg/g pomada | 58868 | POMADA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
MUPIROCINA GALENICUMDERMA 20 MG/G POMADA | Galenicum Derma S.L.U. | 86458 | POMADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
MUPIROCINA FARMALIDER 20 mg/g POMADA | Farmalider S.A. | 75869 | POMADA | Medicamento Sujeto A Prescripción Médica | Commercialized |
MUPIROCINA ISDIN 20 mg/g POMADA | 75862 | POMADA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
PLASIMINE 20 mg/g POMADA | 58987 | POMADA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
MUPIROCINA INFECTOPHARM 20 MG/G POMADA | 84009 | POMADA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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