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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/10/09 | Phase 4 | Recruiting | Swiss Paraplegic Research, Nottwil | ||
2024/08/07 | Not Applicable | Recruiting | |||
2024/04/16 | Phase 1 | 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 | ||
2020/02/27 | Phase 3 | Completed | Reig Jofre Group | ||
2020/01/10 | Phase 4 | Completed |
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 |
|---|---|---|---|---|---|
| Mupirocin Ointment | 国药准字H20253043 | 化学药品 | 软膏剂 | 1/2/2025 | |
| Mupirocin Ointment | 国药准字H20253011 | 化学药品 | 软膏剂 | 1/2/2025 | |
| Mupirocin Ointment | 国药准字H20249432 | 化学药品 | 软膏剂 | 11/22/2024 | |
| Mupirocin Ointment | 国药准字H20253638 | 化学药品 | 软膏剂 | 3/18/2025 | |
| Mupirocin Ointment | 国药准字H20249203 | 化学药品 | 软膏剂 | 10/29/2024 | |
| Mupirocin Ointment | 国药准字HC20160015 | 化学药品 | 软膏剂 | 3/2/2021 | |
| Mupirocin Ointment | 国药准字H20244094 | 化学药品 | 软膏剂 | 6/18/2024 | |
| Mupirocin Ointment | 国药准字H20193036 | 化学药品 | 软膏剂 | 12/14/2023 | |
| Mupirocin Ointment | 国药准字H20249649 | 化学药品 | 软膏剂 | 12/1/2024 | |
| Mupirocin Ointment | 国药准字H20183302 | 化学药品 | 软膏剂 | 5/22/2023 |
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 | hind wing co ltd | N/A | N/A | 3/8/2016 |
| BACTROBAN OINT 2% | N/A | glaxosmithkline limited | 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 |