Bacitracin
A mixture of cyclic peptide antibiotics used in some topical first-aid products.
- Evidence grade
- BModerate Human Evidence
Moderate Human Evidence
- Regulatory status
- Not FDA Approved
Some topical products are lawfully marketed OTC, but that is not blanket individual FDA drug approval. Injectable bacitracin approval was withdrawn for safety reasons.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
A mixture of cyclic peptide antibiotics used in some topical first-aid products.
Some topical products are lawfully marketed OTC, but that is not blanket individual FDA drug approval. Injectable bacitracin approval was withdrawn for safety reasons.
An OTC product may be marketed under an applicable monograph rather than individually FDA-approved; product and route must be specified.
Why It's Being Studied
- Topical antibacterial care
- Cell-wall biology
Mechanism of Action
It interferes with recycling of bacterial cell-wall precursors, unlike cosmetic peptides intended to signal human skin cells.
It interferes with recycling of bacterial cell-wall precursors, unlike cosmetic peptides intended to signal human skin cells. An OTC product may be marketed under an applicable monograph rather than individually FDA-approved; product and route must be specified.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- Topical antibacterial care
- Cell-wall biology
- Topical products
Evidence Summary
Established topical antibacterial use is separate from evidence and approval history for injectable bacitracin, which was withdrawn for safety reasons.
Higher tiers carry more weight. Filled tiers have evidence for Bacitracin; tap to read it.
- Established topical antibacterial use is separate from evidence and approval history for injectable bacitracin, which was withdrawn for safety reasons.
1 cited sources.
- Regulatory document1
Human clinical evidence
- Established topical antibacterial use is separate from evidence and approval history for injectable bacitracin, which was withdrawn for safety reasons.
Reported Adverse Events in Research
- Topical contact allergy is important. Injectable products raised nephrotoxicity and anaphylaxis concerns.
Limitations of Current Evidence
- An OTC product may be marketed under an applicable monograph rather than individually FDA-approved; product and route must be specified.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Bacitracin | Trofinetide | |
|---|---|---|
| Evidence grade | B — Moderate Human Evidence | B — Moderate Human Evidence |
| Regulatory status | Not FDA Approved | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Topical products | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Regulatory document
Bacitracin — regulatory document