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Benzalkonium chloride (BAK)
Benzalkonium chloride is a quaternary ammonium compound that disrupts bacterial and fungal cell membranes, exerting antimicrobial and preservative effects.
Benzalkonium chloride is a quaternary ammonium compound that disrupts bacterial and fungal cell membranes, exerting antimicrobial and preservative effects. Used for Preservative in ophthalmic solutions (eye drops, contact lens solutions), Antimicrobial agent in topical pharmaceutical formulations, Preservative in various injectable and non-injectable pharmaceutical products.
At a glance
| Generic name | Benzalkonium chloride (BAK) |
|---|---|
| Sponsor | Gangnam Severance Hospital |
| Drug class | Quaternary ammonium compound / Antimicrobial preservative |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology / Dermatology / Antimicrobial |
| Phase | FDA-approved |
Mechanism of action
BAK functions as a cationic surfactant that penetrates and destabilizes the lipid bilayer of microbial cell membranes, leading to leakage of cellular contents and cell death. It is widely used as a preservative in ophthalmic solutions, topical formulations, and other pharmaceutical products to prevent microbial contamination. BAK also exhibits some anti-inflammatory properties in certain contexts.
Approved indications
- Preservative in ophthalmic solutions (eye drops, contact lens solutions)
- Antimicrobial agent in topical pharmaceutical formulations
- Preservative in various injectable and non-injectable pharmaceutical products
Common side effects
- Ocular irritation (when used in eye drops)
- Conjunctival hyperemia
- Allergic contact dermatitis (topical exposure)
- Corneal toxicity (at high concentrations)
Key clinical trials
- A Comparative Study Between Preservative With Benzalkonium Chloride vs Preservative Free Eye Drops on the Ocular Surface (PHASE4)
- Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells (PHASE4)
- Comparison of Preserved and Preservative-free Latanoprost 0.005% in Primary Open Angle Glaucoma and Ocular Hypertensive Patients, at Guinness Eye Centre, Lagos. (PHASE4)
- Comparison of Different Drugs on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study
- Efficacy and Tolerability of an Innovative Formulation of BAK-free Latanoprost (PHASE4)
- Efficacy and Tolerability of Preservative-free 0.0015% Tafluprost in Glaucoma Patients (PHASE4)
- An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® (PHASE4)
- Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Benzalkonium chloride (BAK) CI brief — competitive landscape report
- Benzalkonium chloride (BAK) updates RSS · CI watch RSS
- Gangnam Severance Hospital portfolio CI