Polihexanide 0.02% eye drops preservative free
Requires a prescription from a doctor or prescriber
Polihexanide, also known as polyhexamethylene biguanide (PHMB), is a broad-spectrum antimicrobial polymer primarily used for topical antisepsis and wound management.
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Suspected adverse reactions reported for Polihexanide
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Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 10 · Randomised trials: 11 · 2007–2026
Showing the 50 most relevant studies, sorted by most relevant.
Castiello G, Caravella G, Ghizzardi G, et al.
2023
- Biguanides
- Anti-Infective Agents
- Postoperative Complications
Singh M, Husain N, Dutta S, et al.
2026
- Eye Infections, Parasitic
- Acanthamoeba Keratitis
- Biguanides
N. Hübner, Axel Kramer
Skin Pharmacology and Physiology, 2010
Santos DSF, Peralta-Mamani M, Brandão FS, et al.
2022
- Chlorine Compounds
- Chlorhexidine
- Oxides
BackgroundMaintenance of oral microbiota balance is the simplest way to prevent infectious oral diseases, through controlling dental biofilm. Combined use of mouthwash and mechanical removal has been shown to be a very effective way for this.ObjectivesTo identify clinical studies comparing the antimicrobial effect and possible adverse effects and/or side effects of chlorhexidine-based mouthwashes with those of mouthwashes containing chlorine dioxide and/or polyhexanide, for controlling oral microbiota.Design and settingSystematic review designed by the stomatology sector of postgraduation in applied dental sciences of Bauru Dentistry School, University of São Paulo, Brazil.MethodsA systematic review was conducted using online databases (PubMed, Embase, Web of Science and Science Direct) up to April 8, 2020. The search was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.ResultsThe studies included comprised eight articles published between 2001 and 2017. A total of 295 young adults, adults and elderly people were evaluated (males 44.75% and females 55.25%). Three articles compared polyhexanide with chlorhexidine and five articles compared chlorine dioxide with chlorhexidine. No studies comparing all three mouthwashes were found. The concentrations of the study solutions were quite varied, and all rinses had an antimicrobial effect. In four studies, it was stated that no side effects or adverse effects had been found. Three studies did not address these results and only one study addressed side effects and/or adverse effects.ConclusionMouthwashes containing chlorine dioxide and polyhexanide are viable alternatives to chlorhexidine, since they reduce oral biofilm and have little or no reported side or adverse effects.
Abstract licence: CC BY
Riemma G, Mainini G, Lukanović D, et al.
2023
- Vulvovaginitis
- Hydrogels
- Biguanides
Background and Objectives: Signs and symptoms of vulvovaginitis, especially when recurrent, have a significant impact on a woman's quality of life. The aim of this study was to survey gynecologists about their habits regarding the treatments of the pathology and to evaluate the efficacy of a novel vaginal hydrogel composed of wheat extracts and polyhexanide aimed at reducing vulvovaginitis symptomatology. Materials and Methods: A cross-sectional analysis of a national survey using 155 Italian gynecologists and a prospective, open-label, observational study were carried out in 75 outpatient clinics across Italy. Pre- and postmenopausal women with suspicion of vulvovaginitis due to at least four of the following symptoms (leucoxanthorrhea, bad odor from genitalia, vulvovaginal dryness, petechiae, burning, and pruritus) while waiting for microbiological swab analysis were included and treated with one hydrogel application every 3 days for 1 week. Primary endpoint was the complete resolution of symptomatology. Results: The pre-study survey reported that, for most clinicians, local or oral treatment (65.7% and 82.8%, respectively) with antibiotics or antifungals is used very often. Therefore, we proceeded to carry out an observational study. Overall, 615 (362 of fertile age and 253 in postmenopause) women were included in this study. At the 28th follow-up examination, complete resolution of symptomatology was achieved in 578/615 (94.1%; p p = 0.342). All of the evaluated symptoms were significantly reduced after treatment (p = 0.001) without differences according to the patient's menopausal status. A slightly significant reduction in Gardnerella Vaginalis (p = 0.040) and Candida Albicans (p = 0.049) was found after treatment. No patient reported side effects, adverse reactions, or discontinued therapy. Conclusions: This pilot study showed that a hydrogel based on Rigenase® (wheat extract) and polyhexanide could be a promising treatment for the relief of vulvovaginitis symptoms. However, these results are limited by the absence of a control group. Additional comparative and randomized controlled trials between the hydrogel and other non-antibiotic devices as well as local antibiotic therapy should be performed to increase the validity of the findings.
Abstract licence: CC BY
Peters M, Eberle D, Reese S, et al.
2026
- Wound Infection
- Bites and Stings
- Dog Diseases
Therapy of dog bite wounds often includes empirical usage of antibiotics. This prospective clinical study aimed to compare the efficacy of polyhexanide and hypochlorous acid in reducing bacterial wound bio-burden and preventing the necessity for prophylactic antibiotics and to monitor the prevalence of multidrug- resistant bacteria. Thirty-four dogs with 51 bite wounds were randomly assigned to one of the treatment groups. Wounds were surgically debrided and treated with polyhexanide or hypochlorous acid. Swabs for culturing were taken three times: before and directly after debridement and directly after lavage. Veterinary patients were further divided into post-surgery care with and without prophylactic antibiotics. Wound healing until suture removal was monitored. Data were analyzed using a generalized linear model for ordinal data. Positive bacterial culture results after the first swab were obtained in 82.4 % wounds. Staphylococcus pseudintermedius was overrepresented in wounds, which later on developed complications. Neisseria species and streptococci species were overrepresented in cases of delayed wound closure. In 41.2 % of wounds multi-drug resistant bacteria could be detected. No negative effect of occurrence of multi-drug resistant bacteria on wound healing was observed. None of the compared antiseptics showed a significantly better wound decontamination. No superior antiseptic was found for wound lavage. Hypochlorous acid-based antiseptics provide the practical advantage of a shorter contact time. Prophylactic antibiotics should always be considered in severe dog bite wounds and might not be needed in low grade bite wounds.
Abstract licence: CC BY
Ontiveros AH, Inat S, Fernández JCN, et al.
2026
Abstract Introduction: Acanthamoeba keratitis (AK) is a rare but potentially vision-threatening corneal infection. Until recently, no pharmacological treatment had been officially approved. The first licensed therapy in the European Union, polihexanide (PHMB) 0.08%, demonstrated an 84.8% medical cure rate without surgery in a randomized clinical trial (Dart et al., 2024). This study reports the first real-world evaluation of PHMB 0.08% in clinical practice in Spain. Methods Fourteen patients with PCR-confirmed AK were treated with PHMB 0.08% at Hospital La Fe (Valencia) under a national compassionate use program. Treatment followed the protocol used in the pivotal clinical trial, for up to 6 months or until clinical resolution. Patients were monitored for one year. The primary endpoint was medical cure, defined as complete resolution of inflammation and full corneal re-epithelialization. Safety outcomes were also assessed. Results All patients achieved medical cure. The median treatment duration was 122 days. Final best-corrected visual acuity reached a median of 20/20 (Snellen). Three patients underwent optical penetrating keratoplasty due to residual central stromal scarring, not active infection. No severe adverse effects were reported. Conclusions This first real-world experience with PHMB 0.08% in Spain confirms that the efficacy observed in clinical trials is reproducible in routine clinical practice, across various stages of AK severity. These results support the implementation of standardized protocols for improved management of AK.
Abstract licence: CC BY
Suludere MA, Malone M, Siah MC, et al.
2026
- Wound Infection
- Diabetic Foot
- Biguanides
The aim of this study was to compare the microbial loads of patients with diabetic foot infections treated with negative pressure wound therapy (NPWT) with and without irrigation with polyhexamethylene biguanide (NPWTi-P). This is a post hoc analysis of combined data of two randomized clinical trials. We evaluated people with diabetes treated with moderate and severe diabetic foot infections that required surgery. Tissue specimens were obtained after the initial surgery and following a second planned return to the operating room after 48-72 h of NPWT or NPWTi-P, prior to the second surgery. We used quantitative polymerase chain reaction (qPCR) to determine the total microbial loads (Log10 16S copies per gram of tissue). There was no difference in mean quantitative bacterial cultures among patients that received NPWT and NPWTi-P (before first surgery Log10: NPWT = 6.4 ± 1.8, NPWTi-P = 7.5 ± 1.7 vs before second surgery Log10: NPWT = 6.7 ± 1.8, NPWTi-P = 7.6 ± 1.9 p = .12). There was no difference in wound healing (59.5% vs 50.0%, p = .51) or time to heal (127 ± 109.3 vs 143 ± 95.9), p = .71). There were fewer re-infections in people that received traditional NPWT (28.6% vs 56.3%, p = .05).Level of Clinical Evidence: Level 1.
Abstract licence: CC BY-NC
M. Romanelli, V. Dini, S. Barbanera, et al.
Skin Pharmacology and Physiology, 2010
Papa V, van der Meulen I, Rottey S, et al.
2022
- Acanthamoeba Keratitis
- Biguanides
- Healthy Volunteers
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
Not available
Mechanism
Polihexanide exerts its antimicrobial activity by binding to the negatively char…
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
[L53003]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Polihexanide is approved in Europe under the name Akantior for the treatment of Acanthamoeba keratitis, an ocular infection caused by the Acanthamoeba parasite. [L53003] It was initially approved in August of 2024, and is the first and only approved therapy to treat patients with Acanthamoeba keratitis. [L53143]
[L53003]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L53003]
ATC S01AX24
ATC D08AC05
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Polihexanide
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72