Surgical Prophylaxis: Assessing Decolonization Efficacy of Polyhexanide Versus Mupirocin and Chlorhexidine in Decolonizing Staphylococcus Aureus Preoperatively in Elective Spine Surgery (SPADE): a Pilot Randomized Controlled Trial

This pilot randomized controlled trial evaluates the feasibility, tolerability, and preliminary efficacy of a decolonization regimen using polyhexanide in reducing Staphylococcus aureus colonization in the preoperative phase of elective spine surgery, compared to the standard mupirocin and chlorhexidine regimen. The trial involves 24 participants randomized into two groups: one receiving polyhexanide and the other receiving mupirocin and chlorhexidine. The primary outcome is the randomization rate, with secondary outcomes including other feasibility outcomes, tolerability, and efficacy measures such as the reduction in S. aureus colony-forming units (CFUs) and changes in the nasal and skin microbiome composition.

Start Date01 Apr 2025

Sponsor / Collaborator-

NCT06213649

/ RecruitingPhase 3IIT

Parasitic Ulcer Treatment Trial

The Parasitic Ulcer Treatment Trial (PUTT) is a multi-center, parallel-group, randomized clinical trial. The purpose of this study is to determine whether including topical corticosteroids in a regimen for acanthamoeba keratitis (AK) will improve vision. Patients presenting to all enrollment centers with evidence of acanthamoeba keratitis will be eligible for the trial if there is evidence of ocular inflammation after 4 weeks of anti-amoebic therapy. Those who agree to participate will be randomized to one of two treatment groups:
* Group 1: Topical corticosteroid
* Group 2: Topical placebo

Start Date01 Jul 2024

Sponsor / Collaborator

The University of California, San Francisco

[+13]

NCT06338163

/ Not yet recruitingPhase 4

Polihexanide SSIs Measures Bundle (PSMB) During Enhanced Recovery After Major Digestive Surgery

This is a randomized controlled, prospective, multicenter superiority trial with two parallel treatment groups and single blinding (local investigators performing postoperative follow up will be blinded for group allocation), with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers. All patients undergoing elective major gastro-intestinal (GI) tract surgery (upper GI, HPB, & lower GI) will be included in a prospective database after written informed consent. A total of 2,000 patients is expected based on a mean of 100 cases per center.

Start Date01 Jul 2024

Sponsor / Collaborator-

100 Clinical Results associated with Polihexanide

100 Translational Medicine associated with Polihexanide

100 Patents (Medical) associated with Polihexanide

860

Literatures (Medical) associated with Polihexanide

01 Jun 2025·CARBOHYDRATE RESEARCH

Enhanced wound healing and antibacterial efficacy of a novel chitosan quaternary ammonium salt gel incorporating Echinacea purpurea extract

Article

Author: Abtahi, Hamid ; Jafari, Hasan ; Isfahani, Morteza Sanagooiezadeh ; Memarzadeh, Mohammadreza ; Almasi-Hashiani, Amir ; Fahimirad, Shohreh

Wound healing is a complex and dynamic process involving hemostasis, inflammation, proliferation, and remodeling. This study introduces Chitagel, a novel wound-healing gel formulated with 4 % (w/w) chitosan quaternary ammonium salt, 0.1 % (w/w) polyhexamethylene biguanide (PHMB), and 6 % (w/w) Echinacea purpurea extract, designed to provide antibacterial and antioxidant properties. To enhance hydration, 2 % (w/w) dexpanthenol, 10 % (w/w) glycerin, and 4 % (w/w) sorbitol were incorporated as humectants. In vitro analysis demonstrated 92.3 % inhibition of methicillin-resistant Staphylococcus aureus (MRSA) and 89.63 % antioxidant activity via the DPPH assay. Water content analysis confirmed a 62.9 % hydration level, facilitating a moist wound environment. Zeta potential measurement (+44.9 mV) indicated colloidal stability, ensuring sustained antimicrobial activity. In an MRSA-infected rat wound model, Chitagel significantly accelerated wound closure, achieving 82.5 % healing by day 15, compared to 54.3 % in the untreated group. The MTT assay showed enhanced fibroblast proliferation, with 400 μg/mL stimulating the highest cell viability. Histological analysis confirmed improved re-epithelialization, reduced inflammation, and granulation tissue formation. These findings highlight Chitagel as a promising therapeutic for infected wounds, combining antibacterial, antioxidant, and regenerative properties. Further clinical studies are required to validate its efficacy and safety in human applications and to establish its role as a novel wound-healing agent.

01 May 2025·JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT

Systematics, diagnosis and treatment of wound infections in chronic wounds: A position paper from WundDACH

Review

Author: Motzkus, Martin ; Rembe, Julian‐Dario ; Probst, Sebastian ; Traber, Jürg ; Dissemond, Joachim ; Panfil, Eva‐Maria ; Assenheimer, Bernd ; Kurz, Peter ; Schwarzkopf, Andreas ; Strohal, Robert ; Barysch‐Bonderer, Marjam ; Gerber, Veronika ; Kottner, Jan

Summary:

Wound infections are still an interdisciplinary and interprofessional challenge, because of numerous complications, particularly in people with chronic wounds. There are many different concepts and approaches in this field today. Therefore, WundDACH, the umbrella organization of the German‐speaking wound healing societies, wrote a position paper on this important topic. An interdisciplinary and interprofessional group of experts from German‐speaking countries developed definitions and procedures for nomenclature, diagnosis and treatment of wound infections in people with chronic wounds in a modified Delphi process.The importance of correctly diagnosing wound infections is emphasized so that adequate treatment can be carried out as early and specifically as possible. For a differentiated assessment, a simplified continuum of wound infection with contamination, colonization, local and systemic infection and the corresponding therapeutic consequences was described. Most bacteria in wounds can be removed by repeated wound‐irrigation and debridement. Local wound infections are diagnosed based on clinical signs of infection and TILI score. Treatment is then usually exclusively local, for example with modern antiseptics such as polyhexanide. Systemic antibiotics should mostly be considered when signs of systemic infections appear. The indication for antimicrobial wound therapy should be critically reviewed after 10–14 days at the latest.

01 May 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

Enhanced wound healing and antimicrobial efficacy of PHMB-loaded injectable chitosan/quaternary chitosan/NaHCO3/β-glycerophosphate hydrogels for seawater-infected wounds

Article

Author: Fu, Qiang ; Chen, Zhiqian ; Wang, Xin ; Zhou, Dengyun

Bacterial infection is often linked to delayed wound healing. Seawater immersion further increases the risk of wound infection from bacteria in the water. A suitable wound environment is important for healing. In this study, to promote the healing of seawater immersion wounds, an injectable thermosensitive chitosan /quaternary chitosan/NaHCO₃/β-glycerophosphate hydrogel wound dressings loaded with polyhexamethylene biguanide (PHMB) was developed. The physicochemical properties of the hydrogel were characterized, and antimicrobial and wound-healing capabilities were assessed. The hydrogel showed rapid gelling (2 min) at physiological temperature (35.15 °C), exhibiting adequate mechanical properties and enhanced network. The hydrogel demonstrates the ability to release 79.9 % of PHMB within 6 h. It also exhibits favorable adhesion and biocompatibility profile, characterized by a hemolysis ratio that remains below the 2 % threshold. In addition, the hydrogel loaded with 1 mg/mL PHMB demonstrated excellent antimicrobial properties both in vivo and in vitro. Furthermore, the hydrogel can reduce inflammatory cells, increase collagen fibre deposition and promote angiogenesis, demonstrating a high healing rate (95.03 % after 14 days) for wounds immersed in seawater. In summary, this injectable thermosensitive hydrogel shows great potential as a multifunctional dressing for treating complex bacterial wound infections and seawater-immersed wounds.

News (Medical) associated with Polihexanide

19 May 2025

·www.prnewswire.com

SIFI receives Marketing Authorisation and Promising Innovative Medicine Designation for AKANTIOR® in the UK

MHRA granted on 6th May the Promising Innovative Medicine (PIM) Designation MHRA granted on 15th May the Marketing Authorisation, confirming the Orphan Drug Designation and the New Active Substance status CATANIA, Italy, May 19, 2025 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Marketing Authorization for AKANTIOR® (polihexanide 0.08%) confirming the Orphan Drug Designation of the product in the treatment of Acanthamoeba keratitis in adults and children from 12 years of age. The Marketing Authorisation confirms the New Active Substance status, recognizing the investments made by SIFI in developing polihexanide as an active pharmaceutical ingredient according to good manufacturing practices, a key element in ensuring the level of efficacy and safety seen in the ODAK trial and real world evidence. A few days before, the MHRA also awarded AKANTIOR the Promising Innovative Medicine (PIM) designation, confirming that AKANTIOR® meets all three of the following criteria established by the MHRA: The condition is life-threatening or seriously debilitating with special emphasis on patient quality of life, and there is high unmet need as there is no method of treatment available or existing methods have serious limitations. The medicinal product is likely to offer a major advantage over current methods used in the UK. The benefits of the medicinal products are likely to outweigh potential adverse effects. AKANTIOR® becomes the first and only approved treatment for Acanthamoeba keratitis in the United Kingdom, representing a transformative step for UK patients affected by Acanthamoeba keratitis, an ultra-rare and devastating eye infection that can lead to blindness if left untreated. Following the Marketing Authorization in the European Economic Area granted in August 2024, MHRA approval expands the availability into another major European market of AKANTIOR®. SIFI is currently engaged with the National Institute of Clinical Excellence (NICE) and expects to file a full reimbursement dossier by end of June 2025. "Granting Marketing Authorization for AKANTIOR® and its recognition with the Positive PIM designation marks important progress in our mission to provide Acanthamoeba keratitis patients in the UK with access to this innovative treatment," said Manuela Marrano, Executive Director, Regulatory and Market Access, SIFI "This recognition by the MHRA underscores the potential of AKANTIOR® to address this high unmet medical need, confirming AKANTIOR® has significant benefits for patients with severely debilitating conditions. We also look forward to continuing our interaction with NICE to ensure the widest access in the Country for AKANTIOR." AKANTIOR® (polihexanide 0.08%) is the first and only approved drug specifically developed for the treatment of Acanthamoeba keratitis in the world. It contains an anti-amoebic polymer that acts on both the trophozoite and cyst forms of the protozoan acanthamoeba. AKANTIOR® is formulated as eye drops in single-dose containers at a 0.08% concentration and it is effective as monotherapy. Acanthamoeba keratitis is an ultra-rare, severe, and progressive corneal infection characterized by intense pain and photophobia. It primarily affects contact lens wearers and, if left untreated, can lead to poor vision, blindness, or even loss of the eye. The condition often requires one or multiple corneal transplants. About SIFI SIFI is a leading international ophthalmic company headquartered in Italy, featuring an integrated business model from research and development to manufacturing and commercialization in both pharmaceutical and biomedical sectors. Founded in 1935, SIFI's mission is to improve people's lives through meaningful innovation in eye care. The company exports to more than 60 countries worldwide with a direct presence in major European markets, Mexico, and through joint ventures in China and the United Arab Emirates. For more information, visit WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugDrug Approval

16 Dec 2024

·www.prnewswire.com

SIFI provides updates on the UK and US regulatory pathways for AKANTIOR® in the treatment of acanthamoeba keratitis

Filing of ASMF and MAA sets the stage for a potential approval in Q2 2025 in the UK Type C meeting feedback confirms pre-clinical and clinical data are adequate for an NDA submission and potential approval of AKANTIOR® in the US CATANIA, Italy, Dec. 16, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced the accomplishment of a key milestone in the pursuit of regulatory approvals in the United Kingdom ("UK") and regulatory progress for filing in the United States of America ("USA") for AKANTIOR® in the treatment of Acanthamoeba Keratitis ("AK"). In the UK, SIFI submitted a Marketing Authorization Application ("MAA") for AKANTIOR® and an Active Substance Master File ("ASMF") for its proprietary GMP-grade polihexanide to the Medicines and Healthcare products Regulatory Agency ("MHRA"). This submission follows the European Commission's authorization for AKANTIOR as an orphan medicinal product and the confirmation of eligibility for the International Recognition Procedure from the MHRA. SIFI also applied for an Orphan Drug Designation ("ODD"), which will be evaluated during the regulatory procedure, and for a Promising Innovative Medicine Designation. In the USA, SIFI held a Type C meeting with the Food and Drug Administration ("FDA"), according to its regulatory strategy targeting a New Drug Application ("NDA") in the second half of 2025. The outcome of the meeting supports the company's position that its existing data package, both clinical and non-clinical, will be sufficient for the submission of a NDA and the potential approval of AKANTIOR® in the US, currently anticipated in 2026. The FDA granted the ODD for the US patent in 2025 and of the New Chemical Entity status for polihexanide upon approval. "Following the successful pivotal trial, approval and the commercial launch in the European Union, the regulatory submission in the UK and the pre-submission meeting in the USA mark further important milestones in our commitment to making AKANTIOR®, the first and only approved treatment for AK, available to patients globally." said Fabrizio Chines, Chairman and CEO of SIFI. "As the proportion of population wearing contact lenses in the USA is four times higher than in the European Union, we believe our innovative medicine can make an even higher impact on the medical and social needs of patients suffering from this devastating disease." ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%) is the first and only approved drug for the treatment of AK in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. ABOUT AK: AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba, although incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 60 Countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at SOURCE SIFI S.p.A. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugDrug ApprovalNDA

30 Sep 2024

·www.prnewswire.com

SIFI announces allowance of patent on polihexanide for Europe and commercial launch of AKANTIOR® in Germany

The company's intellectual property ("IP") covers the formulation and method of use of polihexanide in the treatment of acanthamoeba keratitis and fungal keratitis The patent, already granted in Italy and EurAsian Countries, ensures IP protection until 2040 AKANTIOR® will be commercially available in Germany from Oct. 1st CATANIA, Italy, Sept. 30, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced that is has received a Notice of Allowance from the European Patent Office ("EPO") for EP4216966. The newly granted patent, entitled "formulation based on polyhexamethylene biguanide for use in the treatment of acanthamoeba keratitis and/or fungal infections" ("Patent"), relates to the novel formulation of polihexanide in high concentration, its method of manufacturing and administration regimen in the treatment of acanthamoeba keratitis ("AK") and fungal keratitis ("FK"). The Patent was already granted in Italy in 2022 (IT102020000027155) and in Eurasian Countries earlier this year (EA047258). SIFI is seeking global IP protection through additional patent applications, including in USA, Canada, Mexico, South Korea, India, Australia, Japan and China. The Patent grant follows SIFI's findings in the Phase 3 clinical trial, where AKANTIOR® (polihexanide 0.08%) demonstrated an 86% clinical resolution rate in AK, with an average time-to-cure of approximately 4 months. The Patent also covers the novel dosing regimen of 16 drops/day for first 5 days, 8 drops/day for the following 7 days, 6 drops/day for the following 7 days and 4 drops/day until clinical resolution. The proven dosing regimen represents also a major improvement in patients' quality of life, as it allows during the initial and most intensive phase of the treatment daytime-only instillation of a single medicinal product compared to 24 hourly instillations of up to 3 off-label or unlicensed drugs used as best supportive care until now. Following the granting of a marketing authorisation for the treatment of AK by the European Commission in August, SIFI is launching AKANTIOR® in Germany, where the product will be commercially available from Oct. 1st. Additional European markets will follow based on local early access and reimbursement process timelines. "The granting of the European Patent further demonstrates the innovative profile of our asset for rare corneal infectious diseases, that are very severe and difficult to resolve." Fabrizio Chines, Chairman and CEO of SIFI. "The launch of Akantior® in Germany also marks a significant milestone in our corporate development, establishing a direct presence in Europe's largest pharmaceutical market." SIFI's polihexanide received two orphan drug designation ("ODD") from the US Food and Drug Administration for the treatment of AK and FK, and an additional ODD from the European Medicines Agency for the treatment of FK. ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%) is the first approved drug for the treatment of AK in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers. ABOUT AK: AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba, although incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI exports to more than 40 Countries worldwide with a direct presence in major European markets, Mexico and, through joint ventures, in China and the United Arab Emirates. More information available at WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultOrphan DrugPhase 3Drug Approval

100 Deals associated with Polihexanide

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KEGG	Wiki	ATC	Drug Bank
D08399	Polihexanide	D08AC05	DB12277

R&D Status

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Indication	Country/Location	Organization	Date
Acanthamoeba Keratitis	European Union	SIFI SpA	22 Aug 2024
Acanthamoeba Keratitis	Iceland	SIFI SpA	22 Aug 2024
Acanthamoeba Keratitis	Liechtenstein	SIFI SpA	22 Aug 2024
Acanthamoeba Keratitis	Norway	SIFI SpA	22 Aug 2024
Disinfectants	-	B. Braun Medical, Inc.	-
Wounds and Injuries	-	B. Braun Medical, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03274895 (Pubmed) Manual	Phase 3	Acanthamoeba Keratitis	127	PHMB 0.02%+ propamidine 0.1%	kcrrpfzkkn(ppopfgmsyv) = xbzoohyzmh hbckvjovok (vqowvnqhnq ) View more	Positive	01 Mar 2024
				PHMB 0.08%+ placebo	kcrrpfzkkn(ppopfgmsyv) = ujwlcqdttf hbckvjovok (vqowvnqhnq ) View more
NCT03274895 (The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial, CTgov)	Phase 3	Acanthamoeba Keratitis	135	placebo+PHMB 0.08% (PHMB 0.08% Plus Placebo)	plhwewfzku = gjbmczbggr rmcymmwudq (vuwthuxzbb, ytdggdwhpz - vcctlnkcpr) View more	-	02 Aug 2023
				PHMB 0.02%+Propamidine 0.1% (PHMB 0.02% Plus Propamidine 0.1%)	plhwewfzku = zvccbytfmx rmcymmwudq (vuwthuxzbb, olzgdrhrey - jsewsbsmga) View more
NCT03274895 (PRNewswire) Manual	Phase 3	Acanthamoeba Keratitis	135	Placebo+Polihexanide	uwbkyuidum(ldhibzlhzu) = jmsdlnkbdi ldurfkmmfb (navckgrgks ) View more	Non-inferior	13 Oct 2022
				polihexanide+Polihexanide	uwbkyuidum(ldhibzlhzu) = nygieaytog ldurfkmmfb (navckgrgks ) View more
NCT02506257 (CTgov)	Phase 1	Acanthamoeba Keratitis	90	0.04% PHMB (0.04% PHMB)	unkuineaek = sokgaetron ytalxbmtif (ldjwckqime, nlzvikpqjq - uhswkntyns) View more	-	23 Nov 2016
				0.06% PHMB (0.06% PHMB)	unkuineaek = tqlcujjomt ytalxbmtif (ldjwckqime, nmclvpfnip - pnbxynjrwb) View more
ODAK (ARVO2014)	Not Applicable	Acanthamoeba Keratitis	100	Polyhexamethylene biguanide (PHMB)	gvdkkjfpri(jdnksguumy) = cvkbrxavav rubxotxbqh (jxasrwkzgi )	-	01 Apr 2014
				Combination therapy (PHMB and propamidine)	gvdkkjfpri(jdnksguumy) = tyrsndjznj rubxotxbqh (jxasrwkzgi )
NCT01153620 (Lavasept 2, CTgov)	Phase 4	Wounds and Injuries	61	Lavasept 0.04% (Lavasept 0.04%)	gsmyeehxbm(pimcdmndch) = sllciimtlc zbbgnicnom (suovzzzywp, 1.00) View more	-	29 Nov 2011
				Ringer's Solution (Ringer's Solution)	gsmyeehxbm(pimcdmndch) = keyemplbvi zbbgnicnom (suovzzzywp, 0.85) View more
AAO2004	Not Applicable	-	43	Polyhexamethylene Biguanide (PHMB)	bdagekonsj(frnygtmugq) = irkjojjnfj rfaqbvfprs (abkvyhyupu ) View more	Negative	25 Oct 2004
				Chlorhexidine (CH)	bdagekonsj(frnygtmugq) = lcwnwyxuje rfaqbvfprs (abkvyhyupu ) View more
ARVO2004	Not Applicable	-	-	PHMB (Focus NIGHT & DAY TM)	kztjcndsfv(lkloqoleqc) = qvzlzazvhu pnwtzalapm (xuryjhggqx ) View more	-	01 May 2004
				PHMB (PureVision TM)	kztjcndsfv(lkloqoleqc) = wzafxmdbjf pnwtzalapm (xuryjhggqx )

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