Drugs / Polihexanide

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Akantior 2024-08-22 europa.eu

Trials 8 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT07355075 Jul 2025 → Jul 2026 overdue atopic eczema Turn Therapeutics Recruiting No outcome recorded
Phase 2 NCT05306431 Jun 2022 pulpitis Altamash Institute of Dental Medicine Completed No outcome recorded
Phase 32 trials
Phase 3 NCT04055233 Feb 2015 → Sep 2018 Johannes Lauscher Completed No outcome recorded
Phase 3 NCT02394821 Sep 2013 → Jul 2014 neoplasm University of Sao Paulo Completed No outcome recorded
Phase 43 trials
Phase 4 NCT06633588 May 2025 → Jun 2026 staphylococcus aureus infection Swiss Paraplegic Research, Nottwil Completed No outcome recorded
Phase 4 NCT06338163 Jul 2024 → Jun 2025 Marco Catarci Unknown No outcome recorded
Phase 4 NCT01330706 Feb 2010 → Mar 2011 nail disorder, skin disorder Universidad Complutense de Madrid Completed No outcome recorded
Phase not applicable1 trial
NCT02375178 Aug → Oct 2014 periodontal disorder, smooth surface dental caries Universidade do Vale do Sapucai Completed No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 32 trials
Phase 3 NCT06213649 Background Jul 2024 → Jul 2029 expected Acanthamoeba keratitis Jeremy Keenan, MD, MPH Recruiting No outcome recorded
Phase 3 NCT03274895 Comparator Aug 2017 → Jun 2021 Acanthamoeba keratitis SIFI SpA Completed No outcome recorded
Phase 41 trial
Phase 4 NCT01153620 Comparator Aug 2010 → Jan 2011 B. Braun Ltd. Centre of Excellence Infection Control Completed No outcome recorded
Phase not applicable1 trial
NCT02621073 Comparator Nov 2015 → Dec 2017 infectious disease Brett Crist Terminated No outcome recorded

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as Polihexanide Polihexanide (Prontosan®) is a modern antiseptic that combines a broad antimicrobial spectrum with low toxicity, high tissue compatibility, no reported adsorption and good...” NCT02621073
5

“PURPOSE: To compare topical PHMB (polihexanide) 0.02% (0.2 mg/ml)+ propamidine 0.1% (1 mg/ml) with PHMB 0.08% (0.8 mg/ml)+ placebo (PHMB 0.08%) for Acanthamoeba keratitis (AK)...” PMID 37802392 Oct 2023

NCT01330706

NCT02394821

NCT06338163

NCT04055233

Known as Akantior ChEMBL registry synonym — accepted as the source's own label CHEMBL2106939
Known as Cosmocil cq ChEMBL registry synonym — accepted as the source's own label CHEMBL2106939
Known as Lavasept ClinicalTrials.gov intervention name — accepted as the source's own label NCT01153620
Known as Microcare mbg ChEMBL registry synonym — accepted as the source's own label CHEMBL2106939
Known as PHMB “This Phase 2 study is designed to evaluate the efficacy and safety of GX-03, a topical petrolatum-based ointment containing polyhexanide (PHMB), in adult subjects with moderate...” NCT07355075
2

“PURPOSE: To compare topical PHMB (polihexanide) 0.02% (0.2 mg/ml)+ propamidine 0.1% (1 mg/ml) with PHMB 0.08% (0.8 mg/ml)+ placebo (PHMB 0.08%) for Acanthamoeba keratitis (AK)...” PMID 37802392 Oct 2023

“Polyhexamethylene biguanide (PHMB)” NCT06213649

Known as Polihexanida ChEMBL registry synonym — accepted as the source's own label CHEMBL2106939
Known as Polihexanide hydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL2106939
Known as Polyhexamethylene biguanide ClinicalTrials.gov intervention name — accepted as the source's own label NCT05306431
2

NCT02375178

NCT06213649

Known as Polyhexanide “This Phase 2 study is designed to evaluate the efficacy and safety of GX-03, a topical petrolatum-based ointment containing polyhexanide (PHMB), in adult subjects with moderate...” NCT07355075
1

NCT06633588

Known as Prontosan “Polihexanide (Prontosan®) is a modern antiseptic that combines a broad antimicrobial spectrum with low toxicity, high tissue compatibility, no reported adsorption and good...” NCT02621073
Known as Purista ChEMBL registry synonym — accepted as the source's own label CHEMBL2106939
Known as Serasept “Polihexanide; SeraseptNCT04055233
Known as Vantocil ChEMBL registry synonym — accepted as the source's own label CHEMBL2106939
Modality Other / unclassified “Polihexanide (Prontosan®) is a modern antiseptic” NCT02621073
Route Topical “placed on the wound” NCT01153620