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 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 21 trial
Phase 2 NCT05306431 Jun 2022 pulpitis Altamash Institute of Dental Medicine Completed No outcome recorded
Phase 32 trials · 1 met primary
Phase 3 NCT04055233 Feb 2015 → Sep 2018 — Johannes Lauscher Completed Met primary
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
Comparator or background therapy4 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 4 NCT01153620 Comparator Aug 2010 → Jan 2011 — B. Braun Ltd. Centre of Excellence Infection Control Completed No outcome recorded
— NCT02621073 Comparator Nov 2015 → Dec 2017 infectious disease Brett Crist Terminated No outcome recorded Stop: Enrollment

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 12 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

NCT02394821 ↗

NCT01330706 ↗

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 “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
1

“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 NCT02375178 ↗
2

NCT05306431 ↗

NCT06213649 ↗

Known as Polyhexanide ClinicalTrials.gov intervention name — accepted as the source's own label 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; Serasept” NCT04055233 ↗
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 ↗