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Drug

Polihexanide

Approved · EMA
Late-stage development

Also known as Polyhexanide, POLYHEXAMETHYLENE BIGUANIDE, Poly(hexamethylene biguanide).

RxNorm1373041UNII322U039GMF
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Parasitic Ulcer Treatment Trial

Clinical trial2026-05-01Results expected Q3 2029 · ClinicalTrials.gov

Approval: Akantior (EMA)

Regulatory2024-08-22EMA

Antimicrobial Activity of Two Mouthwashes

Clinical trial2015-12-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Polihexanide
Aliases & brands
PolyhexanidePOLYHEXAMETHYLENE BIGUANIDEPoly(hexamethylene biguanide)
RxNorm CUI
1373041
UNII
322U039GMF
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-08-22
Latest approval
2024-08-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-08-22Approval
Approval: Akantior (EMA)

Indication: Akantior is indicated for the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

5 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
5
registered trials across all phases
LATEST COMPLETION 2026
1
Active studies
1
Recruiting
4
Late-stage (III+)
4
Completed
PHASE DISTRIBUTIONn = 5
Phase 21Phase 31Phase 42Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.