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Hexoral (HEXETIDINE)
Hexoral (generic name: HEXETIDINE) is a hexetidine drug. It is currently in Phase 2 development.
Hexoral works by disrupting the cell membrane of microorganisms, ultimately leading to their death.
Hexoral is a small molecule used as a mouthwash to treat conditions such as gingivitis and periodontitis, and has also been studied for its effectiveness in preventing bacteremia following dental procedures. It has been compared to chlorhexidine in clinical trials, and has also been used in combination with antibiotics such as amoxicillin.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | HEXETIDINE |
|---|---|
| Drug class | hexetidine |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's cells are like houses, and the bad guys (bacteria) are trying to break in. Hexoral is like a special lock that makes it hard for the bad guys to get in and multiply, helping to keep you healthy.
Approved indications
Common side effects
Key clinical trials
- A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures (NA)
- Methodology Antiseptic Application, Influence on Oral Biofilm. (PHASE4)
- Bacteraemia Secondary to Tooth Extraction: Chlorhexidine Prophylaxis Protocols (PHASE4)
- Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth. (PHASE4)
- Hexetidine and Chlorobutanol for Lesions Due to Prostheses (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Hexoral CI brief — competitive landscape report
- Hexoral updates RSS · CI watch RSS
Frequently asked questions about Hexoral
What is Hexoral?
How does Hexoral work?
What is the generic name of Hexoral?
What drug class is Hexoral in?
What development phase is Hexoral in?
Related
- Drug class: All hexetidine drugs
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing