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OCTENIDINE
OCTENIDINE is a octenidine drug. It is currently in Phase 2 development.
OCTENIDINE works by disrupting the function of microorganisms on the skin.
OCTENIDINE is a small molecule drug in the octenidine class, developed by an unknown entity and currently owned by an unknown entity. Its target and exact mechanism of action are not specified. OCTENIDINE is used to treat unknown indications, and its commercial status, including patent status and generic availability, is unclear. Key safety considerations for OCTENIDINE are not well-documented. Further research is needed to fully understand this medication.
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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 | OCTENIDINE |
|---|---|
| Drug class | octenidine |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
Imagine your skin as a battlefield where germs and bacteria try to invade. OCTENIDINE is like a special soldier that helps keep the bad guys from taking over by interfering with their ability to attach to and multiply on the skin. This helps to prevent infections and keep your skin healthy.
Approved indications
Common side effects
Key clinical trials
- Multi-centre, Open-label, First-in-man Study With Mucopad HA (NA)
- Hyaluronic Acid and Octenidine Gel as an Adjunct to Non-surgical Periodontal Treatment (NA)
- Pocket-X Gel Non-surgical Periodontal Therapy (NA)
- Evaluating Safety and Effectiveness of Octenidine Dihydrochloride (PHASE2)
- The Effect of Using Octenidine Hydrochloride as a Final Irrigation Solution on Teeth With Asymptomatic Apical Periodontitis on Postoperative Pain and Treatment Success: A Prospective Randomized Clinical Study (NA)
- Octenidine and Sodium Hypochlorite for Pulp Irrigation in Direct Pulp Capping (NA)
- Oxycodone (10, 20 mg) in a Postoperative Dressing (PHASE4)
- The Effect of Supraglottic and Oropharyngeal Decontamination on the Incidence of Ventilator-associated Pneumonia (NA)
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:
- OCTENIDINE CI brief — competitive landscape report
- OCTENIDINE updates RSS · CI watch RSS
Frequently asked questions about OCTENIDINE
What is OCTENIDINE?
How does OCTENIDINE work?
What drug class is OCTENIDINE in?
What development phase is OCTENIDINE in?
Related
- Drug class: All octenidine drugs
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing