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Sodium hypochlorite 5.25%
Sodium hypochlorite 5.25% is a Oxidizing disinfectant/antiseptic Small molecule drug developed by Dow University of Health Sciences. It is currently in Phase 3 development for Wound irrigation and disinfection, Oral rinse for oral hygiene and infection control, Surface disinfection. Also known as: NaOCl.
Sodium hypochlorite releases hypochlorous acid, which oxidizes and denatures bacterial and viral proteins, disrupting cell membranes and nucleic acids to exert broad-spectrum antimicrobial activity.
Sodium hypochlorite 5.25% is a small molecule used as an endodontic irrigant, studied for its effects on post-operative pain, symptomatic irreversible pulpitis, caries, and other dental conditions. It is also known by various synonyms, including household bleach and Dakin's solution.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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 | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Sodium hypochlorite 5.25% |
|---|---|
| Also known as | NaOCl |
| Sponsor | Dow University of Health Sciences |
| Drug class | Oxidizing disinfectant/antiseptic |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Disinfection |
| Phase | Phase 3 |
Mechanism of action
Sodium hypochlorite is a non-selective oxidizing agent that generates hypochlorous acid (HOCl) in aqueous solution. This highly reactive species penetrates microbial cell walls and membranes, oxidizing essential proteins, lipids, and nucleic acids, leading to rapid cell death. It is effective against a wide range of bacteria, viruses, fungi, and spores, making it a potent disinfectant and antiseptic.
Approved indications
- Wound irrigation and disinfection
- Oral rinse for oral hygiene and infection control
- Surface disinfection
Common side effects
- Tissue irritation or burning sensation
- Allergic contact dermatitis
- Bleaching of fabrics or discoloration
Key clinical trials
- Comparing Two Root Canal Cleaning Solutions (Chlorhexidine vs. Sodium Hypochlorite) for Pain After Treatment (NA)
- Complete Pulpotomy and Root Canal Treatment Patients With Irreversible Pulpitis With Type 2 Diabetes Mellitus (NA)
- Etch-bleach-seal Technique in Managing Opacities Related MIH Using Icon® (NA)
- Evaluation of the Survival of Fissure Sealants Applied With Different Pretreatment Methods on Permanent First Molars: A One-Year Follow-Up (NA)
- The Effect of Different Sodium Hypochlorite Concentrations and Activation Techniques on Postoperative Pain (NA)
- The Effect of Different Deproteinizing Agents on the Clinical Success of Fissure Sealants in Primary Teeth (NA)
- The Effect of Different Deproteinising Agents on the Clinical Success of Fissure Sealants in Permanent Teeth (NA)
- Minimally Invasive Root Canal Treatment With Active Disinfection on Single Rooted Teeth With Periapical Lesions (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:
- Sodium hypochlorite 5.25% CI brief — competitive landscape report
- Sodium hypochlorite 5.25% updates RSS · CI watch RSS
- Dow University of Health Sciences portfolio CI
Frequently asked questions about Sodium hypochlorite 5.25%
What is Sodium hypochlorite 5.25%?
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Is Sodium hypochlorite 5.25% also known as anything else?
What drug class is Sodium hypochlorite 5.25% in?
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Related
- Drug class: All Oxidizing disinfectant/antiseptic drugs
- Manufacturer: Dow University of Health Sciences — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Disinfection
- Indication: Drugs for Wound irrigation and disinfection
- Indication: Drugs for Oral rinse for oral hygiene and infection control
- Indication: Drugs for Surface disinfection
- Also known as: NaOCl
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing