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Ozonated olive oil gel
Ozonated olive oil gel is a Topical wound healing agent Biologic drug developed by Suez Canal University. It is currently in Phase 3 development for Wound healing and tissue repair (Phase 3 indication presumed based on development stage). Also known as: Group II, Study Group, Ozonated olive oil gel = Oxactiv gel.
Ozonated olive oil gel delivers ozone and its reactive oxygen species to tissue surfaces to promote wound healing and antimicrobial activity.
Ozonated olive oil gel has been studied as a potential treatment for various dental conditions, including periodontal diseases and pulp disease, in clinical trials. The exact mechanism of action of ozonated olive oil gel is currently unknown, according to ChEMBL.
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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).
| 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 | Ozonated olive oil gel |
|---|---|
| Also known as | Group II, Study Group, Ozonated olive oil gel = Oxactiv gel |
| Sponsor | Suez Canal University |
| Drug class | Topical wound healing agent |
| Modality | Biologic |
| Therapeutic area | Dermatology / Wound Care |
| Phase | Phase 3 |
Mechanism of action
Ozone gas dissolved in olive oil creates a topical formulation that generates reactive oxygen species upon contact with wound tissue. These reactive species are thought to stimulate local immune responses, increase blood flow, and exert antimicrobial effects against bacteria and fungi. The oil base provides a protective barrier while allowing gradual ozone release.
Approved indications
- Wound healing and tissue repair (Phase 3 indication presumed based on development stage)
Common side effects
- Local irritation or erythema
- Allergic contact dermatitis
Key clinical trials
- Clinical Efficacy of NST With Adjunctive Local Delivery of Ozonated Olive Versus Curcumin Gel in Stage II Grade B Periodontitis. (NA)
- Validity of Ozonated Olive Oil Gel Versus Injectable Bone Graft (PHASE2)
- Ozonized Olive Oil in the Treatment of Periodontal Pockets (NA)
- Clinical & Radiographic Evaluation of Zinc Oxide-Ozonated Oil as a New Primary Root Canal Filling (NA)
- Evaluation of the Use of Ozone Gel Versus Hyaluronic Acid Gel on Palatal Wound Healing . (NA)
- Effect of Ozone Gel on Treatment of Chronic Periodontitis (PHASE2)
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:
- Ozonated olive oil gel CI brief — competitive landscape report
- Ozonated olive oil gel updates RSS · CI watch RSS
- Suez Canal University portfolio CI
Frequently asked questions about Ozonated olive oil gel
What is Ozonated olive oil gel?
How does Ozonated olive oil gel work?
What is Ozonated olive oil gel used for?
Who makes Ozonated olive oil gel?
Is Ozonated olive oil gel also known as anything else?
What drug class is Ozonated olive oil gel in?
What development phase is Ozonated olive oil gel in?
What are the side effects of Ozonated olive oil gel?
Related
- Drug class: All Topical wound healing agent drugs
- Manufacturer: Suez Canal University — full pipeline
- Therapeutic area: All drugs in Dermatology / Wound Care
- Indication: Drugs for Wound healing and tissue repair (Phase 3 indication presumed based on development stage)
- Also known as: Group II, Study Group, Ozonated olive oil gel = Oxactiv gel
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing