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Ozone auto-hemotherapy
Ozone auto-hemotherapy is a Biologic drug developed by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. It is currently in Phase 3 development for Chronic diseases and immune-related conditions (specific indications in phase 3 trial not publicly detailed).
Ozone auto-hemotherapy involves withdrawing a patient's blood, exposing it to ozone gas, and reinfusing it to stimulate immune and antioxidant responses.
Ozone auto-hemotherapy is a treatment that involves the use of ozone, a small molecule composed of triatomic oxygen, in a medical procedure. It has been studied as a potential treatment for COVID-19 pneumonia in a clinical trial, specifically in adults hospitalized with the condition.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Ozone auto-hemotherapy |
|---|---|
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
The procedure is proposed to work by inducing mild oxidative stress that triggers the body's antioxidant defense systems and enhances immune function. Ozone is thought to activate white blood cells and increase oxygen delivery to tissues, potentially improving circulation and immune response. The mechanism remains incompletely characterized and is not widely accepted in conventional medicine.
Approved indications
- Chronic diseases and immune-related conditions (specific indications in phase 3 trial not publicly detailed)
Common side effects
- Hemolysis
- Transient fever
- Chest discomfort
Key clinical trials
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:
- Ozone auto-hemotherapy CI brief — competitive landscape report
- Ozone auto-hemotherapy updates RSS · CI watch RSS
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta portfolio CI
Frequently asked questions about Ozone auto-hemotherapy
What is Ozone auto-hemotherapy?
How does Ozone auto-hemotherapy work?
What is Ozone auto-hemotherapy used for?
Who makes Ozone auto-hemotherapy?
What development phase is Ozone auto-hemotherapy in?
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Related
- Manufacturer: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Chronic diseases and immune-related conditions (specific indications in phase 3 trial not publicly detailed)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing