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normobaric oxygen with face mask
normobaric oxygen with face mask is a Oxygen therapy / Medical gas Small molecule drug developed by Shahid Beheshti University of Medical Sciences. It is currently in Phase 3 development for Hypoxemia and tissue hypoxia (specific indication under investigation in Phase 3 trial not fully specified).
Normobaric oxygen therapy increases arterial oxygen partial pressure to enhance tissue oxygenation and reduce hypoxia-related pathology.
Normobaric oxygen therapy increases arterial oxygen partial pressure to enhance tissue oxygenation and reduce hypoxia-related pathology. Used for Hypoxemia and tissue hypoxia (specific indication under investigation in Phase 3 trial not fully specified).
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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 | normobaric oxygen with face mask |
|---|---|
| Sponsor | Shahid Beheshti University of Medical Sciences |
| Drug class | Oxygen therapy / Medical gas |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Critical Care / Multiple therapeutic areas |
| Phase | Phase 3 |
Mechanism of action
Normobaric oxygen (oxygen delivered at normal atmospheric pressure via face mask) increases the dissolved oxygen content in blood plasma and enhances hemoglobin saturation, improving oxygen delivery to tissues. This mechanism is used to treat hypoxemic conditions and may reduce ischemic injury, inflammation, and support tissue healing in various acute and chronic conditions.
Approved indications
- Hypoxemia and tissue hypoxia (specific indication under investigation in Phase 3 trial not fully specified)
Common side effects
- Oxygen toxicity (with prolonged high-concentration exposure)
- Discomfort or drying of nasal/oral mucosa
- Hyperoxia-related complications
Key clinical trials
- Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate (NA)
- Intermittent Hypoxic-hyperoxic Training in Patients With Cardiovascular Pathology After COVID-19 Infection. (NA)
- Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset：Longterm Outcome (NA)
- Oxygen Concentration Target in Stroke Endovascular Treatment (NA)
- Normobaric Hyperoxia Combined With Endovascular Treatment for Acute Ischemic Stroke (NA)
- Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke：Longterm Outcome (OPENS-3L) (PHASE3)
- Normobaric Hyperoxia Combined With Intravenous Thrombolysis for Acute Ischemic Stroke (OPENS-3) (PHASE3)
- Treatment Duration on Normobaric Hyperoxia in Acute Ischemic Stroke (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:
- normobaric oxygen with face mask CI brief — competitive landscape report
- normobaric oxygen with face mask updates RSS · CI watch RSS
- Shahid Beheshti University of Medical Sciences portfolio CI
Frequently asked questions about normobaric oxygen with face mask
What is normobaric oxygen with face mask?
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Related
- Drug class: All Oxygen therapy / Medical gas drugs
- Manufacturer: Shahid Beheshti University of Medical Sciences — full pipeline
- Therapeutic area: All drugs in Respiratory / Critical Care / Multiple therapeutic areas
- Indication: Drugs for Hypoxemia and tissue hypoxia (specific indication under investigation in Phase 3 trial not fully specified)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing