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Low pressure hyperbaric oxygen therapy
Low pressure hyperbaric oxygen therapy is a Small molecule drug developed by Paul G. Harch, M.D.. It is currently in Phase 1 development. Also known as: HBOT.
Low pressure hyperbaric oxygen therapy has been studied for various conditions, including Post-Concussion Syndrome, Traumatic Brain Injury, and Adult and Pediatric Chronic Cerebral Disorders, through ClinicalTrials.gov. The therapy involves the use of hyperbaric oxygen, as seen in studies such as NCT02089594, which investigated its effectiveness in treating mild Traumatic Brain Injury and Persistent Post-Concussion Syndrome.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Low pressure hyperbaric oxygen therapy |
|---|---|
| Also known as | HBOT |
| Sponsor | Paul G. Harch, M.D. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Validation of the Use of the Arteriovenous Tension Difference in CO2 Under Hyperbaric Conditions
- Transcranial Magnetic Stimulation and Hyperbaric Chamber for Women Fibromyalgia (NA)
- Enriched Oxygen Mixtures in Athletes (PHASE2)
- Hyperbaric Oxygen Therapy and Acute Kidney Injury (NA)
- Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) (PHASE1)
- Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Traumatic Brain Injury (PHASE1)
- Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS) (PHASE3)
- Oxygen Toxicity of HBOT in Chronic Brain Injury (PHASE1)
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:
- Low pressure hyperbaric oxygen therapy CI brief — competitive landscape report
- Low pressure hyperbaric oxygen therapy updates RSS · CI watch RSS
- Paul G. Harch, M.D. portfolio CI
Frequently asked questions about Low pressure hyperbaric oxygen therapy
What is Low pressure hyperbaric oxygen therapy?
Who makes Low pressure hyperbaric oxygen therapy?
Is Low pressure hyperbaric oxygen therapy also known as anything else?
What development phase is Low pressure hyperbaric oxygen therapy in?
Related
- Manufacturer: Paul G. Harch, M.D. — full pipeline
- Also known as: HBOT
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing