Last reviewed · How we verify
Supplemental oxygen therapy
Supplemental oxygen therapy is a Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD) with hypoxemia, Acute respiratory distress syndrome (ARDS), Interstitial lung disease.
Supplemental oxygen therapy increases the concentration of oxygen delivered to the lungs and bloodstream to improve tissue oxygenation in patients with hypoxemia.
Supplemental oxygen therapy is used to treat conditions such as Covid-19, heart failure, sleep apnea syndromes, and hypoxemia, as indicated by ClinicalTrials.gov. Oxygen is a small molecule essential for cellular homeostasis, as verified by ChEMBL.
-
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 | Supplemental oxygen therapy |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Modality | Small molecule |
| Therapeutic area | Respiratory / Pulmonary Medicine |
| Phase | Phase 3 |
Mechanism of action
Supplemental oxygen works by delivering higher concentrations of oxygen than ambient air (21% O₂) directly to the patient's airways via various delivery devices (nasal cannula, mask, etc.). This increases the partial pressure of oxygen in the alveoli and enhances oxygen diffusion across the alveolar-capillary membrane, thereby raising arterial oxygen saturation and improving oxygen delivery to tissues. This is particularly beneficial in conditions where the lungs cannot extract sufficient oxygen from room air due to disease or dysfunction.
Approved indications
- Chronic obstructive pulmonary disease (COPD) with hypoxemia
- Acute respiratory distress syndrome (ARDS)
- Interstitial lung disease
- Cystic fibrosis
- Pulmonary hypertension
- Acute hypoxemic respiratory failure
Common side effects
- Oxygen-induced hypoventilation (in CO₂ retainers)
- Dry airways and mucous membrane irritation
- Atelectasis (absorption atelectasis with high FiO₂)
- Oxygen toxicity (with prolonged high-concentration exposure)
- Discomfort from delivery device
Key clinical trials
- Asymmetric High-Flow Nasal Cannula During Pulmonary Rehabilitation in COPD (NA)
- THRIVE in Sedated Gastrointestinal Endoscopy
- Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment (PHASE4)
- Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (PHASE2, PHASE3)
- Effect of CPAP on Abnormal Gastroesophageal Reflux and Lung Inflammation in IPF (NA)
- Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia (NA)
- Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure (NA)
- Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease (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:
- Supplemental oxygen therapy CI brief — competitive landscape report
- Supplemental oxygen therapy updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about Supplemental oxygen therapy
What is Supplemental oxygen therapy?
How does Supplemental oxygen therapy work?
What is Supplemental oxygen therapy used for?
Who makes Supplemental oxygen therapy?
What development phase is Supplemental oxygen therapy in?
What are the side effects of Supplemental oxygen therapy?
Related
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
- Therapeutic area: All drugs in Respiratory / Pulmonary Medicine
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) with hypoxemia
- Indication: Drugs for Acute respiratory distress syndrome (ARDS)
- Indication: Drugs for Interstitial lung disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing