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Nitric Oxide plus Oxygen
Nitric Oxide plus Oxygen is a Inhaled vasodilator Small molecule drug developed by Mallinckrodt. It is currently in Phase 3 development for Acute respiratory distress syndrome (ARDS), Pulmonary hypertension in critically ill patients, Hypoxemic respiratory failure. Also known as: Inhaled Nitric Oxide, Oxygen.
Nitric oxide gas combined with oxygen improves oxygenation and vasodilation in the lungs to reduce pulmonary hypertension and improve gas exchange.
Nitric oxide, in combination with oxygen, is being studied as a treatment for various conditions, including Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Oropharynx, and Pulmonary Arterial Hypertension. Nitric oxide is a soluble guanylate cyclase activator, a small molecule that works by activating this enzyme.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | Nitric Oxide plus Oxygen |
|---|---|
| Also known as | Inhaled Nitric Oxide, Oxygen |
| Sponsor | Mallinckrodt |
| Drug class | Inhaled vasodilator |
| Target | Soluble guanylate cyclase / cGMP pathway |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular / Pulmonary |
| Phase | Phase 3 |
Mechanism of action
Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator that relaxes vascular smooth muscle in the lungs, reducing pulmonary vascular resistance and improving ventilation-perfusion matching. When combined with supplemental oxygen, this combination enhances systemic oxygenation while minimizing systemic hypotension, as nitric oxide is rapidly inactivated by hemoglobin.
Approved indications
- Acute respiratory distress syndrome (ARDS)
- Pulmonary hypertension in critically ill patients
- Hypoxemic respiratory failure
Common side effects
- Methemoglobinemia
- Rebound pulmonary hypertension upon discontinuation
- Nitrogen dioxide formation (oxidative stress)
Key clinical trials
- Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 (PHASE2)
- Design, Development and Evaluation of a Digital Health Assistant for Paediatric Asthma
- Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction. (PHASE3)
- Effects of Beetroot Extract on Blood Pressure and Exercise in Hypertensive Older Women (NA)
- Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients (PHASE4)
- Methemoglobin Concentration in High Dose Inhaled Nitric Oxide (EARLY_PHASE1)
- Effects of Nitric Oxide on the Endothelium During Hemolysis. (PHASE2)
- Preoperative Coadministration of Low-concentration Carbohydrate and Nitrates Loading vs Low- Concentration Carbohydrate Loading Alone in Patients Undergoing Open Gynecological Surgeries (PHASE4)
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:
- Nitric Oxide plus Oxygen CI brief — competitive landscape report
- Nitric Oxide plus Oxygen updates RSS · CI watch RSS
- Mallinckrodt portfolio CI
Frequently asked questions about Nitric Oxide plus Oxygen
What is Nitric Oxide plus Oxygen?
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Is Nitric Oxide plus Oxygen also known as anything else?
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Related
- Drug class: All Inhaled vasodilator drugs
- Target: All drugs targeting Soluble guanylate cyclase / cGMP pathway
- Manufacturer: Mallinckrodt — full pipeline
- Therapeutic area: All drugs in Cardiovascular / Pulmonary
- Indication: Drugs for Acute respiratory distress syndrome (ARDS)
- Indication: Drugs for Pulmonary hypertension in critically ill patients
- Indication: Drugs for Hypoxemic respiratory failure
- Also known as: Inhaled Nitric Oxide, Oxygen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing