Nitric Oxide clinical trials
Nitric Oxide is named as an intervention in 3 current clinical trials in our China and South Korea registers. 1 is recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Lee's Pharmaceutical Limited (1). The most-studied condition is Pulmonary Hypertension.
Where Nitric Oxide is approved
All regulators →Of the three regulators tracked here, the first to approve Nitric Oxide was the US, on 23 Dec 1999. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of cystic fibrosis (24 Apr 2015, withdrawn)
- 1 EU safety letter (DHPC), latest: quality defect for INOmax, 3 Jun 2021
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Nitric Oxide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Nitric Oxide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 27 listed patents; the last listed expires 22 Jul 2040 (US 11672938).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
How Nitric Oxide works
All drug targets →- Soluble guanylate cyclase activator ActivatorTarget: Soluble guanylate cyclaseChEMBL only
- COVID-19Phase 3
- Cognitive impairmentPhase 3
- HypoxemiaPhase 3
- SepsisPhase 3
- Acute bronchiolitisPhase 3
- Acute kidney injuryPhase 3
- Acute respiratory distress syndromePhase 3
- Brain injuryPhase 3
- Congestive heart failurePhase 3
- Cutaneous leishmaniasisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1200689, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Nitric Oxide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 5 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: INOmaxEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Nitric Oxide
- ATC code
- R07AX01
- ChEMBL
- CHEMBL1200689
- DrugBank
- DB00435
- PubChem CID
- 145068
- CAS number
- 10102-43-9
- FDA UNII
- 31C4KY9ESH
- Wikidata
- Q207843
- Wikipedia
- Nitric oxide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Nitric Oxide
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
Inhaled Nitric Oxide for the Treatment of Neonatal Hypoxic Respiratory Failure With Pulmonary Hypertension
NCT07099144 · ClinicalTrials.gov ↗ · Pulmonary Hypertension, Hypoxic Respiratory Failure
|
Observational | Recruiting | Lee's Pharmaceutical Limited | China |
|
Efficacy of Inhaled Nitric Oxide in Congenital Diaphragmatic Hernia
NCT07247240 · ClinicalTrials.gov ↗ · Congenital Diaphragmatic Hernia, Pulmonary Hypertension
|
Phase 4 | Not yet open | Asan Medical Center | South Korea |
|
Inhaled Nitric Oxide for Prevention of Postoperative AKI in High-Risk Cardiac Surgery Patients
NCT07544147 · ClinicalTrials.gov ↗ · Cardiac Surgery Associated - Acute Kidney Injury, Cardiac Surgery With Cardiopulmonary Bypass
|
Not applicable | Not yet open | Shanghai Zhongshan Hospital | China |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Nitric Oxide across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
5 single-substance products containing Nitric Oxide on the HPRA medicines list.
- Neophyr 1000 ppm mol/mol, medicinal gas, compressedSOL S.p.A. · PA1848/001/001 · Marketed
- Neophyr 225 ppm mol/mol, medicinal gas, compressedSOL S.p.A. · PA1848/001/003 · Marketed
- Neophyr 450 ppm mol/mol, medicinal gas, compressedSOL S.p.A. · PA1848/001/002 · Marketed
- INOmaxAGA AB · EU/1/01/194/001
- INOmax 400 ppm mol/mol medicinal gas, compressedINO Therapeutics AB · EU/1/01/194/003-004
Supply shortages
No entry for Nitric Oxide in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Nitric Oxide
5 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Lee's Pharmaceutical Limited | 1 |
| Shanghai Zhongshan Hospital | 1 |
| Asan Medical Center | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 2 | 1 |
| Clinical trials in South Korea | 1 | 0 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Nitric Oxide trials
How many clinical trials are testing Nitric Oxide?
3 current trials in our China and South Korea registers name Nitric Oxide as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Nitric Oxide trials recruiting patients?
Yes. 1 of the 3 trials is recruiting: 1 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Nitric Oxide clinical trials?
Lee's Pharmaceutical Limited (1), Shanghai Zhongshan Hospital (1) and Asan Medical Center (1). The number in brackets is how many trials each organisation leads.
Is Nitric Oxide licensed in Ireland?
Yes. The HPRA medicines list includes 5 single-substance products containing Nitric Oxide, for example Neophyr 1000 ppm mol/mol, medicinal gas, compressed (SOL S.p.A.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Nitric Oxide shortage?
Not in the lists we track: Nitric Oxide has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Nitric Oxide works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Nitric Oxide works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Nitric Oxide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.