Chronic Obstructive Pulmonary Disease (COPD) is a lung disorder commonly caused by smoking, which makes breathing more difficult. When COPD patients exercise, they are not efficient breathers and this leads to serious breathing difficulties, which often causes these patients to stop exercise at low intensities. Even though patients with a mild form of COPD have relatively well preserved lung function, they still have inefficient breathing during exercise. The investigators think that these individuals have problems exchanging fresh gas (i.e., oxygen) into the blood stream because of poor lung blood vessel function. The investigators will test whether inhaled medications, specifically nitric oxide, can improve lung blood vessel function and decrease breathing difficulties during exercise. With this research, the investigators will understand more about breathing efficiency and lung blood vessel function in individuals with mild COPD, and find out whether improving lung blood vessel function helps COPD patients breathe easier and exercise longer. Understanding the reasons behind the feeling of difficult breathing may lead to more effective therapy and improved quality of life in COPD patients.

Start Date01 Oct 2025

Sponsor / Collaborator

University of Alberta

NCT06675435

/ Not yet recruitingNot ApplicableIIT

The Effect of Inhaled Nitric Oxide on Intrapulmonary Shunt in Acutely Hypoxemic Patients With Severe Obesity

The goal of this clinical trial is to learn about the effects of inhaled nitric oxide on oxygenation and lung perfusion in participants with severe obesity who have acute hypoxemic respiratory failure and are on mechanical ventilation
The main questions it aims to answer are:
1. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on oxygenation in participants with severe obesity compared to participants with normal body weight.
2. In acute hypoxemic respiratory failure, what are the effects of inhaled nitric oxide on lung perfusion and heart function in participants with severe obesity compared to participants with normal body weight.
3. In acute hypoxemic respiratory failure, does severe obesity impact nitric oxide signaling pathways?
Participants with acute hypoxemic respiratory failure will be exposed to inhaled nitric oxide (20 ppm) while being clinically monitored.

Start Date01 Oct 2025

Sponsor / Collaborator

The Massachusetts General Hospital

NCT04996667

/ WithdrawnPhase 2IIT

Study to Evaluate the Role of Inhaled Nitric Oxide (iNO) on Pulmonary Hemodynamics in Patients with Intermediate/submassive and Massive Pulmonary Embolism (PE)

A single center study to evaluate the effect of inhaled nitric oxide (iNO) on pulmonary dynamics in patients presenting with imaging confirmed intermediate/submassive or massive pulmonary embolism (PE). The target enrollment is 20 subjects at Ronald Reagan UCLA Medical Center. PE patients undergoing catheter-based intervention will be administered iNO during their intervention and pulmonary hemodynamic measurement will be measured before, during, and after iNO administration (Invasive Cohort). Patients who are not undergoing catheter-based intervention will also be administered iNO and will have pulmonary hemodynamics, blood pressure, and heart rate measured non-invasively (Non-Invasive Cohort).

Start Date01 Jun 2025

Sponsor / Collaborator

University of California, Los Angeles

[+1]

100 Clinical Results associated with Nitric oxide (inhaled)

100 Translational Medicine associated with Nitric oxide (inhaled)

100 Patents (Medical) associated with Nitric oxide (inhaled)

222,816

Literatures (Medical) associated with Nitric oxide (inhaled)

31 Dec 2025·Energy Sources, Part A: Recovery, Utilization, and Environmental Effects

Comparison of the physical properties of cotton and sesame stalk pellets produced at different moisture contents and combustion of the finest pellets

Author: Çanakci, Murad ; Yilmaz, Hasan ; Karayel, Davut ; Topakci, Mehmet

In this study, cotton and sesame stalks that are grown regionally and burned in coarse form as a source of heat energy form in the current application are used as pellet raw materials.Although these residues are used as biomass raw materials in different forms, there is limited information about their use as pellets.In order to compare the production efficiency and phys. properties of the pellets obtained, production capacity, specific energy consumption, bulk d., particle d., durability, compression resistance, specific compression resistance, and tensile strength tests have been applied.In the moisture content ranges pellet durability, bulk d., particle d. and tensile strength were achieved as 89-98%, 430-695 kg/m³, 921-1367 kg/m³, 2.83-7.28 Mpa for cotton stalk pellets, and 93-97%, 510-660 kg/m³, 4.26-5.85 Mpa for sesame stalk pellets, resp. 20% pelletizing moisture for both stalks increased pellet production capacity, reduced energy consumption, but affected neg. their phys. structures.It was concluded that the ideal pelleting moisture values for cotton stalks and sesame stalks were 10% and 15%, resp.During combustion experiments, O₂, CO₂, CO, and NO_x emissions, flue gas temperature, and combustion efficiency were observedAccording to the results of combustion experiments, CO and NO_x emissions were found to be 1646 ppm and 50 ppm for cotton stalks, 2862 ppm and 134 ppm for sesame stalks, resp.High O₂ emission values (18-19%) were observed for both pellets.

31 Dec 2025·Energy Sources, Part A: Recovery, Utilization, and Environmental Effects

A comparative study of six-cylinder direct injection compression ignition engine fueled with Argemone Mexicana bio-diesel with and without selective catalytic reduction

Author: Kajavali, A. ; Ezhilnilavan, R.

The present exptl. investigation is related to the performance and exhaust emission parameters of Multi-Cylinder Direct Injection (DI) Compression Ignition (CI) engine fueled with various proportions of Argemone Mexicana (Argemone Mexicana Linn.) with diesel such as 0BD+100D (Neat Diesel), 25BD+75D, 50BD+50D, 75BD+25D, and 100BD+0D (Neat Bio-diesel) at various speed ranges of 1200, 1600, 2000, and 2400 rpm.The present work focuses on reducing the oxides of nitrogen (NO_x) by using the Selective Catalytic Reduction (SCR) technique and compared the test results with the Conventional Engine (CE) method at various speed and different blends of fuel.In Conventional Engine, the percentage reduction in brake thermal efficiency for neat biodiesel (B-100) at lower speed and higher speed is 3.49% and 3.07%, resp., as compared to B-0 and B-25.For B-100, the percentage increase in brake-specific fuel consumption at lower speed and higher speed is 29.16% and 30.01%, resp., as compared to B-0 and B-25.The percentage reduction in heat release rate for neat bio-diesel is 27.44% at zero degree crank angle as compared to neat diesel fuel.At lower speed (1200 rpm) and higher speed (2400 rpm), the percentage reduction in smoke d. is 8.31% and 9.61% for B-25 as compared with B-100, resp.The percentage reduction in hydrocarbon at lower speed and higher speed is 21.42% and 23.53% for B-0 as compared with B-100, resp.The percentage reduction in CO for B-25 is 4.17% and 11.43% at lower speed and higher speed, resp., as compared with B-0.The same trend is observed from the SCR technique method.There is a significant reduction of oxides of nitrogen noted for B-100 with SCR technique at a lower and higher speed of 16.45% and 17.56%, resp., as compared to Conventional Engine.However, the engine performance such as Brake Thermal Efficiency (BTE), Brake Specific Fuel Consumption (BSFC), Heat Release Rate (HRR), and other emissions such as Hydrocarbon (HC), Carbon monoxide (CO), and Smoke D. (SD), B-25 (25BD+75D) gives better results while compared to neat diesel (0BD+100D) and higher blends for all the speeds in Conventional Engine and Selective Catalytic Reduction technique.

31 Dec 2025·Energy Sources, Part A: Recovery, Utilization, and Environmental Effects

Control Strategies on HCCI Engine Performance and Emission characteristics by Combined Effect of Exhaust Gas Recirculation with Blend of Biodiesel and N-Heptane

Author: N, Murugu Nachippan ; M, Parthasarathy ; B, Dhinesh ; S, Ramkumar ; P.V, Elumalai

The usage of Tamanu Me ester (TME) in a conventional CI engine produces more NO_x emission because of in-built oxygen content in biodiesel.Simultaneous reduction of NO_x and smoke is a really difficult way in a conventional CI engine.The usage of biodiesel in the HCCI engine would be a better way to reduce smoke and NO_x emission due to the homogenous mixture rather than heterogeneous combustion and lower in-cylinder temperatureIn this study, the exptl. anal. was carried out on a single-cylinder engine operated in HCCI mode.The test fuels used for this experiment are TME 90% + n-heptane 10% (TME90nH10), TME 80% + n-heptane 20% (TME80nH20), TME 70% + n-heptane 30% (TME70nH30), and TME 60% + n-heptane 40% (TME60nH40).The test results noticed that brake thermal efficiency (BTE) of TME70nH30 showed higher when compared to neat TME, diesel, and other blends.The CO, HC, and smoke emission were decreased by 3.1%, 6.5%, and 9.2%, resp., for a blend TME60nH40 when compared to TME70nH30.The smoke and UBHC emission of TME60nH40 was 23.5% and 26.4% lower than the HCCI mode of operation in diesel fuel.When n-heptane concentration increases beyond 40% in the blend, the performance characteristics of the engine started to decrease due to the high cetane rate of n-heptane which leads to shortening the span of the autoignition period that results in too advanced combustion.Based on emission characteristics of the engine, TME60nH40 was chosen to be the best blend and further study was carried out using TME60nH40 at different exhaust gas recirculation (EGR) percentages.The engine was operated with TME60nH40 with different EGR percentages of 5, 10, and 15.With the increase in the percentage of EGR increases the CO and UBHC emissions but on the other side, NO_x emission was drastically decreased.

News (Medical) associated with Nitric oxide (inhaled)

13 Feb 2025

·www.prnewswire.com

Linde Gas & Equipment Inc. Announces Filing of 510(k) to the U.S. FDA for Inhaled Nitric Oxide Delivery System

DANBURY, Conn., Feb. 13, 2025 /PRNewswire/ -- Linde Gas & Equipment Inc. announced today the submission of a 510(k) premarket notification application with the U.S. Food and Drug Administration (FDA) for NOXBOX® I PLUS, a nitric oxide delivery and monitoring system for NOXIVENT® (nitric oxide) gas, for inhalation. "This FDA submission builds on the success of our innovative NOxBOX®i delivery system," said Jason Aexel, Director of Clinical Healthcare, Linde Gas & Equipment Inc. "With the addition of the NOXBOX® I PLUS, we are committed to providing healthcare professionals with an enhanced system that offers an economical and reliable way to deliver inhaled nitric oxide therapy." Linde has made targeted enhancements to the delivery system's functionality including a streamlined setup process, ergonomic refinements, precise controls, and further compatibility with various ventilators allowing for an enhanced user experience "We look forward to NOXBOX I PLUS' 510(k) clearance, and we remain steadfast in our commitment to nitric oxide therapy and continuous improvement in our technology," said Jason Aexel, Director of Clinical Healthcare, Linde Gas & Equipment Inc. Linde's NOXIVENT (nitric oxide) gas, for inhalation is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. The NOxBOX®i delivery system has been in commercial use in 40+ countries since 2013 and in the U.S. since October 2018. Currently, in the U.S., the NOxBOX®i delivery system is being used in hundreds of locations. Contraindication: NOXIVENT is contraindicated in neonates dependent on right-to-left shunting of blood. Rebound: Abrupt discontinuation of NOXIVENT may lead to worsening oxygenation and increasing pulmonary artery pressure The NOxBOXi delivery system and NOXIVENT (nitric oxide) gas, for inhalation must only be used in accordance with the indications, contraindications, warnings, precautions, and other information and conditions of use described in the nitric oxide drug prescribing information and labeling (currently neonates). Refer to this material before use. Important safety information and full prescribing information can be found at . About Linde Gas & Equipment Inc. Linde Gas & Equipment Inc. is a leading provider of medical gases and associated therapies. Hospitals, clinics, nursing homes and other healthcare facilities trust Linde to provide medical gases like nitrogen to preserve vital blood and tissue, helium for MRIs, and oxygen and respiratory therapy gases to help patients breathe. Linde offers a full line of pure medical gases in high-pressure cylinders under our Medipure™ trademark, your assurance of quality and purity. In an industry that touches all our lives, we know our customers expect the highest quality medical gases and equipment and the most comprehensive service — and that's what we deliver. We are a single reliable source for medical and specialty gases, equipment and services. Our distribution network is one of the largest in the United States — and we are committed to innovation that helps you stay one step ahead. Please visit: SOURCE Linde Gas & Equipment, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

03 Dec 2024

·www.globenewswire.com

Beyond Cancer Announces Approval by the Israeli Ministry of Health to Conduct a Phase 1b Clinical Trial Utilizing Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) in Combination with Anti-PD-1 Therapy

The Phase 1b study will evaluate LV UNO in unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic solid tumor cancer patients that have progressed or have prolonged stable disease on single agent PD-1 inhibitorsThe primary objective of the Phase 1b study is to assess preliminary efficacy by objective response rate (ORR) and duration of response (DOR) per RECIST version 1.1 and secondarily immune-related response via iRECISTThe study will recruit patients from four sites across Israel HAMILTON, Bermuda, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., a clinical-stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that the Israeli Ministry of Health (IMOH) has approved the use of Low Volume UNO (LV UNO) in a Phase 1b clinical trial of LV UNO in combination with anti-PD-1 therapy. The trial will be conducted at four sites in Israel and patient screening will begin in the first quarter of 2025. The Phase 1b trial (NCT05351502) is a clinical proof-of-concept trial that will assess the intratumoral administration of LV UNO in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (≥ 12 weeks) after receiving a single agent anti-PD-1 containing treatment. The trial, which is expected to enroll up to 20 subjects, is designed to assess the preliminary efficacy of LV UNO by objective response rate (ORR) and duration of response (DOR) per RECIST v1.1 and secondarily immune-related response via iRECIST. Safety and tolerability of LV UNO in combination with anti-PD-1 therapy, as well as its potential to enhance the type, density, and distribution of immune cells within the tumor microenvironment will also be observed. Topline data from the Phase 1b portion of the study are anticipated in the second half of 2025. “We are excited to initiate the Phase 1b trial of LV UNO, a potentially groundbreaking solid tumor treatment approach, in combination with PD-1 inhibitors,” said Dr. Jedidiah Monson, Chief Medical Officer of Beyond Cancer. “In preclinical studies, a single dose of UNO has been shown to increase PD-L1 expression and improve overall survival in animal models compared to anti-PD-1 alone. Further, Phase 1a human data that demonstrated immune system activation were presented at ASCO’s Key Opinion Leader Event held in June 2024. We look forward to the Phase 1b trial results to establish the basis of further investigation of UNO in combination with PD-1 inhibitors.” “The initiation of the Phase 1b trial represents a major step forward in our vision for personalized cancer treatment. We see UNO as a complementary therapy for future cancer treatment paradigms, particularly for patients with anti-PD-1 refractory or resistant disease, potentially offering more patients access to effective treatment,” stated Dr. Selena Chaisson, Chief Executive Officer, and Director of Beyond Cancer. About Nitric Oxide Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens. About UNO Therapy for Solid Tumors Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond Cancer, Ltd. believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment and with limited toxicity or off-target effects. About Beyond Cancer, Ltd. Beyond Cancer, Ltd. is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human study is underway in patients with solid tumors. Beyond Cancer is also conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols. For more information, visit www.beyondcancer.com. Forward Looking Statements This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks forward,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials concerning the ultra-high concentration nitric oxide product candidate; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for the ultra-high concentration nitric oxide product candidate; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; obtaining, maintaining and protecting intellectual property utilized by products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air, Inc.’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air, Inc.’s website. Beyond Cancer and Beyond Air undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law. CONTACTS:Corey Davis, PhDLifeSci Advisors, LLCCdavis@lifesciadvisors.com(212) 915-2577 Matt Johnson, Head of Corporate Development & StrategyBeyond Cancer, Ltd.Mjohnson@beyondcancer.com

Phase 1Immunotherapy

10 Oct 2024

·www.prnewswire.com

Mallinckrodt Announces an Expanded Rollout of the INOmax® EVOLVE™ DS Delivery System in U.S. Hospitals

– The INOmax EVOLVE DS is our next-generation nitric oxide delivery system that combines mini-cylinder technology, automation, integration, and interaction into one device1 – – The INOmax EVOLVE DS is now available for contracting and distribution for use in U.S. hospitals – DUBLIN, Oct. 10, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the rollout of the U.S. Food and Drug Administration (FDA) cleared INOmax® EVOLVE™ DS delivery system for the delivery of INOmax® (nitric oxide) gas, for inhalation. This nationwide rollout follows the successful introduction of the INOmax EVOLVE DS Pilot program. The INOmax EVOLVE DS is our next-generation inhaled nitric oxide delivery system with a fully integrated design and includes a primary delivery system, a monitoring system, an electronic blender, automated backup delivery, mini-cylinders, and more.1 The INOmax EVOLVE DS is intended to help meet the needs of neonatal intensive care unit (NICU) patients and healthcare professionals by offering improved automation, which enhances safety features, and a streamlined design that elevates the user experience.1 Please see Applications and Device Warnings below. INOmax is an FDA-approved treatment that is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.2 INOmax is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.2 Please see additional Important Safety Information for INOmax below. "We are excited to enter the nationwide rollout phase of our next-generation INOmax delivery system for NICU patients and the hospital staff responsible for their care," said Lisa French, Executive Vice President & Chief Commercial Officer. "This innovation milestone reflects our long-standing commitment to providing delivery system options with comprehensive safety features.1 We will continue to work closely with our customers to support availability of the INOmax EVOLVE DS delivery system." A few of the many INOmax EVOLVE DS features include1: 1.4-lb mini-cylinders Automated pre-use checkout Pre-high-calibrated NO/NO2 gas sensor modules and automatic low calibration Automatic cylinder switching when empty Electronic blender with automatic activation when a minimum amount of oxygen flow has been detected Electronic medical record connectivity that transfers over 100 data parameters3 Touchscreen display with an easy-to-use interface The comprehensive INOmax EVOLVE DS Pilot program provided users the opportunity for an extensive review of our next-generation delivery system. We appreciate each hospital's feedback including one Respiratory Therapist's (RT) statement that, "After using the INOmax EVOLVE DS during the pilot introduction, and in current use, it is evident that Mallinckrodt took the input from bedside RTs into account. The smaller cylinders and streamlined design make it easier to move the device around the hospital and store supplies."1 INOmax has a well-established efficacy and safety profile with more than 20 years on the market and over 875,000 patients treated globally.2,4 In 2023, the INOmax EVOLVE DS was awarded the Human Factors and Ergonomics Society Stanley Caplan User-Centered Product Design Award, presented to teams that have demonstrated outstanding innovation and design for products, software, and systems. Mallinckrodt accepted the award on February 15, 2024. If a customer is interested in learning more about the INOmax EVOLVE DS, they can reach out to their local representative or visit INOmax.com for the latest updates. APPLICATIONS The INOmax EVOLVE DS delivery system delivers INOmax (nitric oxide) gas, for inhalation. The EVOLVE DS must only be used in accordance with the indications, usage, contraindications, and warnings and precautions described in the INOmax package insert and labeling and is indicated for use in term and near term (>34 weeks gestation) neonates with hypoxic respiratory failure (HRF) associated with clinical or echocardiographic evidence of pulmonary hypertension. The EVOLVE DS is indicated for a maximum of 14 days of use. DEVICE WARNINGS Abrupt discontinuation of INOmax can lead to worsening oxygenation and increasing pulmonary artery pressure (rebound pulmonary hypertension syndrome). To avoid abrupt discontinuation, use the eINOblender as a backup immediately to reinstate INOmax therapy and refer to the INOmax package insert. Do not discontinue INOmax delivery if the high NO2 alarm activates. Assess the delivery system for proper setup while maintaining INOmax delivery and verify INOmax and/or FiO2 are appropriate. Do not use equipment that is not specified as part of the system or that is not designed for INOmax mixtures. Using equipment that is not specified can cause the system to malfunction. If an alarm occurs, safeguard the patient first before performing troubleshooting procedures. Use only INOmax, pharmaceutical grade NO. Rx Only For technical assistance or for information on the INOmax EVOLVE DS delivery system, call (877) 566-9466. IMPORTANT SAFETY INFORMATION (Cont'd) Abrupt discontinuation of INOmax may lead to increasing pulmonary artery pressure and worsening oxygenation. Methemoglobinemia and NO2 levels are dose dependent. Nitric oxide donor compounds may have an additive effect with INOmax on the risk of developing methemoglobinemia. Nitrogen dioxide may cause airway inflammation and damage to lung tissues. In patients with pre-existing left ventricular dysfunction, INOmax may increase pulmonary capillary wedge pressure leading to pulmonary edema. Monitor for PaO2, inspired NO2, and methemoglobin during INOmax administration. INOmax must be administered using a calibrated FDA-cleared Nitric Oxide delivery system. Please see Full Prescribing Information . ABOUT MALLINCKRODT Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market, and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products. Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt, visit . CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS This release contains forward-looking statements, including with regard to INOmax (nitric oxide) gas, the INOmax EVOLVE™ DS delivery system, the potential of these products to improve health and treatment outcomes, their potential impact on patients and the availability of the INOmax EVOLVE™ DS delivery system in U.S. hospitals in the future. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: the effects of Mallinckrodt's recent emergence from bankruptcy; satisfaction of, and compliance with, regulatory and other requirements, including the clinical guidelines and protocols, and hospital policies and practices; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; changes in market demand; issues with product quality, manufacturing or supply, or patient safety issues or adverse side effects or adverse reactions associated with INOmax (nitric oxide) gas and the INOmax EVOLVE™ DS delivery system; and other risks identified and described in more detail in the "Risk Factors" section and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Mallinckrodt's most recent Annual Report on Form 10-K , Quarterly Reports on Form 10-Q, and other filings with the SEC, all of which are available on its website. The forward-looking statements made herein speak only as of the date hereof and Mallinckrodt does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise, except as required by law. CONTACT Media Inquiries Green Room Communications 908-577-4531 [email protected] Investor Relations Derek Belz Vice President, Investor Relations 314-654-3950 [email protected] Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. ©2024 Mallinckrodt. US-2400582 10/24 References 1 INOmax EVOLVETM DS Operation Manual. Mallinckrodt Pharmaceuticals. 2 INOmax. Package insert. INO Therapeutics LLC; 2023. 3 EVOLVE DS. Serial Data Protocol for versions 01.04.09 and later. Technical Bulletin. TB-23001. Mallinckrodt Pharmaceuticals. 2023. 4 Data on File – Ref-01753. Mallinckrodt Pharmaceuticals. SOURCE Mallinckrodt plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Nitric oxide (inhaled)

External Link

KEGG	Wiki	ATC	Drug Bank
-	Nitric oxide (inhaled)	R07AX01	DB00435

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
COVID-19	India	SaNOtize Research & Development Corp.Startup	09 Feb 2022
Pulmonary Arterial Hypertension	Japan	AIR WATER MEDICAL INC	16 Jul 2008
Hypoxic respiratory failure	Australia	Ikaria Australia Pty Ltd.	22 Nov 2007
Hypertension, Pulmonary	Iceland	Linde Healthcare AB	01 Aug 2001
Hypertension, Pulmonary	European Union	Linde Healthcare AB	01 Aug 2001
Hypertension, Pulmonary	Liechtenstein	Linde Healthcare AB	01 Aug 2001
Hypertension, Pulmonary	Norway	Linde Healthcare AB	01 Aug 2001
Neonatal respiratory failure	Iceland	Linde Healthcare AB	01 Aug 2001
Neonatal respiratory failure	Liechtenstein	Linde Healthcare AB	01 Aug 2001
Neonatal respiratory failure	Norway	Linde Healthcare AB	01 Aug 2001
Neonatal respiratory failure	European Union	Linde Healthcare AB	01 Aug 2001
Respiratory Insufficiency	United States	MALLINCKRODT HOSP PRODUCTS IP LTD	23 Dec 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic lung disease	Phase 3	Finland	Mallinckrodt Plc	29 May 2005
Reperfusion Injury	Phase 3	United States	Mallinckrodt Plc	01 Aug 2001
Respiratory Distress Syndrome, Adult	Phase 3	United States	Mallinckrodt Plc	01 Sep 2000
Hypoxic respiratory failure	Preclinical	United States	Mallinckrodt Plc	01 Jan 2002
Reperfusion Injury	Preclinical	United States	Mallinckrodt Plc	01 Aug 2001
Persistent Fetal Circulation Syndrome	Preclinical	United States	Mallinckrodt Plc	01 Aug 1998
Pneumonia, Aspiration	Preclinical	United States	Mallinckrodt Plc	01 Aug 1998
Respiratory Distress Syndrome, Newborn	Preclinical	United States	Mallinckrodt Plc	01 Aug 1998
Respiratory Failure	Preclinical	United States	Mallinckrodt Plc	01 Aug 1998
Respiratory Insufficiency	Preclinical	United States	Mallinckrodt Plc	01 Aug 1998

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00515281 (NOVA2, CTgov)	Phase 2/3	Bronchopulmonary Dysplasia \| Leukomalacia, Periventricular \| Cerebral Intraventricular Hemorrhage \| Obstetric Labor, Premature	273	inhaled nitric oxide (INO Control (Short iNO))	xoohdfmvtn(xjyddeyqfo) = yiqsshogfs gwsrokawxz (bzmtbvdvtc, wgstggpwja - egdwnxwbtq) View more	-	17 Oct 2024
				oxygen+inhaled nitric oxide (INO Treatment (Long iNO))	xoohdfmvtn(xjyddeyqfo) = nrxbvypnic gwsrokawxz (bzmtbvdvtc, onfrfsncio - yrxcrgwygy) View more
ATS2024	Not Applicable	COVID-19	-	High flow nasal oxygen (HFNO)	yofevhypyd(icldlnyklp) = tmkzesqrqi ovcoomugim (kszpnnrqfz, 1.47% - 2.1%)	-	19 May 2024
				High flow nasal oxygen (HFNO) + inhaled nitric oxide (iNO)	swozndebgu(ktwgpfqgeh) = jzqbpcyrlj ewmnitmbql (ctwgxgfimx ) View more
ATS2024	Not Applicable	airway disease	-	Inhaled Nitric Oxide (Bilateral lung injury)	vhynvnkjkd(qypveucbyx) = jsyzkysqan hihjqkctvl (csajifficp, 2 - 8) View more	-	19 May 2024
				Inhaled Nitric Oxide (Asymmetrical lung injury)	vhynvnkjkd(qypveucbyx) = szuvojymvw hihjqkctvl (csajifficp, 1 - 2) View more
NCT03873298 (Pubmed) Manual	Phase 2	Lung Diseases, Interstitial pulmonary hypertension	44	nitric oxideic oxide	(vybmzappzd) = xygazzzytd enijhodgyq (wcixzedmfb, 265 - 409)	Positive	10 May 2024
				Placebo	(vybmzappzd) = spbxcriznf enijhodgyq (wcixzedmfb, 250 - 407)
NCT03044314 (OVATION, CTgov)	Phase 4	Hypertension, Pulmonary	27	nitric oxide administration+Iloprost	bssacgikkq(vlfdrlxiux) = ehkfiebcly nqrgkxbykm (shgsvzfhxg, jzozbnrklt - zsuqwonjyl) View more	-	02 Apr 2024
NCT03081052 (Pubmed)	Phase 4	-	231	Inhaled Epoprostenol	wogdnubzml(ndpxemfylb) = rtxiaaqhgi jcytvcfzie (axzxttgehm )	-	04 Jul 2023
				Nitric Oxide	wogdnubzml(ndpxemfylb) = ckrexjfdbv jcytvcfzie (axzxttgehm )
EHA2023	Phase 2	refractory acute lymphoid leukemia in relapse Consolidation	110	mini-HCVD + InO	uqowiovovn(tilousoaen) = npwiozfhqa jyzjpaoham (uafdyxwqtc ) View more	-	08 Jun 2023
				mini-HCVD + InO + blina	uqowiovovn(tilousoaen) = ftlzyqgrrk jyzjpaoham (uafdyxwqtc ) View more
ATS2023	Not Applicable	Hypertension, Pulmonary	-	Inhaled Iloprost	adqbewxzbq(euoclfwhzx) = gcklincwcw rpwxcyipbr (xtsqwvrsyv, 12.2)	-	21 May 2023
				Inhaled Nitric Oxide	adqbewxzbq(euoclfwhzx) = rptepozzmy rpwxcyipbr (xtsqwvrsyv, 12.2)
ATS2023	Not Applicable	COVID-19	-	Inhaled Nitric Oxide	mcjygsefqg(vdvcywfnrr) = nytmkmicuy qfbzmdnrso (mhwmwioowg ) View more	-	21 May 2023
NCT00945529 (CTgov)	Phase 2/3	Heart Defects, Congenital	21	iNO (No Intervention/ Historical Control Group)	sfklifptxa(hxqbpluygn) = glnjdyxnrm uwjpcbmmkc (bynjccagle, frfyfefnhc - qssdsubprf) View more	-	19 May 2023
				inhaled nitric oxide (iNO) (Intervention)	sfklifptxa(hxqbpluygn) = gllgfcvkyk uwjpcbmmkc (bynjccagle, juyprqjhgp - gvaoviwyjb) View more

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