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INOmax

(Nitric Oxide)

ApprovedSmall molecule

Nitric oxide is a gas that is inhaled to help improve oxygen levels in newborns and infants with severe lung problems, particularly those with a condition where the blood vessels in the lungs are too constricted.[2] INOmax is currently approved and in use across 44 indications[4].[1]

INOmax is one of 716 small molecule programs targeting Blood Pressure Trait. It is currently in Approved.

44

Indications

68

Total Trials

4

Active Trials

715

Competitors

14

FDA Applications

NDA/BLA/ANDA regulatory filings

46

Patents

Pipeline

Status by Indication[4][1]

Indication

Blood Pressure TraitActive, not recruiting

Respiratory System DiseaseActive, not recruiting

Respiratory Distress Syndrome in Premature InfantsActive, not recruiting

Lung DiseaseApproved

Sickle Cell DiseaseApproved

Anemia (phenotype)Approved

Colorectal CancerApproved

Coronavirus Infectious DiseaseApproved

Myocardial IschemiaApproved

PneumoniaApproved

Blood Pressure TraitPreclinical

Active, not recruiting

Respiratory System DiseaseApproved

Active, not recruiting

Respiratory Distress Syndrome in Premature InfantsPreclinical

Active, not recruiting

Lung DiseaseApproved

Approved

Sickle Cell DiseaseApproved

Approved

Anemia (phenotype)Approved

Approved

Colorectal CancerApproved

Approved

Coronavirus Infectious DiseaseApproved

Approved

Myocardial IschemiaApproved

Approved

PneumoniaApproved

Approved

Showing 10 of 44 indications

Competition

Competitive Landscape

268 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

INOmax

Camptosar

Tyvyt

Innovent Biologics (Suzhou) Co. Ltd.

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Mitosol

UUroGen Pharma Ltd.

XL092

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Thymosin Alpha1

SSun Yat-sen University

IBI363

Innovent Biologics (Suzhou) Co. Ltd.

Tucidinostat

CChipscreen Biosciences, Ltd.

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 3Recruiting

AKI

NCT04216927

Clinical

Trials by Indication[1]

Nitric Oxide13 trials

The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation

Completed·MMallinckrodt·Phase 2·NCT00060840·150 enrolled

Nitric Oxide During Bypass for Arterial Switch Operation

Completed·MMurdoch Childrens Research Institute·Phase 3·NCT03661385·300 enrolled

RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot Study

Completed·UUniversity Hospital Southampton NHS Foundation Trust·Phase 2·NCT02295566·12 enrolled

Show 10 more trials

Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises

Completed·MMallinckrodt·Phase 2·NCT00094887·150 enrolled

Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID19 Infection

Withdrawn·XXijing Hospital·Phase 2·NCT04290858

The Effect of Inhaled Nitric Oxide on Deadspace in COPD

Completed·—·Phase 1·NCT04069052·13 enrolled

Mechanism of Nitric Oxide on Ventilator-induced Diaphragm Dysfunction with Extracorporeal Membrane Lung Assistance

Active, not recruiting·ZZhongnan Hospital··NCT06660784·80 enrolled

Inhaled Nitric Oxide for Pediatric Painful Sickle Crisis

Terminated·—·Phase 2·NCT00142051·18 enrolled

Inhaled Nitric Oxide for Patients With MABSC

Completed·BBeyond Air Inc.·Phase 2·NCT03208764·9 enrolled

Nitric Oxide, GeNO Nitrosyl Delivery System

Completed·WWake Forest University Health Sciences·Phase 2·NCT01165047·10 enrolled

Diffuse Optical Monitoring With Inhaled Nitric Oxide

Active, not recruiting·SSteven Messe·Phase 2·NCT03023449·40 enrolled

Vitamin C Versus Nitric Oxide in Prolonged Ventilation

Completed·KKing Abdul Aziz Specialist Hospital··NCT04411160·60 enrolled

Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot

Completed·NNitric Solutions Inc.·Phase 2·NCT02871011·20 enrolled

COVID-196 trials

High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients)

Completed·UUniversity Health Network, Toronto·Phase 1·NCT04383002·21 enrolled

Prone Positioning vs. Prone Positioning and NO Inhalation in COVID-19 ARDS.

Unknown status·SShanghai Zhongshan Hospital··NCT05715788·30 enrolled

Inhaled Nitric Oxide for Preventing Progression in COVID-19

Terminated·TTufts Medical Center·Phase 2·NCT04388683·10 enrolled

Show 3 more trials

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection

Terminated·SSanotize Research and Development corp.·Phase 3·NCT05109611·1,389 enrolled

Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19

Completed·SSanotize Research and Development corp.·Phase 3·NCT05599919·306 enrolled

Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19

Terminated·MMassachusetts General Hospital·Phase 2·NCT04305457·62 enrolled

Cardiopulmonary Bypass5 trials

Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass

Completed·TTomsk National Research Medical Center of the Russian Academy of Sciences·Phase 1/2·NCT03500783·60 enrolled

Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass

Completed·WWashington University School of Medicine·Phase 1/2·NCT00585013·17 enrolled

Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation

Completed·MMedical College of Wisconsin·Phase 2/3·NCT03455218·40 enrolled

Show 2 more trials

Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery

Completed·NNikolay Kamenshchikov·Phase 1/2·NCT03527381·96 enrolled

Nitric Oxide During Cardiopulmonary Bypass in Adult Surgery

Unknown status·RRabin Medical Center·Phase 3·NCT04807413·300 enrolled

Pulmonary Hypertension4 trials

Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT02217683

Inhaled Nitric Oxide for ARDS-related Pulmonary Hypertension

Unknown status·YYuri Matusov·Phase 1·NCT06249633·20 enrolled

Nitric Oxide and Transfusion Therapy for Sickle Cell Patients With Pulmonary Hypertension

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT00023296·59 enrolled

Show 1 more trial

Role of the Nitric Oxide (NO) in Pre-oxygenation Before Anesthetic Induction in Patients With a Pulmonary Hypertension in Cardiac Surgery. Pilot Study of Feasibility

Unknown status·UUniversity Hospital, Clermont-Ferrand·Phase 2·NCT02345616·30 enrolled

Bronchiolitis3 trials

Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis

Completed·BBeyond Air Inc.·Phase 2·NCT04060979·95 enrolled

Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Bronchiolitis

Completed·BBeyond Air Inc.·Phase 3·NCT03053388·69 enrolled

Evaluation of the Safety and Tolerability of Nitric Oxide (NO) Via Inhalation to Subjects With Bronchiolitis

Completed·BBeyond Air Inc.·Phase 1/2·NCT01768884·43 enrolled

34 more indications

Acute Respiratory Distress Syndrome2 trials

Studies of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome

Terminated·NNorthern State Medical University·Phase 1·NCT00159510·28 enrolled

Nitric Oxide Administration for Acute Respiratory Distress Syndrome

Completed·—·Phase 3·NCT00240487·52 enrolled

Myocardial Infarction2 trials

Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT01398384·250 enrolled

Nitric Oxide in Myocardial Infarction Size

Terminated·MMallinckrodt·Phase 2·NCT00568061·29 enrolled

Pulmonary Embolism2 trials

Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism

Completed·WWake Forest University Health Sciences·Phase 1·NCT00848731·25 enrolled

Inhaled Nitric Oxide (iNO) in Post-Pulmonary Embolism (Post-PE)

Completed·—·N/A·NCT04920695·16 enrolled

Anemia1 trial

Effects of Nitric Oxide and Nitroglycerin in Patients With Sickle Cell Anemia

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 2·NCT00001716·58 enrolled

MRSA1 trial

Reduction of Bacteria in MRSA Positive Ulcers

Terminated·NNitric BioTherapeutics, Inc·Phase 1/2·NCT00771368·20 enrolled

Interstitial Lung Disease1 trial

The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease.

Withdrawn·UUniversity of Alberta·Phase 1/2·NCT04181359

Idiopathic Pulmonary Fibrosis1 trial

Inhaled Nitric Oxide (iNO) in Idiopathic Pulmonary Fibrosis (IPF).

Recruiting·—·Phase 1·NCT05052229·40 enrolled

Non-healing Wound1 trial

Topical Nitric Oxide Trial in Chronic Non-Healing Wounds

Terminated·LLoma Linda University·Phase 2·NCT00823095·7 enrolled

Chronic Rhinosinusitis1 trial

Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)

Completed·SSanotize Research and Development corp.·Phase 2·NCT04163978·56 enrolled

Hemolysis1 trial

Effects of Nitric Oxide on the Endothelium During Hemolysis.

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT03748082

Children1 trial

Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely

Completed·—·Phase 4·NCT00390065·108 enrolled

Cystic Fibrosis1 trial

Evaluation of the Safety and Tolerability of Inhaled Nitric Oxide to Subjects With Cystic Fibrosis

Completed·BBeyond Air Inc.·Phase 1/2·NCT01958944·9 enrolled

ESS1 trial

Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH

Completed·—·Phase 2·NCT02734953·10 enrolled

Cardiac Surgical Patients1 trial

Effects of Prolonged Delivery of Nitric Oxide Gas on Plasma Reduction-Oxidation Reactions in Cardiac Surgical Patients

Withdrawn·MMassachusetts General Hospital·Phase 2·NCT04022161

Dyspnea1 trial

The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in COPD

Completed·UUniversity of Alberta·Phase 1/2·NCT03679312·140 enrolled

Candidiasis1 trial

Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis

Completed·SSanotize Research and Development corp.·Phase 1·NCT06120816·6 enrolled

Ventricular Function1 trial

Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function

Unknown status·FFernando Suarez Sipmann·N/A·NCT06097026·54 enrolled

Acute Kidney Injury1 trial

Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients

Completed·—·Phase 4·NCT06622291·106 enrolled

Chronic Lung Disease1 trial

Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

Completed·MMallinckrodt·Phase 3·NCT00551642·800 enrolled

Plantar Wart1 trial

Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts)

Completed·SSanotize Research and Development corp.·Phase 2·NCT05877313·20 enrolled

Bronchopulmonary Dysplasia1 trial

Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

Completed·FFudan University·Phase 2/3·NCT01503801·400 enrolled

Acute Chest Syndrome1 trial

Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT00748423·100 enrolled

Lung Transplantation1 trial

Safety and Efficacy Study of Nitric Oxide in Patients Going Through Lung Transplantation

Completed·MMallinckrodt·Phase 2·NCT00570245·49 enrolled

Endothelial Dysfunction1 trial

Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.

Completed·MMassachusetts General Hospital·Phase 3·NCT02836899·250 enrolled

Safety and Efficacy1 trial

Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Pressure Sore

Unknown status·—·Phase 1/2·NCT01351493·40 enrolled

Staphylococcus Aureus1 trial

Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)

Terminated·NNitric BioTherapeutics, Inc·Phase 2·NCT00790608·8 enrolled

Diabetic Neuropathy1 trial

A Study on the Safety and Efficacy of Nitric Oxide Gel in Subjects With Painful Diabetic Neuropathy

Completed·—·Phase 2·NCT01633086·24 enrolled

Liver Transplant1 trial

Effect of Nitric Oxide (NO) on Ischemic/Reperfusion Injury During Extended Donor Criteria (EDC) Liver Transplantation

Terminated·UUniversity of Colorado, Denver·N/A·NCT00948194·13 enrolled

Cardiac Arrest1 trial

Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest

Terminated·CCameron Dezfulian·Phase 2·NCT03079102·57 enrolled

Tinea Pedis1 trial

Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)

Completed·NNitric BioTherapeutics, Inc·Phase 2·NCT00771342·50 enrolled

After Cardiac Surgery1 trial

Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement

Completed·SStanford University·Phase 4·NCT01717209·14 enrolled

Fontan1 trial

Pulmonary Capillary Recruitment in Fontan Patients

Unknown status·JJewish General Hospital··NCT04292483·15 enrolled

Hypoxia1 trial

The Effect of Inhaled Nitric Oxide on Maximal Oxygen Consumption During Exercise in Hypoxia

Completed·UUniversity of Alberta·Phase 1/2·NCT04231773·20 enrolled

AKI1 trial

Efficacy of Nitric Oxide Administration During Cardiopulmonary Bypass in Neonates at Reducing the Risk of Acute Kidney Injury

Recruiting·CChildren's Hospital Medical Center, Cincinnati·Phase 3·NCT04216927·40 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 23, 1999

INOMAX

NDA NDA020845

May 21, 2001

INOMAX

NDA NDA020845

Jun 15, 2004

INOMAX

NDA NDA020845

Dec 4, 2007

INOMAX

NDA NDA020845

Aug 26, 2009

INOMAX

NDA NDA020845

Dec 21, 2010

INOMAX

NDA NDA020845

Mar 4, 2013

INOMAX

NDA NDA020845

Feb 28, 2014

INOMAX

NDA NDA020845

Oct 9, 2015

INOMAX

NDA NDA020845

Oct 9, 2015

INOMAX

NDA NDA020845

Apr 5, 2016

INOMAX

NDA NDA020845

Feb 13, 2019

INOMAX

NDA NDA020845

Dec 20, 2019

GENOSYL

NDA NDA202860

Jan 17, 2023

INOMAX

NDA NDA020845

Sources

References

[1]
ClinicalTrials.gov — 68 trial records for Nitric Oxide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — INOmax drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nitric Oxide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nitric Oxide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020845). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for INOmax. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Mallinckrodt company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Soluble Guanylate Cyclase Activator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMallinckrodt

Patent Landscape[6]

Patent Cliff

Oct 17, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8057742Jan 18, 2026

7618594Oct 17, 2026

7947227Oct 17, 2026

7560076Apr 21, 2027

9701538Jan 28, 2029

41 more patents

8431163Jun 30, 2029

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8795741Jun 30, 2029

8846112Jun 30, 2029

11931377Jun 30, 2029

9604028Aug 13, 2029

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8846112*PEDDec 30, 2029

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9770570*PEDNov 3, 2036

11672938Jul 22, 2040

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