INOMAX (nitric oxide)
INOMAX is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension. It is administered in conjunction with ventilatory support and other appropriate medical agents.
How INOMAX Works
Nitric oxide relaxes vascular smooth muscle by binding to the heme moiety of cytosolic guanylate cyclase, increasing intracellular levels of cyclic guanosine 3',5'-monophosphate (cGMP). When inhaled, it selectively dilates the pulmonary vasculature. Because it is rapidly inactivated by hemoglobin scavenging, it has minimal effect on the systemic vasculature. This selective dilation redistributes pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward better-ventilated areas, improving arterial oxygenation (PaO2).
Development Insights
Details
- Status
- Prescription
- First Approved
- 1999-12-23
- Patent Cliff
- 2036
- Routes
- INHALATION
- Dosage Forms
- GAS
INOMAX Approval History
What INOMAX Treats
2 indicationsINOMAX is approved for 2 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoxic Respiratory Failure
- Pulmonary Hypertension
INOMAX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in INOMAX's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications INOMAX treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to INOMAX
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
42 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04305457 NoCovid results posted | NOgas mildCOVID-19 | Ph 2 | terminated | Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 |
| NCT02836899 MGHK23 results posted | MGH K23 K23HL128882-01 | Ph 3 | completed | Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction. |
| NCT06622291 | 2024-16-20240626 Z191100006619095, 2025AZB6001 | Ph 4 | completed | Perioperative Nitric Oxide Prevents Acute Kidney Injury in Acute Type A Aortic Dissection Patients |
| NCT03748082 | EndoNO | Ph 2 | withdrawn | Effects of Nitric Oxide on the Endothelium During Hemolysis. |
| NCT04022161 | RedOx-NO | Ph 2 | withdrawn | Effects of Prolonged Delivery of Nitric Oxide Gas on Plasma Reduction-Oxidation Reactions in Cardiac Surgical Patients |
| NCT05109611 results posted | COVID-NONS-04 | Ph 3 | terminated | Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection |
| NCT03023449 DOMINO | 824559 | Ph 2 | active not recruiting | Diffuse Optical Monitoring With Inhaled Nitric Oxide |
| NCT04216927 | MOD00004808 | Ph 3 | recruiting | NO During CPB in Neonates to Reduce Risk of AKI |
| NCT01165047 results posted | 1.0 | Ph 2 | completed | Nitric Oxide, GeNO Nitrosyl Delivery System |
| NCT04181359 iNO | Pro00092702 | Ph 1, Ph 2 | withdrawn | The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease. |
| NCT04231773 iNO | Pro00092939 | Ph 1, Ph 2 | completed | The Effect of Inhaled Nitric Oxide on Maximal Oxygen Consumption During Exercise in Hypoxia |
| NCT06120816 | NORM-POC-01 | Ph 1 | completed | Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis |
| NCT02295566 RATNO | RHM CHI0548 2010-023529-39, 11/H0502/7 | Ph 2 | completed | RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot Study |
| NCT03661385 NASO | 38017 ACTRN12618000089235p | Ph 3 | completed | Nitric Oxide During Bypass for Arterial Switch Operation |
| NCT05877313 | HPV-Warts-01 | Ph 2 | completed | Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts) |
| NCT03679312 iNO | Pro00078715 | Ph 1, Ph 2 | completed | The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in COPD |
| NCT05599919 | GPL/CT/2021/004/III | Ph 3 | completed | Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19 |
| NCT04163978 | NOSi-CTP-02 | Ph 2 | completed | Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS) |
| NCT03079102 iNOOHCA results posted | PRO16100408 | Ph 2 | terminated | Inhaled Nitric Oxide After Out-of-Hospital Cardiac Arrest |
| NCT00848731 | CMC_kline_iNO1.1 | Ph 1 | completed | Phase I Trial of Inhaled Nitric Oxide to Treat Acute Pulmonary Embolism |
| NCT04388683 NO-COVID-19 results posted | STUDY00000554 | Ph 2 | terminated | Inhaled Nitric Oxide for Preventing Progression in COVID-19 |
| NCT04383002 | 20-5449 | Ph 1 | completed | High Dose Inhaled Nitric Oxide for COVID-19 (ICU Patients) |
| NCT03455218 results posted | 1111115-1NO in CPB 001 | Ph 2, Ph 3 | completed | Nitric Oxide Administration During Pediatric Cardiopulmonary Bypass Surgery to Prevent Platelet Activation |
| NCT04060979 | AIT_CP_BRONC_03.01 | Ph 2 | completed | Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis |
| NCT04290858 NoCovid | COVID19 NOgas mild | Ph 2 | withdrawn | Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID19 Infection |
| NCT03527381 NephroNO | NephroNO | Ph 1, Ph 2 | completed | Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery |
| NCT02871011 results posted | SAN-CPT-01 | Ph 2 | completed | Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot |
| NCT03053388 | AIT_CP_BRONC02.01 | Ph 3 | completed | Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Bronchiolitis |
| NCT03208764 | AIT_ CP_ CFNTM_01 | Ph 2 | completed | Inhaled Nitric Oxide for Patients With MABSC |
| NCT03500783 NOinCPB | NOinCPB | Ph 1, Ph 2 | completed | Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass |
| NCT02734953 results posted | RC6167 | Ph 2 | completed | Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH |
| NCT01717209 results posted | 25471 | Ph 4 | completed | Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement |
| NCT01958944 | AIT_ CP_ CF 01 | Ph 1, Ph 2 | completed | Evaluation of the Safety and Tolerability of Inhaled Nitric Oxide to Subjects With Cystic Fibrosis |
| NCT01768884 | AIT_CP_BRONC01.01 | Ph 1, Ph 2 | completed | Evaluation of the Safety and Tolerability of Nitric Oxide (NO) Via Inhalation to Subjects With Bronchiolitis |
| NCT02217683 | BloodiNO | Ph 2 | withdrawn | Use of Inhaled Nitric Oxide to Prevent Pulmonary Hypertension Associated to Stored Blood Transfusion |
| NCT00585013 results posted | CHECP1 | Ph 1, Ph 2 | completed | Inhaled NO as an Anti-inflammatory and Anti-reperfusion Agent in Infants and Children Undergoing Cardiopulmonary Bypass |
| NCT01398384 NOMI | LCC2010.01 | Ph 2 | completed | Effects of Nitric Oxide for Inhalation in Myocardial Infarction Size |
| NCT00748423 INOSTA | P060701 | Ph 2, Ph 3 | completed | Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study) |
| NCT01503801 NO-BPD | FudanU | Ph 2, Ph 3 | completed | Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia |
| NCT00771368 | CTP 7 | Ph 1, Ph 2 | terminated | Reduction of Bacteria in MRSA Positive Ulcers |
| NCT00790608 | CTP 5 EudraCT 2008-001287-36 | Ph 2 | terminated | Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA) |
| NCT00771342 | CTP 6 | Ph 2 | completed | Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INOMAX FDA Label Details
Indications & Usage
FDA Label (PDF)INOMAX is indicated for the treatment of Hypoxic Respiratory Failure; Pulmonary Hypertension.
INOMAX Patents & Exclusivity
Patents (32 active)
Pro Intelligence Preview
Deep insights for INOMAX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 159 active patents
Trial Analysis
- • 42 total trials
- • Stage: Declining
Competitive Landscape
- • 4 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment