Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication INOmax ® 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. FDA label
Nitric Oxide · 5 trials · 4 indications
LOS is measured in hours from the time of first treatment dose to the time of physician decision to discharge.
Time to "fit for discharge". "Fit for discharge" is a composite endpoint measured by the following: * Achieving Modified Tal score \[mTal\] ≤ 5 And * Oxygen saturation (SpO2) ≥92% at room air (without oxygen supplementation) sustained for at least 2 hours Both of these will be determined from the time of enrollment (when the ICF is signed).
| Arm | Type | Description |
|---|---|---|
| Group 1 - Nitric Oxide treatment | EXPERIMENTAL | • Group 1 (NO treatment) - will receive inhalations of 160 ppm NO combined with O2/air for 30 minutes, every 3-4.5 hours, five times a day (24 hours), for up to 5 days (maximum 25 inhalations), in addition to standard supportive treatment. |
| Group 2 - Control treatment | ACTIVE_COMPARATOR | • Group 2 (Control) - will receive inhalations O2/air using the same treatment schedule and equipment as group 1, in addition to standard supportive treatment. |
| Group 1- NO treatment- dose 1 | EXPERIMENTAL | Will comprise of approximately 30 patients and will receive inhalations of dose 1 of NO combined with O2/air for 40 minutes, every 4.5 hours during the day four times a day for up to 5 days in addition to standard supportive treatment. |
| Group 2- NO treatment- dose 2 | EXPERIMENTAL | Will comprise of approximately 30 patients and will receive inhalations of dose 2 of NO combined with O2/air for 40 minutes, every 4.5 hours during the day four times a day for up to 5 days in addition to standard supportive treatment. |
| Group 3- Control treatment | OTHER | Will comprise of approximately 30 patients and will receive O2/air using the same treatment schedule and equipment as groups 1 and 2, in addition to standard supportive treatment. |
| Nitric Oxide treatment | EXPERIMENTAL | - |
| Nitric oxide + standard treatment | EXPERIMENTAL | Inhalation of 160 ppm NO for 30 minutes, 3 times daily, for a duration of 10 working days with the exclusion of weekend days (Friday \& Saturday) in which no treatment under this study will be provided. |
| Nitric oxide inhalation + standard treatment | EXPERIMENTAL | Inhalation of 160 ppm gNO for 30 minutes, 5 times daily, for 5 consecutive days or until discharged, which occurs first. |
| Standard treatment | PLACEBO_COMPARATOR | Standard treatment |
| Name | Type | Description |
|---|---|---|
| Nitric Oxide | DRUG | Nitric Oxide given via inhalation in cycles |
| Supportive treatment | OTHER | Supportive treatment (including oxygen) |
| Standard Supportive treatment | OTHER | Standard Supportive treatment (including oxygen) |
| Placebo | DRUG | - |
Inclusion Criteria: 1. 1\. Pediatric subjects 0-12-months old. a. Including subjects born at ≥28 weeks of gestation. 2. Subjects with acute bronchiolitis requiring in-patient hospitalization expected for 24 hours and more. 3. Clinical score of between 7 to 10 at Screening (without oxygen supple...
Nitric Oxide is being developed for respiratory conditions including bronchiolitis, acute bronchiolitis, cystic fibrosis, and Mycobacterium abscessus infection. It is administered intermittently via inhalation. Beyond Air, Inc. is developing it as an investigational therapy across these indications.
Nitric Oxide targets GUCY1B1, GUCY1A2, and GUCY1A1, which are subunits of soluble guanylate cyclase. It acts as an activator of this enzyme complex. This mechanism is distinct from the vasodilatory signaling typically associated with nitric oxide in other contexts.
Beyond Air, Inc. (ticker: XAIR) is developing inhaled Nitric Oxide for respiratory indications. The company holds the development program covering bronchiolitis, cystic fibrosis, and Mycobacterium abscessus infection.
Nitric Oxide is in Phase 3 development. It is investigational and has not been approved by the FDA. The Phase 3 trial NCT03053388 evaluated its efficacy, safety, and tolerability in bronchiolitis and has been completed.
Four completed trials have studied Nitric Oxide: NCT03053388 (Phase 3, bronchiolitis, 69 patients), NCT04060979 (Phase 2, acute bronchiolitis, 95 patients), NCT03208764 (Phase 2, Mycobacterium abscessus infection, 9 patients), and NCT01958944 (Phase 1, cystic fibrosis, 9 patients). All were conducted in Israel.
Nitric Oxide is also known by its chemical abbreviation NO. It is the same molecule referenced in trial titles as Nitric Oxide (NO). The ChEMBL identifier is CHEMBL1200689.