Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NO delivered via INOpulse DS-C Device · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Inhaled NO @ 0.003 mg/kg/ ideal body weight (IBW)/hr (Part A) | ACTIVE_COMPARATOR | Inhaled NO using 3.0 mg/L \[2440 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Inhaled NO @ 0.010 mg/kg/IBW/hr (Part A) | ACTIVE_COMPARATOR | Inhaled NO using 3.0 mg/L \[2440 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Inhaled NO @ 0.015 mg/kg/IBW/hr (Part A) | ACTIVE_COMPARATOR | Inhaled NO using 6.0 mg/L \[4880 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Placebo random @ 0.003, 0.010 or 0.015 mg/kg/IBW/hr (Part A) | PLACEBO_COMPARATOR | Placebo using 99.999% N2 minicylinder delivered via INOpulse® DS-C device |
| Inhaled NO @ 0.030 mg/kg IBW/hr (Part B) | ACTIVE_COMPARATOR | Inhaled NO using 6.0 mg/L \[4880 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Inhaled NO @ 0.075 mg/kg IBW/hr (Part B) | ACTIVE_COMPARATOR | Inhaled NO using 6.0 mg/L \[4880 ppm\] NO minicylinder delivered via INOpulse® DS-C device |
| Placebo random @ 0.030 or 0.075 mg/kg/IBW (Part B) | ACTIVE_COMPARATOR | Placebo using 99.999% N2 minicylinder delivered via INOpulse® DS-C device |
| Name | Type | Description |
|---|---|---|
| Inhaled NO delivered via INOpulse DS-C Device | COMBINATION_PRODUCT | Subjects will be treated with nitric oxide by means of an INOpulse DS-C device using an INOpulse nasal cannula. |
| Placebo delivered via INOpulse DS-C Device | COMBINATION_PRODUCT | Subjects will be treated with nitrogen gas by means of an INOpulse DS-C device using an INOpulse nasal cannula. |
Inclusion Criteria: 1. Former smokers with at least 10 pack-years of tobacco cigarette smoking history before study entry and who have stopped smoking ≥ 1 month prior to enrollment 2. Age ≥ 40 years, ≤ 80 years 3. A confirmed diagnosis of COPD by the Global initiative for chronic Obstructive Lung D...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag |
| Merck & Co., Inc. | MRK | 6 | PHASE3 | Riociguat |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | Selexipag |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | TNX-103 |
| Inhibikase Therapeutics, Inc. | IKT | 1 | PHASE3 | IKT-001 |
| Gossamer Bio, Inc. | GOSS | 2 | PHASE3 | Seralutinib |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| Tectonic Therapeutic Inc | TECX | 1 | PHASE2 | TX000045- Dose A, TX000045- Dose B |
| Abbott Laboratories | ABT | 1 | N/A | Undisclosed |
Nitric oxide delivered via the INOpulse DS-C Device is used for pulmonary hypertension, specifically in patients with WHO Group 3 pulmonary hypertension associated with chronic obstructive pulmonary disease (COPD). It is an investigational small molecule being studied as a pulsed inhaled treatment for this condition.
Pulse Biosciences, Inc (NASDAQ: PLSE) is developing nitric oxide delivered via the INOpulse DS-C Device. The company is conducting clinical research on this pulsed inhaled nitric oxide treatment for pulmonary hypertension associated with COPD.
Nitric oxide delivered via the INOpulse DS-C Device is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 trial has been completed, and the drug remains under clinical investigation.
Nitric oxide delivered via the INOpulse DS-C Device has one completed clinical trial, NCT01728220, titled "Two-Part Dose-Confirming Study of Pulsed Inhaled Nitric Oxide in Subjects With WHO Group 3 Pulmonary Hypertension Associated With COPD." This Phase 2, randomized, double-blind, placebo-controlled study enrolled 159 participants in the United States.
Nitric oxide delivered via the INOpulse DS-C Device works as a pulmonary vasodilator. It is administered as a pulsed inhaled gas to target the pulmonary vasculature, potentially reducing pulmonary artery pressure in patients with pulmonary hypertension associated with COPD.
Yes, nitric oxide delivered via the INOpulse DS-C Device is a form of pulsed inhaled nitric oxide. The clinical trial for this drug specifically evaluates "Pulsed Inhaled Nitric Oxide" in patients with WHO Group 3 pulmonary hypertension associated with COPD.