INOmax® (nitric oxide) for inhalation

While INOmax was approved for commercialization for its initial indication in December 1999, our Research and Development program continues to expand.  We are actively searching for new indications and uses for inhaled nitric oxide in special patient populations.  Our program of phase 1, 2, and 3 studies address both interesting scientific questions and unmet medical needs.  Currently we have four ongoing sponsored INOmax trials in four different therapeutic areas and more than 30 investigator-sponsored trials, ranging in scope from non-clinical studies to human trials.

http://www.clinicaltrials.gov/ct2/show/NCT00551642

Some diseases of the heart and lungs can compromise the ability of the right ventricle to pump blood into the pulmonary vasculature.  It has been shown that inhaled nitric oxide may reduce pulmonary blood pressure enough to allow a compromised right ventricle to effectively pump blood through the lungs.^5,6  Ikaria is conducting a clinical study to assess the safety and efficacy of inhaled nitric oxide for the management of acute right ventricular failure in patients receiving a left ventricular assist device (LVAD).

http://www.clinicaltrials.gov/ct2/show/NCT00060840

Inhaled nitric oxide for the Treatment of Pain Crisis in Sickle Cell Disease

Sickle cell disease affects 70,000 people in the United States.  Many patients with sickle cell disease experience recurrent episodes of pain that require them to receive treatment in the hospital.  Ikaria is studying the effects of inhaled nitric oxide on the duration of the acute pain episodes associated with sickle cell disease.

http://www.clinicaltrials.gov/ct2/show/NCT00094887

Inhaled Nitric Oxide for Reduction in the Size of Myocardial Infarction

Myocardial infarction (MI) is a leading cause of death and disability. Each year about 800,000 people in the US suffer a myocardial infarction.

The extent of myocardial injury is a determinant of functional recovery and survival after an MI.  Early restoration of myocardial blood flow decreases the magnitude of injury and improves patient prognosis.  However, restoration of blood flow itself can cause ischemia/reperfusion injury and thereby increase myocardial damage.  Recent preclinical studies demonstrated that inhaled nitric oxide reduced the size of myocardial infarction in animals.^7,8

Ikaria is studying the role of inhaled nitric oxide in the mitigation of ischemia/reperfusion injury and the subsequent reduction in the size of the infarct.

http://clinicaltrials.gov/ct2/show/NCT00568061

Investigator Initiated Studies of Inhaled Nitric Oxide

In addition to our sponsored studies, Ikaria is supporting a number of investigator initiated studies.  These studies include animal studies of various pulmonary, cardiac, and neurologic conditions and human trials in disease states including transplantation, sickle cell disease, prematurity, sepsis, and many others, including a variety of in vitro and preclinical studies.

Carbon Monoxide for Inhalation Research and Development Program

Carbon monoxide is an endogenous mediator of a number of biologic processes.  Inhaled carbon monoxide may have cytoprotective, anti-inflammatory, anti-apoptotic, and anti-proliferative effects.¹⁰  Animal studies suggest that inhaled carbon monoxide may prevent organ transplant rejection.¹¹  Ikaria is investigating the therapeutic potential of inhaled carbon monoxide in solid organ transplantation.

http://www.clinicaltrials.gov/ct2/show/NCT00531856

IK-1001 (Sodium Sulfide for Injection)

Based upon research on the bioactivity of gaseous signaling molecule hydrogen sulfide, or H2S, Ikaria is investigating the impact of the sulfide ion, administered as sodium sulfide, in a number of disease models.  Preclinical studies suggest that sulfide may be useful in the management of multiple hypoxic/ischemic conditions.^{11,12,13,14,15}

IK-1001 is in Phase 1 trials.

References