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Research Pipeline

NRx Research Pipeline

Our pipeline includes medicinal candidates in Phase 2 and Phase 3 trials for COVID-19-related Lung Injury and Acute Respiratory Distress (ARDS), and the first drug in development to treat Bipolar Depression in Patients with Acute Suicidal Ideation & Behavior (ASIB).

PSYCHIATRY

BIPOLAR DEPRESSION with SUICIDAL IDEATION

Indication
Compound Name
Phase
Submission Type
Compound Type
Severe Bipolar Depression in patients with Acute Suicidal Ideation & Behavior (ASIB)

SPA, Breakthrough Therapy designation, Biomarker Letter of Support
NRX-100/NRX-101™
Phase 3
NDA

Sequential Therapy for the Treatment of Severe Bipolar Depression.

Status
Completed
Study Results
No Results Available
Locations
Research Site, Birmingham, Birmingham, Alabama, United States | Research Site, Charlotte, Charlotte, North Carolina, United States | Research Site, Houston, Houston, Texas, United States
Bipolar Depression in patients with Sub-Acute Suicidal Ideation & Behavior (SSIB)
NRX-101™
Phase 2
NDA

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation

Status
Recruiting
Study Results
No Results Available
Locations
JP Smith Hospital, Fort Worth, Texas, United States | Research Centers of America, Hollywood, Florida, United States | Research Site, Birmingham, Birmingham, Alabama, United States | Research Site, Houston, Houston, Texas, United States | Texas Health Hospital Frisco, Frisco, Texas, United States | University of California – Irvine, Irvine, California, United States | University of Louisville Hospital, Louisville, Kentucky, United States | University of Utah Health (Site 211-002), 419 Wakara Way, Ste. 207, Salt Lake City, Utah, United States

RESPIRATORY / COVID-19

Indication
Compound Name
Phase
Submission Type
Compound Type
Critical COVID-19 (Acute Respiratory Failure)

FAST TRACK



Intravenous ZYESAMI® (Avipdatil)
Phase 3 Complete – Regulatory Interactions
EUA

Study Sponsored by National Institute of Health | ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

Status
Recruiting
Study Results
No Results Available
Locations
Duke University Hospital (Site 301-006), 2301 Erwin Road, Durham, North Carolina, United States | University of Utah Health (Site 211-002), 419 Wakara Way, Ste. 207, Salt Lake City, Utah, United States

Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

Status
Completed
Study Results
No Results Available
Locations
Baptist Hospital of Miami, Miami, Florida, United States | Heartland/Mosaic Health, Saint Joseph, Missouri, United States | Hendrick Health, Abilene, Texas, United States | Houston Methodist Hospital, Houston, Texas, United States | Miller School of Medicine / University of Miami Medical Center, Miami, Florida, United States | St. Jude Medical Center, Fullerton, California, United States | Texas Health Harris Methodist Hospital, Fort Worth, Texas, United States | Texas Health Hospital Frisco, Frisco, Texas, United States | University of California – Irvine, Irvine, California, United States | University of Louisville Hospital, Louisville, Kentucky, United States
Critical COVID-19 (Acute Respiratory Failure)

Study being conducted by NIH
Intravenous ZYESAMI® (Avipdatil)
Phase 3
EUA & NDA

Study Sponsored by National Institute of Health | ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19

Status
Recruiting
Study Results
No Results Available
Locations
Duke University Hospital (Site 301-006), 2301 Erwin Road, Durham, North Carolina, United States | University of Utah Health (Site 211-002), 419 Wakara Way, Ste. 207, Salt Lake City, Utah, United States

Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure

Status
Completed
Study Results
No Results Available
Locations
Baptist Hospital of Miami, Miami, Florida, United States | Heartland/Mosaic Health, Saint Joseph, Missouri, United States | Hendrick Health, Abilene, Texas, United States | Houston Methodist Hospital, Houston, Texas, United States | Miller School of Medicine / University of Miami Medical Center, Miami, Florida, United States | St. Jude Medical Center, Fullerton, California, United States | Texas Health Harris Methodist Hospital, Fort Worth, Texas, United States | Texas Health Hospital Frisco, Frisco, Texas, United States | University of California – Irvine, Irvine, California, United States | University of Louisville Hospital, Louisville, Kentucky, United States
Severe COVID-19*

Study Paused
Inhaled ZYESAMI® (Aviptadil Acetate)
Phase 3
NDA

Inhaled ZYESAMI® (Aviptadil Acetate) for the Treatment of Moderate and Severe COVID-19

Study Results
No Results Available
Locations
St. Jude Medical Center, Fullerton, California, United States | University of California – Irvine, Irvine, California, United States | University of Louisville Hospital, Louisville, Kentucky, United States
Acute Respiratory Distress Syndrome**

Investigator Initiated Study



VIP
Phase 1
NDA

* This study has been paused while NRx evaluates whether to increase the sample size, change the trial endpoint / enrollment criteria or discontinue the study.  A separate inhaled study that was being conducted by Quantum Leap Healthcare Collaborative (I-SPY) has been stopped.
** Data and rights held by Research Foundation for the State University of New York; NRx Pharmaceuticals has a license