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Pipeline

NRx Clinical Pipeline

Our pipeline includes the first drug in development to treat Bipolar Depression in Patients with Acute and Sub-Acute Suicidal Ideation & Behavior (ASIB & SSIB).

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)

FDA SPA, Breakthrough Therapy Designation, Biomarker Letter of Support

Data Readout Expected Q3 2023
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
Indication
Compound Name
Phase
Submission Type
Compound Type
Moderate Bipolar Depression with Sub-Acute Suicidal Ideation
& Behavior (SSIB)

Currently Enrolling

Data Readout Expected Q1 2023
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

POST TRAUMATIC STRESS DISORDER (PTSD)

Indication
Compound Name
Phase
Submission Type
Compound Type
PTSD in patients with Depression & Suicidality

Pending

P2 Trial Initiation and Data Readout Expected in 2023
NRX-101™
Phase 1
NDA

Study Results
No Study Results

Expanded Access Policy on RTT: NRX-101 is not currently available outside of clinical trials.