5 completed, 3 unknown, 1 available, 1 recruiting. 8 Phase 3, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 4, Unknown 2, Recruiting 1, Withdrawn 1 |
| Phase 2 | 6 | Completed 3, Recruiting 1, Unknown 1, Withdrawn 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Robotic Transcranial Magnetic Stimulation for Treatment Resistant Depression: The SPARC-TMS Trial Neuronavigated robotic-enabled TMS, NRX-101, Sham TMS - Treatment Resistant Depression, Treatment Resistant Depression (TRD) | Phase 2 / Phase 3 | Recruiting | NeuroRx, Inc. | 240 | 2026-12-01 | 2026-10-21 |
| NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis NRX101 (a fixed dose combination of D-cycloserine (DCS) and lurasidone HCl (lurasidone)) - Urinary Tract Infections, Pyelonephritis | Phase 2 | Unknown | NeuroRx, Inc. | 13 | 2024-03-31 | 2023-11-13 |
| NRX-101 for Bipolar Depression With Subacute Suicidal Ideation NRX-101, Lurasidone HCl - Bipolar Depression, Suicidal Ideation and Behavior | Phase 2 / Phase 3 | Completed | NeuroRx, Inc. | 74 | 2022-05-12 | 2024-05-08 |
| Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine. IIBR-100, Active Comparator - COVID-19 | Phase 2 / Phase 3 | Withdrawn | NeuroRx, Inc. | 2021-09-30 | 2024-01-19 | |
| Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial) Aviptadil, Aviptadil Placebo, Corticosteroid - Covid19 | Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 471 | 2021-04-20 | 2025-10-09 |
| ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 Remdesivir, Remdesivir Placebo, Aviptadil - Covid19 | Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 473 | 2021-04-20 | 2025-10-24 |
| NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation NRX-101, Lurasidone HCl - Bipolar Depression, Suicidal Ideation | Phase 3 | Unknown | NeuroRx, Inc. | 72 | 2019-12-01 | 2024-01-19 |
| NRX100 vs. Placebo for Rapid Stabilization of Acute Suicidal Ideation and Behavior in Bipolar Depression Ketamine Hydrochloride, Placebo - Bipolar Depression, Suicidal Ideation | Phase 3 | Unknown | NeuroRx, Inc. | 150 | 2019-06-25 | 2024-01-19 |
| NRX101 Glx Biomarker Validation Study NRX-101, Lurasidone HCl, Placebo - Bipolar Depression, Suicidal Ideation | Phase 2 / Phase 3 | Completed | NeuroRx, Inc. | 8 | 2018-11-01 | 2022-08-09 |
| Sequential Therapy for the Treatment of Severe Bipolar Depression. NRX-101 Oral Capsule, Lurasidone Oral Capsule, Ketamine Intravenous Infusion - Bipolar Depression, Suicidal Ideas | Phase 2 | Completed | NeuroRx, Inc. | 22 | 2018-01-15 | 2021-05-25 |
| NRX-101 Expanded Access NRX-101, Transcranial Magnetic Stimulation Sham - Treatment-Resistant Depression | Available | NeuroRx, Inc. | 2026-09-17 |
Bipolar Disorder (5) · Suicidal Ideation (5) · COVID-19 (3) · Coronaviridae Infections (2) · Coronavirus Infections (2) · Depressive Disorder, Treatment-Resistant (2) · Nidovirales Infections (2) · RNA Virus Infections (2) · Severe Acute Respiratory Syndrome (2) · Virus Diseases (2) · Behavior (1) · Depression (1) · Pyelonephritis (1) · Suicide, Attempted (1) · Urinary Tract Infections (1)
Lurasidone Hydrochloride (5) · Adrenal Cortex Hormones (2) · Cycloserine (2) · Vasoactive Intestinal Peptide (2) · aviptadil (2) · Ketamine (1) · rVSV-deltaG-spike COVID-19 vaccine (1) · remdesivir (1)
United States (9)
Jonathan C Javitt, MD, MPH (3) · Martin Brecher, MD (3) · Prof. James Neaton (2) · Samuel Brown, MD (2) · Andrew A Nierenberg, MD (1) · Andrew Nierenberg, MD (1) · Daniel C Javitt, MD (1) · Jonathan Javitt, MD, MPH (1) · Joshua Brown, MD, PhD (1) · Joshua T Kantrowicz, MD (1)
PMID 32785636, PMID 34149476, PMID 34825704, PMID 36695483, PMID 37348524, PMID 37573534, PMID 39714786