Drugs / Sodium Nitrite
Sodium Nitrite
also known as
AIR001 · INS NO.250 · INS-250 · NaNO2 · Natrii nitris · Natrum nitrosum · Nitrous acid soda · NSC-77391 · +2 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NITHIODOTE | — | 2011-01-14 | fda.gov ↗ |
Trials 41
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05798481 | Mar 2024 → Apr 2025 | hypertensive disorder | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 111 trials | ||||||
| Phase 1 | NCT05893160 | Jun 2026 → Oct 2027 | — | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 1 | NCT04289558 | Jun → Oct 2021 | Plasmodium falciparum malaria | Duke University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02987088 | Dec 2016 → Apr 2017 | cardiac arrest | University of Washington | Completed | No outcome recorded |
| Phase 1 | NCT01681836 | Oct 2012 → Oct 2013 | — | Gladwin, Mark, MD | Completed | No outcome recorded |
| Phase 1 | NCT01409122 | Jul 2011 → Jan 2012 | pulmonary arterial hypertension | Aires Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01316796 | Mar 2011 → Sep 2015 | sickle cell disease | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 1 | NCT01178359 | Jan 2010 → Apr 2016 | cardiac arrest | University of Washington | Completed | No outcome recorded |
| Phase 1 | NCT00105222 | Mar 2005 → Aug 2013 | — | National Heart, Lung, and Blood Institute (NHLBI) | Terminated | No outcome recorded |
| Phase 1 | NCT00103025 | Feb 2005 → May 2011 | — | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 1 | NCT00102271 | Jan 2005 → Apr 2011 | — | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 1 | NCT00095472 | Nov 2004 → Aug 2007 | sickle cell disease | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT04354051 | Jul → Dec 2018 | cardiovascular disorder | University of East Anglia | Completed | No outcome recorded |
| Phase 1/2 | NCT02694393 | Feb 2016 → Jul 2022 | cystic fibrosis | Schmidhofer, Mark, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02022670 | Oct 2011 → Dec 2013 | arterial disorder | University of Colorado, Boulder | Completed | No outcome recorded |
| Phase 1/2 | NCT01033227 | Dec 2009 → Jun 2012 | sickle cell disease | Children's Hospital Los Angeles | Terminated | No outcome recorded Stop: Enrollment |
| Phase 220 trials · 2 met primary · 7 missed | ||||||
| Phase 2 | NCT04405180 | Apr 2021 → Jul 2023 | — | Gladwin, Mark, MD | Completed | Missed primary |
| Phase 2 | NCT02863068 | Apr 2018 → Nov 2023 | sickle cell disease | caterina P minniti | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT03015402 | Oct 2017 → Jan 2023 | heart failure, pulmonary hypertension | University of Pittsburgh | Completed | Missed primary |
| Phase 2 | NCT03544242 | May 2017 → Jun 2019 | diabetes mellitus | University of Alabama at Birmingham | Terminated | No outcome recorded |
| Phase 2 | NCT02918552 | Apr 2017 → Dec 2018 | heart failure | Gladwin, Mark, MD | Completed | No outcome recorded |
| Phase 2 | NCT02742129 | Aug 2016 → Dec 2017 | heart failure | Adrian Hernandez | Completed | Missed primary |
| Phase 2 | NCT02552888 | Mar 2016 → Jun 2017 | chronic kidney disease | Tulane University | Completed | Missed primary |
| Phase 2 | NCT02433977 | Sep 2015 → Nov 2019 | asthma | Gladwin, Mark, MD | Completed | No outcome recorded |
| Phase 2 | NCT02262078 | Oct 2014 → Dec 2015 | heart failure | Mayo Clinic | Completed | Met primary |
| Phase 2 | NCT02176837 | Jun 2014 → Jan 2017 | subarachnoid hemorrhage | Hope Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT01932606 | Aug 2013 → Oct 2014 | diastolic heart failure, pulmonary hypertension | Barry Borlaug | Completed | Met primary |
| Phase 2 | NCT04001283 | Jan 2013 → Jul 2019 | atherosclerosis, coronary artery disorder, diabetes mellitus | University of East Anglia | Unknown | No outcome recorded |
| Phase 2 | NCT01431313 | Jun 2012 → Oct 2017 | diastolic heart failure, pulmonary hypertension | Schmidhofer, Mark, MD | Completed | Missed primary |
| Phase 2 | NCT01584453 | Apr 2012 → Nov 2013 | myocardial infarction, myocardial ischemia | Barts & The London NHS Trust | Completed | Missed primary |
| Phase 2 | NCT01715883 | Oct 2011 → May 2017 | — | Gladwin, Mark, MD | Terminated | No outcome recorded |
| Phase 2 | NCT01401517 | Jul 2011 → Jan 2013 | peripheral arterial disease | TheraVasc Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00873015 | Apr → Nov 2010 | subarachnoid hemorrhage | Hope Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01098409 | Feb 2010 → Jan 2012 | — | University Hospital Birmingham NHS Foundation Trust | Unknown | No outcome recorded |
| Phase 2 | NCT00924118 | Jul 2009 → Jun 2016 | acute myocardial infarction | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00048477 | Oct 2002 → Nov 2003 | — | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 2/33 trials · 1 missed | ||||||
| Phase 2/3 | NCT04842331 | Sep 2021 → Jan 2022 | COVID-19, viral respiratory tract infection | Thirty Respiratory Limited | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT03452917 | Feb 2018 → Dec 2019 | cardiac arrest | University of Washington | Completed | Missed primary |
| Phase 2/3 | NCT01388504 | Jul 2011 → Jan 2014 | ST-elevation myocardial infarction | University of Aberdeen | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04386070 | May 2022 → Dec 2026 | COVID-19, severe acute respiratory syndrome | University of Birmingham | Suspended | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02393742 | Mar 2015 → May 2019 | premature aging syndrome | University of Colorado, Boulder | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT03077763 Comparator | Dec 2016 → Mar 2018 | — | University of East Anglia | Unknown | No outcome recorded |
| Phase 1 | NCT02527837 Comparator | May 2015 → Oct 2016 | hypertensive disorder | Erling Bjerregaard Pedersen | Unknown | No outcome recorded |
| Phase 1 | NCT02078908 Comparator | Sep 2013 → Jun 2014 | — | Erling Bjerregaard Pedersen | Completed | No outcome recorded |
| Phase 1 | NCT00814645 Comparator | Dec 2008 → Apr 2009 | pulmonary arterial hypertension | Aires Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04401527 Comparator | Jul → Aug 2020 | COVID-19, acute respiratory distress syndrome | Hope Pharmaceuticals | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02713126 Comparator | Sep 2016 → Apr 2022 | heart failure | Barry Borlaug | Completed | No outcome recorded |
| Phase 2 | NCT02412852 Comparator | Apr → Dec 2015 | diabetes mellitus | TheraVasc Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02015260 Comparator | Sep 2001 → May 2003 | anogenital human papillomavirus infection | University of Aberdeen | Completed | No outcome recorded |
| Phase 3 | NCT03331146 Comparator | Oct 2018 → Jun 2019 | acute kidney injury | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-03-17 | NuvOx LLC | Regulatory NuvOx Announces Receipt of IND for Study of NanO2 as Cardioprotectant in Acute Myocardial Infarction nuvoxtherapeutics.com ↗ |
| 2024-07-11 | NuvOx LLC | Regulatory NuvOx Pharma LLC Announces Authorization of ARDS Trial from Health Canada nuvoxtherapeutics.com ↗
NuvOx Pharma LLC (“NuvOx”) announced that it has received authorization from Health Canada for its EXTEND : nov E l o X ygen T h E rapeutic N anO2 for mild respiratory distress in Phase Ib and AR D S in Phase II Trials |
| 2021-09-09 | NuvOx LLC | Results NuvOx Pharma Generates Positive Preclinical Data Showing NanO2TM Boosts Efficacy of Immunotherapy nuvoxtherapeutics.com ↗
NuvOx Pharma, a biotechnology company based in Tucson, Arizona, has generated positive preclinical data showing that its lead drug, NanO2TM, boosts the efficacy of immunotherapy in a mouse model of triple negative breast cancer. |
| 2021-07-29 | NuvOx LLC | Regulatory NuvOx Pharma Receives FDA Allowance to Proceed with Phase II Clinical Trial of NanO2TM nuvoxtherapeutics.com ↗
NuvOx Pharma, a Tucson-based biopharmaceutical company, has received notice from the FDA that they may proceed with a Phase II clinical trial of their drug, NanO2TM, in ischemic stroke. |
| 2020-06-30 | NuvOx LLC | Regulatory Health Canada Allows Phase IIa Clinical Trial in COVID-19 Patients with Respiratory Failure nuvoxtherapeutics.com ↗
NuvOx Pharma has received a “No Objection Letter” from Health Canada to proceed with a Phase IIa clinical trial of NanO2 in COVID-19 subjects with acute hypoxic respiratory failure (AHRF). |
| 2019-02-28 | NuvOx LLC | Results NuvOx Pharma’s NanO2 Shows Positive Results in Phase Ib/II Stroke Trial nuvoxtherapeutics.com ↗
Positive results of NuvOx Pharma’s NanO2 (DDFPe) in the treatment of stroke have been published at the International Stroke Conference. |
All press releases naming this drug 6 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sodium Nitrite | “Sodium nitrite infused during resuscitation from cardiac arrest has recently been shown to improve survival in a mouse model of cardiac arrest and our group is eager to test...” NCT01178359 ↗49“strategies to prevent IR injury and subsequent islet cell destruction, such as the administration of inhaled nitric oxide (NO) or sodium nitrite (NaNO2) could enhance islet...” NCT03544242 ↗ “The dosage form of JAN101 to be used in clinical investigations is a sustained release (SR) tablet containing Sodium Nitrite drug substance.” NCT05893160 ↗ “RESP301 is a formulation consisting of three agents already used in clinical practice: mannitol, sodium nitrite and citric acid.” NCT04386070 ↗ “RESP301 is a formulation consisting of 3 agents currently used in clinical practice: mannitol, sodium nitrite and citric acid.” NCT04842331 ↗ “Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability.” NCT01431313 ↗ “before and 15 min after treatment with either sodium nitrite or matching placebo” PMID 26449137 ↗ Oct 2015 “A) 3% sodium nitrite + 4.5% citric acid creams twice daily” NCT02015260 ↗ |
| Known as | AIR001 | “Sodium Nitrite Inhalation Solution (AIR001) 45mg dosage with one subsequent escalation dosage of 90mg based on tolerability.” NCT01431313 ↗ |
| Known as | INS NO.250 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1161681 ↗ |
| Known as | INS-250 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1161681 ↗ |
| Known as | NaNO2 | “strategies to prevent IR injury and subsequent islet cell destruction, such as the administration of inhaled nitric oxide (NO) or sodium nitrite (NaNO2) could enhance islet...” NCT03544242 ↗ |
| Known as | Natrii nitris | ChEMBL registry synonym — accepted as the source's own label CHEMBL1161681 ↗ |
| Known as | Natrum nitrosum | ChEMBL registry synonym — accepted as the source's own label CHEMBL1161681 ↗ |
| Known as | Nitrous acid soda | ChEMBL registry synonym — accepted as the source's own label CHEMBL1161681 ↗ |
| Known as | NSC-77391 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1161681 ↗ |
| Known as | Sodium nitrite component of nithiodote | ChEMBL registry synonym — accepted as the source's own label CHEMBL1161681 ↗ |
| Known as | sodium nitrite injection, usp | “Drug: sodium nitrite injection, usp” NCT01033227 ↗ |
| Action | Restore | “This study examines ways in which nitric oxide (NO), an important molecule that controls how blood flows through the body's vessels, might be restored with a compound called...” NCT00095472 ↗ |
| Modality | Small molecule | — CHEMBL1161681 ↗ |
| Route | Other | “nitrite will be placed in the forearm” NCT00095472 ↗ |