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Sodium Nitrite

(sodium nitrite)

PreclinicalSmall molecule

HHope Pharmaceuticals

Sodium nitrite is used as an emergency antidote to treat cyanide poisoning by helping the body neutralize the cyanide. It's also used to treat a rare condition called methemoglobinemia where the blood cannot carry oxygen properly.[1] Sodium Nitrite is currently being investigated across 4 indications[3], with its most advanced program in Preclinical.[1]

Sodium Nitrite is one of 122 small molecule programs targeting Poisoning. It is currently in Preclinical.

4

Indications

32

Total Trials

0

Active Trials

121

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

PoisoningUnknown

AgeActive, not recruiting

Myocardial InfarctionUnknown

FunctionCompleted

PoisoningPreclinical

Unknown

AgePreclinical

Active, not recruiting

Myocardial InfarctionPreclinical

Unknown

FunctionPreclinical

Completed

Competition

Competitive Landscape

87 competitors in Myocardial Infarction

#DrugCompanyPhaseTrials

Praluent

Crestor

Aldactone

Neoral

Adenocard

Heparin Sodium

BBaxter Healthcare Corporation

Kengreal

CChiesi USA, Inc.

Angiomax

BBaxter Healthcare Corporation

Coreg

Akero Therapeutics

Reglan

IIstituto Clinico Humanitas

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Acute Myocardial Infarction3 trials

Nitrites in Acute Myocardial Infarction

Completed·UUniversity of Aberdeen·Phase 2/3·NCT01388504·200 enrolled

Safety and Effectiveness of Intra-coronary Nitrite in Acute Myocardial Infarction

Completed·BBarts & The London NHS Trust·Phase 2·NCT01584453·80 enrolled

Sodium Nitrite in Acute Myocardial Infarction

Completed·JJohns Hopkins University·Phase 2·NCT00924118·30 enrolled

Infusion2 trials

Nitrite Infusion Studies

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT00102271·36 enrolled

Nitrite Infusion in Healthy Volunteers

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT00103025·12 enrolled

Cardiac Arrest2 trials

Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Completed·UUniversity of Washington·Phase 1·NCT02987088·120 enrolled

Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

Completed·UUniversity of Washington·Phase 2/3·NCT03452917·1,502 enrolled

Sickle Cell Disease2 trials

Therapeutic Application of Intravascular Nitrite for Sickle Cell Disease

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT00095472·18 enrolled

Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers

Terminated·Ccaterina P minniti·Phase 2·NCT02863068·18 enrolled

Heart Failure2 trials

Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction

Completed·GGladwin, Mark, MD·Phase 2·NCT02918552·15 enrolled

Inorganic Nitrite to Amplify the Benefits and Tolerability of Exercise Training in Heart Failure With Preserved Ejection Fraction (HFpEF) (INABLE-Training)

Completed·BBarry Borlaug·Phase 2·NCT02713126·92 enrolled

21 more indications

COVID-191 trial

Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite

Withdrawn·HHope Pharmaceuticals·Phase 2·NCT04401527

Phase 21 trial

A Phase 2a Study to Assess Safety & Pharmacokinetics of Sustained Release Sodium Nitrite in Patients With Diabetic Pain

Completed·TTheraVasc Inc.·Phase 2·NCT02412852·26 enrolled

HAE1 trial

The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation

Unknown status·UUniversity of East Anglia·Phase 1·NCT03077763·41 enrolled

Pulmonary Hypertension1 trial

Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction

Completed·UUniversity of Pittsburgh·Phase 2·NCT03015402·33 enrolled

Cardiac1 trial

Nitrite Effects on Cardiac Muscle in CABG

Unknown status·UUniversity of East Anglia·Phase 2·NCT04001283·75 enrolled

Aging1 trial

Sodium Nitrite to Treat Arterial Aging

Completed·UUniversity of Colorado, Boulder·Phase 1/2·NCT02022670·33 enrolled

Lung Transplant1 trial

Sodium Nitrite in Lung Transplant Patients to Minimize the Risk of Pulmonary Graft Dysfunction

Terminated·GGladwin, Mark, MD·Phase 2·NCT01715883·3 enrolled

Cystic Fibrosis1 trial

Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis

Terminated·SSchmidhofer, Mark, MD·Phase 1/2·NCT02694393·4 enrolled

Blood Pressure1 trial

The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Hypertensive Versus Healthy Subjects

Unknown status·EErling Bjerregaard Pedersen·Phase 1·NCT02527837·30 enrolled

Subarachnoid Hemorrhage1 trial

Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

Terminated·HHope Pharmaceuticals·Phase 2·NCT02176837·6 enrolled

Cardiopulmonary Bypass1 trial

Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass

Withdrawn·UUniversity of Alabama at Birmingham·Phase 3·NCT03331146

Prevention1 trial

Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm

Completed·HHope Pharmaceuticals·Phase 2·NCT00873015·19 enrolled

Chronic Leg Ulcer1 trial

Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT01316796·28 enrolled

Endothelial Dysfunction1 trial

Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial

Completed·TTulane University·Phase 2·NCT02552888·70 enrolled

Asthma1 trial

The Effects of NOx and Conjugated Linoleic Acid on Asthmatics

Completed·GGladwin, Mark, MD·Phase 2·NCT02433977·6 enrolled

Coronary Artery Bypass1 trial

Nitrite Mediated Cardioprotection During Coronary Artery Bypass Surgery

Unknown status·UUniversity Hospital Birmingham NHS Foundation Trust·Phase 2·NCT01098409·50 enrolled

Malaria1 trial

Nitrite Infusion in Children With Malaria

Withdrawn·—·Phase 1·NCT04289558

Metabolism1 trial

Effect of Nitrite on Exercise Physiology and Metabolism

Terminated·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT00105222·15 enrolled

Peripheral Arterial Disease1 trial

Phase IIa: Safety, PK, & Tolerability of Sodium Nitrite in Patients With Peripheral Arterial Disease-SONIC

Completed·TTheraVasc Inc.·Phase 2·NCT01401517·55 enrolled

Function1 trial

Nitrite Supplementation for Improving Physiological Function in Older Adults

Completed·UUniversity of Colorado, Boulder·N/A·NCT02393742·49 enrolled

Unspecified1 trial

The Nitrite and Coronary Flow Study

Completed·UUniversity of East Anglia·Phase 1/2·NCT04354051·14 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 14, 2012

SODIUM NITRITE

NDA NDA203922

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for sodium nitrite. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — sodium nitrite compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for sodium nitrite. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203922). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Hope Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: HHope Pharmaceuticals

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