Nitrite

Generic Name: Nitrite

Drug Type: Small Molecule

Chemical Formula: NO_₂

CAS Number: 14797-65-0

Unique Ingredient Identifier: J39976L608

Overview

Nitrite is under investigation for the treatment of Heart Failure.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy	2021/05/27	NCT04905173	Not Applicable	Withdrawn	Mayo Clinic
Treatment of Lung Injury From COVID-19 Infection With Intravenous Sodium Nitrite	2020/05/26	NCT04401527	Phase 2	Withdrawn	Hope Pharmaceuticals
The Nitrite and Coronary Flow Study	2020/04/21	NCT04354051	Phase 1	Completed	University of East Anglia
Nitrite Infusion in Children With Malaria	2020/02/28	NCT04289558	Phase 1	Withdrawn	Duke University
Nitrite Effects on Cardiac Muscle in CABG	2019/06/28	NCT04001283	Phase 2	UNKNOWN	University of East Anglia
Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass	2017/11/06	NCT03331146	Phase 3	Withdrawn	University of Alabama at Birmingham
The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation	2017/03/13	NCT03077763	Phase 1	UNKNOWN	University of East Anglia
Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction	2017/01/10	NCT03015402	Phase 2	Completed	University of Pittsburgh
Phase 1 Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest	2016/12/08	NCT02987088	Phase 1	Completed	University of Washington
Oral Nitrite for Older Heart Failure With Preserved Ejection Fraction	2016/09/29	NCT02918552	Phase 2	Completed	Gladwin, Mark, MD

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sodium Nitrite	Hope Pharmaceuticals	60267-311	INTRAVENOUS	30 mg in 1 mL	1/20/2021
FRAICHE 5000 SENSITIVE	True Marker Pharmaceuticals, Inc.	83592-816	TOPICAL	4.5 g in 100 g	3/14/2024

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
HOPE PHARMACEUTICALS SODIUM NITRITE INJECTION sodium nitrite 300 mg/10 mL solution for injection vial	276671	Hope Pharmaceuticals Pty Ltd	Medicine	A	5/16/2017
OPTHALMIC LABS SODIUM NITRITE 3% 300mg/10mL injection	23074	Phebra Pty Ltd	Medicine	A	10/14/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
SODIUM NITRITE INJECTION, USP	HOPE PHARMACEUTICALS LTD	02440466	Solution - Intravenous	30 MG / ML	7/20/2016

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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