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sodium nitrite

Small moleculeapprovedOrphan Drug FDA

Approved

Jan 14, 2011

Sodium nitrite is an inorganic compound with the chemical formula NaNO2. It is a white to slightly yellowish crystalline powder that is very soluble in water and is hygroscopic. From an industrial perspective, it is the most important nitrite salt. It is a precursor to a variety of organic compounds, such as pharmaceuticals, dyes, and pesticides, but it is probably best known as a food additive used in processed meats and in fish products. — Wikipedia

Clinical trial activity

54 trials · 39 clinical orgs · 1 marketing orgs

Phase 1
20
Phase 2
33
Phase 3
5
Phase 4
0

Earliest trial started Oct 1, 2002 (NCT00048477)

Timeline

2000s

  1. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  3. Apr 9, 2008

    Orphan Drug Designation

2010s

  1. Jan 14, 2011

    Earliest FDA Approval

  2. Jan 14, 2011

    Hope Pharmaceuticals — NDA Secondary Org

  3. Feb 4, 2012

    Hope Pharmaceuticals — First NDA Organization

  4. Feb 4, 2012

    Hope Pharmaceuticals — NDA Organization

  5. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

  • Unspecified targetUnclear

    unclear

Combination products

Approval history

  • approvedPriority reviewJan 14, 2011

Chemistry & pharmacology

Loading structure…

SMILES

O=N[O-].[Na+]
Mol. weight
69 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • e250
  • e250
  • nitrite sodium
  • nitrous acid, sodium salt
  • nitrous acid, sodium salt
  • nitrous acid, sodium salt
  • nitrous acid, sodium salt
  • nitrous acid, sodium salt
  • nitrous acid, sodium salt
  • sodium nitrite
  • sodium nitrite
  • sodium nitrite
  • sodium nitrite
  • sodium nitrite
  • sodium nitrite
  • sodium nitrite
  • sodium nitrite

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05893160Phase 1Feb 1, 2024University of Alabama, Birmingham
NCT05798481Early Phase 1 (Phase 1)Jan 1, 2024University of Alabama, Birmingham
NCT06041919Phase 2Sep 27, 202330 Technology
NCT05101915Phase 2Nov 1, 2021Papworth Hospital NHS Foundation Trust
NCT04858451Phase 2Apr 30, 202130 Technology
NCT04842331Phase 2/Phase 3 (Phase 3)Apr 30, 202130 Technology
NCT04405180Phase 2Aug 1, 2020National Institute on Aging (NIA), National Institutes of Health (NIH), University of Pittsburgh
NCT04460183Phase 2/Phase 3 (Phase 3)Jul 29, 202030 Technology
NCT04401527Phase 2Jun 30, 2020Hope Pharmaceuticals
NCT04289558Phase 1Apr 1, 2020Duke University, National Heart, Lung, and Blood Institute (NHLBI)
NCT03331146Phase 3Oct 1, 2018University of Alabama, Birmingham
NCT04354051Phase 1/Phase 2 (Phase 2)Jul 1, 2018Imperial College London, University of East Anglia
NCT03452917Phase 2/Phase 3 (Phase 3)Feb 8, 2018National Heart, Lung, and Blood Institute (NHLBI), University of Washington
NCT03015402Phase 2Jun 1, 2017National Heart, Lung, and Blood Institute (NHLBI), University of Pittsburgh
NCT02517697Phase 2Jun 1, 2017University of Pittsburgh
NCT02918552Phase 2Jan 1, 2017National Institute on Aging (NIA), University of Pittsburgh
NCT02987088Phase 1Dec 1, 2016University of Washington
NCT03077763Phase 1Dec 1, 2016University of East Anglia
NCT02863068Phase 2Nov 1, 2016Yeshiva University
NCT02713126Phase 2Sep 1, 2016Aires Pharmaceuticals, Inc., Mast Therapeutics, Mayo Clinic, National Heart, Lung, and Blood Institute (NHLBI)
Showing 20 of 54 trials
Page 1 / 3

Organizations

Research & Development (39)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Heart, Lung, and Blood Institute (NHLBI)Government11532002
University of PittsburghAcademic/Hospital101022011
Aires Pharmaceuticals, Inc.For profit7422008
Hope PharmaceuticalsFor profit5312009
30 TechnologyFor profit4422020
Mayo ClinicAcademic/Hospital3212014
TheraVasc Inc.For profit3212011
University of Alabama, BirminghamAcademic/Hospital3322018
University of East AngliaAcademic/Hospital3322013
Aarhus UniversityAcademic/Hospital2212013
Baylor UniversityAcademic/Hospital2012012
Duke UniversityAcademic/Hospital2222016
Mast TherapeuticsFor profit2012016
National Institute of Neurological Disorders and Stroke (NINDS)Government2122005
National Institute on Aging (NIA)Government2012017
National Institutes of Health (NIH)Government2122004
University of AberdeenAcademic/Hospital2122010
University of BirminghamAcademic/Hospital2122010
University of Colorado, BoulderAcademic/Hospital2222011
University of LondonAcademic/Hospital2022011
39 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
Hope PharmaceuticalsFor profitNDA2Jan 14, 2011
Hope PharmaceuticalsFor profitNDAFeb 4, 2012