Sodium Nitrite

(Nitrite)

Phase 2Small molecule

OOrthopedic Foot and Ankle Center, Ohio

Sodium Nitrite is one of 69 small molecule programs targeting Cardiac Arrest. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cardiac ArrestActive, not recruiting

Heart FailureActive, not recruiting

Cardiac ArrestPhase 1

Active, not recruiting

Heart FailurePhase 2

Active, not recruiting

Competition

Competitive Landscape

687 competitors in Heart Failure

#DrugCompanyPhaseTrials

Sodium Nitrite

OOrthopedic Foot and Ankle Center, Ohio

Phase 2

1 2

Amidate

Pfizer

Preclinical

1 3

Monoferric

PPharmacosmos A/S

Preclinical

5 4

Zemplar

AbbVie

Preclinical

—5

Bystolic

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

4 6

Xifaxan

SSalix

Preclinical

2 7

Zoloft

VViatris Specialty LLC

Preclinical

2 8

Coumadin

AAbbott

Preclinical

1 9

Thiazolidinediones

Sanofi

Preclinical

1 10

Alpha-Glucosidase Inhibitors

Sanofi

Preclinical

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

Clinical

Trials by Indication[1]

Function1 trial

Haemodynamic Effects of Dobutamine and Nitrite in LV Dysfunction

Unknown status·KKing's College London··NCT02888561·45 enrolled

Altitude1 trial

Three New Ideas to Protect Special Forces From the Stress of High Altitude

Completed·UUniversity of Colorado, Denver·Phase 4·NCT02463357·148 enrolled

Heart Failure1 trial

Acute Effects of Inorganic Nitrite on Cardiovascular Hemodynamics in Heart Failure With Preserved Ejection Fraction

Completed·BBarry Borlaug·Phase 2·NCT01932606·28 enrolled

Cardiac Arrest1 trial

Pilot Study of Sodium Nitrite in Resuscitated Cardiac Arrest Patients

Completed·UUniversity of Washington·Phase 1·NCT01178359·11 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 14, 2012

SODIUM NITRITE

NDA NDA203922

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Nitrite. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nitrite compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nitrite. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203922). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Sodium Nitrite. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Orthopedic Foot and Ankle Center, Ohio company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: OOrthopedic Foot and Ankle Center, Ohio

Patent Landscape[5]

Patent Cliff

Feb 10, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9687506Feb 10, 2030

8568793Dec 24, 2031

Sodium Nitrite

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Function1 trial

Altitude1 trial

Heart Failure1 trial

Cardiac Arrest1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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