Nipride

(Sodium Nitroprusside)

ApprovedSmall molecule

Nipride is a small molecule that works as a Soluble Guanylate Cyclase Activator.[2] It is being used across 9 indications, with its most advanced program in Approved.[1]

Nipride is one of 269 small molecule programs targeting Hemorrhage. It is currently in Approved.

Indications

Total Trials

Active Trials

268

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HemorrhageUnknown

Congestive Heart FailureUnknown

Diabetes MellitusActive, not recruiting

HypertensionUnknown

Chronic Kidney DiseaseTerminated

InteractionCompleted

SystemicCompleted

Sex DifferencesCompleted

Hot FlashesActive, not recruiting

HemorrhagePreclinical

Unknown

Congestive Heart FailurePreclinical

Unknown

Diabetes MellitusPreclinical

Active, not recruiting

HypertensionPreclinical

Unknown

Chronic Kidney DiseaseApproved

Terminated

InteractionPreclinical

Completed

SystemicPreclinical

Completed

Sex DifferencesPreclinical

Completed

Hot FlashesPreclinical

Active, not recruiting

Competition

Competitive Landscape

169 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Nipride

EExela Pharma Sciences, LLC.

Approved

3 2

Uloric

Takeda

Preclinical

2 3

Sovaldi

Gilead

Preclinical

1 4

Glucotrol

Pfizer

Preclinical

1 5

Vemlidy

Gilead

Preclinical

1 6

Lorelco

Sanofi

Preclinical

1 7

Activase

Flomax

PROCRIT

1 10

Verquvo

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Hot Flashes

NCT05193968

Q1 2027

Recruiting

Endothelial Function

NCT06443151

Q4 2027

Phase 1Active, not recruiting

Obesity

NCT03318094

Q4 2031

Active, not recruiting

Estrogen

NCT06043310

Clinical

Trials by Indication[1]

Schizophrenia4 trials

A Proof of Concept Study of Intravenous Sodium Nitroprusside in Adults With Symptomatic Schizophrenia

Completed·MMassachusetts General Hospital·Phase 2·NCT02164981·60 enrolled

Sodium Nitroprusside in Early Course Schizophrenia

Terminated·—·Phase 2·NCT04986072·1 enrolled

The Effect of Nitric Oxide on Spatial Working Memory in Patients With Schizophrenia - Pilot Study

Completed·KKing's College London·Phase 1·NCT02176044·21 enrolled

Show 1 more trial

Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia

Completed·UUniversity of Sao Paulo·Phase 2·NCT01548612·20 enrolled

Chronic Kidney Disease3 trials

Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

Completed·WWatson Pharmaceuticals·Phase 4·NCT00224042·52 enrolled

Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients

Completed·WWatson Pharmaceuticals·Phase 4·NCT00224055·89 enrolled

Anemia Study in Chronic Kidney Disease (CKD) : Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat -Forearm Blood Flow (ASCEND-FBF)

Terminated· GSK logo

GSK·Phase 2·NCT03446612·6 enrolled

Heart Failure2 trials

Intravenous Vasodilator vs. Inotropic Therapy in Patients With Heart Failure

Withdrawn·MMontefiore Medical Center·Phase 4·NCT02767024

Inhaled Sodium Nitrite on Heart Failure With Preserved Ejection Fraction

Completed·MMayo Clinic·Phase 2·NCT02262078·26 enrolled

Humans1 trial

Endothelial Hyperpolarization in Humans

Terminated·EEmory University·Phase 2·NCT00166166·174 enrolled

Safety and Efficacy1 trial

Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

Completed·WWatson Pharmaceuticals·Phase 4·NCT00224003·23 enrolled

30 more indications

IBS1 trial

Cheno Effect on Transit in Health and IBS-C

Completed·MMayo Clinic·Phase 2·NCT00912301·36 enrolled

PrEP1 trial

Comparison Between Effects of Two Iron Preparations on Protein in the Urine

Completed·WWatson Pharmaceuticals·Phase 1·NCT00534144·74 enrolled

Hemodynamic1 trial

Ocular Hemodynamic Effects of Nitrovasodilators in Healthy Subjects

Completed·MMedical University of Vienna·N/A·NCT00810381·14 enrolled

Growth1 trial

Nutritional and Contractile Regulation of Muscle Growth

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT00891696·144 enrolled

Microcirculation1 trial

Mechanisms of Human Cutaneous Microcirculation in Healthy Volunteers

Completed·UUniversity Hospital, Angers··NCT00152724·85 enrolled

Sarcopenia1 trial

Insulin and Sarcopenia in the Elderly

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT00690534·88 enrolled

Hot flashes1 trial

Hot Flashes and Neurovascular Function in Women

Recruiting·MMayo Clinic·N/A·NCT05193968·120 enrolled

Intraocular Pressure1 trial

Choroidal Thickness During Changes in Intraocular Pressure and Arterial Blood Pressure

Terminated·MMedical University of Vienna·N/A·NCT01333891·1 enrolled

Skin1 trial

The Effect of Antioxidants on Skin Blood Flow-BH4

Completed·TThe University of Texas at Arlington·Phase 1·NCT03680573·16 enrolled

Cytokines1 trial

Role of Adenosine in the Release of VEGF and Cytokines

Terminated·VVanderbilt University·Phase 1·NCT00580905·8 enrolled

Diabetes Mellitus1 trial

Microvascular Response in Diabetes Mellitus

Unknown status·UUniversity Hospital, Angers··NCT00160927·90 enrolled

Vascular Dysfunction1 trial

Targeting ER Stress in Vascular Dysfunction

Terminated·—·Phase 1·NCT04001647·17 enrolled

Vascular Function1 trial

The Impact of Carbon Monoxide and Altitude on Vascular Function

Completed·UUniversity of Alberta·N/A·NCT04928183·19 enrolled

Obesity1 trial

Role of Sympathetic Vasoconstriction on Insulin-Mediated Microvascular Recruitment and Glucose Uptake in Obesity

Active, not recruiting·VVanderbilt University Medical Center·Phase 1·NCT03318094·36 enrolled

Metabolism1 trial

Muscle Perfusion and Protein Metabolism in Elderly

Completed·TThe University of Texas Medical Branch, Galveston·Phase 1·NCT00945256·62 enrolled

Endothelial Function1 trial

Role of Endothelial Function in SCI CVD Risk

Recruiting·—··NCT06443151·60 enrolled

Hypertension1 trial

Clevidipine in the Perioperative Treatment of Hypertension (ECLISPE-SNP)

Completed· Novartis logo

Novartis·Phase 3·NCT00093912·739 enrolled

Vasodilation1 trial

Pyridoxine, P2 Receptor Antagonism, and ATP-mediated Vasodilation in Young Adults

Completed·—·Phase 1·NCT03738943·9 enrolled

PTSD1 trial

Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV

Suspended·EEmory University·Phase 2·NCT02560805·134 enrolled

Interaction1 trial

Interaction of Apelin and Angiotensin in the Human Forearm Circulation

Completed·UUniversity of Edinburgh·N/A·NCT00901888·12 enrolled

Exercise Training1 trial

Role of Acetylcholine in Blood Flow Regulation in Healthy Adults: Effects of Age and Exercise Training

Withdrawn·—·Phase 1·NCT03972683

Infusion1 trial

Clinical Study Investigating the Effect of Sodium Nitroprusside Infusion on Thyroidal Function

Unknown status·KKavaklıdere Umut Hospital·Phase 4·NCT00636584·106 enrolled

Cancer1 trial

HeartPhone Cancer Survivors Trial 2019

Terminated·PPenn State University·Phase 1/2·NCT03953326·2 enrolled

Vasoconstriction1 trial

The Effect of Endothelin and L-Arginine on Racial Differences in Vasoconstriction

Completed·TThe University of Texas at Arlington·Phase 1·NCT03679780·19 enrolled

Systemic1 trial

Investigating Systemic and Local Vascular Responses to Apelin in the Context of Renin-angiotensin Upregulation

Completed·UUniversity of Edinburgh·N/A·NCT00901719·12 enrolled

Anemia1 trial

Darbepoetin Alfa With or Without Iron in Treating Anemia Caused By Chemotherapy in Patients With Cancer

Completed·MMayo Clinic·Phase 3·NCT00661999·502 enrolled

Sex Differences1 trial

Sex Differences in Sympathetic Vascular Reactivity at High Altitude

Completed·UUniversity of Alberta·N/A·NCT05525416·17 enrolled

Acute Lung Injury1 trial

Safety Study of Nebulized Sodium Nitroprusside in Adult Acute Lung Injury

Unknown status·MMount Sinai Hospital, Canada·Phase 1·NCT01619280·30 enrolled

Estrogen1 trial

Effects of Continuous Estrogen on Human in Vivo Microvascular Function

Active, not recruiting·MMedical College of Wisconsin··NCT06043310·45 enrolled

Unspecified3 trials

Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers

Completed·AAires Pharmaceuticals, Inc.·Phase 1·NCT00814645·25 enrolled

Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects

Completed·AAires Pharmaceuticals, Inc.·Phase 1·NCT01409122·42 enrolled

Effect of C21 on Forearm Blood Flow

Completed·VVicore Pharma AB·Phase 1·NCT05277922·5 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

NIPRIDE

NDA NDA017546

Jan 1, 1982

NITROPRESS

NDA NDA018450

Jul 28, 1982

SODIUM NITROPRUSSIDE

NDA NDA018581

Mar 8, 2017

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%

NDA NDA209387

Dec 7, 2017

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%

NDA NDA209387

May 23, 2018

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%

NDA NDA209387

Jul 13, 2018

NIPRIDE RTU IN SODIUM CHLORIDE 0.9%

NDA NDA209387

Sources

References

[1]
ClinicalTrials.gov — 43 trial records for Sodium Nitroprusside. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Sodium Nitroprusside compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Sodium Nitroprusside. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209387). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Exela Pharma Sciences, LLC. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Soluble Guanylate Cyclase Activator[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: EExela Pharma Sciences, LLC.

Nipride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q4 2031

Trials by Indication[1]

Schizophrenia4 trials

Chronic Kidney Disease3 trials

Heart Failure2 trials

Humans1 trial

Safety and Efficacy1 trial

IBS1 trial

PrEP1 trial

Hemodynamic1 trial

Growth1 trial

Microcirculation1 trial

Sarcopenia1 trial

Hot flashes1 trial

Intraocular Pressure1 trial

Skin1 trial

Cytokines1 trial

Diabetes Mellitus1 trial

Vascular Dysfunction1 trial

Vascular Function1 trial

Obesity1 trial

Metabolism1 trial

Endothelial Function1 trial

Hypertension1 trial

Vasodilation1 trial

PTSD1 trial

Interaction1 trial

Exercise Training1 trial

Infusion1 trial

Cancer1 trial

Vasoconstriction1 trial

Systemic1 trial

Anemia1 trial

Sex Differences1 trial

Acute Lung Injury1 trial

Estrogen1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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