Monopril

(Fosinopril)

ApprovedSmall molecule

Bristol-Myers Squibb

Monopril is one of 118 small molecule programs targeting Hyperinsulinemia. It is currently in Approved.

Indications

Total Trials

Active Trials

117

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

HyperinsulinemiaActive, not recruiting

Chronic Obstructive Pulmonary DiseaseActive, not recruiting

Chronic Kidney DiseaseUnknown status

Fasting ConditionsCompleted

FedCompleted

HyperinsulinemiaPreclinical

Active, not recruiting

Chronic Obstructive Pulmonary DiseaseApproved

Active, not recruiting

Chronic Kidney DiseaseApproved

Unknown status

Fasting ConditionsPreclinical

Completed

FedPreclinical

Completed

Competition

Competitive Landscape

169 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Monopril

Bristol-Myers Squibb

Approved

2 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

Januvia

ZZydus Therapeutics Inc.

Preclinical

1 10

Baraclude

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

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

Clinical

Trials by Indication[1]

Chronic Kidney Disease2 trials

Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients With Hypertension

Unknown status·SShanghai Changzheng Hospital·Phase 4·NCT02646397·508 enrolled

A Pilot Randomized Clinical Trial to Assess Feasibility, Safety, and Efficacy of Rapid, Simultaneous Therapy Initiation in Chronic Kidney Disease and Type 2 Diabetes: RAPID-CKD

Enrolling by invitation·BBaylor Research Institute·Approved·NCT07547878·64 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Angiotensin-converting Enzyme (ACE)-Inhibition and Mechanisms of Skeletal Muscle Weakness in Chronic Obstructive Pulmonary Disease (COPD)

Completed·IImperial College London·Phase 4·NCT01014338·80 enrolled

Albuminuria1 trial

Eplerenone, ACE Inhibition and Albuminuria

Completed·RRadboud University Medical Center·Phase 2·NCT00315016·30 enrolled

Hyperinsulinemia1 trial

The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension

Completed·—·N/A·NCT01342614·140 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Fosinopril 40mg Tablets Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00776334·40 enrolled

3 more indications

Fed1 trial

Bioequivalence Study of Fosinopril 40mg Tablets Under Fed Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00776672·24 enrolled

Cardiovascular Risk Factor1 trial

ACE Inhibition and Novel Cardiovascular Risk Factors

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00051389

Prevention1 trial

Prevention of Renal and Vascular Endstage Disease Intervention Trial

Completed·UUniversity Medical Center Groningen·Phase 3·NCT03073018·864 enrolled

Regulatory

FDA Approval Timeline[4]

May 16, 1991

MONOPRIL

NDA NDA019915

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for Fosinopril. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fosinopril compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fosinopril. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA019915). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Bristol-Myers Squibb

Monopril

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Chronic Kidney Disease2 trials

Chronic Obstructive Pulmonary Disease1 trial

Albuminuria1 trial

Hyperinsulinemia1 trial

Fasting Conditions1 trial

Fed1 trial

Cardiovascular Risk Factor1 trial

Prevention1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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