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Apresoline

(Hydralazine)

Phase 3Small molecule

Hydralazine is a medication used to lower high blood pressure by relaxing blood vessels, allowing blood to flow more easily through the body. It helps prevent serious complications like heart disease, stroke, and kidney damage that can result from untreated high blood pressure.[1] Apresoline is currently being investigated across 6 indications[3], with its most advanced program in Phase 3.[1]

Apresoline is one of 139 small molecule programs targeting Stroke. It is currently in Phase 3.

6

Indications

18

Total Trials

2

Active Trials

138

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

StrokeActive, not recruiting

Polycystic Kidney DiseaseActive, not recruiting

HypertensionActive, not recruiting

PreeclampsiaActive, not recruiting

Breast CancerActive, not recruiting

Heart FailureActive, not recruiting

StrokePhase 2

Active, not recruiting

Polycystic Kidney DiseasePhase 1

Active, not recruiting

HypertensionPreclinical

Active, not recruiting

PreeclampsiaPhase 1/Phase 2

Active, not recruiting

Breast CancerPhase 1/Phase 2

Active, not recruiting

Heart FailurePhase 3

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Apresoline

Avastin

BBio-Thera Solutions

MS Contin

Voltaren

MS Contin

HHikma Pharmaceuticals LLC

Zinecard

CChildren's Oncology Group

Recentin

NNational Cancer Institute (NCI)

Tricor

Recombinant Human Endostatin

PPeking University Third Hospital

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Treatment

NCT06218199

Clinical

Trials by Indication[1]

Hypertension7 trials

Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT00000499

Black Education and Treatment of Hypertension (BEAT HTN)

Completed·—·Phase 4·NCT00661895·99 enrolled

Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension

Terminated·UUniversity of Chicago·N/A·NCT00607477·2 enrolled

Show 4 more trials

Treatment of Supine Hypertension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223717·152 enrolled

Randomized Controlled Trial of Labetalol Versus Hydralazine for Severe Hypertension in Obstetric Patients.

Completed·—·Phase 2·NCT02050529·190 enrolled

Efficacy of Nifedipine Versus Hydralazine in Management of Severe Hypertension in Pregnancy

Completed·AAdebayo Joshua Adeniyi·N/A·NCT04435210·69 enrolled

Sildenafil and Exercise Capacity in Hypertension

Completed·UUniversity of Edinburgh·N/A·NCT00599235·30 enrolled

Stroke2 trials

Blood Pressure Management in Stroke Following Endovascular Treatment

Completed·HHamilton Health Sciences Corporation·Phase 2·NCT04484350·30 enrolled

Blood Pressure After Endovascular Stroke Therapy-II

Completed·UUniversity of Cincinnati·Phase 2·NCT04116112·120 enrolled

Breast Cancer1 trial

Hydralazine as Demethylating Agent in Breast Cancer

Withdrawn·UUniversity of Arkansas·Phase 1/2·NCT00575978

CAR1 trial

Nitrates In Combination With Hydralazine in cardiorEnal Syndrome (NICHE) Study

Unknown status·NNational University Hospital, Singapore·Phase 3·NCT02343393·100 enrolled

Treatment1 trial

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Recruiting·HHeart Center Research, LLC·Phase 4·NCT06218199·80 enrolled

6 more indications

Heart Failure1 trial

Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure

Unknown status·UUniversity of Cape Town·Phase 3·NCT01822808·500 enrolled

Hypertensive1 trial

Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols

Withdrawn·SSt. Louis University·N/A·NCT02933593

Polycystic Kidney Disease1 trial

Assessing a Dose-Response Relationship of Hydralazine and Its Effects on DNA Methyltransferase 1 in Polycystic Kidney Disease Patients

Completed·UUniversity of Kansas Medical Center·Phase 1·NCT03423810·14 enrolled

Pregnancy1 trial

Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

Completed·SSaint Thomas Hospital, Panama·Phase 3·NCT01538875·261 enrolled

Preeclampsia1 trial

Intravenous Labetalol Versus Hydralazine in Preeclampsia

Recruiting·TTanta University·Phase 1/2·NCT06360601·40 enrolled

Rectal Cancer1 trial

Hydralazine as a Demethylating Agent in Rectal Cancer

Withdrawn·UUniversity of Arkansas·Phase 1/2·NCT00575640

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

APRESOLINE

NDA NDA008303

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Hydralazine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Hydralazine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Hydralazine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA008303). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

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