Normodyne

(Labetalol)

ApprovedSmall molecule

Normodyne is a small molecule that works as Adrenergic Receptor Antagonist.[2] It is being used across 12 indications, with its most advanced program in Approved.[1]

Normodyne is one of 355 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

354

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Nicotine DependenceApproved

Severe Pre-EclampsiaApproved

SinusitisApproved

StrokeActive, not recruiting

Cocaine DependenceApproved

Intracerebral HemorrhageApproved

HypertensionActive, not recruiting

PreeclampsiaActive, not recruiting

MigraineActive, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Nicotine DependenceApproved

Approved

Severe Pre-EclampsiaApproved

Approved

SinusitisApproved

Approved

StrokePhase 2

Active, not recruiting

Cocaine DependenceApproved

Approved

Intracerebral HemorrhageApproved

Approved

HypertensionApproved

Active, not recruiting

PreeclampsiaPhase 1

Active, not recruiting

MigrainePhase 3

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

566 competitors in Hypertension

#DrugCompanyPhaseTrials

Normodyne

AAlvogen Korea

Approved

7 2

Apresoline

Novartis

Preclinical

7 3

Zebeta

Teva

Preclinical

6 4

Deltavit

HHyundai Pharmaceutical Co., LTD.

Preclinical

2 5

Avastin

BBio-Thera Solutions

Preclinical

1 6

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 7

Disalcid

JJoslin Diabetes Center

Preclinical

1 8

Vivarin

HHikma Pharmaceuticals LLC

Salbutamol

1 10

Glucocorticoids

Novartis

Preclinical

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

Timeline

Expected Milestones

Q3 2027

Recruiting

Infants

NCT03511118

Q4 2027

Post-ApprovalRecruiting

Hypertension

NCT05139238

Phase 3Recruiting

Hypertension

NCT05551104

Clinical

Trials by Indication[1]

Hypertension7 trials

Comparison of Tab.Labetalol and Tab.Nifedipine for Management of Postpartum Hypertension

Unknown status·—·Phase 3·NCT02426177·98 enrolled

Oral Antihypertensive Regimens for Management of Hypertension in Pregnancy

Completed·GGynuity Health Projects·Phase 4·NCT01912677·894 enrolled

Postpartum Hypertension Study

Recruiting·—·Phase 4·NCT05139238·104 enrolled

Show 4 more trials

Treatment Targets for Chronic Hypertension in Pregnancy

Withdrawn·WWeill Medical College of Cornell University·Phase 1/2·NCT00194974

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

Completed·—·Phase 2·NCT02050529·190 enrolled

Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

Recruiting·LLoma Linda University·Phase 3·NCT05551104·500 enrolled

Labetalol or Nifedipine for Control of Postpartum Hypertension: A Randomized Controlled Trial

Recruiting·NNebraska Methodist Health System·Phase 4·NCT05309460·600 enrolled

Hypertensive4 trials

Changes in Central Arterial Pressure When Comparing ACOG Hypertensive Urgency Protocols

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

PEACE Trial: Postpartum Evaluation of Antihypertensive Cessation and Efficacy

Not yet recruiting·UUniversity of California, Los Angeles·Phase 4·NCT06915792·110 enrolled

Response to Anti-hypertensives in Pregnant and Postpartum Patients

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT03506724·109 enrolled

Show 1 more trial

Postpartum Management of Gestational Hypertensive Disorders Using Furosemide

Terminated·WWright State University·Phase 4·NCT04343235·13 enrolled

Pregnancy4 trials

Early Vascular Adjustments During Hypertensive Pregnancy

Unknown status·MMaastricht University Medical Center·Phase 4·NCT02531490·368 enrolled

Treatment of Elevated Blood Pressures in Early Pregnancy

Terminated·MMarshall University·Phase 2·NCT05955040·2 enrolled

Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy

Recruiting·MMarshall University··NCT04755764·60 enrolled

Show 1 more trial

Hydralazine Versus Labetalol for the Management of Hypertensive Disorders of Pregnancy

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

Stroke3 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

A Comparison of Nicardipine and Labetalol for Blood Pressure Control in Intensive Care Patients After Hemorrhagic Stroke Brain Surgery

Completed·UUniversitas Sumatera Utara·N/A·NCT07364201·30 enrolled

Hypotension2 trials

Effects of Nitroglycerin Versus Labetalol on Tissue Perfusion During Deliberate Hypotension

Completed·—·Phase 4·NCT03809065·40 enrolled

The Efficacy of Dexmedetomidine Versus Labetalol In Providing Controlled Hypotension In Dacryocystorhinostomy SurgeryA Comparative Randomized Prospective Study

Recruiting·SSohag University·N/A·NCT06346561·50 enrolled

18 more indications

CAR2 trials

Nicardipine Versus Labetalol During Intubation

Unknown status·SSeoul National University Bundang Hospital·N/A·NCT01041066·70 enrolled

Nicardipine vs. Labetalol

Completed·HHaseki Training and Research Hospital·Phase 4·NCT07277283·34 enrolled

Intravenous2 trials

Evaluation of Intravenous Cardene(Nicardipine)and Labetalol Use in the Emergency Department

Completed·TThe Cleveland Clinic·Phase 4·NCT00765648·226 enrolled

Comparative Study of Intravenous Labetalol Versus Intravenous Nitroglycerin Versus Sublingual Nifedipine

Unknown status·SSohag University·N/A·NCT06265415·60 enrolled

Hypotensive Anesthesia2 trials

Effect of Hypotensive Anesthesia on the Perfusion Index

Completed·—·Phase 1·NCT03059316·40 enrolled

Hypotensive Anesthesia for Orthognathic Surgery

Active, not recruiting·—·Phase 4·NCT06093893·90 enrolled

Preeclampsia2 trials

Intravenous Labetalol vs Phentolamine for the Management of Severe Preeclampsia.

Not yet recruiting·—·N/A·NCT06385600·200 enrolled

Intravenous Labetalol Versus Hydralazine in Preeclampsia

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

Laparoscopic Cholecystectomy1 trial

Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy

Recruiting·—·N/A·NCT07192081·116 enrolled

Post Operative Pain1 trial

Labetalol and Esmolol: Vital Signs and Post Operative Pain Management

Completed·—·Phase 4·NCT01114971·75 enrolled

Eclampsia1 trial

Oral Nifedipine Versus IV Labetalol in Severe Pre Eclampsia

Unknown status·SServices Institute of Medical Sciences, Pakistan·Phase 2/3·NCT03325348·194 enrolled

AIN1 trial

Effects of Labetalol on Human Cocaine Use - 8

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000291

Dexmedetomidine1 trial

Dexmedetomidine vs Labetalol for Airway Stress in Hypertensive Craniotomy Patients

Enrolling by invitation·—·Phase 4·NCT07034898·60 enrolled

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Sinus Surgery1 trial

Esmolol vs. Labetalol in Endoscopic Sinus Surgery

Completed·TThe University of Texas Medical Branch, Galveston·Phase 2·NCT03661346·28 enrolled

Intraoperative1 trial

The Effect of Intraoperative Labetalol on Time to Discharge

Completed·—·Phase 2·NCT02997800·172 enrolled

Oral1 trial

Oral Nifedipine Versus Oral Labetalol

Completed·—·N/A·NCT02168309·50 enrolled

Humans1 trial

Effects of Labetalol on Nicotine Administration in Humans - 14

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00000297

Blood Pressure1 trial

Control of Emergence Blood Pressure During Craniotomy for Tumor Surgery Between Labetolol and Diltiazem

Completed·MMahidol University·Phase 1/2·NCT01408524·184 enrolled

Ischemic stroke1 trial

Perfusion and Antihypertensive Therapy in Acute Ischemic Stroke

Completed·UUniversity of Alberta·Phase 2·NCT02327793·65 enrolled

Magnesium Sulfate1 trial

Labetalol Versus Magnesium Sulfate (MgSO4) for the Prevention of Eclampsia Trial

Withdrawn·—·Phase 2/3·NCT00293735

Migraine1 trial

BHV3500-301: Zavegepant Nasal Spray in Migraine

Completed· Pfizer logo

Pfizer·Phase 3·NCT04688203·1,405 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 1, 1984

NORMODYNE

NDA NDA018686

May 24, 1985

TRANDATE

NDA NDA018716

Dec 31, 1985

TRANDATE

NDA NDA019425

Aug 31, 1987

NORMODYNE

NDA NDA018687

Mar 18, 2022

LABETALOL HYDROCHLORIDE

NDA NDA213330

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for Labetalol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Labetalol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Labetalol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213330). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Alvogen Korea company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAlvogen Korea

Normodyne

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Trials by Indication[1]

Hypertension7 trials

Hypertensive4 trials

Pregnancy4 trials

Stroke3 trials

Hypotension2 trials

CAR2 trials

Intravenous2 trials

Hypotensive Anesthesia2 trials

Preeclampsia2 trials

Laparoscopic Cholecystectomy1 trial

Post Operative Pain1 trial

Eclampsia1 trial

AIN1 trial

Dexmedetomidine1 trial

Infants1 trial

Sinus Surgery1 trial

Intraoperative1 trial

Oral1 trial

Humans1 trial

Blood Pressure1 trial

Ischemic stroke1 trial

Magnesium Sulfate1 trial

Migraine1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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