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Ephedrine Sulfate

(Ephedrine)

ApprovedSmall molecule

DDr. Reddys Laboratories, SA

Ephedrine is used to treat low blood pressure and to relieve symptoms of asthma and congestion by opening airways and improving breathing. It can also help with nasal congestion and wheezing.[2] Ephedrine Sulfate is currently approved and in use across 20 indications[4].[1]

Ephedrine Sulfate is one of 381 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

20

Indications

68

Total Trials

6

Active Trials

380

Competitors

6

FDA Applications

NDA/BLA/ANDA regulatory filings

7

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Gestational DiabetesActive, not recruiting

Cognitive ImpairmentApproved

BradycardiaActive, not recruiting

Brain InjuryActive, not recruiting

DeliriumActive, not recruiting

Nasal CongestionActive, not recruiting

Nausea and VomitingActive, not recruiting

Congenital Myasthenic SyndromesApproved

Congenital Myasthenic SyndromeApproved

Cardiovascular DiseaseApproved

Active, not recruiting

Gestational DiabetesPreclinical

Active, not recruiting

Cognitive ImpairmentApproved

Approved

BradycardiaApproved

Active, not recruiting

Brain InjuryPhase 2/Phase 3

Active, not recruiting

DeliriumPreclinical

Active, not recruiting

Nasal CongestionApproved

Active, not recruiting

Nausea and VomitingPhase 2

Active, not recruiting

Congenital Myasthenic SyndromesApproved

Approved

Congenital Myasthenic SyndromeApproved

Approved

Showing 10 of 18 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Ephedrine Sulfate

DDr. Reddys Laboratories, SA

Veramyst

Xolair

Singulair

Nucala

GGlaxo Dba Glaxosmithkline

Cinqair

Dupixent

AAzienda U.S.L. 1 di Massa e Carrara

Asmanex

Celexa

Spiriva

Boehringer Ingelheim

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

Timeline

Expected Milestones

Q4 2026

N/AActive, not recruiting

Intravenous

NCT03620942

Clinical

Trials by Indication[1]

Hypotension12 trials

Closed-loop Double-vasopressor Automated System to Treat Hypotension During Spinal Anaesthesia for Caesarean Section

Completed·KKK Women's and Children's Hospital·Phase 2/3·NCT04025918·216 enrolled

Ephedrine and Phenylephrine for Spinal Hypotension

Completed·—·Phase 2/3·NCT03047109·60 enrolled

Evaluation of Post-Induction Hypotension Treatment with PRAM Method

Active, not recruiting·—··NCT06787404·100 enrolled

Show 9 more trials

Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients

Completed·—·N/A·NCT02542748·66 enrolled

Maternal and Neonatal Outcomes of the Use of Vasopressors to Treat Hypotension During Spinal Anesthesia for Cesarean

Withdrawn·IInstituto Materno Infantil Prof. Fernando Figueira·Phase 3·NCT01451060

Norepinephrine Versus Ephedrine in Treatment of Hypotension During Spinal Anesthesia for Caesarean Section

Completed·MMongi Slim Hospital·N/A·NCT03163407·110 enrolled

Ephedrine Versus Phenylephrine for Spinal Block - Related Hypotension in Cesarean Delivery

Completed·CCentre of Postgraduate Medical Education··NCT06741410·94 enrolled

Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting

Completed·RRatiopharm GmbH··NCT02893241·2,013 enrolled

Comparative Efficacity of Ephedrine Versus Norepinephrine to Correct Anesthesia Induction Related Hypotension

Unknown status·—·Phase 3·NCT05497700·60 enrolled

Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery

Completed·—·Phase 1·NCT07034911·100 enrolled

Management of Post-Induction Hypotension in Emergency Abdominal Surgery

Terminated·HHopital Charles Nicolle·Phase 4·NCT07259655·100 enrolled

Intramuscular Ephedrine in the Prevention of Hypotension in Patients Undergoing Spinal Anesthesia

Unknown status·HHospital de Base·Phase 4·NCT05498857·202 enrolled

Cesarean Section12 trials

Management of Postspinal Anesthesia Hypotension During Elective Cesarean Section: Baby Norepinephrine Versus Ephedrine

Recruiting·HHopital Charles Nicolle·N/A·NCT06498076·126 enrolled

The Effect of Low-dose Atropine on Sympathetic Blockade in Spinal Cesarean Section Patients

Completed·—·Phase 4·NCT05892913·60 enrolled

Could Ephedrine Replace Dexmedetomidine Fordexmedetomidine Prevention of Shivering in Women Undergoing Cesarean Section Under Spinal Anaesthesia

Unknown status·—·N/A·NCT06233032·200 enrolled

Show 9 more trials

Colloid Pre-Loading on D-Dimer During Cesarean Section Under Spinal Anesthesia

Completed·—·Phase 2·NCT02622126·60 enrolled

Manging Post Spinal Hypotension During Elective Cesarean Section

Completed·BBen marzouk Sofiene·Phase 4·NCT03704909·143 enrolled

Effect of Ephedrine vs. Norepinephrine on Prevention of Fetal Acidosis During Cesarean Section Under Spinal Anesthesia

Completed·Mmehmet özkılıç·Phase 4·NCT06921473·102 enrolled

Prophylaxis Ephedrine or Ondansetron Prevents Hypotension After Spinal Anesthesia for Cesarean Section

Completed·MMahidol University·N/A·NCT02194192·168 enrolled

Ephedrine Doses to Prevent Maternal Hypotension After Spinal Anesthesia in Cesarean Section

Completed·—·Phase 4·NCT06668337·120 enrolled

Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section

Unknown status·MMongi Slim Hospital·Phase 4·NCT03719625·200 enrolled

Ephedrine vs. Nor Epinephrine Infusion in Preventing Hypotension After Spinal Anesthesia for Cesarean Section

Completed·UUniversity Tunis El Manar·Phase 4·NCT02477501·120 enrolled

Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section

Completed·MMansoura University··NCT04370847·100 enrolled

Comparative Study Among Different Doses of Ephedrine During Elective Cesarean Section Under Subarachnoid Block.

Completed·—·Phase 4·NCT05993182·300 enrolled

Spinal Anesthesia4 trials

Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

Unknown status·IInstitut Kassab d'Orthopédie·N/A·NCT02428257·120 enrolled

Comparison of Phenylephrine and Ephedrine in the Treatment of Hemodynamic Disorders After Spinal Anesthesia in the Elderly

Completed·MMedical University of Warsaw·N/A·NCT03858465·50 enrolled

Single Bolus Intravenous Ephedrine Attenuates Reduction of Core Body Temperature in Patients Undergoing Spinal Anesthesia for Arthroscopic Knee and Ankle Surgery

Completed·RRamathibodi Hospital·N/A·NCT02948920·40 enrolled

Show 1 more trial

Phenylephrine in Spinal Anesthesia in Preeclamptic Patients

Completed·NNorthwestern University·N/A·NCT00458003·110 enrolled

Cesarean Delivery3 trials

Prophylactic Perioperative Infusion of Ephedrine Versus Noradrenaline in Patients Undergoing Cesarean Delivery Under Spinal Anesthesia

Completed·TTanta University·N/A·NCT07067944·100 enrolled

Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery

Completed·MMansoura University·N/A·NCT02961842·200 enrolled

Changes in Cardiac Output During Cesarean Delivery Under Spinal Anesthesia

Completed·MMansoura University··NCT05269537·60 enrolled

Major Abdominal Surgery2 trials

HIgh Versus STAndard Blood Pressure Target in Hypertensive High-risk Patients Undergoing Major Abdominal Surgery

Completed·HHumanitas Clinical and Research Center·N/A·NCT05637606·636 enrolled

Evaluation of the Early Use of Norepinephrine in Major Abdominal Surgery on Postoperative Organ Dysfunction

Completed·—·Phase 3·NCT05276596·500 enrolled

30 more indications

Caesarean Section2 trials

Intrathecal Levobupivacaine With Opioids for Caesarean Section

Completed·—·Phase 3·NCT01858090·93 enrolled

The Oxygenation of the Brain During Caesarean Section

Completed·NNaestved Hospital·Phase 4·NCT01509521·24 enrolled

Preeclampsia2 trials

Phenylephrine Versus Ephedrine in Pre-eclampsia

Terminated·—·Phase 4·NCT02025426·13 enrolled

Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery

Completed·MMansoura University·N/A·NCT03252496·140 enrolled

Carotid Endarterectomy2 trials

Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (TCD Part)

Completed·—·N/A·NCT05665881·90 enrolled

Effects of Vasopressors on Cerebral Hemodynamics in Patients With Carotid Endarterectomy (MRI Part)

Unknown status·—·N/A·NCT05414877·60 enrolled

General Anesthesia2 trials

Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.

Completed·HHelse Fonna·Phase 4·NCT03864094·128 enrolled

Biphasic Effects of Different Doses Ephedrine on Hemodynamics in Elderly Patients Under General Anesthesia

Unknown status·YYangzhou University·N/A·NCT04934852·70 enrolled

ESS2 trials

Vasopressor Effects in Anesthetized Patients

Completed·UUniversity of Aarhus·Phase 4·NCT02713087·48 enrolled

Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study

Recruiting·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT04053478·144 enrolled

Closed-Loop1 trial

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability

Completed·KKK Women's and Children's Hospital·Phase 2/3·NCT02277730·252 enrolled

Cardiac1 trial

Ephedrine, Phenylephrine and Metaraminol Effects on Maternal Cardiac Output, Uterine Blood Flow and Fetal Circulation

Unknown status·UUniversity of Sao Paulo General Hospital·N/A·NCT02245191·60 enrolled

Monitored Anaesthesia Care1 trial

Comparison of Remifentanil and Dexmedetomidine for Monitored Anaesthesia Care During Vertebroplasty and Kyphoplasty

Completed·HHallym University Medical Center·N/A·NCT02476981·75 enrolled

Hemodynamic Response1 trial

Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study

Completed·KKing Faisal University·Phase 2·NCT01006863·150 enrolled

Asthenia1 trial

Ephedrine for the Treatment of Congenital Myasthenia

Unknown status·HHadassah Medical Organization·Phase 1/2·NCT00541216·15 enrolled

Gestational Diabetes1 trial

Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study

Suspended·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT06285396·96 enrolled

Epidural1 trial

Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

Completed·SSharp HealthCare·Phase 4·NCT02062801·710 enrolled

Hand Surgery1 trial

Effects of Systemic or Adjunct Tramadol Addition to Lidocaine Used for IVRA in Patients Undergoing Hand Surgery

Completed·—·Phase 3·NCT02658721·60 enrolled

Obesity1 trial

Effect on Energy Metabolism at Cellular Level of Diet Plus Treatment With Ephedrine and Caffeine in Obesity

Completed·IIstituto Auxologico Italiano·Phase 3·NCT02048215·13 enrolled

Metabolism1 trial

Cerebral Flow-metabolism Coupling During Adult Surgery

Unknown status·JJason Chui·Phase 4·NCT05941494·80 enrolled

Delirium1 trial

Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine

Not yet recruiting·RRiverside University Health System Medical Center··NCT06844201·10,000 enrolled

Laparoscopic Cholecystectomy1 trial

Intraoperative Lidocaine Infusion vs. Esmolol Infusion for Postoperative Analgesia in Laparoscopic Cholecystectomy

Completed·—·Phase 4·NCT02327923·90 enrolled

Brain Injury1 trial

Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly

Suspended·FFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico·Phase 2/3·NCT02428062·1,812 enrolled

Prevention1 trial

Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

Unknown status·LLagos State Health Service Commission·Phase 2·NCT02441673·130 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Sedation1 trial

Anticholinergic Premedication for Sedation With Dexmedetomidine During Spinal Anesthesia

Completed·SSira Bang·Phase 4·NCT02522858·120 enrolled

Intravenous1 trial

Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System

Active, not recruiting·KKK Women's and Children's Hospital·N/A·NCT03620942·173 enrolled

Heart1 trial

Impact of Prophylactic Ephedrine on Fetal Heart Tracing and Uterine Tetanic Contraction After CSE

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT05873218·135 enrolled

Subcutaneous Fat1 trial

"Pecos" B-adrenergic and PPAR-G Stimulation Upregulates Lipid Metabolism in Human Subcutaneous Fat

Completed·PPennington Biomedical Research Center·Phase 2·NCT00377975·96 enrolled

Rocuronium1 trial

Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment

Completed·—·Phase 3·NCT05725031·75 enrolled

Infusion1 trial

Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion

Unknown status·HHospices Civils de Lyon·Phase 3·NCT00146926·200 enrolled

Bradycardia1 trial

Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients

Completed·—·Phase 4·NCT03984526·102 enrolled

Nausea and vomiting1 trial

Study of the Effect of Intramuscular Ephedrine on the Incidence of Nausea and Vomiting During Elective Cesarean Section

Completed·WWeill Medical College of Cornell University·Phase 2·NCT00432991·53 enrolled

Dexmedetomidine1 trial

Effect of Dexmedetomidine Infusion Dose Versus Rapid Bolus Dose on Hemodynamic Changes During Laryngoscopy and Tracheal Intubation in Adults. A Randomized Comparative Study.

Completed·KKasr El Aini Hospital·Phase 2·NCT06327399·70 enrolled

Unspecified1 trial

Ephedrine vs Phenylephrine - ECG Changes

Terminated·UUniversity College London Hospitals·Phase 4·NCT01243970·29 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 27, 2017

CORPHEDRA

NDA NDA208943

Mar 1, 2017

EPHEDRINE SULFATE

NDA NDA208609

Jun 14, 2021

REZIPRES

NDA NDA213536

Aug 2, 2021

AKOVAZ

NDA NDA208289

Apr 22, 2022

EPHEDRINE SULFATE

NDA NDA213994

Feb 28, 2023

EMERPHED

NDA NDA213407

Sources

References

[1]
ClinicalTrials.gov — 68 trial records for Ephedrine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ephedrine Sulfate drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ephedrine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ephedrine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213407). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ephedrine Sulfate. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Dr. Reddys Laboratories, SA company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: DDr. Reddys Laboratories, SA

Patent Landscape[6]

Patent Cliff

Jan 22, 2040

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12029710Jan 22, 2040

10869845Jan 22, 2040

11571398May 16, 2040

11478436May 16, 2040

11241400May 16, 2040

2 more patents

11464752May 16, 2040

11090278May 16, 2040

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