Ephedrine Sulfate

(Ephedrine)

ApprovedSmall molecule

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 25 indications[4].[1]

Ephedrine Sulfate is one of 361 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

360

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Gestational DiabetesActive, not recruiting

Cognitive ImpairmentApproved

BradycardiaActive, not recruiting

DeliriumActive, not recruiting

Nasal CongestionActive, not recruiting

Congenital Myasthenic SyndromesApproved

Congenital Myasthenic SyndromeApproved

PreeclampsiaApproved

AsthmaActive, not recruiting

Cardiovascular DiseaseApproved

Active, not recruiting

Gestational DiabetesPreclinical

Active, not recruiting

Cognitive ImpairmentApproved

Approved

BradycardiaApproved

Active, not recruiting

DeliriumPreclinical

Active, not recruiting

Nasal CongestionApproved

Active, not recruiting

Congenital Myasthenic SyndromesApproved

Approved

Congenital Myasthenic SyndromeApproved

Approved

PreeclampsiaApproved

Approved

AsthmaApproved

Active, not recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

161 competitors in Asthma

#DrugCompanyPhaseTrials

Ephedrine Sulfate

DDr. Reddys Laboratories, SA

Approved

69 2

Celexa

AbbVie

Preclinical

1 3

Arcoxia

Novartis

Preclinical

—4

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

1 5

DUPIXENT

Regeneron

Preclinical

1 6

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 7

Aclidinium Bromide

AstraZeneca

Preclinical

—8

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 9

Lexapro

SShirley Ryan AbilityLab

Preclinical

1 10

Biological Drug

UUniversitaire Ziekenhuizen KU Leuven

Preclinical

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

Timeline

Expected Milestones

Q4 2026

PreclinicalRecruiting

Postinduction Hypotension

NCT07722013

Q4 2027

PreclinicalActive, not recruiting

Hypotension

NCT03620942

Clinical

Trials by Indication[1]

Hypotension14 trials

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

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

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

Show 11 more trials

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

Unknown status·—·Phase 3·NCT05497700·60 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

Ketamine vs Ephedrine on Post Spinal Hypotension in Caesarean Delivery

Completed·—·Phase 1·NCT07034911·100 enrolled

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

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

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

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

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

Management of Post-Induction Hypotension in Emergency Abdominal Surgery

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

Development of Advanced Double Intravenous Vasopressor Automated (ADIVA) System With Improved Hemodynamic Trend Control During Spinal Anaesthesia for Caesarean Section

Active, not recruiting·KKK Women's and Children's Hospital·Preclinical·NCT03620942·173 enrolled

A Novel Closed-loop Integrated System for the Maintenance of Haemodynamic Stability to Improve Perioperative Outcome During Spinal Anaesthesia for Caesarean Section

Completed·KKK Women's and Children's Hospital·Preclinical·NCT02277730·252 enrolled

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

Completed·KKK Women's and Children's Hospital·Preclinical·NCT04025918·216 enrolled

Cesarean Section11 trials

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

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

Manging Post Spinal Hypotension During Elective Cesarean Section

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

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

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

Show 8 more trials

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

Completed·—·Phase 4·NCT06668337·120 enrolled

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

Completed·—·Phase 2·NCT02622126·60 enrolled

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

Completed·—·Phase 4·NCT05892913·60 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

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

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

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

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

Cesarean Delivery4 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

Show 1 more trial

Comparative Effects of Ephedrine and Norepinephrine on Fetal Acid-Base Status During Cesarean Delivery Under Spinal Anesthesia: A Randomized Double-Blind Study

Completed·Mmehmet özkılıç·Approved·NCT06921473·155 enrolled

Spinal Anesthesia4 trials

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

Phenylephrine in Spinal Anesthesia in Preeclamptic Patients

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

Continuous Spinal Anesthesia With Hypobaric Bupivacaine to Preserve Hemodynamics in Elderly

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

Show 1 more trial

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

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

29 more indications

General Anesthesia2 trials

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

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

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

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

Caesarean Section2 trials

The Oxygenation of the Brain During Caesarean Section

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

Intrathecal Levobupivacaine With Opioids for Caesarean Section

Completed·—·Phase 3·NCT01858090·93 enrolled

ESS2 trials

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

Vasopressor Effects in Anesthetized Patients

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

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

Laparoscopic Cholecystectomy1 trial

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

Completed·—·Phase 4·NCT02327923·90 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

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

Prevention1 trial

Nefopam vs Tramadol in the Prevention of Post Anaesthetic Shivering

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

Epidural1 trial

Prophylactic Ephedrine and Combined Spinal Epidurals for Labor

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

Rocuronium1 trial

Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment

Completed·—·Phase 3·NCT05725031·75 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

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

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

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

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

Delirium1 trial

Postoperative Delirium After Intraoperative Ephedrine Versus Norepinephrine

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

Asthenia1 trial

Ephedrine for the Treatment of Congenital Myasthenia

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

Metabolism1 trial

Cerebral Flow-metabolism Coupling During Adult Surgery

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

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

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

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

Postinduction Hypotension1 trial

Intermittent Ephedrine Boluses for Prophylaxis Against Postinduction Hypotension in High-risk Patients Undergoing Major Abdominal Surgery: a Randomized Double-blinded Controlled Trial: a Randomized Double-blinded Controlled Trial

Recruiting·CCairo University·Preclinical·NCT07722013·124 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]

Apr 29, 2016

AKOVAZ

NDA NDA208289

Jan 27, 2017

CORPHEDRA

NDA NDA208943

Jan 27, 2017

CORPHEDRA

NDA NDA208943

Mar 1, 2017

EPHEDRINE SULFATE

NDA NDA208609

Aug 10, 2018

AKOVAZ

NDA NDA208289

Oct 28, 2019

EPHEDRINE SULFATE

NDA ANDA209784

Apr 8, 2020

AKOVAZ

NDA NDA208289

Apr 17, 2020

EMERPHED

NDA NDA213407

Aug 4, 2020

EPHEDRINE SULFATE

NDA ANDA209646

Oct 3, 2020

EPHEDRINE SULFATE

NDA ANDA212649

Oct 16, 2020

EPHEDRINE SULFATE

NDA NDA213994

Nov 24, 2020

EPHEDRINE SULFATE

NDA ANDA209784

Dec 15, 2020

EPHEDRINE SULFATE

NDA ANDA214334

Jun 14, 2021

REZIPRES

NDA NDA213536

Aug 2, 2021

AKOVAZ

NDA NDA208289

Aug 2, 2021

AKOVAZ

NDA NDA208289

Feb 25, 2022

EPHEDRINE SULFATE

NDA ANDA216146

Mar 31, 2022

EPHEDRINE SULFATE

NDA ANDA214579

Mar 31, 2022

EPHEDRINE SULFATE

NDA ANDA212932

Mar 31, 2022

EPHEDRINE SULFATE

NDA ANDA212932

Apr 14, 2022

EPHEDRINE SULFATE

NDA ANDA216129

Apr 21, 2022

EPHEDRINE SULFATE

NDA ANDA215825

Apr 22, 2022

EPHEDRINE SULFATE

NDA NDA213994

Apr 22, 2022

EPHEDRINE SULFATE

NDA NDA213994

Feb 28, 2023

EMERPHED

NDA NDA213407

Feb 28, 2023

EMERPHED

NDA NDA213407

Mar 9, 2023

EPHEDRINE SULFATE

NDA ANDA214528

Jun 30, 2023

EPHEDRINE SULFATE

NDA ANDA212649

Jul 18, 2024

EPHEDRINE SULFATE

NDA ANDA219050

Aug 15, 2024

EMERPHED

NDA NDA213407

Oct 11, 2024

EPHEDRINE SULFATE

NDA ANDA217721

Jan 16, 2025

EPHEDRINE SULFATE

NDA ANDA218211

Mar 11, 2025

EPHEDRINE SULFATE

NDA ANDA218271

Jul 8, 2026

EPHEDRINE SULFATE

NDA ANDA216740

Sources

References

[1]
ClinicalTrials.gov — 69 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 ANDA216740). 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

Ephedrine Sulfate

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Hypotension14 trials

Cesarean Section11 trials

Cesarean Delivery4 trials

Spinal Anesthesia4 trials

Major Abdominal Surgery2 trials

General Anesthesia2 trials

Caesarean Section2 trials

ESS2 trials

Carotid Endarterectomy2 trials

Preeclampsia2 trials

Laparoscopic Cholecystectomy1 trial

Blood Pressure1 trial

Sedation1 trial

Hemodynamic Response1 trial

Prevention1 trial

Epidural1 trial

Rocuronium1 trial

Monitored Anaesthesia Care1 trial

Subcutaneous Fat1 trial

Hand Surgery1 trial

Heart1 trial

Obesity1 trial

Delirium1 trial

Asthenia1 trial

Metabolism1 trial

Gestational Diabetes1 trial

Infusion1 trial

Bradycardia1 trial

Nausea and vomiting1 trial

Brain Injury1 trial

Cardiac1 trial

Postinduction Hypotension1 trial

Dexmedetomidine1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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