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ephedrine

Small moleculeapproved

Approved

Apr 29, 2016

Ephedrine (l-form) is an alkaloid, which was initially purified from Ephedra plant. The extract form Ephedra has been used in China for medicinal purposes for several thousand years. Ephedrine acts as an agonist at alpha- and beta-adrenergic receptors and indirectly causes the release of norepinephrine from sympathetic neurons. The drug crosses the blood brain barrier and stimulates the central nervous system. Ephedrine products are now banned in many countries, as they are a major source for the production of the addictive compound methamphetamine. FDA has approved ephedrine only for the treatment of clinically important hypotension occurring in the setting of anesthesia. — NCATS

Clinical trial activity

84 trials · 77 clinical orgs · 31 marketing orgs

Phase 1
3
Phase 2
17
Phase 3
12
Phase 4
29

Earliest trial started Feb 1, 2000 (NCT02048215)

Timeline

1920s

  1. Jul 1, 1923

    Evidence of US Marketing

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2007

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Apr 29, 2016

    Exela Pharma Sciences, LLC. — Earliest FDA Approval

  2. Apr 29, 2016

    Flamel Technologies — NDA Secondary Org

  3. Apr 29, 2016

    Avadel Pharmaceuticals — Marketing Organization

  4. Apr 29, 2016

    Exela Pharma Sciences, LLC. — Marketing Organization

  5. Apr 29, 2016

    Exela Pharma Sciences, LLC. — NDA Secondary Org

  6. Apr 29, 2016

    Exela Pharma Sciences, LLC. — NDA Organization

  7. Jan 27, 2017

    Par Pharmaceuticals — NDA Secondary Org

  8. Jan 27, 2017

    Bristol-Myers Squibb — NDA Secondary Org

  9. Jan 27, 2017

    PH HEALTH — Marketing Organization

  10. Mar 1, 2017

    Akorn, Inc. — Marketing Organization

  11. Mar 1, 2017

    Akorn, Inc. — NDA Secondary Org

  12. Mar 1, 2017

    Renew Group — Marketing Organization

  13. Aug 23, 2017

    Sandoz — Marketing Organization

  14. Aug 23, 2017

    Novartis — Marketing Organization

  15. Oct 23, 2019

    Amneal Pharmaceuticals — Marketing Organization

2020s

  1. Apr 17, 2020

    Nexus Pharmaceuticals — Marketing Organization

  2. Apr 17, 2020

    Nexus Pharmaceuticals — NDA Secondary Org

  3. Aug 4, 2020

    Fresenius — Marketing Organization

  4. Oct 6, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  5. Oct 16, 2020

    Nevakar, LLC — Marketing Organization

  6. Oct 16, 2020

    Endo Pharmaceuticals — Marketing Organization

  7. Oct 16, 2020

    OPERAND PHARMS — Marketing Organization

  8. Oct 16, 2020

    OPERAND PHARMS — NDA Secondary Org

  9. Dec 15, 2020

    Hikma — Marketing Organization

  10. Jun 14, 2021

    Aurobindo Pharma — Marketing Organization

  11. Jun 14, 2021

    Sintetica SA — Marketing Organization

  12. Jun 14, 2021

    Eton Pharmaceuticals, Inc. — Marketing Organization

  13. Jun 14, 2021

    Eugia Pharma — Marketing Organization

  14. Jun 14, 2021

    Dr. Reddy's Laboratories — NDA Secondary Org

  15. Feb 25, 2022

    Gland Pharma Ltd — Marketing Organization

  16. Feb 25, 2022

    Fosun — Marketing Organization

  17. Apr 14, 2022

    Mankind Pharma — Marketing Organization

  18. Apr 21, 2022

    Exeltis — Marketing Organization

  19. Mar 9, 2023

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  20. Mar 9, 2023

    Nichi-Iko Pharmaceutical Co., Ltd. — Marketing Organization

  21. May 16, 2023

    Zydus Discovery DMCC — Marketing Organization

  22. Jul 18, 2024

    Caplin Point Laboratories — Marketing Organization

  23. Dec 23, 2025

    CIVICA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedApr 29, 2016
  • approvedJul 1, 1923

Chemistry & pharmacology

Loading structure…

SMILES

CN[C@@H](C)[C@H](O)C1=CC=CC=C1
Mol. weight
165.2322 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • (1r,2s)-1-phenyl-1-hydroxy-2-methylaminopropane
  • (1r,2s)-1-phenyl-1-hydroxy-2-methylaminopropane
  • amesec
  • amesec
  • amesec
  • aminophyline - amobarbital - pseudophedrine
  • aminophyline, amobarbital, pseudophedrine drug combination
  • asmapax
  • bronchipax
  • c.a.m.
  • chlorpheniramine - ephedrine
  • chlorpheniramine, ephedrine drug combination
  • demazin chronosules
  • do-do
  • ephed hcl
  • ephed in nor saline
  • ephedra
  • ephedra
  • ephedrin
  • ephedrine
  • ephedrine
  • ephedrine
  • ephedrine
  • ephedrine
  • ephedrine
  • ephedrine
  • ephedrine
  • ephedrine
  • (-)-ephedrine
  • (-)-ephedrine
  • ephedrine hcl
  • ephedrine hcl
  • ephedrine hcl
  • ephedrine hydrochloride
  • ephedrine hydrochloride
  • ephedrine hydrochloride
  • ephedrine hydrochloride
  • ephedrine - phenobarbital - theophylline
  • ephedrine, phenobarbital, theophylline drug combination
  • ephedrine sulfate
  • ephedrine sulfate
  • ephedrine sulfate
  • ephedrine sulfate
  • ephedrine sulfate
  • ephedrine sulphate
  • ephedrine sulphate
  • ephedrine sulphate
  • ephedrine sulphate
  • ephedrine sulphate
  • ephedrine sulphate
  • ephetonin
  • ephetonin
  • ephetonin
  • expansyl
  • expurhin
  • franol
  • franol
  • franol plus
  • franol-plus
  • haymine
  • haymine
  • haymine
  • isofedrol
  • isofedrol
  • l-ephedrine
  • l-ephedrine
  • l(-)-ephedrine
  • l(-)-ephedrine
  • l-erythro-2-(methylamino)-1-phenylpropan-1-ol
  • l-erythro-2-(methylamino)-1-phenylpropan-1-ol
  • novafed a syrup
  • sch-4855
  • secron
  • tabasan
  • taumasthman
  • tedral
  • tedral
  • tedral
  • tedralan
  • tedral sa

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06921473Phase 4Sep 1, 2025Saglik Bilimleri Universitesi
NCT07259655Phase 4Mar 6, 2025Rouen Normandy University
NCT06681662Phase 4Dec 31, 2024University of Copenhagen
NCT06498076N/AAug 1, 2024Rouen Normandy University
NCT07034911Phase 1Apr 1, 2024Ain Shams University
NCT06285396N/AMar 18, 2024Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital, Canada
NCT06257316Phase 4Feb 15, 2024Seoul National University
NCT06233032N/AFeb 10, 2024Assiut University
NCT06327399Phase 2Jan 21, 2024Cairo University
NCT05941494Phase 4Oct 3, 2023University of Western Ontario
NCT05993182Phase 4Aug 20, 2023Aswan University
NCT05892913Phase 4Jul 19, 2023Abant Izzet Baysal University
NCT07067944N/AJul 1, 2023Tanta University
NCT05873218Phase 4Jun 26, 2023Icahn School of Medicine at Mount Sinai
NCT05725031Phase 3Feb 22, 2023Ain Shams University
NCT05637606N/AJan 8, 2023Humanitas University, Società Italiana Anestesia, Analgesia, Rianimazione e Terapia Intensiva - SIAARTI
NCT05414877N/ADec 30, 2022Capital Medical University
NCT05665881N/ANov 1, 2022Capital Medical University
NCT05497700Phase 3Sep 15, 2022Free University of Brussels
NCT05498857Phase 4Jul 15, 2022University of Brasilia
Showing 20 of 84 trials
Page 1 / 5

Organizations

Research & Development (77)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Ain Shams UniversityAcademic/Hospital3332021
Assiut UniversityAcademic/Hospital3332016
Icahn School of Medicine at Mount SinaiAcademic/Hospital3322019
KK Women's and Children's HospitalAcademic/Hospital3322011
Mansoura UniversityAcademic/Hospital3222004
Tunis UniversityAcademic/Hospital3312016
B.P. Koirala Institute of Health SciencesAcademic/Hospital2212014
Capital Medical UniversityAcademic/Hospital2212022
Mahidol UniversityAcademic/Hospital2212014
Monash UniversityAcademic/Hospital2212009
Mongi Slim HospitalAcademic/Hospital2222016
Mount Sinai Hospital, CanadaAcademic/Hospital2012019
Rouen Normandy UniversityAcademic/Hospital2222024
Silesian University of MedicineAcademic/Hospital2212015
University Clermont AuvergneAcademic/Hospital2212012
University of CopenhagenAcademic/Hospital2112012
University of LyonAcademic/Hospital2222005
University of MilanAcademic/Hospital2112000
University of VermontAcademic/Hospital2222001
Utrecht UniversityAcademic/Hospital2112011
77 organizations
Page 1 / 4

Marketing (45)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGMar 1, 2017
Akorn, Inc.For profitNDA2Mar 1, 2017
Amneal PharmaceuticalsFor profitMKTGOct 23, 2019
Amneal PharmaceuticalsFor profitSYNOct 23, 2019
Aurobindo PharmaFor profitMKTGJun 14, 2021
Avadel PharmaceuticalsFor profitMKTGApr 29, 2016
Bristol-Myers SquibbFor profitNDA2Jan 27, 2017
CIVICAFor profitMKTGDec 23, 2025
Caplin Point LaboratoriesFor profitMKTGJul 18, 2024
Dr. Reddy's LaboratoriesFor profitMKTGOct 6, 2020
Dr. Reddy's LaboratoriesFor profitSYNOct 3, 2020
Dr. Reddy's LaboratoriesFor profitSYNJun 14, 2021
Dr. Reddy's LaboratoriesFor profitNDA2Jun 14, 2021
Endo PharmaceuticalsFor profitMKTGOct 16, 2020
Endo PharmaceuticalsFor profitSYNJan 27, 2017
Eton Pharmaceuticals, Inc.For profitMKTGJun 14, 2021
Eugia PharmaFor profitMKTGJun 14, 2021
Exela Pharma Sciences, LLC.For profitMKTGApr 29, 2016
Exela Pharma Sciences, LLC.For profitNDA2Apr 29, 2016
Exela Pharma Sciences, LLC.For profitNDAApr 29, 2016
ExeltisFor profitMKTGApr 21, 2022
Flamel TechnologiesFor profitNDA2Apr 29, 2016
FosunFor profitMKTGFeb 25, 2022
FreseniusFor profitMKTGAug 4, 2020
Gland Pharma LtdFor profitMKTGFeb 25, 2022
Gland Pharma LtdFor profitSYNFeb 25, 2022
HikmaFor profitMKTGDec 15, 2020
HikmaFor profitSYNDec 15, 2020
Mankind PharmaFor profitMKTGApr 14, 2022
Nevakar, LLCFor profitMKTGOct 16, 2020
Nexus PharmaceuticalsFor profitMKTGApr 17, 2020
Nexus PharmaceuticalsFor profitSYNApr 17, 2020
Nexus PharmaceuticalsFor profitNDA2Apr 17, 2020
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGMar 9, 2023
NovartisFor profitMKTGAug 23, 2017
OPERAND PHARMSFor profitMKTGOct 16, 2020
OPERAND PHARMSFor profitNDA2Oct 16, 2020
PH HEALTHFor profitMKTGJan 27, 2017
Par PharmaceuticalsFor profitNDA2Jan 27, 2017
Renew GroupFor profitMKTGMar 1, 2017
Sagent Pharmaceuticals, Inc.For profitMKTGMar 9, 2023
SandozFor profitMKTGAug 23, 2017
SandozFor profitSYNAug 23, 2017
Sintetica SAFor profitMKTGJun 14, 2021
Zydus Discovery DMCCFor profitMKTGMay 16, 2023