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neostigmine

Trade name: bloxiverz

Small moleculeapproved

Approved

May 31, 2013

Neostigmine is a cholinesterase inhibitor used in the treatment of myasthenia gravis and to reverse the effects of muscle relaxants such as gallamine and tubocurarine. Neostigmine, unlike physostigmine, does not cross the blood-brain barrier. By inhibiting acetylcholinesterase, more acetylcholine is available in the synapse, therefore, more of it can bind to the fewer receptors present in myasthenia gravis and can better trigger muscular contraction. Neostigmine is used for the symptomatic treatment of myasthenia gravis by improving muscle tone. — NCATS

Clinical trial activity

197 trials · 135 clinical orgs · 25 marketing orgs

Phase 1
20
Phase 2
38
Phase 3
27
Phase 4
88

Earliest trial started Sep 1, 1996 (NCT00001520)

Timeline

1930s

  1. Jul 1, 1935

    Evidence of US Marketing

2000s

  1. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

  3. May 3, 2013

    Avadel Pharmaceuticals — First NDA Organization

  4. May 3, 2013

    Avadel Pharmaceuticals — NDA Organization

  5. May 31, 2013

    Earliest FDA Approval

  6. May 31, 2013

    Avadel Pharmaceuticals — NDA Secondary Org

  7. May 31, 2013

    Exela Pharma Sciences, LLC. — Marketing Organization

  8. May 31, 2013

    Exela Pharma Sciences, LLC. — NDA Secondary Org

  9. Jan 8, 2015

    Fresenius — NDA Secondary Org

  10. Dec 28, 2015

    Eurohlth Intl Sarl — Marketing Organization

  11. Apr 26, 2017

    Par Pharmaceuticals — Marketing Organization

  12. Apr 26, 2017

    Bristol-Myers Squibb — Marketing Organization

  13. Sep 25, 2017

    Amphastar Pharmaceuticals — Marketing Organization

  14. May 4, 2018

    Lutipold — Marketing Organization

  15. May 4, 2018

    Sankyo — Marketing Organization

  16. May 4, 2018

    Daiichi Sankyo — Marketing Organization

  17. Jun 15, 2018

    Amneal Pharmaceuticals — Marketing Organization

  18. Jul 10, 2018

    Dr. Reddy's Laboratories — Marketing Organization

  19. Aug 22, 2018

    Amring Pharmaceticals — Marketing Organization

  20. May 13, 2019

    BE Pharmaceuticals — Marketing Organization

  21. Oct 16, 2019

    Gland Pharma Ltd — Marketing Organization

  22. Oct 16, 2019

    Fosun — Marketing Organization

2020s

  1. Apr 5, 2021

    Meitheal — Marketing Organization

  2. Apr 20, 2021

    Caplin Point Laboratories — Marketing Organization

  3. Oct 1, 2021

    Indoco Remedies — Marketing Organization

  4. Jul 13, 2022

    Hikma — Marketing Organization

  5. Nov 3, 2022

    Nivagen Pharmaceuticals Inc. — Marketing Organization

  6. Nov 25, 2022

    Avet Lifesciences — Marketing Organization

  7. Feb 17, 2023

    Sagent Pharmaceuticals, Inc. — Marketing Organization

  8. Feb 17, 2023

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

  9. Feb 23, 2023

    Slayback Pharma Llc — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedMay 31, 2013
  • approvedJul 1, 1935

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)C(=O)OC1=CC(=CC=C1)[N+](C)(C)C
Mol. weight
223.2915 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 3-trimethylammoniumphenyl n,n-dimethylcarbamate
  • 3-trimethylammoniumphenyl n,n-dimethylcarbamate
  • eustigmin
  • eustigmin
  • eustigmin
  • eustigmine
  • eustigmine
  • eustigmine
  • (m-hydroxyphenyl)trimethylammonium dimethylcarbamate
  • (m-hydroxyphenyl)trimethylammonium dimethylcarbamate
  • m-trimethylammoniumphenyldimethylcarbamate
  • m-trimethylammoniumphenyldimethylcarbamate
  • neostigimine
  • neostigimine
  • neostigmine
  • neostigmine
  • neostigmine
  • neostigmine
  • neostigmine
  • neostigmine
  • neostigmine
  • neostigmine
  • neostigmine
  • neostigmine
  • neostigmine bromide
  • neostigmine bromide
  • neostigmine bromide
  • neostigmine methylsulfate
  • neostigmine methylsulfate
  • neostigmine methylsulfate
  • neostigmine methylsulfate
  • neostigmine metilsulfate
  • neostigmine metilsulfate
  • prostigmin
  • prostigmine
  • prostigmine
  • prostigmine
  • robinul-neostig
  • vagostigmine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07271875Phase 3Jan 1, 2026Xijing Hospital
NCT07309393N/ADec 30, 2025Huazhong University of Science and Technology
NCT07253428N/AOct 30, 2025Ain Shams University
NCT07203287Phase 4Aug 26, 2025University of Texas, Galveston
NCT07097441Phase 1/Phase 2 (Phase 2)Mar 12, 2025Ziauddin University
NCT06787638Phase 1Jan 25, 2025Aswan University
NCT06678451N/ADec 31, 2024Shanxi Bethune Hospital
NCT06729047Phase 1/Phase 2 (Phase 2)Dec 15, 2024Assiut University
NCT06685705Phase 4Dec 1, 2024Assiut University
NCT06794450Phase 1/Phase 2 (Phase 2)Nov 5, 2024Padjadjaran University
NCT06982092Phase 1Aug 26, 2024Ain Shams University
NCT06513013Phase 2/Phase 3 (Phase 3)Jul 20, 2024Assiut University
NCT06493838Phase 4Jul 15, 2024Minia University
NCT06436768N/AJun 1, 2024Capital Medical University, Nanjing Medical University
NCT06398899N/AMay 1, 2024National Taiwan University
NCT06334562N/AMay 1, 2024Zhejiang University
NCT06275542N/AApr 1, 2024University of Surabaya
NCT06871033Phase 3Jan 1, 2024Alexandria University
NCT06136585N/AJan 1, 2024Merck, The Cleveland Clinic
NCT06228092Phase 4Dec 4, 2023University of Copenhagen
Showing 20 of 197 trials
Page 1 / 10

Organizations

Research & Development (135)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit361432005
Cairo UniversityAcademic/Hospital10842014
Seoul National UniversityAcademic/Hospital101032013
Department of Veteran AffairsGovernment9942009
Assiut UniversityAcademic/Hospital8832017
Ajou UniversityAcademic/Hospital5512018
Mansoura UniversityAcademic/Hospital5532016
Yonsei UniversityAcademic/Hospital5512013
Ain Shams UniversityAcademic/Hospital4432021
The Cleveland ClinicAcademic/Hospital4422017
Alexandria UniversityAcademic/Hospital3332020
Palacky UniversityAcademic/Hospital3212012
Pontificia Catholic University of São PauloAcademic/Hospital3012021
Pontificia Universidade Catolica de Sao PauloAcademic/Hospital3312021
The University of Texas, DallasAcademic/Hospital3332017
Ankara Yildirim Beyazıt UniversityAcademic/Hospital2222012
Campus Bio-Medico UniversityAcademic/Hospital2212018
Emory UniversityAcademic/Hospital2222017
Fayoum UniversityAcademic/Hospital2012018
Government of KoreaGovernment2012019
135 organizations
Page 1 / 7

Marketing (29)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGJun 15, 2018
Amneal PharmaceuticalsFor profitSYNJun 15, 2018
Amphastar PharmaceuticalsFor profitMKTGSep 25, 2017
Amring PharmaceticalsFor profitMKTGAug 22, 2018
Avadel PharmaceuticalsFor profitNDAMay 3, 2013
Avadel PharmaceuticalsFor profitNDA2May 31, 2013
Avet LifesciencesFor profitMKTGNov 25, 2022
BE PharmaceuticalsFor profitMKTGMay 13, 2019
Bristol-Myers SquibbFor profitMKTGApr 26, 2017
Caplin Point LaboratoriesFor profitMKTGApr 20, 2021
Daiichi SankyoFor profitMKTGMay 4, 2018
Dr. Reddy's LaboratoriesFor profitMKTGJul 10, 2018
Dr. Reddy's LaboratoriesFor profitSYNJul 10, 2018
Eurohlth Intl SarlFor profitMKTGDec 28, 2015
Exela Pharma Sciences, LLC.For profitMKTGMay 31, 2013
Exela Pharma Sciences, LLC.For profitNDA2May 31, 2013
FosunFor profitMKTGOct 16, 2019
FreseniusFor profitNDA2Jan 8, 2015
Gland Pharma LtdFor profitMKTGOct 16, 2019
HikmaFor profitMKTGJul 13, 2022
Indoco RemediesFor profitMKTGOct 1, 2021
LutipoldFor profitMKTGMay 4, 2018
MeithealFor profitMKTGApr 5, 2021
Nichi-Iko Pharmaceutical Co., Ltd.For profitMKTGFeb 17, 2023
Nivagen Pharmaceuticals Inc.For profitMKTGNov 3, 2022
Par PharmaceuticalsFor profitMKTGApr 26, 2017
Sagent Pharmaceuticals, Inc.For profitMKTGFeb 17, 2023
SankyoFor profitMKTGMay 4, 2018
Slayback Pharma LlcFor profitNDA2Feb 23, 2023