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amantadine

Trade name: symmetrel

Small moleculeapproved

Approved

Oct 1, 1966

Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug. The mechanism by which amantadine exerts its antiviral activity is not clearly understood. It appears to mainly prevent the release of infectious viral nucleic acid into the host cell by interfering with the function of the transmembrane domain of the viral M2 protein. In certain cases, amantadine is also known to prevent virus assembly during virus replication. It does not appear to interfere with the immunogenicity of inactivated influenza A virus vaccine. The mechanism of action of amantadine in the treatment of Parkinson's disease and drug-induced extrapyramidal reactions is not known. Data from earlier animal studies suggest that amantadine hydrochloride may have direct and indirect effects on dopamine neurons. More recent studies have demonstrated that amantadine is a weak, non-competitive NMDA receptor antagonist (K1 = 10µM). Although amantadine has not been shown to possess direct anticholinergic activity in animal studies, clinically, it exhibits anticholinergic-like side effects such as dry mouth, urinary retention, and constipation. Amantadine was approved by the FDA in 1966 as a prophylactic agent against Asian influenza, and eventually received approval for the treatment of influenza virus A in adults. In 1969, it was also discovered by accident to help reduce symptoms of Parkinson's disease, drug-induced extrapyramidal syndromes, and akathisia. — NCATS

Clinical trial activity

86 trials · 96 clinical orgs · 46 marketing orgs

Phase 1
7
Phase 2
45
Phase 3
27
Phase 4
16

Earliest trial started Mar 1, 1996 (NCT00000301)

Timeline

1960s

  1. Oct 1, 1966

    Earliest FDA Approval

  2. Feb 14, 1968

    Endo Pharmaceuticals — First NDA Organization

  3. Feb 14, 1968

    Endo Pharmaceuticals — NDA Secondary Org

  4. Feb 14, 1968

    Endo Pharmaceuticals — NDA Organization

1970s

  1. Jul 20, 1976

    DuPont — NDA Secondary Org

1980s

  1. Jan 7, 1987

    Upsher-Smith Laboratories — Marketing Organization

  2. Feb 18, 1987

    Sandoz — Marketing Organization

1990s

  1. Oct 30, 1990

    G & W Laboratories Inc. — Marketing Organization

  2. Aug 23, 1991

    Teva — Marketing Organization

  3. Jun 28, 1993

    Mikart — Marketing Organization

  4. Jun 28, 1993

    ANDA Repository — Marketing Organization

  5. Oct 28, 1994

    Hi Tech Pharmaceuticals — Marketing Organization

  6. Oct 28, 1994

    Akorn, Inc. — Marketing Organization

  7. Oct 28, 1994

    Aurobindo Pharma — Marketing Organization

  8. Jul 17, 1995

    Pharmaceutical Associates — Marketing Organization

  9. Jan 1, 1996

    Earliest Phase 2 Sponsor(trial)

  10. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

  11. Dec 24, 1998

    Wockhardt — Marketing Organization

  12. Dec 24, 1998

    Xttrium Laboratories — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 3 Sponsor(trial)

  2. Sep 11, 2002

    CMP Therapeutics Ltd — Marketing Organization

  3. Sep 10, 2004

    Lannett Company, Inc. — Marketing Organization

  4. Sep 10, 2004

    Genus Oncology, LLC — Marketing Organization

  5. Feb 23, 2006

    Actavis — Marketing Organization

  6. Dec 12, 2006

    Vintage — Marketing Organization

  7. Dec 12, 2006

    Endo Pharmaceuticals — Marketing Organization

  8. May 29, 2008

    Bionpharma Inc — Marketing Organization

2010s

  1. May 31, 2016

    Zydus Discovery DMCC — Marketing Organization

  2. Sep 30, 2016

    Graviti Pharmaceuticals — Marketing Organization

  3. Sep 30, 2016

    Invagen Pharms — Marketing Organization

  4. Sep 30, 2016

    Cipla — Marketing Organization

  5. Dec 6, 2016

    Watson Pharmaceuticals — Marketing Organization

  6. Dec 6, 2016

    Allergan PLC (2015) — Marketing Organization

  7. Jun 7, 2017

    Strides Pharma Science — Marketing Organization

  8. Jun 12, 2017

    Heritage Pharma — Marketing Organization

  9. Jun 12, 2017

    Emcure — Marketing Organization

  10. Jun 15, 2017

    Chartwell Pharmaceuticals — Marketing Organization

  11. Jun 21, 2017

    Alembic — Marketing Organization

  12. Aug 24, 2017

    Adamas Pharmaceuticals, Inc. — NDA Secondary Org

  13. Aug 24, 2017

    Supernus Pharmaceuticals — Marketing Organization

  14. Aug 24, 2017

    Adamas Pharmaceuticals, Inc. — Marketing Organization

  15. Feb 7, 2018

    Jubilant Innovation Ltd. — Marketing Organization

  16. Feb 16, 2018

    Osmotica Pharmaceutical — NDA Secondary Org

2020s

  1. Mar 2, 2020

    Invatech — Marketing Organization

  2. Mar 2, 2020

    Novelgenix Therapeutics — Marketing Organization

  3. Mar 2, 2020

    Rising Pharmaceuticals — Marketing Organization

  4. Mar 10, 2020

    Athem — Marketing Organization

  5. May 21, 2020

    Rubicon Research — Marketing Organization

  6. Aug 20, 2021

    Elysium Health — Marketing Organization

  7. May 27, 2022

    Edenbridge Pharms — Marketing Organization

  8. May 27, 2022

    Adaptis Pharma — Marketing Organization

  9. Dec 20, 2022

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

  10. Sep 26, 2024

    Zhejiang Jutai Pharm — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 1, 1966

Chemistry & pharmacology

Loading structure…

SMILES

NC12CC3CC(CC(C3)C1)C2
Mol. weight
151.25 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1-adamantanamine
  • 1-adamantanamine
  • 1-adamantylamine
  • 1-adamantylamine
  • 1-aminoadamantane
  • 1-aminoadamantane
  • adamantamine
  • adamantamine fumarate
  • adamantanamine
  • adamantanamine hcl
  • adamantanamine hcl
  • adamantylamine
  • ads-8902
  • amantadina
  • amantadina
  • amantadine
  • amantadine
  • amantadine
  • amantadine
  • amantadine
  • amantadine
  • amantadine
  • amantadine
  • amantadine
  • amantadine
  • amantadine
  • amantadine hcl
  • amantadine hcl
  • amantadine hcl
  • amantadine hydrochloride
  • amantadine hydrochloride
  • amantadine hydrochloride
  • amantadine hydrochloride
  • amantadine hydrochloride
  • amantadine sulfate
  • amantadine sulfate
  • amantadine sulfate
  • amantadine sulphate
  • amantadine sulphate
  • amantadinum
  • amantadinum
  • amantidine
  • amantidine
  • amantidine
  • aminoadamantane
  • aminoadamantane
  • exp-105-1
  • exp-105-1
  • lysovir
  • lysovir
  • mantadine
  • mantadine
  • symadine
  • symadine
  • symmetrel
  • symmetrel
  • symmetrel
  • tcmdc-125869
  • tcmdc-125869
  • tricyclo[3.3.1.1(3,7)]decan-1-amine
  • tricyclo[3.3.1.1(3,7)]decan-1-amine
  • tricyclo[3.3.1.1(3,7)]decan-1-ylamine
  • tricyclo[3.3.1.1(3,7)]decan-1-ylamine
  • tricyclo[3.3.1.1(3,7)]decane-1-amine
  • tricyclo[3.3.1.1(3,7)]decane-1-amine
  • viregyt
  • viregyt
  • virosol
  • virosol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07125222Phase 2Sep 30, 2025Cornell University, Supernus Pharmaceuticals
NCT06817200Phase 2May 1, 2025University of Toulouse
NCT06234462Phase 2Dec 13, 2024The University of Texas, Dallas
NCT07113015N/AJul 5, 2024Multan Medical And Dental College
NCT06253923Phase 2Jun 1, 2024Duke University, SHINKEI Therapeutics, Inc
NCT06833203N/ADec 1, 2023Cairo University
NCT06055244Phase 1Oct 15, 2023Ohio State University
NCT06052787Phase 3Sep 1, 2023Ain Shams University
NCT06183242Phase 2/Phase 3 (Phase 3)May 27, 2023Polysan, Ltd.
NCT05713578Early Phase 1 (Phase 1)Mar 1, 2023Shandong University
NCT05667077Phase 2Dec 26, 2022Shahid Beheshti University of Medical Sciences
NCT05809414Phase 3Nov 28, 2022Universidad Complutense de Madrid
NCT05479032Phase 2Sep 30, 2022University of Tuebingen
NCT05140148Phase 2Dec 1, 2021University of Pennsylvania
NCT04936126Phase 4Aug 7, 2021All India Institute of Medical Sciences, Indian Council of Medical Research
NCT04894617Phase 3Jun 1, 2021University of Copenhagen
NCT04952519Phase 3Mar 30, 2021Noblewell, Silesian Medical University
NCT04854759Phase 3Mar 15, 2021Independent Public Clinical Hospital No. 4 in Lublin
NCT04527289Phase 4Sep 30, 2020Damanhour University
NCT04387773Phase 4Jul 31, 2020Adamas Pharmaceuticals, Inc., Oregon Health and Science University
Showing 20 of 86 trials
Page 1 / 5

Organizations

Research & Development (96)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Adamas Pharmaceuticals, Inc.For profit9832009
RocheFor profit4032001
Assiut UniversityAcademic/Hospital3322016
Department of EducationGovernment3032003
National Institute on Drug Abuse (NIDA)Government3121996
Seoul National UniversityAcademic/Hospital3322011
Tel Aviv UniversityAcademic/Hospital3332008
University of FloridaAcademic/Hospital3312003
University of ManitobaAcademic/Hospital3322003
Ain Shams UniversityAcademic/Hospital2222017
BioMark Technologies Inc.For profit2012003
Canadian Institutes of Health Research (CIHR)Academic/Hospital2012003
Department of Veteran AffairsGovernment2122003
Eli LillyFor profit2122005
Harvard UniversityAcademic/Hospital2022003
Johns Hopkins UniversityAcademic/Hospital2222005
Ohio State UniversityAcademic/Hospital2122009
Oregon Health and Science UniversityAcademic/Hospital2222009
Osmotica PharmaceuticalFor profit2212014
University of PennsylvaniaAcademic/Hospital2211999
96 organizations
Page 1 / 5

Marketing (55)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGJun 28, 1993
ActavisFor profitMKTGFeb 23, 2006
Adamas Pharmaceuticals, Inc.For profitNDA2Aug 24, 2017
Adamas Pharmaceuticals, Inc.For profitMKTGAug 24, 2017
Adaptis PharmaFor profitMKTGMay 27, 2022
Akorn, Inc.For profitMKTGOct 28, 1994
AlembicFor profitMKTGJun 21, 2017
AlembicFor profitSYNJun 21, 2017
Allergan PLC (2015)For profitMKTGDec 6, 2016
AthemFor profitMKTGMar 10, 2020
Aurobindo PharmaFor profitMKTGOct 28, 1994
Bionpharma IncFor profitMKTGMay 29, 2008
Bionpharma IncFor profitSYNMay 29, 2008
CMP Therapeutics LtdFor profitMKTGSep 11, 2002
Chartwell PharmaceuticalsFor profitMKTGJun 15, 2017
Chartwell PharmaceuticalsFor profitSYNJun 28, 1993
CiplaFor profitMKTGSep 30, 2016
DuPontFor profitNDA2Jul 20, 1976
Edenbridge PharmsFor profitMKTGMay 27, 2022
Elysium HealthFor profitMKTGAug 20, 2021
EmcureFor profitMKTGJun 12, 2017
Endo PharmaceuticalsFor profitNDA2Feb 14, 1968
Endo PharmaceuticalsFor profitNDAFeb 14, 1968
Endo PharmaceuticalsFor profitMKTGDec 12, 2006
G & W Laboratories Inc.For profitMKTGOct 30, 1990
Genus Oncology, LLCFor profitMKTGSep 10, 2004
Graviti PharmaceuticalsFor profitMKTGSep 30, 2016
Heritage PharmaFor profitMKTGJun 12, 2017
Hi Tech PharmaceuticalsFor profitMKTGOct 28, 1994
Invagen PharmsFor profitMKTGSep 30, 2016
InvatechFor profitMKTGMar 2, 2020
Jubilant Innovation Ltd.For profitMKTGFeb 7, 2018
Lannett Company, Inc.For profitMKTGSep 10, 2004
MikartFor profitMKTGJun 28, 1993
Novelgenix TherapeuticsFor profitMKTGMar 2, 2020
Osmotica PharmaceuticalFor profitNDA2Feb 16, 2018
Pharmaceutical AssociatesFor profitMKTGJul 17, 1995
Rising PharmaceuticalsFor profitMKTGMar 2, 2020
Rubicon ResearchFor profitMKTGMay 21, 2020
SandozFor profitMKTGFeb 18, 1987
SolvayFor profitMKTG—
Strides Pharma ScienceFor profitMKTGJun 7, 2017
Supernus PharmaceuticalsFor profitMKTGAug 24, 2017
TevaFor profitMKTGAug 23, 1991
Upsher-Smith LaboratoriesFor profitMKTGJan 7, 1987
Upsher-Smith LaboratoriesFor profitSYNDec 16, 2002
VintageFor profitMKTGDec 12, 2006
Watson PharmaceuticalsFor profitMKTGDec 6, 2016
WockhardtFor profitMKTGDec 24, 1998
Xttrium LaboratoriesFor profitMKTGDec 24, 1998
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGDec 20, 2022
Zhejiang Jutai PharmFor profitMKTGSep 26, 2024
Zydus Discovery DMCCFor profitMKTGMay 31, 2016
Zydus Discovery DMCCFor profitSYNAug 26, 2024
Zydus Discovery DMCCFor profitSYNSep 29, 2022