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dextromethorphan

Trade name: delsym

Small moleculeapproved

Approved

Dec 3, 1957

Dextromethorphan is a non-narcotic morphine derivative widely used as an antitussive for almost 40 years. It has attracted attention due to its anticonvulsant and neuroprotective properties. It is a cough suppressant in many over-the-counter cold and cough medicines. In 2010, the FDA approved the combination product dextromethorphan/quinidine for the treatment of pseudobulbar affect. Dextromethorphan suppresses the cough reflex by a direct action on the cough center in the medulla of the brain. Dextromethorphan shows high-affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist and acts as a non-competitive channel blocker. It is one of the widely used antitussives and is used to study the involvement of glutamate receptors in neurotoxicity. Dextromethorphan (DM) is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist. The mechanism by which dextromethorphan exerts therapeutic effects in patients with pseudobulbar affect is unknown. Dextromethorphan should not be taken with monoamine oxidase inhibitors due to the potential for serotonin syndrome. Dextromethorphan is extensively metabolized by CYP2D6 to dextrorphan, which is rapidly glucuronidated and unable to cross the blood-brain barrier. — NCATS

Clinical trial activity

154 trials · 139 clinical orgs · 43 marketing orgs

Phase 1
62
Phase 2
58
Phase 3
24
Phase 4
23

Earliest trial started Mar 1, 1993 (NCT00001344)

Timeline

1950s

  1. Dec 3, 1957

    Earliest FDA Approval

  2. Dec 3, 1957

    Ani Pharmaceuticals — NDA Secondary Org

1980s

  1. Oct 8, 1982

    Reckitt Benckiser Pharmaceutical — First NDA Organization

  2. Oct 8, 1982

    Reckitt Benckiser Pharmaceutical — NDA Secondary Org

  3. Oct 8, 1982

    Reckitt Benckiser Pharmaceutical — NDA Organization

  4. Aug 24, 1984

    AH Robins — NDA Secondary Org

  5. Oct 31, 1984

    G & W Laboratories Inc. — Marketing Organization

  6. Jan 4, 1985

    PHARMOBEDIENT — Marketing Organization

  7. Mar 2, 1987

    Halsey — Marketing Organization

  8. Dec 22, 1988

    Wockhardt — Marketing Organization

1990s

  1. Jan 1, 1993

    Earliest Phase 2 Sponsor(trial)

  2. Jul 31, 1996

    Hi Tech Pharmaceuticals — Marketing Organization

  3. Jul 31, 1996

    Akorn, Inc. — Marketing Organization

  4. Jul 31, 1996

    Hikma — Marketing Organization

  5. Jan 1, 1998

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Feb 14, 2006

    Slate Pharmaceuticals — Marketing Organization

  3. Feb 14, 2006

    Vintage — Marketing Organization

  4. Feb 14, 2006

    SLATE RUN PHARMA — Marketing Organization

2010s

  1. Oct 29, 2010

    Avanir — NDA Secondary Org

  2. May 25, 2012

    Tris Pharma, Inc. — Marketing Organization

  3. Jun 28, 2012

    Cosette — Marketing Organization

  4. Jul 15, 2014

    Paddock Laboratories — Marketing Organization

  5. Jul 15, 2014

    Padagis Us — Marketing Organization

  6. Jul 21, 2014

    Pharmaceutical Associates — Marketing Organization

  7. Aug 31, 2015

    Actavis — Marketing Organization

  8. Aug 31, 2015

    Allergan PLC (2015) — Marketing Organization

  9. Dec 23, 2015

    Par Pharmaceuticals — Marketing Organization

  10. Dec 23, 2015

    Bristol-Myers Squibb — Marketing Organization

  11. Sep 20, 2016

    Acella Pharmaceuticals — Marketing Organization

  12. Feb 27, 2017

    Taro Pharmaceuticals — Marketing Organization

  13. Mar 17, 2017

    Aurobindo Pharma — Marketing Organization

  14. Jul 28, 2017

    Amneal Pharmaceuticals — Marketing Organization

  15. Mar 5, 2018

    Perrigo — Marketing Organization

  16. Dec 4, 2018

    Mayne Pharma — Marketing Organization

2020s

  1. Apr 17, 2020

    Chartwell Pharmaceuticals — Marketing Organization

  2. Apr 17, 2020

    Lannett Company, Inc. — Marketing Organization

  3. Jun 16, 2020

    Wes Pharma Inc — Marketing Organization

  4. Jun 16, 2020

    Eywa Pharma — Marketing Organization

  5. Jun 16, 2020

    HIBROW HLTHCARE — Marketing Organization

  6. Jul 14, 2020

    Alkem Labs Ltd — Marketing Organization

  7. Sep 30, 2020

    Esteve Labs — Marketing Organization

  8. Sep 30, 2020

    Bionpharma Inc — Marketing Organization

  9. Nov 5, 2020

    Rhodes Pharmaceuticals, L.P. — Marketing Organization

  10. Jul 1, 2021

    Sun Pharmaceuticals — Marketing Organization

  11. Aug 18, 2022

    Axsome Therapeutics, Inc. — NDA Secondary Org

  12. Aug 1, 2023

    Dr. Reddy's Laboratories — Marketing Organization

  13. Aug 28, 2024

    Hetero Labs Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedDec 3, 1957

Chemistry & pharmacology

Loading structure…

SMILES

COC1=CC=C2C[C@H]3[C@H]4CCCC[C@@]4(CCN3C)C2=C1
Mol. weight
271.3972 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
Yes
Delivery
Oral
Availability
Over the Counter

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • beecham coughcaps
  • benylin dm
  • benylin dm
  • brontyl
  • brontyl
  • contac coughcaps
  • delsym
  • delsym
  • delsym
  • delta-methorphan
  • delta-methorphan
  • dex
  • dex
  • dextromethophan
  • dextromethorfan
  • dextromethorfan
  • dextromethorphan
  • dextromethorphan
  • dextromethorphan
  • dextromethorphan
  • dextromethorphan
  • dextromethorphan
  • dextromethorphan
  • dextromethorphan
  • (+)-dextromethorphan
  • (+)-dextromethorphan
  • (+)-dextromethorphan
  • dextrométhorphane
  • dextrométhorphane
  • dextromethorphan hydriodide
  • dextromethorphan hydrobromide
  • dextromethorphan hydrobromide
  • dextromethorphan hydrobromide
  • dextromethorphan hydrobromide
  • dextromethorphan hydrobromide hydrate
  • dextromethorphan hydrobromide monohydrate
  • dextromethorphan hydrobromide monohydrate
  • dextromethorphan hydrobromide monohydrate
  • dextromethorphan hydrobromide oros tablets
  • dextromethorphan hydrobromide oros tablets
  • dextromethorphan hydrochloride
  • dextromethorphan hydrochloride
  • dextromethorphan hydrochloride
  • dextromethorphan hydrochloride
  • dextromethorphan hydrochloride
  • dextromethorphan hydrochloride
  • dextromethorphan polistirex
  • dextromethorphan polistirex
  • dextromethorphan polistirex
  • dextromethorphan polistirex
  • dextromethorphan / quinidine
  • dextromethorphanum
  • dextromethorphanum
  • dextrometorfano
  • dextrometorfano
  • dextrometorphan
  • dextrometorphan
  • dimetane-dx
  • dm
  • dm
  • d-methorphan
  • d-methorphan
  • d-methorphan
  • drixoral cough
  • drixoral cough
  • franolyn dry
  • franolyn sed
  • pediacare 1
  • pediacare 1
  • romilar
  • romilar
  • st
  • st
  • tussabron
  • tuxium

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07241065Phase 1Jan 28, 2026AstraZeneca, Parexel
NCT06957223N/AMay 6, 2025CMH Nowshera, Pakistan Army
NCT06958692Phase 3Apr 11, 2025Yiling Pharmaceutical Inc.
NCT06383338Phase 1Mar 31, 2025Murdoch University
NCT06772753Phase 1Feb 5, 2025Johns Hopkins University
NCT06716645Phase 4Dec 3, 2024Healeon Medical Inc
NCT06632990Phase 1Nov 30, 2024Allyx Therapeutics, National Institute on Aging (NIA)
NCT06736509Phase 3Nov 21, 2024Axsome Therapeutics, Inc.
NCT06566794N/AAug 20, 2024University of Helsinki
NCT06348290Phase 1Apr 1, 2024Jemincare
NCT06223880Phase 4Dec 27, 2023Axsome Therapeutics, Inc.
NCT05944510Phase 4Aug 31, 2023All India Institute of Medical Sciences
NCT05699993Phase 1Mar 10, 2023Innovent Biologics (Suzhou) Co. Ltd.
NCT05947604Phase 1Feb 9, 2023Drugs for Neglected Diseases Initiative
NCT05602675Phase 1Nov 2, 2022Eli Lilly
NCT05278494N/ASep 15, 2022University of Southern California
NCT05557409Phase 3Sep 6, 2022Axsome Therapeutics, Inc.
NCT05444556Phase 1Jul 7, 2022Eli Lilly
NCT05236530Phase 1Mar 9, 2022Medicines for Malaria Venture, Novartis
NCT05181527Phase 4Feb 10, 2022All India Institute of Medical Sciences
Showing 20 of 154 trials
Page 1 / 8

Organizations

Research & Development (139)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AvanirFor profit161442001
Axsome Therapeutics, Inc.For profit131232017
National Cheng Kung UniversityAcademic/Hospital8832005
Boehringer IngelheimFor profit6522005
GlaxoSmithKlineFor profit5522009
Government of TaiwanGovernment5242007
Johns Hopkins UniversityAcademic/Hospital5331995
Johnson and JohnsonFor profit5422004
National Institute of Neurological Disorders and Stroke (NINDS)Government4221993
PfizerFor profit4422008
Harvard UniversityAcademic/Hospital3212003
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Academic/Hospital3222004
University Clermont AuvergneAcademic/Hospital3322012
University of GenevaAcademic/Hospital3322014
All India Institute of Medical SciencesAcademic/Hospital2212022
ALS AssociationAcademic/Hospital2012013
AstellasFor profit2212012
Bristol-Myers SquibbFor profit2222008
Department of Veteran AffairsGovernment2222003
Duke UniversityAcademic/Hospital2222015
139 organizations
Page 1 / 7

Marketing (53)

OrganizationOrg typeRelationshipDate
AH RobinsFor profitNDA2Aug 24, 1984
Acella PharmaceuticalsFor profitMKTGSep 20, 2016
ActavisFor profitSYNOct 10, 2017
ActavisFor profitMKTGAug 31, 2015
Akorn, Inc.For profitMKTGJul 31, 1996
Alkem Labs LtdFor profitMKTGJul 14, 2020
Allergan PLC (2015)For profitMKTGAug 31, 2015
AlpharmaFor profitMKTG—
Amneal PharmaceuticalsFor profitMKTGJul 28, 2017
Amneal PharmaceuticalsFor profitSYNFeb 8, 2011
Amneal PharmaceuticalsFor profitSYNJul 28, 2017
Ani PharmaceuticalsFor profitNDA2Dec 3, 1957
Aurobindo PharmaFor profitMKTGMar 17, 2017
Aurobindo PharmaFor profitSYNMar 17, 2017
AvanirFor profitNDA2Oct 29, 2010
Axsome Therapeutics, Inc.For profitNDA2Aug 18, 2022
Bionpharma IncFor profitMKTGSep 30, 2020
Bristol-Myers SquibbFor profitMKTGDec 23, 2015
Chartwell PharmaceuticalsFor profitMKTGApr 17, 2020
CosetteFor profitMKTGJun 28, 2012
Dr. Reddy's LaboratoriesFor profitMKTGAug 1, 2023
Dr. Reddy's LaboratoriesFor profitSYNDec 4, 2018
Esteve LabsFor profitMKTGSep 30, 2020
Eywa PharmaFor profitMKTGJun 16, 2020
G & W Laboratories Inc.For profitMKTGOct 31, 1984
HIBROW HLTHCAREFor profitMKTGJun 16, 2020
HalseyFor profitMKTGMar 2, 1987
Hetero Labs LtdFor profitMKTGAug 28, 2024
Hi Tech PharmaceuticalsFor profitMKTGJul 31, 1996
HikmaFor profitMKTGJul 31, 1996
Lannett Company, Inc.For profitMKTGApr 17, 2020
Mayne PharmaFor profitMKTGDec 4, 2018
PHARMOBEDIENTFor profitMKTGJan 4, 1985
Padagis UsFor profitMKTGJul 15, 2014
Paddock LaboratoriesFor profitMKTGJul 15, 2014
Paddock LaboratoriesFor profitSYNJul 15, 2014
Par PharmaceuticalsFor profitMKTGDec 23, 2015
PerrigoFor profitMKTGMar 5, 2018
Pharmaceutical AssociatesFor profitMKTGJul 21, 2014
Pharmaceutical AssociatesFor profitSYNFeb 14, 2006
Reckitt Benckiser PharmaceuticalFor profitNDA2Oct 8, 1982
Reckitt Benckiser PharmaceuticalFor profitNDAOct 8, 1982
Rhodes Pharmaceuticals, L.P.For profitMKTGNov 5, 2020
SLATE RUN PHARMAFor profitMKTGFeb 14, 2006
Slate PharmaceuticalsFor profitMKTGFeb 14, 2006
Sun PharmaceuticalsFor profitMKTGJul 1, 2021
Taro PharmaceuticalsFor profitMKTGFeb 27, 2017
Tris Pharma, Inc.For profitMKTGMay 25, 2012
VintageFor profitSYNJul 21, 2014
VintageFor profitMKTGFeb 14, 2006
Wes Pharma IncFor profitMKTGJun 16, 2020
WockhardtFor profitMKTGDec 22, 1988
WockhardtFor profitSYNJan 4, 1985