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methadone

Trade name: methadose

Small moleculeapproved

Approved

Aug 13, 1947

Methadone, sold under the brand names Dolophine among others, is an synthetic opioid that is used as the hydrochloride to treat pain and as maintenance therapy or to help with detoxification in people with opioid dependence. Methadone hydrochloride is a mu-agonist; a synthetic opioid analgesic with multiple actions qualitatively similar to those of morphine. Some data also indicate that methadone acts as an antagonist at the NMDA-receptor. The contribution of NMDA receptor antagonism to methadone’s efficacy is unknown. Most common adverse reactions are: lightheadedness, dizziness, sedation, nausea, vomiting, and sweating. Avoid use mixed agonist/antagonist and partial agonist opioid analgesics with DOLOPHINE because they may reduce analgesic effect of DOLOPHINE or precipitate withdrawal symptoms. — NCATS

Clinical trial activity

200 trials · 186 clinical orgs · 23 marketing orgs

Phase 1
44
Phase 2
72
Phase 3
42
Phase 4
58

Earliest trial started Feb 1, 1995 (NCT00004390)

Timeline

1940s

  1. Aug 13, 1947

    Earliest FDA Approval

  2. Aug 13, 1947

    Mylan — NDA Secondary Org

  3. Aug 13, 1947

    West-Ward Pharmaceutical — NDA Secondary Org

  4. Aug 13, 1947

    Hikma — Marketing Organization

  5. Aug 13, 1947

    Hikma — NDA Secondary Org

  6. Dec 15, 1947

    Mallinckrodt — NDA Secondary Org

1970s

  1. Mar 14, 1973

    Specgx Llc — NDA Secondary Org

  2. Mar 14, 1973

    Sandoz — Marketing Organization

  3. Mar 14, 1973

    Sandoz — NDA Secondary Org

1980s

  1. Mar 8, 1983

    Roxane Laboratories — Marketing Organization

  2. Mar 8, 1983

    Boehringer Ingelheim — Marketing Organization

1990s

  1. Apr 15, 1993

    Specgx Llc — Marketing Organization

  2. Nov 30, 1994

    VistaPharm, Inc. — Marketing Organization

  3. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  4. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  5. Jan 1, 1999

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Nov 25, 2009

    Thepharmanetwork Llc — Marketing Organization

2010s

  1. Aug 18, 2015

    Epic Pharma Llc — Marketing Organization

  2. Aug 31, 2015

    Aurobindo Pharma — Marketing Organization

  3. Oct 27, 2017

    Akorn, Inc. — Marketing Organization

  4. Oct 27, 2017

    LONG GROVE PHARMS — Marketing Organization

  5. Mar 30, 2018

    Sun Pharmaceuticals — Marketing Organization

  6. Aug 2, 2018

    Elite Laboratories, Inc — Marketing Organization

  7. Aug 2, 2018

    Nostrum Laboratories — Marketing Organization

  8. Jan 3, 2019

    Ascent Pharmahealth — Marketing Organization

  9. Jan 3, 2019

    Allergan PLC (2015) — Marketing Organization

  10. Aug 22, 2019

    Pharmaceutical Associates — Marketing Organization

  11. Aug 22, 2019

    Mallinckrodt (2013) — Marketing Organization

2020s

  1. Nov 2, 2020

    Lannett Company, Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 13, 1947

Chemistry & pharmacology

Loading structure…

SMILES

CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Mol. weight
309.45 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 6-dimethylamino-4,4-diphenyl-3-heptanone
  • 6-dimethylamino-4,4-diphenyl-3-heptanone
  • amidone
  • amidone
  • dl-methadone
  • dl-methadone
  • d-methadone
  • d-methadone
  • dolophine
  • dolophine
  • dolophine
  • dolophine hcl
  • dolophine hcl
  • eptadone
  • eptadone
  • heptadon
  • heptadon
  • martindale
  • metadone
  • metadone
  • metadone
  • metadone
  • metadone
  • metadone
  • methadone
  • methadone
  • methadone
  • methadone
  • methadone
  • methadone
  • methadone
  • methadone
  • (+-)-methadone
  • (+-)-methadone
  • (+/-)-methadone
  • (+/-)-methadone
  • (±)-methadone
  • (±)-methadone
  • methadone hcl
  • methadone hcl
  • methadone hcl
  • methadone hydrochloride
  • methadone hydrochloride
  • methadone hydrochloride
  • methadone hydrochloride
  • methadone hydrochloride
  • methadone hydrochloride intensol
  • methadone hydrochloride intensol
  • methadon hcl
  • methadonium chloride
  • methadonium chloride
  • methadonum
  • methadonum
  • methadose
  • methadose
  • metharose
  • methex
  • methex
  • phy
  • phy
  • physeptone
  • physeptone
  • pinadone
  • pinadone
  • symoron
  • symoron
  • synastone
  • westadone
  • westadone

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06940570Phase 3Jan 1, 2028Children's Medical Center Dallas, The University of Texas, Dallas
NCT07221617Phase 4Jan 1, 2026Mayo Clinic
NCT07226245Early Phase 1 (Phase 1)Dec 31, 2025Wake Forest University
NCT07227064Phase 3Dec 1, 2025Medical University of South Carolina
NCT07092475Phase 3Nov 30, 2025University of Utah
NCT07226076Phase 3Nov 28, 2025Medical University of South Carolina
NCT07222072Phase 4Nov 3, 2025The Cleveland Clinic
NCT06877858Phase 1Sep 1, 2025University of Pennsylvania
NCT06962306Phase 4Jun 4, 2025Duke University
NCT06868589Phase 4May 1, 2025Tufts University
NCT06810336Early Phase 1 (Phase 1)Mar 10, 2025University of Virginia
NCT06843174Phase 4Feb 19, 2025AFP Innovation Fund, Unity Health Toronto
NCT06826742Phase 4Feb 12, 2025Mayo Clinic
NCT06784999Phase 4Jan 10, 2025Indiana University
NCT06626035Phase 2Jan 1, 2025National Institutes of Health (NIH), University of Pittsburgh
NCT06626503Phase 2Jan 1, 2025National Institutes of Health (NIH), University of Pittsburgh
NCT06720415Phase 4Dec 15, 2024Mayo Clinic
NCT06536517Phase 2Nov 30, 2024Johns Hopkins University
NCT06576830Phase 4Oct 1, 2024Duke University, National Institutes of Health (NIH)
NCT06525740Phase 4Sep 3, 2024Mayo Clinic
Showing 20 of 200 trials
Page 1 / 10

Organizations

Research & Development (186)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute on Drug Abuse (NIDA)Government26551995
Johns Hopkins UniversityAcademic/Hospital10831995
Northwestern UniversityAcademic/Hospital8332010
Washington University in St. LouisAcademic/Hospital8732008
National Institutes of Health (NIH)Government7251996
University of ChicagoAcademic/Hospital7612010
Duke UniversityAcademic/Hospital6532018
Yale UniversityAcademic/Hospital6532005
Aarhus UniversityAcademic/Hospital5532019
Friends Research Institute, Inc.Academic/Hospital5532003
Mayo ClinicAcademic/Hospital5522007
National Institute of Allergy and Infectious Diseases (NIAID)Government5531999
University of Texas at HoustonAcademic/Hospital5542007
Canadian Institutes of Health Research (CIHR)Academic/Hospital4022005
State University of New York, BuffaloAcademic/Hospital4222009
University of British ColumbiaAcademic/Hospital4432005
University of CalgaryAcademic/Hospital4332003
University of PennsylvaniaAcademic/Hospital4432008
University of PittsburghAcademic/Hospital4321996
University of Sao PauloAcademic/Hospital4421998
186 organizations
Page 1 / 10

Marketing (27)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGOct 27, 2017
Allergan PLC (2015)For profitMKTGJan 3, 2019
Ascent PharmahealthFor profitMKTGJan 3, 2019
Aurobindo PharmaFor profitMKTGAug 31, 2015
Boehringer IngelheimFor profitMKTGMar 8, 1983
Eli LillyFor profitNDA—
Elite Laboratories, IncFor profitMKTGAug 2, 2018
Epic Pharma LlcFor profitMKTGAug 18, 2015
HikmaFor profitMKTGAug 13, 1947
HikmaFor profitSYNAug 13, 1947
HikmaFor profitNDA2Aug 13, 1947
LONG GROVE PHARMSFor profitMKTGOct 27, 2017
Lannett Company, Inc.For profitMKTGNov 2, 2020
MallinckrodtFor profitNDA2Dec 15, 1947
Mallinckrodt (2013)For profitMKTGAug 22, 2019
MylanFor profitNDA2Aug 13, 1947
Nostrum LaboratoriesFor profitMKTGAug 2, 2018
Pharmaceutical AssociatesFor profitMKTGAug 22, 2019
Roxane LaboratoriesFor profitMKTGMar 8, 1983
SandozFor profitMKTGMar 14, 1973
SandozFor profitNDA2Mar 14, 1973
Specgx LlcFor profitNDA2Mar 14, 1973
Specgx LlcFor profitMKTGApr 15, 1993
Sun PharmaceuticalsFor profitMKTGMar 30, 2018
Thepharmanetwork LlcFor profitMKTGNov 25, 2009
VistaPharm, Inc.For profitMKTGNov 30, 1994
West-Ward PharmaceuticalFor profitNDA2Aug 13, 1947