CDEK
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codeine

Trade name: Phenergan

Small moleculeapproved

Approved

Jan 21, 1952

Codeine is an opiate used to manage mild to moderate pain severe enough to require an opioid. Codeine is a selective agonist for the mu opioid receptor and has an affinity to delta and kappa-opioid receptors. In some countries, this drug is regulated under various narcotic control laws, because its chronic use can cause physical dependence. In others, it is available without a medical prescription in combination with paracetamol. — NCATS

Clinical trial activity

82 trials · 96 clinical orgs · 78 marketing orgs

Phase 1
16
Phase 2
18
Phase 3
12
Phase 4
31

Earliest trial started Sep 1, 2001 (NCT00029770)

Timeline

1830s

  1. Jun 1, 1836

    Rosengarten & Sons, Inc. — Marketing Organization

1950s

  1. Jan 21, 1952

    Earliest FDA Approval

  2. Jan 21, 1952

    Ani Pharmaceuticals — NDA Secondary Org

  3. Jun 1, 1952

    American Home Products — First NDA Organization

  4. Jun 1, 1952

    American Home Products — NDA Organization

  5. Apr 28, 1954

    Forest Laboratories — NDA Secondary Org

1960s

  1. Oct 5, 1960

    Meda Pharmaceuticals — NDA Secondary Org

1970s

  1. May 31, 1974

    Carnrick Laboratories — Marketing Organization

  2. Jul 22, 1975

    AH Robins — Marketing Organization

  3. May 10, 1976

    Roxane Laboratories — Marketing Organization

  4. Jul 9, 1976

    Johnson and Johnson — Marketing Organization

  5. Feb 10, 1977

    Sandoz — Marketing Organization

  6. Aug 23, 1977

    Lumara Health — Marketing Organization

  7. Dec 19, 1977

    Whiteworth Towne Paulsen — Marketing Organization

  8. Jan 20, 1978

    Mutual Pharmaceutical — Marketing Organization

  9. Mar 14, 1978

    Warner Chilcott — Marketing Organization

  10. Mar 17, 1978

    Everylife Foundation for Rare Diseases — Marketing Organization

  11. May 10, 1978

    R.P. Scherer — Marketing Organization

  12. Jun 20, 1978

    Actavis — Marketing Organization

  13. Nov 6, 1978

    Sun Pharmaceuticals — Marketing Organization

  14. Mar 27, 1979

    ACI Limited — Marketing Organization

1980s

  1. Aug 21, 1981

    Pharmaceutical Associates — Marketing Organization

  2. Aug 21, 1981

    Genus Oncology, LLC — Marketing Organization

  3. May 26, 1982

    Watson Pharmaceuticals — Marketing Organization

  4. Jun 22, 1982

    Upsher-Smith Laboratories — Marketing Organization

  5. Nov 3, 1982

    Lederle — Marketing Organization

  6. Nov 3, 1982

    American Cyanamid — Marketing Organization

  7. Dec 10, 1982

    Puracap Pharmaceutical — Marketing Organization

  8. Dec 29, 1983

    Teva — Marketing Organization

  9. Feb 6, 1984

    Duramed Research — Marketing Organization

  10. Mar 20, 1984

    Vanguard — Marketing Organization

  11. Oct 12, 1984

    Wockhardt — Marketing Organization

  12. Mar 22, 1985

    STI Pharma, LLC — Marketing Organization

  13. Mar 22, 1985

    Animas Corporation — Marketing Organization

  14. Oct 18, 1985

    Superpharm — Marketing Organization

  15. Nov 22, 1985

    Fondazione Golgi Cenci — Marketing Organization

  16. Feb 25, 1986

    Mikart — Marketing Organization

  17. May 28, 1986

    Fisons — NDA Secondary Org

  18. Mar 2, 1987

    Halsey — Marketing Organization

  19. Mar 3, 1987

    Am Therap — Marketing Organization

  20. Feb 10, 1988

    Rhodes Pharmaceuticals, L.P. — Marketing Organization

  21. Sep 30, 1988

    Vintage — Marketing Organization

  22. Apr 25, 1989

    Boehringer Ingelheim — Marketing Organization

1990s

  1. Oct 26, 1990

    Allergan — NDA Secondary Org

  2. Oct 26, 1990

    SmithKline Beecham — NDA Secondary Org

  3. Jul 16, 1992

    Fosun — Marketing Organization

  4. Jul 30, 1992

    Actavis — NDA Secondary Org

  5. Oct 27, 1992

    Chartwell Pharmaceuticals — Marketing Organization

  6. Oct 27, 1992

    ANDA Repository — Marketing Organization

  7. Apr 16, 1996

    Novartis — Marketing Organization

  8. Apr 26, 1996

    Akorn, Inc. — Marketing Organization

  9. Apr 26, 1996

    Hi Tech Pharmaceuticals — Marketing Organization

  10. Sep 20, 1996

    DAVA Pharmaceuticals — Marketing Organization

  11. Aug 31, 1998

    Jerome Stevens Pharmaceuticals — Marketing Organization

  12. Dec 29, 1998

    Oxford Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Mar 23, 2001

    Hikma — Marketing Organization

  3. May 31, 2001

    Specgx Llc — Marketing Organization

  4. Aug 22, 2001

    Bausch Health Companies — Marketing Organization

  5. Nov 30, 2001

    LGM Pharma — Marketing Organization

  6. Nov 30, 2001

    Nexgen Pharma, Inc — Marketing Organization

  7. Aug 1, 2002

    Able Laboratories — Marketing Organization

  8. Jun 21, 2004

    Lannett Company, Inc. — NDA Secondary Org

  9. Jan 1, 2005

    Johnson and Johnson — Earliest Phase 1 Sponsor(trial)

  10. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

  11. May 29, 2008

    Amneal Pharmaceuticals — Marketing Organization

  12. Jul 16, 2009

    West-Ward Pharmaceutical — NDA Secondary Org

  13. Jul 16, 2009

    Hikma — NDA Secondary Org

2010s

  1. Jan 7, 2010

    Ingenus Pharmaceuticals — Marketing Organization

  2. Mar 17, 2010

    Nostrum Laboratories — Marketing Organization

  3. Jun 29, 2012

    Tris Pharma, Inc. — Marketing Organization

  4. Apr 15, 2013

    Aurobindo Pharma — Marketing Organization

  5. Jun 13, 2014

    Lannett Company, Inc. — Marketing Organization

  6. Apr 30, 2015

    AYTU BioScience — NDA Secondary Org

  7. Apr 30, 2015

    Tris Pharma, Inc. — NDA Secondary Org

  8. Jun 22, 2015

    Mainpointe — NDA Secondary Org

  9. Oct 30, 2015

    Mayne Pharma — Marketing Organization

  10. Oct 30, 2015

    Dr. Reddy's Laboratories — Marketing Organization

  11. Jun 27, 2019

    Eywa Pharma — Marketing Organization

  12. Jun 27, 2019

    Wes Pharma Inc — Marketing Organization

  13. Sep 10, 2019

    Elite Laboratories, Inc — Marketing Organization

2020s

  1. Jul 8, 2020

    Strides Pharma Science — Marketing Organization

  2. Oct 8, 2020

    Quagen Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedJan 21, 1952

Chemistry & pharmacology

Loading structure…

SMILES

COC1=C2O[C@H]3[C@@H](O)C=C[C@H]4[C@H]5CC(C=C1)=C2[C@@]34CCN5C
Mol. weight
299.3642 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 3-methylmorphin
  • 3-methylmorphin
  • 3-methylmorphine
  • (5alpha,6alpha)-7,8-didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol
  • (5alpha,6alpha)-7,8-didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol
  • (5α,6α)-7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol diacetate (ester)
  • (5α,6α)-7,8-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol diacetate (ester)
  • (5α,6α)-7,8-didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol
  • (5α,6α)-7,8-didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol
  • 7,8-didehydro-4,5alpha-epoxy-3-methoxy-17-methylmorphinan-6alpha-ol
  • 7,8-didehydro-4,5alpha-epoxy-3-methoxy-17-methylmorphinan-6alpha-ol
  • 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
  • 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol
  • 7,8-dihydro-4,5-alpha-epoxy-17-methylmorphinan-3,6-alpha-diol diacetate
  • 7,8-dihydro-4,5-alpha-epoxy-17-methylmorphinan-3,6-alpha-diol diacetate
  • ambenyl cough syrup
  • ambenyl cough syrup
  • bepro
  • codein
  • codein
  • codein
  • codeína
  • codeína
  • codeine
  • codeine
  • codeine
  • codeine
  • codeine
  • codeine
  • codeine
  • codeine
  • (-)-codeine
  • (−)-codeine
  • (−)-codeine
  • codéine
  • codéine
  • codeine anhydrous
  • codeine anhydrous
  • codeine anhydrous
  • codeine monohydrate
  • codeine phosphate
  • codeine phosphate
  • codeine phosphate
  • codeine phosphate
  • codeine phosphate anhydrous
  • codeine phosphate anhydrous
  • codeine phosphate anhydrous
  • codeine phosphate anhydrous
  • codeine phosphate anhydrous
  • codeine phosphate anhydrous
  • codeine phosphate hydrate
  • codeine phosphate hydrate
  • codeine phosphate hydrate
  • codeine polistirex
  • codeine polistirex
  • codeine polistirex
  • codeine polistirex
  • codeine sulfate
  • codeine sulfate
  • codeine sulfate
  • codeine sulfate
  • codeine sulfate
  • codeine sulfate trihydrate
  • codeinum
  • codeinum
  • colrex compound
  • colrex compound
  • cordin
  • evacode
  • galcodine
  • galcodine
  • ibuprofen codeine
  • l-codeine
  • l-codeine
  • methylmorphine
  • methylmorphine
  • methylmorphine
  • methylmorphine
  • morphine 3-methyl ether
  • morphine 3-methyl ether
  • morphine-3-methyl ether
  • morphine-3-methyl ether
  • morphine monomethyl ether
  • morphine monomethyl ether
  • morphine monomethyl ether
  • n-methylmorphine
  • o(3)-methylmorphine
  • o(3)-methylmorphine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05081102Phase 3Feb 28, 2023Eurofarma Laboratorios S.A.
NCT05571072N/AJan 16, 2023Case Western Reserve University
NCT06916234Phase 4Jan 10, 2023Van Yuzuncu Yil University
NCT05477875Phase 2Dec 31, 2022Consortium for Medical Marijuana Clinical Outcomes Research, University of Florida
NCT04972292Phase 3Jul 31, 2022Eurofarma Laboratorios S.A.
NCT04641338Phase 3Jan 31, 2022Brainfarma Industria Química e Farmacêutica S/A, Brazilian Clinical Research Institute
NCT05626140Phase 3Sep 28, 2021Government of Pakistan, Riphah International University
NCT05229965Phase 3Aug 1, 2021University of Monastir
NCT04874675N/AJun 30, 2021University of Zimbabwe, UZ-CHS-PERFECT
NCT04937101N/AJan 1, 2021Zhejiang University
NCT04259333Phase 4Mar 1, 2020Humber River Hospital, University of Toronto
NCT04202406N/ADec 31, 2019Cairo University
NCT04332536N/ADec 1, 2019University of Leeds
NCT03902340N/ADec 19, 2018Eurofins, Hôpital Roger Salengro, Sublimed
NCT03498014N/AOct 31, 2018Centre Hospitalier Universitaire de Nīmes, University of Nimes
NCT05770960Phase 4Jun 27, 2018Katholieke Universiteit Leuven
NCT03469310Phase 4Mar 9, 2018Doctors Hospital at Renaissance
NCT03335423Phase 1Mar 1, 2018University of Southern Denmark
NCT04066426Phase 4Mar 1, 2018Cairo University, Yuzuncu Yıl University
NCT03478423N/AFeb 5, 2018Mount Sinai Hospital, Canada, University of Toronto
Showing 20 of 82 trials
Page 1 / 5

Organizations

Research & Development (96)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Roxane LaboratoriesFor profit6632006
CEDRA Clinical ResearchFor profit5022006
Yeshiva UniversityAcademic/Hospital4432012
Government of CanadaGovernment3332005
Katholieke Universiteit LeuvenAcademic/Hospital3322017
University of Roma La SapienzaAcademic/Hospital3222013
Cairo UniversityAcademic/Hospital2122018
Children's National Medical CenterAcademic/Hospital2122006
Dalhousie UniversityAcademic/Hospital2022005
Eurofarma Laboratorios S.A.For profit2212022
Mayo ClinicAcademic/Hospital2222009
Napo PharmaceuticalsFor profit2212006
National Institutes of Health (NIH)Government2222004
Nexgen Pharma, IncFor profit2212014
University of AnkaraAcademic/Hospital2212014
University of Sao PauloAcademic/Hospital2222014
University of TorontoAcademic/Hospital2122018
WyethFor profit2022007
59th Medical WingAcademic/Hospital1112017
Abdi Ibrahim PharmaceuticalsFor profit1012013
96 organizations
Page 1 / 5

Marketing (95)

OrganizationOrg typeRelationshipDate
ACI LimitedFor profitMKTGMar 27, 1979
ACI LimitedFor profitMKTGMar 27, 1979
AH RobinsFor profitMKTGJul 22, 1975
ANDA RepositoryFor profitMKTGOct 27, 1992
AYTU BioScienceFor profitNDA2Apr 30, 2015
Able LaboratoriesFor profitMKTGAug 1, 2002
ActavisFor profitNDA2Jul 30, 1992
ActavisFor profitMKTGJun 20, 1978
Akorn, Inc.For profitMKTGApr 26, 1996
AllerganFor profitNDA2Oct 26, 1990
AlpharmaFor profitMKTG—
Am TherapFor profitMKTGMar 3, 1987
American CyanamidFor profitMKTGNov 3, 1982
American Home ProductsFor profitNDAJun 1, 1952
Amneal PharmaceuticalsFor profitSYNApr 24, 2013
Amneal PharmaceuticalsFor profitMKTGMay 29, 2008
Ani PharmaceuticalsFor profitNDA2Jan 21, 1952
Animas CorporationFor profitMKTGMar 22, 1985
Aurobindo PharmaFor profitMKTGApr 15, 2013
Bausch Health CompaniesFor profitSYNApr 26, 1978
Bausch Health CompaniesFor profitSYNJan 8, 1979
Bausch Health CompaniesFor profitMKTGAug 22, 2001
Boehringer IngelheimFor profitMKTGApr 25, 1989
Carnrick LaboratoriesFor profitMKTGMay 31, 1974
Chartwell PharmaceuticalsFor profitMKTGOct 27, 1992
Chartwell PharmaceuticalsFor profitSYNNov 10, 2011
DAVA PharmaceuticalsFor profitMKTGSep 20, 1996
Dr. Reddy's LaboratoriesFor profitMKTGOct 30, 2015
Duramed ResearchFor profitMKTGFeb 6, 1984
Elite Laboratories, IncFor profitMKTGSep 10, 2019
Everylife Foundation for Rare DiseasesAcademic/HospitalMKTGMar 17, 1978
Eywa PharmaFor profitMKTGJun 27, 2019
FisonsFor profitNDA2May 28, 1986
Fondazione Golgi CenciAcademic/HospitalMKTGNov 22, 1985
Forest LaboratoriesFor profitNDA2Apr 28, 1954
FosunFor profitMKTGJul 16, 1992
Genus Oncology, LLCFor profitMKTGAug 21, 1981
GlaxoSmithKlineFor profitNDA2—
GlaxoSmithKlineFor profitMKTG—
HalseyFor profitMKTGMar 2, 1987
Hi Tech PharmaceuticalsFor profitMKTGApr 26, 1996
Hi Tech PharmaceuticalsFor profitSYNDec 23, 2014
HikmaFor profitNDA2Jul 16, 2009
HikmaFor profitMKTGMar 23, 2001
Ingenus PharmaceuticalsFor profitMKTGJan 7, 2010
Jerome Stevens PharmaceuticalsFor profitMKTGAug 31, 1998
Johnson and JohnsonFor profitMKTGJul 9, 1976
Johnson and JohnsonFor profitSYNAug 17, 1977
LGM PharmaFor profitMKTGNov 30, 2001
Lannett Company, Inc.For profitMKTGJun 13, 2014
Lannett Company, Inc.For profitNDA2Jun 21, 2004
LederleFor profitMKTGNov 3, 1982
Lumara HealthFor profitMKTGAug 23, 1977
MainpointeFor profitNDA2Jun 22, 2015
Mayne PharmaFor profitMKTGOct 30, 2015
Meda PharmaceuticalsFor profitNDA2Oct 5, 1960
MikartFor profitMKTGFeb 25, 1986
Mutual PharmaceuticalFor profitMKTGJan 20, 1978
Nexgen Pharma, IncFor profitMKTGNov 30, 2001
Nostrum LaboratoriesFor profitMKTGMar 17, 2010
NovartisFor profitMKTGApr 16, 1996
Oxford PharmaceuticalsFor profitMKTGDec 29, 1998
Pharmaceutical AssociatesFor profitMKTGAug 21, 1981
Puracap PharmaceuticalFor profitMKTGDec 10, 1982
Puracap PharmaceuticalFor profitSYNMay 11, 1979
Quagen PharmaFor profitMKTGOct 8, 2020
R.P. SchererFor profitMKTGMay 10, 1978
Rhodes Pharmaceuticals, L.P.For profitMKTGFeb 10, 1988
Rosengarten & Sons, Inc.For profitMKTGJun 1, 1836
Roxane LaboratoriesFor profitMKTGMay 10, 1976
STI Pharma, LLCFor profitMKTGMar 22, 1985
SandozFor profitMKTGFeb 10, 1977
SmithKline BeechamFor profitNDA2Oct 26, 1990
SolvayFor profitMKTG—
Specgx LlcFor profitMKTGMay 31, 2001
Strides Pharma ScienceFor profitMKTGJul 8, 2020
Sun PharmaceuticalsFor profitMKTGNov 6, 1978
SuperpharmFor profitMKTGOct 18, 1985
TevaFor profitMKTGDec 29, 1983
Tris Pharma, Inc.For profitMKTGJun 29, 2012
Tris Pharma, Inc.For profitNDA2Apr 30, 2015
Upsher-Smith LaboratoriesFor profitMKTGJun 22, 1982
VanguardFor profitMKTGMar 20, 1984
VintageFor profitMKTGSep 30, 1988
VintageFor profitSYNSep 30, 1988
VintageFor profitSYNMar 5, 1999
VitarineFor profitMKTG—
Warner ChilcottFor profitMKTGMar 14, 1978
Watson PharmaceuticalsFor profitMKTGMay 26, 1982
Watson PharmaceuticalsFor profitSYNJan 22, 2003
Wes Pharma IncFor profitMKTGJun 27, 2019
West-Ward PharmaceuticalFor profitNDA2Jul 16, 2009
Whiteworth Towne PaulsenFor profitMKTGDec 19, 1977
WockhardtFor profitMKTGOct 12, 1984
WockhardtFor profitSYNJul 22, 1981