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morphine

Small moleculeapproved

Approved

Sep 18, 1984

Morphine is one of the most important and widely used opioid for the treatment of chronic and acute pain: the very wide interindividual variability in the patients’ response to the drug may have genetic derivations. Sulphate salt of morphine sold under the many brand names, one of them, DURAMORPH, which is indicated for the management of pain severe enough to require use of an opioid analgesic by intravenous administration, and for which alternative treatments are not expected to be adequate. In addition for the epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug. Morphine has a high potential for addiction and abuse. Common side effects include drowsiness, vomiting, and constipation. Caution is advised when used during pregnancy or breast-feeding, as morphine will affect the baby. — NCATS

Clinical trial activity

935 trials · 558 clinical orgs · 57 marketing orgs

Phase 1
76
Phase 2
252
Phase 3
163
Phase 4
313

Earliest trial started Aug 1, 1994 (NCT00004696)

Timeline

1820s

  1. Jun 1, 1827

    Merck KGaA — First NDA Organization

  2. Jun 1, 1827

    Evidence of US Marketing

  3. Jun 1, 1827

    Merck KGaA — NDA Organization

1830s

  1. Jun 1, 1832

    Rosengarten & Sons, Inc. — Marketing Organization

1980s

  1. Sep 18, 1984

    Earliest FDA Approval

  2. Sep 18, 1984

    West-Ward Pharmaceutical — NDA Secondary Org

  3. Sep 18, 1984

    Hikma — Marketing Organization

  4. Oct 7, 1986

    Fresenius — NDA Secondary Org

  5. Oct 7, 1986

    Fresenius — Marketing Organization

  6. May 29, 1987

    Purdue Pharmaceuticals — NDA Secondary Org

  7. May 11, 1988

    Hospira — Marketing Organization

1990s

  1. Jul 12, 1990

    Meridien Medical Technologies, Inc. — NDA Secondary Org

  2. Aug 15, 1991

    Xanodyne Pharmaceuticals — NDA Secondary Org

  3. Sep 30, 1991

    Watson Pharmaceuticals — Marketing Organization

  4. Oct 30, 1992

    ICU Medical Inc — NDA Secondary Org

  5. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  7. Jul 3, 1996

    Allergan — NDA Secondary Org

  8. Jul 3, 1996

    Specgx Llc — NDA Secondary Org

  9. Jul 3, 1996

    Allergan — Marketing Organization

  10. Jul 3, 1996

    SmithKline Beecham — NDA Secondary Org

  11. Jul 2, 1998

    Rhodes Pharmaceuticals, L.P. — Marketing Organization

  12. Oct 28, 1998

    Strides Pharma Science — Marketing Organization

  13. Oct 28, 1998

    Vintage — Marketing Organization

2000s

  1. Jan 28, 2000

    DAVA Pharmaceuticals — Marketing Organization

  2. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  3. Mar 20, 2002

    King Pharmaceuticals — NDA Secondary Org

  4. Jul 3, 2003

    Specgx Llc — Marketing Organization

  5. May 18, 2004

    Pacira Pharmaceuticals — NDA Secondary Org

  6. May 19, 2004

    Nesher Pharms — Marketing Organization

  7. Mar 17, 2008

    Hikma — NDA Secondary Org

  8. Aug 13, 2009

    Alpharma — Marketing Organization

2010s

  1. Jun 23, 2011

    Chartwell Pharmaceuticals — Marketing Organization

  2. Jun 23, 2011

    Lannett Company, Inc. — NDA Secondary Org

  3. Jun 23, 2011

    Chartwell Pharmaceuticals — NDA Secondary Org

  4. Oct 18, 2011

    Rising Pharmaceuticals — Marketing Organization

  5. Oct 18, 2011

    Mylan — Marketing Organization

  6. Nov 10, 2011

    Par Pharmaceuticals — Marketing Organization

  7. Nov 14, 2011

    Hospira — NDA Secondary Org

  8. Jan 5, 2012

    VistaPharm, Inc. — Marketing Organization

  9. May 11, 2012

    Sun Pharmaceuticals — Marketing Organization

  10. Aug 6, 2012

    Paddock Laboratories — Marketing Organization

  11. Aug 6, 2012

    Padagis Us — Marketing Organization

  12. Jan 16, 2013

    Actavis — Marketing Organization

  13. Jun 3, 2013

    Upsher-Smith Laboratories — Marketing Organization

  14. Feb 5, 2014

    Nostrum Laboratories — Marketing Organization

  15. Dec 29, 2014

    Teva — Marketing Organization

  16. Apr 6, 2015

    Allergan PLC (2015) — Marketing Organization

  17. May 12, 2015

    Tris Pharma, Inc. — Marketing Organization

  18. May 21, 2015

    Eurohlth Intl Sarl — Marketing Organization

  19. Oct 2, 2015

    Daiichi Sankyo — NDA Secondary Org

  20. Oct 2, 2015

    Ohemo Life — Marketing Organization

  21. Oct 2, 2015

    Ohemo Life — NDA Secondary Org

  22. Dec 16, 2015

    Novel Anti-Infective Technologies, LLC — Marketing Organization

  23. Apr 12, 2016

    Impax Laboratories — Marketing Organization

  24. Jun 23, 2016

    Epic Pharma Llc — Marketing Organization

  25. Oct 28, 2016

    Mayne Pharma — Marketing Organization

  26. Oct 28, 2016

    Dr. Reddy's Laboratories — Marketing Organization

  27. Nov 14, 2016

    Pharmaceutical Associates — Marketing Organization

  28. Jan 9, 2017

    Zyla Life Sciences — NDA Secondary Org

  29. Jan 9, 2017

    Zyla Life Sciences — Marketing Organization

  30. Jul 6, 2017

    Akorn, Inc. — Marketing Organization

  31. Jul 6, 2017

    Hi Tech Pharmaceuticals — Marketing Organization

  32. Apr 17, 2018

    Ani Pharmaceuticals — Marketing Organization

  33. Jul 16, 2018

    Piramal — Marketing Organization

2020s

  1. Dec 3, 2020

    Alkem Labs Ltd — Marketing Organization

  2. Feb 12, 2021

    Winder Labs Llc — Marketing Organization

  3. Apr 29, 2021

    International Medication — Marketing Organization

  4. Aug 4, 2021

    Nortec Dev Assoc — Marketing Organization

  5. Feb 7, 2022

    RiconPharma — Marketing Organization

  6. Feb 7, 2022

    Ingenus Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewSep 18, 1984
  • approvedJun 1, 1827

Chemistry & pharmacology

Loading structure…

SMILES

CN1CC[C@@]23[C@H]4OC5=C2C(C[C@@H]1[C@@H]3C=C[C@@H]4O)=CC=C5O
Mol. weight
285.3377 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

  • (5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol
  • (5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol
  • (5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
  • (5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
  • (5r,6s,9r,13s,14r)-4,5-epoxy-n-methyl-7-morphinen-3,6-diol
  • (5r,6s,9r,13s,14r)-4,5-epoxy-n-methyl-7-morphinen-3,6-diol
  • (5α,6α)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol
  • (5α,6α)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol
  • (5α,6α)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
  • (5α,6α)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol
  • (7r,7as,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1h-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol
  • (7r,7as,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1h-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol
  • astramorph pf
  • astramorph pf
  • avinza
  • avinza
  • depodur
  • depodur
  • duramorph
  • duramorph
  • duramorph pf
  • duramorph pf
  • duromorph
  • duromorph
  • epimorphine
  • filnarine sr
  • infumorph
  • infumorph
  • kadian
  • kadian
  • moraxen
  • morcap sr
  • morfina
  • morfina
  • morphgesic sr
  • morph hcl
  • morphia
  • morphia
  • morphin
  • morphin
  • morphin
  • morphina
  • morphine
  • morphine
  • morphine
  • morphine
  • morphine
  • morphine
  • morphine
  • morphine
  • (−)-morphine
  • (−)-morphine
  • morphine 6-glucuronide
  • morphine 6-glucuronide
  • morphine hcl
  • morphine hcl
  • morphine hcl
  • morphine hydrochloride
  • morphine hydrochloride
  • morphine hydrochloride
  • morphine hydrochloride
  • morphine hydrochloride
  • morphine hydrochloride
  • morphine hydro chloride
  • morphine hydro chloride
  • morphine liposomal
  • morphine oxycodone
  • morphine sulfate
  • morphine sulfate
  • morphine sulfate
  • morphine sulfate
  • morphine sulfate
  • morphine sulfate hydrate
  • morphine sulfate hydrate
  • morphine sulfate hydrate
  • morphine sulphate
  • morphine sulphate
  • morphinum
  • morphinum
  • morphium
  • morphium
  • morpine
  • moxduo
  • mr902
  • ms contin
  • ms contin
  • mst continus
  • oramorph
  • oramorph
  • oramorph sr
  • oramorph sr
  • oramorph udv
  • pf-055
  • q8003
  • q8003
  • q8003
  • rhotard
  • sevredol
  • sevredol
  • srm-rhotard
  • zomorph

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06940570Phase 3Jan 1, 2028Children's Medical Center Dallas, The University of Texas, Dallas
NCT07288528Phase 4Apr 1, 2026McMaster University
NCT07201987Phase 2Jan 31, 2026Harvard University
NCT07229495Phase 4Jan 1, 2026Chinese Academy of Medical Sciences
NCT06875791Phase 1/Phase 2 (Phase 2)Dec 28, 2025Fundacion Clinica Valle del Lili
NCT07203794N/ADec 1, 2025Ataturk University
NCT07232108N/ADec 1, 2025Ataturk University
NCT07231926N/ADec 1, 2025Ataturk University
NCT07246785Phase 4Nov 30, 2025Peking University
NCT07201272N/AOct 1, 2025Tanta University
NCT07164677N/ASep 13, 2025Ondokuz Mayıs University
NCT07164664N/ASep 10, 2025Ondokuz Mayıs University
NCT06976320N/ASep 9, 2025—
NCT06835504Phase 3Sep 1, 2025Columbia University, Medical College of Wisconsin, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)
NCT07126483N/AAug 18, 2025Ondokuz Mayıs University
NCT07104097N/AAug 11, 2025University of Brescia
NCT07076641Phase 3Aug 1, 2025EURAXI Pharma, GCS Ramsay Santé pour l’Enseignement et la Recherche
NCT07186426Phase 3Jul 28, 2025Haisco Pharmaceutical
NCT06854211Early Phase 1 (Phase 1)Jul 1, 2025Harvard University
NCT06985290Phase 2Jul 1, 2025McMaster University
Showing 20 of 935 trials
Page 1 / 47

Organizations

Research & Development (558)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Assiut UniversityAcademic/Hospital343452007
National Institute on Drug Abuse (NIDA)Government18351995
Cairo UniversityAcademic/Hospital151342015
Harvard UniversityAcademic/Hospital131242001
Mahidol UniversityAcademic/Hospital131322008
University of TorontoAcademic/Hospital121042002
Johns Hopkins UniversityAcademic/Hospital11831995
Peking UniversityAcademic/Hospital111032011
PfizerFor profit111142006
Tel Aviv UniversityAcademic/Hospital111132001
University of CopenhagenAcademic/Hospital11932001
Johnson and JohnsonFor profit10422004
University of Texas at HoustonAcademic/Hospital10941998
Chinese Academy of Medical SciencesAcademic/Hospital9922016
Columbia UniversityAcademic/Hospital9941995
MundipharmaFor profit9842006
National Institutes of Health (NIH)Government9441997
Pacira PharmaceuticalsFor profit9822002
University of Western OntarioAcademic/Hospital9842012
GrunenthalFor profit8822007
558 organizations
Page 1 / 28

Marketing (67)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGJan 16, 2013
Akorn, Inc.For profitMKTGJul 6, 2017
Alkem Labs LtdFor profitMKTGDec 3, 2020
AllerganFor profitNDA2Jul 3, 1996
AllerganFor profitMKTGJul 3, 1996
Allergan PLC (2015)For profitMKTGApr 6, 2015
AlpharmaFor profitMKTGAug 13, 2009
Ani PharmaceuticalsFor profitMKTGApr 17, 2018
Ani PharmaceuticalsFor profitMKTGApr 17, 2018
Chartwell PharmaceuticalsFor profitMKTGJun 23, 2011
Chartwell PharmaceuticalsFor profitNDA2Jun 23, 2011
DAVA PharmaceuticalsFor profitMKTGJan 28, 2000
Daiichi SankyoFor profitNDA2Oct 2, 2015
Dr. Reddy's LaboratoriesFor profitMKTGOct 28, 2016
Epic Pharma LlcFor profitMKTGJun 23, 2016
Eurohlth Intl SarlFor profitMKTGMay 21, 2015
FreseniusFor profitNDA2Oct 7, 1986
FreseniusFor profitMKTGOct 7, 1986
Hi Tech PharmaceuticalsFor profitMKTGJul 6, 2017
HikmaFor profitNDA2Mar 17, 2008
HikmaFor profitMKTGSep 18, 1984
HospiraFor profitNDA2Nov 14, 2011
HospiraFor profitMKTGMay 11, 1988
ICU Medical IncFor profitNDA2Oct 30, 1992
Impax LaboratoriesFor profitMKTGApr 12, 2016
Ingenus PharmaceuticalsFor profitMKTGFeb 7, 2022
International MedicationFor profitMKTGApr 29, 2021
King PharmaceuticalsFor profitNDA2Mar 20, 2002
Lannett Company, Inc.For profitNDA2Jun 23, 2011
Mayne PharmaFor profitMKTGOct 28, 2016
Merck KGaAFor profitNDAJun 1, 1827
Meridien Medical Technologies, Inc.For profitNDA2Jul 12, 1990
MylanFor profitMKTGOct 18, 2011
Nesher PharmsFor profitMKTGMay 19, 2004
Nortec Dev AssocFor profitMKTGAug 4, 2021
Nostrum LaboratoriesFor profitMKTGFeb 5, 2014
Novel Anti-Infective Technologies, LLCFor profitMKTGDec 16, 2015
Ohemo LifeFor profitMKTGOct 2, 2015
Ohemo LifeFor profitNDA2Oct 2, 2015
Pacira PharmaceuticalsFor profitNDA2May 18, 2004
Padagis UsFor profitMKTGAug 6, 2012
Paddock LaboratoriesFor profitMKTGAug 6, 2012
Par PharmaceuticalsFor profitMKTGNov 10, 2011
Pharmaceutical AssociatesFor profitMKTGNov 14, 2016
PiramalFor profitMKTGJul 16, 2018
Purdue PharmaceuticalsFor profitNDA2May 29, 1987
Rhodes Pharmaceuticals, L.P.For profitMKTGJul 2, 1998
RiconPharmaFor profitMKTGFeb 7, 2022
Rising PharmaceuticalsFor profitMKTGOct 18, 2011
Rosengarten & Sons, Inc.For profitMKTGJun 1, 1832
SmithKline BeechamFor profitNDA2Jul 3, 1996
Specgx LlcFor profitNDA2Jul 3, 1996
Specgx LlcFor profitMKTGJul 3, 2003
Strides Pharma ScienceFor profitMKTGOct 28, 1998
Sun PharmaceuticalsFor profitMKTGMay 11, 2012
Sun PharmaceuticalsFor profitSYNAug 25, 2016
TevaFor profitMKTGDec 29, 2014
Tris Pharma, Inc.For profitMKTGMay 12, 2015
Upsher-Smith LaboratoriesFor profitMKTGJun 3, 2013
VintageFor profitMKTGOct 28, 1998
VistaPharm, Inc.For profitMKTGJan 5, 2012
Watson PharmaceuticalsFor profitMKTGSep 30, 1991
West-Ward PharmaceuticalFor profitNDA2Sep 18, 1984
Winder Labs LlcFor profitMKTGFeb 12, 2021
Xanodyne PharmaceuticalsFor profitNDA2Aug 15, 1991
Zyla Life SciencesFor profitNDA2Jan 9, 2017
Zyla Life SciencesFor profitMKTGJan 9, 2017