CDEK
← All drugs Report issue

hydromorphone

Trade name: diladid

Small moleculeapproved

Approved

Jan 11, 1984

Hydromorphone (also known as dihydromorphinone and the brand name Dilaudid among others) is a more potent opioid analgesic than morphine and is used for moderate to severe pain. It can be administered by injection, by infusion, by mouth, and rectally. Oral bioavailability is low. The kidney excretes hydromorphone and its metabolites. Some metabolites may have greater analgesic activity than hydromorphone itself but are unlikely to contribute to the pharmacological activity of hydromorphone. With the exception of pruritus, sedation and nausea and vomiting, which may occur less after hydromorphone than after morphine, the side-effects of these drugs are similar. Hydromorphone interacts predominantly with the opioid mu-receptors. These mu-binding sites are discretely distributed in the human brain, with high densities in the posterior amygdala, hypothalamus, thalamus, nucleus caudatus, putamen, and certain cortical areas. It also binds with kappa and delta receptors which are thought to mediate spinal analgesia, miosis and sedation. — NCATS

Clinical trial activity

200 trials · 123 clinical orgs · 28 marketing orgs

Phase 1
23
Phase 2
66
Phase 3
41
Phase 4
75

Earliest trial started Jun 1, 1996 (NCT00003115)

Timeline

1980s

  1. Jan 11, 1984

    Fresenius — Earliest FDA Approval

  2. Jan 11, 1984

    Fresenius — NDA Organization

  3. Jan 11, 1984

    Fresenius — NDA Secondary Org

1990s

  1. Dec 7, 1992

    Rhodes Pharmaceuticals, L.P. — NDA Secondary Org

  2. Aug 23, 1995

    Watson Pharmaceuticals — Marketing Organization

  3. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

  4. Jun 19, 1997

    Hospira — Marketing Organization

  5. Jul 29, 1998

    Hikma — Marketing Organization

  6. Jul 29, 1998

    West-Ward Pharmaceutical — Marketing Organization

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2002

    Earliest Phase 2 Sponsor(trial)

  3. Apr 25, 2003

    Barr Laboratories — Marketing Organization

  4. Sep 24, 2004

    Purdue Pharmaceuticals — Marketing Organization

  5. Sep 24, 2004

    Purdue Pharmaceuticals — NDA Secondary Org

  6. Dec 23, 2004

    Specgx Llc — NDA Secondary Org

  7. Dec 23, 2004

    Specgx Llc — Marketing Organization

  8. Oct 18, 2005

    Nostrum Laboratories — Marketing Organization

  9. Oct 18, 2005

    Elite Laboratories, Inc — Marketing Organization

  10. Oct 18, 2005

    MPP PHARMA — Marketing Organization

  11. Nov 9, 2005

    Nesher Pharms — Marketing Organization

  12. Jun 17, 2008

    Hospira — NDA Secondary Org

  13. Dec 9, 2009

    ANDA Repository — Marketing Organization

  14. Dec 9, 2009

    Genus Oncology, LLC — Marketing Organization

  15. Dec 9, 2009

    Lannett Company, Inc. — Marketing Organization

  16. Dec 9, 2009

    Chartwell Pharmaceuticals — Marketing Organization

2010s

  1. Apr 14, 2010

    Akorn, Inc. — Marketing Organization

  2. Apr 14, 2010

    Rising Pharmaceuticals — Marketing Organization

  3. May 12, 2014

    Actavis — Marketing Organization

  4. Apr 6, 2015

    Paddock Laboratories — Marketing Organization

  5. Apr 6, 2015

    Padagis Us — Marketing Organization

  6. May 13, 2016

    Aurobindo Pharma — Marketing Organization

  7. Jul 7, 2016

    Osmotica Pharmaceutical — Marketing Organization

  8. Oct 27, 2017

    Ascent Pharmahealth — Marketing Organization

  9. Oct 27, 2017

    Allergan PLC (2015) — Marketing Organization

  10. Apr 27, 2018

    Eurohlth Intl Sarl — Marketing Organization

2020s

  1. Sep 23, 2020

    AbbVie — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJan 11, 1984

Chemistry & pharmacology

Loading structure…

SMILES

CN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@H]3[C@H]1C5
Mol. weight
285.34 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 4,5alpha-epoxy-3-hydroxy-17-methyl-6-morphinanone
  • 4,5alpha-epoxy-3-hydroxy-17-methyl-6-morphinanone
  • 4,5-epoxy-3-hydroxy-17-methylmorphinan-6-one
  • 4,5-epoxy-3-hydroxy-17-methylmorphinan-6-one
  • (-)-(5r)-4,5-epoxy-3-hydroxy-9alpha-methylmorphinan-6-one
  • (-)-(5r)-4,5-epoxy-3-hydroxy-9alpha-methylmorphinan-6-one
  • 6-deoxy-7,8-dihydro-6-oxomorphine
  • 6-deoxy-7,8-dihydro-6-oxomorphine
  • 7,8-dihydromorphinone
  • 7,8-dihydromorphinone
  • dihydromorfinon
  • dihydromorfinon
  • dihydromorphinone
  • dihydromorphinone
  • dihydromorphinone
  • dihydromorphinone
  • dihydromorphinone hcl
  • dihydromorphinone hcl
  • dihydromorphone
  • dihydroxymorphinone
  • dihydroxymorphinone
  • dilaudid
  • dilaudid
  • dilaudid
  • dilaudid
  • dilaudid-hp
  • dilaudid-hp
  • dimorphone
  • dimorphone
  • dimorphone
  • exalgo
  • exalgo
  • hidromorfona
  • hidromorfona
  • hydromorfona
  • hydromorfona
  • hydromorphon
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone
  • hydromorphone hcl
  • hydromorphone hcl
  • hydromorphone hcl
  • hydromorphone hydrochloride
  • hydromorphone hydrochloride
  • hydromorphone hydrochloride
  • hydromorphone hydrochloride
  • hydromorphonum
  • hydromorphonum
  • idromorfone
  • idromorfone
  • palladone
  • palladone
  • palladone-sr

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07224620Phase 2Nov 30, 2025Harvard University
NCT06962306Phase 4Jun 4, 2025Duke University
NCT06868589Phase 4May 1, 2025Tufts University
NCT06784180Phase 4Mar 31, 2025University of North Carolina at Chapel Hill
NCT06823180Phase 4Mar 1, 2025Jiangxi Provincial People's Hospital
NCT06617949Early Phase 1 (Phase 1)Jan 31, 2025Medical College of Wisconsin
NCT06949059Phase 1/Phase 2 (Phase 2)Jan 1, 2025Nanjing University, Yichang Humanwell Pharmaceutical Co.,Ltd
NCT06576830Phase 4Oct 1, 2024Duke University, National Institutes of Health (NIH)
NCT06669650Phase 4Sep 25, 2024University of Tennessee
NCT06525740Phase 4Sep 3, 2024Mayo Clinic
NCT06406400Phase 2May 13, 2024AstraZeneca, Parexel
NCT06320041Phase 4Apr 1, 2024Zhejiang University
NCT06411795Phase 2Nov 10, 2023National Cancer Institute (NCI), University of Minnesota
NCT06036797Phase 2Sep 17, 2023Maternal and Child Health Hospital of Hubei Province
NCT05842044Phase 2Sep 15, 2023University of Miami
NCT06785571Phase 2/Phase 3 (Phase 3)Aug 30, 2023Huazhong University of Science and Technology, Yichang Humanwell Pharmaceutical Co.,Ltd
NCT05848635Phase 4May 1, 2023Shandong Province Qianfoshan Hospital
NCT05552443Phase 4Jan 31, 2023Mayo Clinic
NCT05610072Early Phase 1 (Phase 1)Dec 1, 2022National Institute on Drug Abuse (NIDA), University of Kentucky
NCT06218160N/ANov 1, 2022Jilin University
Showing 20 of 200 trials
Page 1 / 10

Organizations

Research & Development (123)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Yeshiva UniversityAcademic/Hospital212142004
AlzaFor profit141432003
Johnson and JohnsonFor profit111132006
Duke UniversityAcademic/Hospital9942013
MallinckrodtFor profit7632002
Mayo ClinicAcademic/Hospital7722014
National Institute on Drug Abuse (NIDA)Government7241997
Janssen Pharmaceutica NVFor profit6032006
Northwestern UniversityAcademic/Hospital6422011
University of TorontoAcademic/Hospital6532008
Johns Hopkins UniversityAcademic/Hospital5331997
University of Texas at HoustonAcademic/Hospital5522013
Case Western Reserve UniversityAcademic/Hospital4422016
Columbia UniversityAcademic/Hospital4432003
Harvard UniversityAcademic/Hospital4432008
University of ChicagoAcademic/Hospital4322011
Fujian Medical UniversityAcademic/Hospital3322018
National Cancer Institute (NCI)Government3022020
National Institutes of Health (NIH)Government3022009
University of AlbertaAcademic/Hospital3322018
123 organizations
Page 1 / 7

Marketing (37)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGDec 9, 2009
AbbVieFor profitMKTGSep 23, 2020
ActavisFor profitMKTGMay 12, 2014
Akorn, Inc.For profitMKTGApr 14, 2010
Allergan PLC (2015)For profitMKTGOct 27, 2017
Ascent PharmahealthFor profitMKTGOct 27, 2017
Aurobindo PharmaFor profitMKTGMay 13, 2016
Barr LaboratoriesFor profitMKTGApr 25, 2003
Chartwell PharmaceuticalsFor profitMKTGDec 9, 2009
Elite Laboratories, IncFor profitMKTGOct 18, 2005
Eurohlth Intl SarlFor profitMKTGApr 27, 2018
FreseniusFor profitNDAJan 11, 1984
FreseniusFor profitNDA2Jan 11, 1984
Genus Oncology, LLCFor profitMKTGDec 9, 2009
Genus Oncology, LLCFor profitSYNDec 9, 2009
HikmaFor profitMKTGJul 29, 1998
HikmaFor profitMKTGJul 29, 1998
HospiraFor profitMKTGJun 19, 1997
HospiraFor profitNDA2Jun 17, 2008
Lannett Company, Inc.For profitSYNDec 9, 2009
Lannett Company, Inc.For profitMKTGDec 9, 2009
MPP PHARMAFor profitMKTGOct 18, 2005
Nesher PharmsFor profitMKTGNov 9, 2005
Nostrum LaboratoriesFor profitMKTGOct 18, 2005
Osmotica PharmaceuticalFor profitSYNJul 7, 2016
Osmotica PharmaceuticalFor profitMKTGJul 7, 2016
Padagis UsFor profitMKTGApr 6, 2015
Paddock LaboratoriesFor profitMKTGApr 6, 2015
Paddock LaboratoriesFor profitSYNApr 6, 2015
Purdue PharmaceuticalsFor profitMKTGSep 24, 2004
Purdue PharmaceuticalsFor profitNDA2Sep 24, 2004
Rhodes Pharmaceuticals, L.P.For profitNDA2Dec 7, 1992
Rising PharmaceuticalsFor profitMKTGApr 14, 2010
Specgx LlcFor profitNDA2Dec 23, 2004
Specgx LlcFor profitMKTGDec 23, 2004
Watson PharmaceuticalsFor profitMKTGAug 23, 1995
West-Ward PharmaceuticalFor profitMKTGJul 29, 1998