dexmedetomidine

Trade name: precedex

Small moleculeapproved

Approved

Dec 17, 1999

Dexmedetomide (biologically active dextroisomer of medetomidine) is an alpha2-adrenergic agonist which was approved by FDA for the sedation purposes. Upon administration the drug activates the alpha2 receptors thus inhibiting the release of norepinephrine and terminating the propagation of pain signals. Also it inhibits sympathetic activity and thus can decrease blood pressure and heart rate. — NCATS

Clinical trial activity

1,633 trials · 564 clinical orgs · 46 marketing orgs

Phase 1
142
Phase 2
301
Phase 3
236
Phase 4
569

Earliest trial started Apr 1, 2002 (NCT00417664)

Timeline

1990s

  1. Dec 17, 1999

    Abbott — Earliest FDA Approval

  2. Dec 17, 1999

    Hospira — NDA Secondary Org

  3. Dec 17, 1999

    Abbott — NDA Organization

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2005

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Aug 18, 2014

    Mylan — Marketing Organization

  2. Aug 18, 2014

    Par Pharmaceuticals — Marketing Organization

  3. Aug 18, 2014

    Endo Pharmaceuticals — Marketing Organization

  4. Aug 18, 2014

    PH HEALTH — Marketing Organization

  5. Nov 24, 2014

    Akorn, Inc. — Marketing Organization

  6. Nov 24, 2014

    Rising Pharmaceuticals — Marketing Organization

  7. Aug 20, 2015

    Sun Pharmaceuticals — Marketing Organization

  8. Aug 20, 2015

    Gland Pharma Ltd — Marketing Organization

  9. Sep 18, 2015

    Fresenius — Marketing Organization

  10. Oct 21, 2015

    Hq Speciality Pharma — NDA Secondary Org

  11. Feb 9, 2016

    Accord Research — Marketing Organization

  12. Mar 17, 2016

    Aurobindo Pharma — Marketing Organization

  13. Mar 17, 2016

    Eugia Pharma — Marketing Organization

  14. Jun 14, 2016

    Sandoz — Marketing Organization

  15. Jun 14, 2016

    Novartis — Marketing Organization

  16. Jun 14, 2016

    Caplin Point Laboratories — Marketing Organization

  17. Oct 17, 2016

    Actavis — Marketing Organization

  18. Oct 17, 2016

    Allergan PLC (2015) — Marketing Organization

  19. Apr 26, 2017

    West-Ward Pharmaceutical — Marketing Organization

  20. May 12, 2017

    Lutipold — Marketing Organization

  21. May 12, 2017

    Sankyo — Marketing Organization

  22. May 12, 2017

    Daiichi Sankyo — Marketing Organization

  23. Sep 19, 2017

    Hengrui Therapeutics, Inc. — Marketing Organization

  24. Sep 19, 2017

    Jiangsu Wuzhong Pharmaceutical Group Co., Ltd. — Marketing Organization

  25. Nov 28, 2017

    Teva — Marketing Organization

  26. Feb 27, 2018

    Zydus Discovery DMCC — Marketing Organization

  27. Mar 29, 2018

    Amneal Pharmaceuticals — Marketing Organization

  28. Aug 21, 2018

    Baxalta — Marketing Organization

  29. Aug 21, 2018

    Shire — Marketing Organization

  30. Jan 18, 2019

    Cipla — Marketing Organization

  31. Jan 18, 2019

    Eu Yan Sang — Marketing Organization

  32. Jan 18, 2019

    Meitheal — Marketing Organization

  33. Dec 4, 2019

    Slayback Pharma Llc — Marketing Organization

  34. Dec 4, 2019

    Wilshire Pharmaceuticals — Marketing Organization

2020s

  1. Jan 30, 2020

    Hikma — Marketing Organization

  2. Jun 3, 2020

    Fosun — Marketing Organization

  3. Sep 15, 2020

    Bristol-Myers Squibb — Marketing Organization

  4. Nov 23, 2020

    Precision Dose — Marketing Organization

  5. Sep 3, 2021

    Piramal — Marketing Organization

  6. Apr 5, 2022

    BioXcel Therapeutics Inc — Marketing Organization

  7. Apr 5, 2022

    BioXcel Therapeutics Inc — NDA Secondary Org

  8. Jun 7, 2023

    Milla Pharms — Marketing Organization

  9. Sep 24, 2024

    Somerset Pharmaceuticals — Marketing Organization

  10. Feb 25, 2026

    Dr. Reddy's Laboratories — Marketing Organization

  11. Mar 9, 2026

    KNACK — Marketing Organization

Indications

Studied for

Mechanism of action

Approval history

  • approvedDec 17, 1999

Chemistry & pharmacology

Loading structure…

SMILES

Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Mol. weight
200.28 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral, Topical
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

Yes

Sources

Also known as

  • (+)-4-((s)-alpha,2,3-trimethylbenzyl)imidazole
  • (+)-4-((s)-alpha,2,3-trimethylbenzyl)imidazole
  • deksmedetomidine
  • dexdor
  • dexmedethomidine
  • dexmedetmoidine
  • dexmedetomedine
  • dexmedetomidin
  • dexmedetomidin
  • dexmedetomidina
  • dexmedetomidina
  • dexmedetomidine
  • dexmedetomidine
  • dexmedetomidine
  • dexmedetomidine
  • dexmedetomidine
  • dexmedetomidine
  • dexmedetomidine
  • dexmedetomidine
  • dexmedetomidine
  • dexmedetomidine
  • dexmédétomidine
  • dexmédétomidine
  • dexmedetomidine hcl
  • dexmedetomidine hcl
  • dexmedetomidine hcl
  • dexmedetomidine hydrochloride
  • dexmedetomidine hydrochloride
  • dexmedetomidine hydrochloride
  • dexmedetomidine hydrochloride
  • dexmedetomidine hydrochloride
  • dexmedetomidine hydrochloride
  • dexmedetomidinum
  • dexmedetomidinum
  • (+)-medetomidine
  • (+)-medetomidine
  • mexmedetomidine
  • mpv1440
  • mpv-1440
  • mpv-1440
  • precedex
  • precedex
  • precedex
  • precedex
  • (s)-medetomidine
  • (s)-medetomidine
  • (s)-medetomidine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07276906Phase 4Jan 31, 2026University of South Alabama
NCT07300826Phase 4Jan 31, 2026Assiut University
NCT07298525Phase 4Jan 10, 2026Sichuan University
NCT07302815N/AJan 10, 2026Tanta University
NCT07279727Phase 1Jan 1, 2026Assiut University
NCT07180095Phase 1/Phase 2 (Phase 2)Jan 1, 2026Liaquat University of Medical & Health Sciences
NCT07289620N/AJan 1, 2026Poznan University
NCT07308756Phase 4Dec 31, 2025Peking University
NCT07271459N/ADec 31, 2025Ain Shams University
NCT07190612Phase 4Dec 31, 2025Ain Shams University
NCT07263165N/ADec 15, 2025Assiut University
NCT07231926N/ADec 1, 2025Ataturk University
NCT07249827Phase 2Dec 1, 2025McGill University
NCT07239479N/ADec 1, 2025Tam Anh Research Institute
NCT07255027N/ADec 1, 2025Capital Medical University, Inner Mongolia Autonomous Region Center for Diseases Prevention and Control (IMCDC)
NCT07246447N/ANov 30, 2025Cairo University
NCT07271147N/ANov 7, 2025Nantong University
NCT07214714Phase 4Nov 1, 2025Assiut University
NCT07214701Phase 4Nov 1, 2025Assiut University
NCT07213037Phase 3Nov 1, 2025Assiut University
Showing 20 of 1,633 trials
Page 1 / 82

Organizations

Research & Development (564)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Assiut UniversityAcademic/Hospital11211152013
Cairo UniversityAcademic/Hospital858052013
Ain Shams UniversityAcademic/Hospital727152016
Tanta UniversityAcademic/Hospital585552013
Yonsei UniversityAcademic/Hospital555522010
Peking UniversityAcademic/Hospital444322011
Mansoura UniversityAcademic/Hospital323042013
Capital Medical UniversityAcademic/Hospital292542011
Harvard UniversityAcademic/Hospital292752006
PfizerFor profit27242005
People's Liberation Army of ChinaGovernment262332013
Zagazig UniversityAcademic/Hospital242452016
Seoul National UniversityAcademic/Hospital222232011
Jiao Tong UniversityAcademic/Hospital211542011
BioXcel Therapeutics IncFor profit181342019
Fudan UniversityAcademic/Hospital181332010
National Cancer Institute, EgyptGovernment181852014
Menoufia UniversityAcademic/Hospital161542013
HospiraFor profit151532005
Huazhong University of Science and TechnologyAcademic/Hospital15942011
564 organizations
Page 1 / 29

Marketing (54)

OrganizationOrg typeRelationshipDate
AbbottFor profitNDADec 17, 1999
Accord ResearchFor profitMKTGFeb 9, 2016
ActavisFor profitMKTGOct 17, 2016
Akorn, Inc.For profitMKTGNov 24, 2014
Akorn, Inc.For profitSYNNov 24, 2014
Allergan PLC (2015)For profitMKTGOct 17, 2016
Amneal PharmaceuticalsFor profitMKTGMar 29, 2018
Amneal PharmaceuticalsFor profitSYNMay 15, 2023
Aurobindo PharmaFor profitMKTGMar 17, 2016
BaxaltaFor profitMKTGAug 21, 2018
BioXcel Therapeutics IncFor profitMKTGApr 5, 2022
BioXcel Therapeutics IncFor profitNDA2Apr 5, 2022
Bristol-Myers SquibbFor profitMKTGSep 15, 2020
Caplin Point LaboratoriesFor profitMKTGJun 14, 2016
CiplaFor profitMKTGJan 18, 2019
Daiichi SankyoFor profitMKTGMay 12, 2017
Dr. Reddy's LaboratoriesFor profitMKTGFeb 25, 2026
Endo PharmaceuticalsFor profitMKTGAug 18, 2014
Eu Yan SangFor profitMKTGJan 18, 2019
Eugia PharmaFor profitMKTGMar 17, 2016
FosunFor profitMKTGJun 3, 2020
FreseniusFor profitMKTGSep 18, 2015
Gland Pharma LtdFor profitMKTGAug 20, 2015
Gland Pharma LtdFor profitMKTGJun 3, 2020
Hengrui Therapeutics, Inc.For profitMKTGSep 19, 2017
Hengrui Therapeutics, Inc.For profitSYNSep 19, 2017
HikmaFor profitMKTGJan 30, 2020
HikmaFor profitSYNApr 26, 2017
HospiraFor profitNDA2Dec 17, 1999
Hq Speciality PharmaFor profitNDA2Oct 21, 2015
Jiangsu Wuzhong Pharmaceutical Group Co., Ltd.For profitMKTGSep 19, 2017
KNACKFor profitMKTGMar 9, 2026
LutipoldFor profitMKTGMay 12, 2017
MeithealFor profitMKTGJan 18, 2019
Milla PharmsFor profitMKTGJun 7, 2023
MylanFor profitMKTGAug 18, 2014
MylanFor profitSYNAug 27, 2020
NovartisFor profitMKTGJun 14, 2016
PH HEALTHFor profitMKTGAug 18, 2014
Par PharmaceuticalsFor profitMKTGAug 18, 2014
PiramalFor profitMKTGSep 3, 2021
Precision DoseFor profitMKTGNov 23, 2020
Rising PharmaceuticalsFor profitMKTGNov 24, 2014
SandozFor profitMKTGJun 14, 2016
SandozFor profitSYNJun 14, 2016
SankyoFor profitMKTGMay 12, 2017
ShireFor profitMKTGAug 21, 2018
Slayback Pharma LlcFor profitMKTGDec 4, 2019
Somerset PharmaceuticalsFor profitMKTGSep 24, 2024
Sun PharmaceuticalsFor profitMKTGAug 20, 2015
TevaFor profitMKTGNov 28, 2017
West-Ward PharmaceuticalFor profitMKTGApr 26, 2017
Wilshire PharmaceuticalsFor profitMKTGDec 4, 2019
Zydus Discovery DMCCFor profitMKTGFeb 27, 2018