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tapentadol

Trade name: nucynta

Small moleculeapproved

Approved

Nov 20, 2008

Tapentadol is the first US FDA-approved centrally acting analgesic having both μ-opioid receptor agonist and noradrenaline (norepinephrine) reuptake inhibition activity with minimal serotonin reuptake inhibition. Tapentadol is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, neuropathic pain associated with diabetic peripheral neuropathy (DPN) severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. — NCATS

Clinical trial activity

66 trials · 20 clinical orgs · 11 marketing orgs

Phase 1
13
Phase 2
44
Phase 3
34
Phase 4
7

Earliest trial started Mar 31, 2003 (NCT03951402)

Timeline

2000s

  1. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2004

    Johnson and Johnson — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2006

    Johnson and Johnson — Earliest Phase 3 Sponsor(trial)

  4. Nov 20, 2008

    Earliest FDA Approval

  5. Nov 20, 2008

    Assertio — NDA Secondary Org

  6. Nov 20, 2008

    Collegium Pharmaceutical, Inc. — Marketing Organization

  7. Nov 20, 2008

    Collegium Pharmaceutical, Inc. — NDA Secondary Org

  8. Dec 24, 2008

    Johnson and Johnson — First NDA Organization

  9. Dec 24, 2008

    Johnson and Johnson — NDA Organization

2010s

  1. May 18, 2015

    Actavis — Marketing Organization

  2. May 18, 2015

    Allergan PLC (2015) — Marketing Organization

  3. May 19, 2015

    Roxane Laboratories — Marketing Organization

  4. May 19, 2015

    Boehringer Ingelheim — Marketing Organization

  5. Mar 31, 2016

    Alkem Labs Ltd — Marketing Organization

  6. May 25, 2017

    West-Ward Pharmaceutical — Marketing Organization

  7. Sep 14, 2017

    Rhodes Pharmaceuticals, L.P. — Marketing Organization

2020s

  1. Apr 28, 2022

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedNov 20, 2008

Chemistry & pharmacology

Loading structure…

SMILES

CC[C@@H](c1cccc(O)c1)[C@@H](C)CN(C)C
Mol. weight
221.34 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 3-((1r,2r)-3-(dimethylamino)-1-ethyl-2-methylpropyl)phenol
  • bn-200
  • bn-200
  • cg5503
  • cg5503
  • cg 5503
  • cg 5503
  • cg-5503
  • cg-5503
  • nucynt
  • nucynt
  • nucynta
  • nucynta
  • nucynta
  • nucynta
  • nucynta
  • nucynta
  • nucynta er
  • nucynta er
  • palexia
  • palexia
  • r331333
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol
  • tapentadol hcl
  • tapentadol hcl
  • tapentadol hcl
  • tapentadol hydrochloride
  • tapentadol hydrochloride
  • tapentadol hydrochloride
  • tapentadol hydrochloride
  • tapentadol hydrochloride

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04718116N/ANov 1, 2021Aretaieion University
NCT03604354Phase 4Aug 1, 2018All India Institute of Medical Sciences
NCT03314792Phase 4Dec 4, 2017University of Oslo
NCT03351517N/ANov 1, 2017All India Institute of Medical Sciences
NCT02604446Phase 3Sep 1, 2015Norwegian University of Science and Technology
NCT03121547Phase 1/Phase 2 (Phase 2)May 19, 2015The Parker Institute, University of Copenhagen
NCT02081391Phase 3Jan 1, 2015Assertio, Grunenthal
NCT02151682Phase 2/Phase 3 (Phase 3)Dec 1, 2014Grunenthal
NCT02221674Phase 2Nov 1, 2014Assertio, Grunenthal
NCT01838616Phase 4Apr 1, 2013Grunenthal
NCT01813890Phase 3Jan 1, 2013Grunenthal, Johnson and Johnson
NCT01729728Phase 2Nov 1, 2012Grunenthal, Johnson and Johnson
NCT01725087Phase 2Nov 1, 2012Forest Laboratories, Grunenthal
NCT01615510Phase 1Oct 1, 2012Universitaetsklinikum Schleswig-Holstein
NCT01631513Phase 4Aug 1, 2012Janssen Pharmaceutica NV, Johnson and Johnson
NCT01516008Phase 3Jan 1, 2012Johnson and Johnson
NCT01134536Phase 2Oct 1, 2011Grunenthal, Johnson and Johnson
NCT01458015Phase 4Oct 1, 2011Universitaetsklinikum Schleswig-Holstein, University of Kiel
NCT01435577Phase 2Sep 1, 2011Grunenthal
NCT01500317Phase 4May 1, 2011Mayo Clinic, National Center for Research Resources (NCRR)
Showing 20 of 66 trials
Page 1 / 4

Organizations

Research & Development (20)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
GrunenthalFor profit442242003
Johnson and JohnsonFor profit423542004
Janssen Pharmaceutica NVFor profit5032008
Medical University of ViennaAcademic/Hospital3012007
Universitaetsklinikum Schleswig-HolsteinAcademic/Hospital3222011
All India Institute of Medical SciencesAcademic/Hospital2222017
AssertioFor profit2022014
Aretaieion UniversityAcademic/Hospital1112021
Forest LaboratoriesFor profit1012012
Institut Gustave RoussyAcademic/Hospital1012007
Mayo ClinicAcademic/Hospital1112011
National Center for Research Resources (NCRR)Government1012011
Norwegian University of Science and TechnologyAcademic/Hospital1112015
Premier Research GroupFor profit1012007
Samodzielny Publiczny SzpitalAcademic/Hospital1012007
The Parker InstituteAcademic/Hospital1012015
University of BirminghamAcademic/Hospital1012009
University of CopenhagenAcademic/Hospital1112015
University of KielAcademic/Hospital1012011
University of OsloAcademic/Hospital1112017
20 organizations
Page 1 / 1

Marketing (15)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGMay 18, 2015
ActavisFor profitSYNMar 31, 2016
Alkem Labs LtdFor profitMKTGMar 31, 2016
Allergan PLC (2015)For profitMKTGMay 18, 2015
AssertioFor profitSYNOct 15, 2012
AssertioFor profitNDA2Nov 20, 2008
Boehringer IngelheimFor profitMKTGMay 19, 2015
Collegium Pharmaceutical, Inc.For profitMKTGNov 20, 2008
Collegium Pharmaceutical, Inc.For profitNDA2Nov 20, 2008
Johnson and JohnsonFor profitNDADec 24, 2008
Rhodes Pharmaceuticals, L.P.For profitMKTGSep 14, 2017
Roxane LaboratoriesFor profitMKTGMay 19, 2015
West-Ward PharmaceuticalFor profitMKTGMay 25, 2017
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGApr 28, 2022
Yichang Humanwell Pharmaceutical Co.,LtdFor profitSYNApr 28, 2022