pentazocine

Trade name: talwin

Small moleculeapproved

Approved

Jul 24, 1967

Pentazocine is a synthetically prepared prototypical mixed agonist-antagonist narcotic (opioid analgesic) drug of the benzomorphan class of opioids used to treat moderate to moderately severe pain. Pentazocine is sold under several brand names, such as Fortral, Sosegon, Talwin NX. Pentazocine acts as an agonist of κ-opioid receptors and as an antagonist of μ-opioid receptors. This compound may exist as one of two enantiomers, named (+)-pentazocine and (−)-pentazocine. Side effects are similar to those of morphine, but pentazocine, due to its action at the kappa opioid receptor is more likely to invoke psychotomimetic effects. High dose may cause high blood pressure or high heart rate. — NCATS

Clinical trial activity

7 trials · 10 clinical orgs · 6 marketing orgs

Phase 1
1
Phase 2
2
Phase 3
0
Phase 4
2

Earliest trial started Sep 1, 2005 (NCT00125931)

Timeline

1960s

  1. Jul 24, 1967

    Hospira — Earliest FDA Approval

  2. Jul 24, 1967

    Hospira — NDA Secondary Org

  3. Jul 24, 1967

    Hospira — NDA Organization

  4. Feb 3, 1969

    Sanofi-Aventis — NDA Secondary Org

1990s

  1. Jan 21, 1997

    Watson Pharmaceuticals — Marketing Organization

2000s

  1. Mar 17, 2000

    Sun Pharmaceuticals — Marketing Organization

  2. Jul 11, 2001

    Lupin — Marketing Organization

  3. Aug 2, 2002

    Gavis Pharmaceuticals — Marketing Organization

  4. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

Indications

Approved for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewJul 24, 1967

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H]1[C@H]2CC3=CC=C(O)C=C3[C@]1(C)CCN2CC=C(C)C
Mol. weight
285.4238 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • cis-(+/-)-pentazocine
  • dl-pentazocine
  • fortral
  • fortral
  • pentazocin
  • pentazocin
  • pentazocin
  • pentazocina
  • pentazocina
  • pentazocine
  • pentazocine
  • pentazocine
  • pentazocine
  • pentazocine
  • pentazocine
  • pentazocine
  • pentazocine
  • pentazocine
  • pentazocine
  • pentazocine hcl
  • pentazocine hcl
  • pentazocine hcl
  • pentazocine hydrochloride
  • pentazocine hydrochloride
  • pentazocine hydrochloride
  • pentazocine hydrochloride
  • pentazocine lactate
  • pentazocine lactate
  • pentazocine lactate
  • pentazocine lactate
  • pentazocinum
  • pentazocinum
  • sosegon
  • sosegon
  • talwin
  • talwin
  • talwin
  • win-20228
  • win-20228

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05565274N/AOct 31, 2022Federal Medical Centre, Yenagoa
NCT04539249N/AOct 31, 2020Federal Medical Centre, Yenagoa
NCT02208596Phase 4Sep 1, 2014Zhengzhou University
NCT01872494Phase 4May 1, 2013People's Liberation Army of China
NCT02070718Phase 1Jan 1, 2013National Center for Advancing Translational Science (NCATS), National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA), National Institutes of Health (NIH), University of Washington
NCT00431184Phase 2Jan 1, 2007Mclean Hospital, Stanley Medical Research Institute
NCT00125931Phase 2Sep 1, 2005Mclean Hospital, Stanley Medical Research Institute
Showing 7 of 7 trials
Page 1 / 1

Organizations

Research & Development (10)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Federal Medical Centre, YenagoaAcademic/Hospital2212020
Mclean HospitalAcademic/Hospital2212005
Stanley Medical Research InstituteAcademic/Hospital2012005
National Center for Advancing Translational Science (NCATS)Government1012013
National Center for Complementary and Integrative Health (NCCIH)Government1012013
National Institute on Aging (NIA)Government1012013
National Institutes of Health (NIH)Government1012013
People's Liberation Army of ChinaGovernment1112013
University of WashingtonAcademic/Hospital1112013
Zhengzhou UniversityAcademic/Hospital1112014
10 organizations
Page 1 / 1

Marketing (7)

OrganizationOrg typeRelationshipDate
Gavis PharmaceuticalsFor profitMKTGAug 2, 2002
HospiraFor profitNDA2Jul 24, 1967
HospiraFor profitNDAJul 24, 1967
LupinFor profitMKTGJul 11, 2001
Sanofi-AventisFor profitNDA2Feb 3, 1969
Sun PharmaceuticalsFor profitMKTGMar 17, 2000
Watson PharmaceuticalsFor profitMKTGJan 21, 1997