trifluoperazine

Trade name: stelazine

Small moleculeapproved

Approved

Apr 16, 1959

Trifluoperazine (Eskazinyl, Eskazine, Jatroneural, Modalina, Stelazine, Terfluzine, Trifluoperaz, Triftazin) is a typical antipsychotic of the phenothiazine chemical class used for the short-term treatment of certain types of anxiety. Trifluoperazine blocks postsynaptic mesolimbic dopaminergic D1 and D2 receptors in the brain; depresses the release of hypothalamic and hypophyseal hormones and is believed to depress the reticular activating system thus affecting basal metabolism, body temperature, wakefulness, vasomotor tone, and emesis. The primary application of trifluoperazine is for schizophrenia. Other official indications may vary country by country, but generally, it is also indicated for use in agitation and patients with behavioral problems, severe nausea, and vomiting as well as severe anxiety. Trials have shown a moderate benefit of this drug in patients with borderline personality disorder. A 2004 meta-analysis of the studies on trifluoperazine found that it is more likely than placebo to cause extrapyramidal side effects such as akathisia, dystonia, and Parkinsonism. It is also more likely to cause somnolence and anticholinergic side effects such as red-eye and xerostomia (dry mouth). — NCATS

Clinical trial activity

2 trials · 3 clinical orgs · 12 marketing orgs

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

Earliest trial started Jun 1, 2019 (NCT03966053)

Timeline

1950s

  1. Apr 16, 1959

    GlaxoSmithKline — Earliest FDA Approval

  2. Apr 16, 1959

    GlaxoSmithKline — NDA Secondary Org

  3. Apr 16, 1959

    GlaxoSmithKline — NDA Organization

1980s

  1. Nov 20, 1981

    Sandoz — Marketing Organization

  2. Apr 15, 1982

    Fosun — Marketing Organization

  3. Apr 15, 1982

    Chartwell Pharmaceuticals — Marketing Organization

  4. Nov 19, 1982

    Ivax — Marketing Organization

  5. Jul 26, 1983

    Wockhardt — Marketing Organization

  6. Apr 23, 1985

    Duramed Research — Marketing Organization

1990s

  1. Oct 25, 1996

    Invatech — Marketing Organization

  2. Oct 25, 1996

    Athem — Marketing Organization

  3. Jul 7, 1997

    Mylan — Marketing Organization

2010s

  1. Jan 1, 2019

    Earliest Phase 1 Sponsor(trial)

2020s

  1. Jan 1, 2025

    Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedApr 16, 1959

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCN(CCCN2c3ccccc3Sc3ccc(C(F)(F)F)cc32)CC1.Cl.Cl
Mol. weight
480.43 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 10-[3-(4-methyl-1-piperazinyl)propyl]-2-(trifluoromethyl)-10h-phenothiazine
  • 10-[3-(4-methyl-1-piperazinyl)propyl]-2-(trifluoromethyl)-10h-phenothiazine
  • 10-[3-(4-methyl-piperazin-1-yl)-propyl]-2-trifluoromethyl-10h-phenothiazine
  • 10-[3-(4-methyl-piperazin-1-yl)-propyl]-2-trifluoromethyl-10h-phenothiazine
  • amylozine
  • flupazine
  • stelazine
  • stelazine
  • stelazine
  • stelazine
  • stelazine fte
  • trifluoperazin
  • trifluoperazina
  • trifluoperazina
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine
  • trifluoperazine dihydrochloride
  • trifluoperazine hcl
  • trifluoperazine hcl
  • trifluoperazine hcl
  • trifluoperazine hydrochloride
  • trifluoperazine hydrochloride
  • trifluoperazine hydrochloride
  • trifluoperazine hydrochloride
  • trifluoperazine maleate
  • trifluoperazine maleate
  • trifluoperazinum
  • trifluoperazinum
  • trifluoromethyl-10-(3'-(1-methyl-4-piperazinyl)propyl)phenothiazine
  • trifluoromethyl-10-(3'-(1-methyl-4-piperazinyl)propyl)phenothiazine
  • trifluoromethylperazine
  • trifluoroperazine
  • trifluoroperazine
  • trifluoroperazine
  • trifluperazine
  • trifluperazine
  • trifluperazine
  • triflurin
  • triperazine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07008235Phase 2/Phase 3 (Phase 3)Jul 1, 2025Dhaka Medical College
NCT03966053Phase 1/Phase 2 (Phase 2)Jun 1, 2019Feinstein Institute for Medical Research, Northwell Health
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Dhaka Medical CollegeAcademic/Hospital1112025
Feinstein Institute for Medical ResearchAcademic/Hospital1112019
Northwell HealthAcademic/Hospital1012019
3 organizations
Page 1 / 1

Marketing (13)

OrganizationOrg typeRelationshipDate
AthemFor profitMKTGOct 25, 1996
Athenex, Inc.For profitMKTG
Chartwell PharmaceuticalsFor profitMKTGApr 15, 1982
Duramed ResearchFor profitMKTGApr 23, 1985
FosunFor profitMKTGApr 15, 1982
GlaxoSmithKlineFor profitNDA2Apr 16, 1959
GlaxoSmithKlineFor profitNDAApr 16, 1959
InvatechFor profitMKTGOct 25, 1996
IvaxFor profitMKTGNov 19, 1982
MylanFor profitMKTGJul 7, 1997
SandozFor profitMKTGNov 20, 1981
Watson PharmaceuticalsFor profitMKTG
WockhardtFor profitMKTGJul 26, 1983