protriptyline

Trade name: vivactil

Small moleculeapproved

Approved

Sep 27, 1967

Protriptyline (trade name Vivactil) is a tricyclic antidepressant, indicated for the treatment of depression. Protriptyline acts by decreasing the reuptake of norepinephrine and to a lesser extent serotonin (5-HT) in the brain. Tricyclic antidepressants act to change the balance of naturally occurring chemicals in the brain that regulate the transmission of nerve impulses between cells. Protriptyline increases the concentration of norepinephrine and serotonin (both chemicals that stimulate nerve cells) and, to a lesser extent, blocks the action of another brain chemical, acetylcholine. The therapeutic effects of protriptyline, like other antidepressants, appear slowly. Maximum benefit is often not evident for at least two weeks after starting the drug. Protriptyline is used primarily to treat depression and to treat the combination of symptoms of anxiety and depression. Like most antidepressants of this chemical and pharmacological class, protriptyline has also been used in limited numbers of patients to treat panic disorder, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, enuresis, eating disorders such as bulimia nervosa, cocaine dependency, and the depressive phase of bipolar disorder (manic-depressive) disorder. It has also been used to support smoking cessation programs. Like all tricyclic antidepressants, protriptyline should be used cautiously and with close physician supervision. This is especially so in the elderly, or people who have benign prostatic hypertrophy (enlarged prostate gland), or urinary retention, or glaucoma, especially angle-closure glaucoma (the most severe form). Before starting treatment, people should discuss the relative risks and benefits of treatment with their doctors to help determine if protriptyline is the right antidepressant for them. A common problem with tricyclic antidepressants is sedation (drowsiness, lack of physical and mental alertness), but protriptyline is considered the least sedating agent among this class of agents. Its side effects are especially noticeable early in therapy. In most people, early tricyclic side-effects decrease or disappear entirely with time, but, until then, patients taking protriptyline should take care to assess which side-effects occur in them and should not perform hazardous activities requiring mental acuity or coordination. The side-effects are increased when protriptyline is taken with central nervous system depressants, such as alcoholic beverages, sleeping medications, other sedatives, or antihistamines, as well as with other antidepressants including SSRIs, SNRIs or monoamine oxidase Inhibitors. — NCATS

Clinical trial activity

1 trials · 2 clinical orgs · 9 marketing orgs

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

Earliest trial started Dec 1, 2006 (NCT00754962)

Timeline

1960s

  1. Sep 27, 1967

    Merck — Earliest FDA Approval

  2. Sep 27, 1967

    Teva — NDA Secondary Org

  3. Sep 27, 1967

    Merck — NDA Organization

1990s

  1. Aug 24, 1995

    Odyssey Pharmaceuticals — Marketing Organization

  2. Aug 24, 1995

    Heritage Pharma — Marketing Organization

  3. Aug 24, 1995

    Chartwell Pharmaceuticals — Marketing Organization

2000s

  1. Sep 16, 2008

    West-Ward Pharmaceutical — Marketing Organization

  2. Sep 16, 2008

    Hikma — Marketing Organization

2010s

  1. May 3, 2010

    Sigmapharm Laboratories — Marketing Organization

  2. Nov 19, 2012

    Epic Pharma Llc — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedSep 27, 1967

Chemistry & pharmacology

Loading structure…

SMILES

CNCCCC1c2ccccc2C=Cc2ccccc21
Mol. weight
263.38 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • 3-(5h-dibenzo[a,d][7]annulen-5-yl)-n-methylpropan-1-amine
  • 3-(5h-dibenzo[a,d][7]annulen-5-yl)-n-methylpropan-1-amine
  • 3-(5h-dibenzo[a,d]cyclohepten-5-yl)-n-methyl-1-propanamine
  • 3-(5h-dibenzo[a,d]cyclohepten-5-yl)-n-methyl-1-propanamine
  • 5-(3-methylaminopropyl)-5h-dibenzo[a,d]cycloheptene
  • 5-(3-methylaminopropyl)-5h-dibenzo[a,d]cycloheptene
  • 7-(3-methylaminopropyl)-1,2:5,6-dibenzocycloheptatriene
  • 7-(3-methylaminopropyl)-1,2:5,6-dibenzocycloheptatriene
  • amimetilina
  • amimetilina
  • concordin-10
  • concordin-5
  • mk-240
  • mk-240
  • n-methyl-5h-dibenzo[a,d]cycloheptene-5-propanamine
  • n-methyl-5h-dibenzo[a,d]cycloheptene-5-propanamine
  • n-methyl-5h-dibenzo[a,d]cycloheptene-5-propylamine
  • n-methyl-5h-dibenzo[a,d]cycloheptene-5-propylamine
  • protriptilina
  • protriptilina
  • protriptylin
  • protriptylin
  • protriptyline
  • protriptyline
  • protriptyline
  • protriptyline
  • protriptyline
  • protriptyline
  • protriptyline
  • protriptyline
  • protriptyline
  • protriptyline
  • protriptyline hcl
  • protriptyline hcl
  • protriptyline hcl
  • protriptyline hydrochloride
  • protriptyline hydrochloride
  • protriptyline hydrochloride
  • protriptyline hydrochloride
  • protriptylinum
  • protriptylinum
  • protryptyline
  • triptil
  • vivactil
  • vivactil
  • vivactil

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT00754962N/ADec 1, 2006Advanced Biomedical Research, Roxane Laboratories
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Advanced Biomedical ResearchFor profit1012006
Roxane LaboratoriesFor profit1112006
2 organizations
Page 1 / 1

Marketing (11)

OrganizationOrg typeRelationshipDate
Chartwell PharmaceuticalsFor profitMKTGAug 24, 1995
Epic Pharma LlcFor profitMKTGNov 19, 2012
Heritage PharmaFor profitSYNAug 24, 1995
Heritage PharmaFor profitMKTGAug 24, 1995
HikmaFor profitMKTGSep 16, 2008
HikmaFor profitSYNSep 16, 2008
MerckFor profitNDASep 27, 1967
Odyssey PharmaceuticalsFor profitMKTGAug 24, 1995
Sigmapharm LaboratoriesFor profitMKTGMay 3, 2010
TevaFor profitNDA2Sep 27, 1967
West-Ward PharmaceuticalFor profitMKTGSep 16, 2008