propantheline bromide

Trade name: pro-banthine

Small moleculeapproved

Approved

Apr 2, 1953

Propantheline is an antimuscarinic agent used for the treatment of excessive sweating (hyperhidrosis), cramps or spasms of the stomach, intestines (gut) or bladder, and involuntary urination (enuresis). It can also be used to control the symptoms of irritable bowel syndrome and similar conditions. Propantheline is one of a group of antispasmodic medications which work by blocking the action of the chemical messenger acetylcholine, which is produced by nerve cells, to muscarinic receptors present in various smooth muscular tissues, in places such as the gut, bladder, and eye. Normally, the binding of acetylcholine induces involuntary smooth muscular contractions. Varying degrees of drying of salivary secretions may occur as well as decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia, and increased ocular tension. Other reported adverse reactions include urinary hesitancy and retention, tachycardia, palpitations, loss of the sense of taste, headache, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, bloated feeling, impotence, suppression of lactation, and allergic reactions or drug idiosyncrasies including anaphylaxis, urticaria and other dermal manifestations. — NCATS

Clinical trial activity

4 trials · 4 clinical orgs · 12 marketing orgs

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

Earliest trial started Oct 1, 2009 (NCT01010048)

Timeline

1950s

  1. Apr 2, 1953

    Shire — Earliest FDA Approval

  2. Apr 2, 1953

    Shire — NDA Secondary Org

  3. Apr 2, 1953

    Shire — NDA Organization

1970s

  1. Sep 9, 1974

    West-Ward Pharmaceutical — Marketing Organization

  2. Sep 9, 1974

    Hikma — Marketing Organization

  3. Jan 15, 1975

    Watson Pharmaceuticals — Marketing Organization

  4. Aug 4, 1976

    Mylan — Marketing Organization

1980s

  1. May 18, 1983

    Ascot Pharmaceuticals — Marketing Organization

  2. Aug 1, 1983

    Sandoz — Marketing Organization

  3. Jun 16, 1988

    Par Pharmaceuticals — Marketing Organization

2010s

  1. Jan 1, 2011

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedApr 2, 1953

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[N+](C)(CCOC(=O)C1c2ccccc2Oc2ccccc21)C(C)C
Mol. weight
368.5 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Discontinued

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • pro-118
  • probanthine
  • pro-banthine
  • pro-banthine
  • pro-banthine
  • propantelina bromuro
  • propantelina bromuro
  • propantelina, bromuro de
  • propantelina, bromuro de
  • propanthelin bromid
  • propanthelin bromid
  • propantheline
  • propantheline
  • propantheline
  • propantheline
  • propantheline
  • propantheline
  • propantheline
  • propantheline bromide
  • propantheline bromide
  • propantheline bromide
  • propantheline bromide
  • propantheline bromide
  • propantheline bromide
  • propantheline bromide
  • propantheline bromide
  • propanthéline, bromure de
  • propanthéline, bromure de
  • propanthelini bromidum
  • propanthelini bromidum
  • propanthelinium

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01657240Phase 3Nov 1, 2014Laboratorios Sophia S.A de C.V.
NCT01640002Phase 1May 1, 2012Federal University of Bahia
NCT01541904Phase 2Mar 1, 2011Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Laboratorios Sophia S.A de C.V.
NCT01010048Phase 4Oct 1, 2009Chongqing Medical University
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Laboratorios Sophia S.A de C.V.For profit2222011
Antiguo Hospital Civil de Guadalajara Fray Antonio AlcaldeAcademic/Hospital1012011
Chongqing Medical UniversityAcademic/Hospital1112009
Federal University of BahiaAcademic/Hospital1112012
4 organizations
Page 1 / 1

Marketing (14)

OrganizationOrg typeRelationshipDate
Ascot PharmaceuticalsFor profitMKTGMay 18, 1983
G D SearleFor profitNDA2
Heather PharmaFor profitMKTG
HikmaFor profitMKTGSep 9, 1974
HikmaFor profitSYNSep 9, 1974
Impax LaboratoriesFor profitMKTG
MylanFor profitMKTGAug 4, 1976
Par PharmaceuticalsFor profitMKTGJun 16, 1988
SandozFor profitMKTGAug 1, 1983
ShireFor profitNDA2Apr 2, 1953
ShireFor profitNDAApr 2, 1953
TablicapsFor profitMKTG
Watson PharmaceuticalsFor profitMKTGJan 15, 1975
West-Ward PharmaceuticalFor profitMKTGSep 9, 1974