propantheline bromide
Trade name: pro-banthine
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
Earliest trial started Oct 1, 2009 (NCT01010048)
Timeline
1950s
1970s
- Sep 9, 1974
West-Ward Pharmaceutical — Marketing Organization
- Sep 9, 1974
Hikma — Marketing Organization
- Jan 15, 1975
Watson Pharmaceuticals — Marketing Organization
- Aug 4, 1976
Mylan — Marketing Organization
1980s
- May 18, 1983
Ascot Pharmaceuticals — Marketing Organization
- Aug 1, 1983
Sandoz — Marketing Organization
- Jun 16, 1988
Par Pharmaceuticals — Marketing Organization
Indications
Approved for
Mechanism of action
- Muscarinic acetylcholine receptor M2ANTAGONIST
CHRM2 antagonist
Indicated for overactive bladder, M2 likely responsible
- Muscarinic acetylcholine receptor M1ANTAGONIST
CHRM1 antagonist
Role in regulating gastric secretion, M1 likely involved
- Muscarinic acetylcholine receptor M3ANTAGONIST
CHRM3 antagonist
Role in regulating gastric secretion and overactive bladded, M3 likely involved
Approval history
- approvedApr 2, 1953
Chemistry & pharmacology
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
- ChEMBLCHEMBL1180725 ↗
- WikipediaPropantheline bromide ↗
- NCATS1306V2B0Q8 ↗
- ChEMBLCHEMBL1240 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT01657240 | Phase 3 | Nov 1, 2014 | Laboratorios Sophia S.A de C.V. |
| NCT01640002 | Phase 1 | May 1, 2012 | Federal University of Bahia |
| NCT01541904 | Phase 2 | Mar 1, 2011 | Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde, Laboratorios Sophia S.A de C.V. |
| NCT01010048 | Phase 4 | Oct 1, 2009 | Chongqing Medical University |
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Laboratorios Sophia S.A de C.V. | For profit | 2 | 2 | 2 | 2011 |
| Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde | Academic/Hospital | 1 | 0 | 1 | 2011 |
| Chongqing Medical University | Academic/Hospital | 1 | 1 | 1 | 2009 |
| Federal University of Bahia | Academic/Hospital | 1 | 1 | 1 | 2012 |
Marketing (14)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ascot Pharmaceuticals | For profit | MKTG | May 18, 1983 |
| G D Searle | For profit | NDA2 | — |
| Heather Pharma | For profit | MKTG | — |
| Hikma | For profit | MKTG | Sep 9, 1974 |
| Hikma | For profit | SYN | Sep 9, 1974 |
| Impax Laboratories | For profit | MKTG | — |
| Mylan | For profit | MKTG | Aug 4, 1976 |
| Par Pharmaceuticals | For profit | MKTG | Jun 16, 1988 |
| Sandoz | For profit | MKTG | Aug 1, 1983 |
| Shire | For profit | NDA2 | Apr 2, 1953 |
| Shire | For profit | NDA | Apr 2, 1953 |
| Tablicaps | For profit | MKTG | — |
| Watson Pharmaceuticals | For profit | MKTG | Jan 15, 1975 |
| West-Ward Pharmaceutical | For profit | MKTG | Sep 9, 1974 |