dicyclomine hydrochloride
Trade name: bentyl
Approved
May 11, 1950
Dicyclomine is an anticholinergic tertiary amine used frequently by oral and parenteral route as an effective anti-spasmodic agent. Dicyclomine hydrochloride salt is approved under brand name bentyl for the treatment of functional bowel/irritable bowel syndrome. In addition is known, that dicyclomine is also used in morning and motion sickness, dysmenorrheal, intestinal hypermotility. It was shown, that Dicyclomine is a selective M1 and M3 muscarinic receptors antagonist, but os shown pharmacological activity via the M1 receptor. — NCATS
Clinical trial activity
1 trials · 1 clinical orgs · 35 marketing orgs
Earliest trial started Nov 15, 2022 (NCT05617690)
Timeline
1950s
- May 11, 1950
Allergan (1948) — Earliest FDA Approval
- May 11, 1950
Allergan — NDA Secondary Org
- May 11, 1950
Allergan — Marketing Organization
- May 11, 1950
Allergan (1948) — NDA Organization
- Apr 30, 1951
Aptalis — NDA Secondary Org
- Aug 13, 1952
AbbVie — NDA Secondary Org
1970s
- Sep 30, 1974
Lannett Company, Inc. — Marketing Organization
- May 20, 1975
Sun Pharmaceuticals — Marketing Organization
- Jul 28, 1976
Watson Pharmaceuticals — Marketing Organization
1980s
- Feb 22, 1984
Dr. Reddy's Laboratories — Marketing Organization
1990s
- Oct 1, 1996
Hikma — Marketing Organization
- Feb 28, 1997
West-Ward Pharmaceutical — Marketing Organization
- Sep 7, 1999
Aurobindo Pharma — Marketing Organization
- Sep 7, 1999
Mylan — Marketing Organization
2000s
- Mar 24, 2005
Teva — Marketing Organization
2010s
- Feb 17, 2017
Lutipold — Marketing Organization
- Feb 17, 2017
Sankyo — Marketing Organization
- Feb 17, 2017
Daiichi Sankyo — Marketing Organization
- May 4, 2018
Akorn, Inc. — Marketing Organization
- Jul 2, 2018
APC Pharmaceuticals — Marketing Organization
- Jul 2, 2018
Fosun — Marketing Organization
- Nov 2, 2018
Slate Pharmaceuticals — Marketing Organization
- Nov 2, 2018
SLATE RUN PHARMA — Marketing Organization
- Jan 25, 2019
Fresenius — Marketing Organization
- Feb 1, 2019
Nexus Pharmaceuticals — Marketing Organization
- Feb 11, 2019
Custopharm Inc — Marketing Organization
- Apr 26, 2019
Praxgen Pharma — Marketing Organization
- Apr 26, 2019
Geneyork Pharmaceuticals — Marketing Organization
- Apr 26, 2019
Athenex, Inc. — Marketing Organization
2020s
- Apr 23, 2021
Novitium Pharma — Marketing Organization
- Apr 23, 2021
Ani Pharmaceuticals — Marketing Organization
- Nov 28, 2022
Amneal Pharmaceuticals — Marketing Organization
- Dec 14, 2022
Rubicon Research — Marketing Organization
- Dec 27, 2022
TWi Biotechnology, Inc. — Marketing Organization
- Aug 4, 2023
Bionpharma Inc — Marketing Organization
Indications
Approved for
Mechanism of action
- Muscarinic acetylcholine receptor M1ANTAGONIST
CHRM1 antagonist
Indicated in irritable bowel, M3 likely involved
- Muscarinic acetylcholine receptor M3ANTAGONIST
CHRM3 antagonist
Indicated in irritable bowel, M3 likely involved
Approval history
- approvedMay 11, 1950
Chemistry & pharmacology
SMILES
CCN(CC)CCOC(=O)C1(C2CCCCC2)CCCCC1- Mol. weight
- 309.49 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
Sources
- ChEMBLCHEMBL1123 ↗
- WikipediaDicycloverine ↗
- NCATSCQ903KQA31 ↗
- ChEMBLCHEMBL222280 ↗
- ChEMBLCHEMBL1200479 ↗
Also known as
- 2-(diethylamino)ethyl 1-cyclohexylcyclohexanecarboxylate
- 2-(diethylamino)ethyl 1-cyclohexylcyclohexanecarboxylate
- bentyl
- bentyl
- bicyclohexyl-1-carboxylic acid 2-diethylamino-ethyl ester
- bicyclohexyl-1-carboxylic acid 2-diethylamino-ethyl ester
- dicicloverina
- dicicloverina
- dicyclomine
- dicyclomine
- dicyclomine
- dicyclomine
- dicyclomine
- dicyclomine
- dicyclomine
- dicyclomine
- dicyclomine
- dicyclomine hcl
- dicyclomine hcl
- dicyclomine hcl
- dicyclomine hydrochloride
- dicyclomine hydrochloride
- dicyclomine hydrochloride
- dicyclomine hydrochloride
- dicyclomine hydrochloride (preservative-free)
- dicyclomine hydrochloride (preservative-free)
- dicycloverin
- dicycloverin
- dicycloverin
- dicycloverine
- dicycloverine
- dicycloverine
- dicycloverine
- dicycloverine
- dicycloverine hcl
- dicycloverine hcl
- dicycloverine hydrochloride
- dicycloverinum
- dicycloverinum
- dicymine
- dicymine
- dicymine
- dicymine
- dicymine
- dicymine
- dicymine
- merbentyl
- merbentyl
- merbentyl 20
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05617690 | N/A | Nov 15, 2022 | Capital Medical University |
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Capital Medical University | Academic/Hospital | 1 | 1 | 1 | 2022 |
Marketing (40)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| APC Pharmaceuticals | For profit | MKTG | Jul 2, 2018 |
| AbbVie | For profit | NDA2 | Aug 13, 1952 |
| Akorn, Inc. | For profit | SYN | May 4, 2018 |
| Akorn, Inc. | For profit | MKTG | May 4, 2018 |
| Allergan | For profit | NDA2 | May 11, 1950 |
| Allergan | For profit | MKTG | May 11, 1950 |
| Allergan (1948) | For profit | NDA | May 11, 1950 |
| Alpharma | For profit | MKTG | — |
| Amneal Pharmaceuticals | For profit | MKTG | Nov 28, 2022 |
| Ani Pharmaceuticals | For profit | MKTG | Apr 23, 2021 |
| Aptalis | For profit | NDA2 | Apr 30, 1951 |
| Athenex, Inc. | For profit | MKTG | Apr 26, 2019 |
| Aurobindo Pharma | For profit | MKTG | Sep 7, 1999 |
| Bionpharma Inc | For profit | MKTG | Aug 4, 2023 |
| Custopharm Inc | For profit | MKTG | Feb 11, 2019 |
| Daiichi Sankyo | For profit | MKTG | Feb 17, 2017 |
| Dow Chemical | For profit | MKTG | — |
| Dr. Reddy's Laboratories | For profit | MKTG | Feb 22, 1984 |
| Fosun | For profit | MKTG | Jul 2, 2018 |
| Fresenius | For profit | MKTG | Jan 25, 2019 |
| Geneyork Pharmaceuticals | For profit | MKTG | Apr 26, 2019 |
| Hikma | For profit | SYN | May 22, 2020 |
| Hikma | For profit | MKTG | Oct 1, 1996 |
| Lannett Company, Inc. | For profit | MKTG | Sep 30, 1974 |
| Lutipold | For profit | MKTG | Feb 17, 2017 |
| Mylan | For profit | MKTG | Sep 7, 1999 |
| Nexus Pharmaceuticals | For profit | MKTG | Feb 1, 2019 |
| Novitium Pharma | For profit | MKTG | Apr 23, 2021 |
| Praxgen Pharma | For profit | MKTG | Apr 26, 2019 |
| Rubicon Research | For profit | MKTG | Dec 14, 2022 |
| SLATE RUN PHARMA | For profit | MKTG | Nov 2, 2018 |
| Sankyo | For profit | MKTG | Feb 17, 2017 |
| Slate Pharmaceuticals | For profit | MKTG | Nov 2, 2018 |
| Sun Pharmaceuticals | For profit | MKTG | May 20, 1975 |
| TWi Biotechnology, Inc. | For profit | MKTG | Dec 27, 2022 |
| Teva | For profit | SYN | Mar 24, 2005 |
| Teva | For profit | MKTG | Mar 24, 2005 |
| Watson Pharmaceuticals | For profit | MKTG | Jul 28, 1976 |
| West-Ward Pharmaceutical | For profit | MKTG | Feb 28, 1997 |
| West-Ward Pharmaceutical | For profit | SYN | Jun 30, 2003 |