clidinium
Trade name: quarzan
Approved
Sep 1, 1966
LIBRAX® combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide. Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds. Clidinium bromide is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. It inhibits muscarinic actions of acetylcholine at postganglionic parasympathetic neuroeffector sites. LIBRAX® is indicated to control emotional and somatic factors in gastrointestinal disorders. It may also be used as adjunctive therapy in the treatment of peptic ulcer and in the treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. — NCATS
Clinical trial activity
1 trials · 2 clinical orgs · 19 marketing orgs
Earliest trial started Jun 1, 2002 (NCT00516854)
Timeline
1960s
- Jun 1, 1966
Roche — First NDA Organization
- Jun 1, 1966
Roche — NDA Organization
- Sep 1, 1966
Earliest FDA Approval
- Sep 1, 1966
Bausch Health Companies — Marketing Organization
- Sep 1, 1966
Bausch Health Companies — NDA Secondary Org
2020s
- Jul 7, 2020
Sunrise Medical Research, Inc. — Marketing Organization
- Jul 7, 2020
Nuvo Research Inc. — Marketing Organization
- Jul 29, 2020
Misemer Pharmaceutical — Marketing Organization
- Oct 20, 2020
Chartwell Pharmaceuticals — Marketing Organization
- Oct 20, 2020
Pharma Life Sciences LLC — Marketing Organization
- Oct 20, 2020
Eci Pharmaceuticals Llc — Marketing Organization
- Apr 26, 2021
Alkem Labs Ltd — Marketing Organization
- May 10, 2021
Dr. Reddy's Laboratories — Marketing Organization
- Oct 25, 2021
Amneal Pharmaceuticals — Marketing Organization
- Nov 2, 2021
Teva — Marketing Organization
- Jul 19, 2022
Micro Labs Ltd India — Marketing Organization
- Jul 29, 2022
Corepharma — Marketing Organization
- Jul 29, 2022
Westminster Pharms — Marketing Organization
- Sep 14, 2023
Aurobindo Pharma — Marketing Organization
- Sep 15, 2023
Alembic — Marketing Organization
- Dec 14, 2023
Torrent Pharmaceuticals Limited — Marketing Organization
- Jul 8, 2024
Winder Labs Llc — Marketing Organization
Indications
Mechanism of action
- 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, M3 likely involved
Combination products
librax
with chlordiazepoxide
Approval history
- approvedSep 1, 1966
Chemistry & pharmacology
SMILES
C[N+]12CCC(CC1)C(OC(=O)C(O)(c1ccccc1)c1ccccc1)C2- Mol. weight
- 352.45 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL620 ↗
- WikipediaClidinium bromide ↗
- NCATSBO76JF850N ↗
- ChEMBLCHEMBL1255790 ↗
- ChEMBLCHEMBL1200950 ↗
- ChEMBLCHEMBL11608 ↗
Also known as
- 3-(2-hydroxy-2,2-diphenyl-acetoxy)-1-methyl-1-azonia-bicyclo[2.2.2]octane
- 3-(2-hydroxy-2,2-diphenyl-acetoxy)-1-methyl-1-azonia-bicyclo[2.2.2]octane
- 3-hydroxy-1-methylquinuclidinium benzilate ester
- 3-hydroxy-1-methylquinuclidinium benzilate ester
- bromure de clidinium
- bromure de clidinium
- bromuro de clidinio
- bromuro de clidinio
- clidinii bromidum
- clidinii bromidum
- clidinium
- clidinium
- clidinium
- clidinium
- clidinium
- clidinium
- clidinium
- clidinium
- clidinium
- clidinium
- clidinium
- clidinium, 11c-labeled
- clidinium, 1-(methyl-11c)-labeled
- clidinium, 3h-labeled
- clidinium bromid
- clidinium bromid
- clidinium bromide
- clidinium bromide
- clidinium bromide
- clidinium bromide
- clidinium bromide
- clidinium iodide
- clidinium iodide, 11c-labeled
- clidinium iodide, 3h-labeled
- clidinium iodide, (+-)-isomer
- n-methyl quinuclidinyl benzilate
- n-methyl quinuclidinyl benzilate
- n-methyl quinuclidinyl benzilate
- quarzan
- quarzan
- quarzan
- quarzan
- ro-23773
- ro-23773
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00516854 | N/A | Jun 1, 2002 | Government of Hong Kong, The University of Hong Kong |
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Government of Hong Kong | Government | 1 | 1 | 1 | 2002 |
| The University of Hong Kong | Academic/Hospital | 1 | 0 | 1 | 2002 |
Marketing (21)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alembic | For profit | MKTG | Sep 15, 2023 |
| Alembic | For profit | SYN | Sep 15, 2023 |
| Alkem Labs Ltd | For profit | MKTG | Apr 26, 2021 |
| Amneal Pharmaceuticals | For profit | MKTG | Oct 25, 2021 |
| Aurobindo Pharma | For profit | MKTG | Sep 14, 2023 |
| Bausch Health Companies | For profit | MKTG | Sep 1, 1966 |
| Bausch Health Companies | For profit | NDA2 | Sep 1, 1966 |
| Chartwell Pharmaceuticals | For profit | MKTG | Oct 20, 2020 |
| Corepharma | For profit | MKTG | Jul 29, 2022 |
| Dr. Reddy's Laboratories | For profit | MKTG | May 10, 2021 |
| Eci Pharmaceuticals Llc | For profit | MKTG | Oct 20, 2020 |
| Micro Labs Ltd India | For profit | MKTG | Jul 19, 2022 |
| Misemer Pharmaceutical | For profit | MKTG | Jul 29, 2020 |
| Nuvo Research Inc. | For profit | MKTG | Jul 7, 2020 |
| Pharma Life Sciences LLC | For profit | MKTG | Oct 20, 2020 |
| Roche | For profit | NDA | Jun 1, 1966 |
| Sunrise Medical Research, Inc. | For profit | MKTG | Jul 7, 2020 |
| Teva | For profit | MKTG | Nov 2, 2021 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Dec 14, 2023 |
| Westminster Pharms | For profit | MKTG | Jul 29, 2022 |
| Winder Labs Llc | For profit | MKTG | Jul 8, 2024 |