Darifenacin hydrobromide
Darifenacin, Emselex (darifenacin hydrobromide) is a small molecule pharmaceutical. Darifenacin hydrobromide was first approved as Emselex on 2004-10-22. It is used to treat overactive urinary bladder and urge urinary incontinence in the USA. It has been approved in Europe to treat overactive urinary bladder and urge urinary incontinence.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| darifenacin | ANDA | 2022-12-01 |
| darifenacin 15 mg darifenacin 7.5 mg | ANDA | 2021-04-30 |
| enablex | New Drug Application | 2010-01-01 |
Indications
FDA
EMA
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Agency Specific
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Patent Expiration
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Clinical
Clinical Trials
29 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | 2 | 3 | 6 | 8 | 19 |
| Healthy volunteers/patients | — | — | — | 2 | 1 | — | 1 | — | 4 |
| Urinary incontinence | D014549 | — | R32 | — | — | — | 2 | 1 | 3 |
| Enuresis | D004775 | — | R32 | — | — | — | 1 | 1 | 2 |
| Nocturia | D053158 | — | R35.1 | — | — | — | 1 | — | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | — | 1 | — | 1 |
| Syndrome | D013577 | — | — | — | — | — | 1 | — | 1 |
| Human t-lymphotropic virus 1 | D015368 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sclerosis | D012598 | — | — | — | 2 | — | — | — | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | 1 | — | — | — | 1 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 1 | — | — | — | 1 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Radiation injuries | D011832 | — | T66 | 1 | — | — | — | — | 1 |
| Cystitis | D003556 | EFO_1000025 | N30 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic diseases | D014570 | — | N39.9 | — | — | — | — | 1 | 1 |
| Urinary bladder diseases | D001745 | — | N32.9 | — | — | — | — | 1 | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | — | 1 | 1 |
| Urge urinary incontinence | D053202 | EFO_0006865 | N39.41 | — | — | — | — | 1 | 1 |
| Fecal incontinence | D005242 | — | R15 | — | — | — | — | 1 | 1 |
| Renal colic | D056844 | EFO_1001412 | N23 | — | — | — | — | 1 | 1 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Darifenacin hydrobromide |
| INN | darifenacin |
| Description | Darifenacin is 2-[(3S)-1-Ethylpyrrolidin-3-yl]-2,2-diphenylacetamide in which one of the hydrogens at the 2-position of the ethyl group is substituted by a 2,3-dihydro-1-benzofuran-5-yl group. It is a selective antagonist for the M3 muscarinic acetylcholine receptor, which is primarily responsible for bladder muscle contractions, and is used as the hydrobromide salt in the management of urinary incontinence. It has a role as a muscarinic antagonist and an antispasmodic drug. It is a member of 1-benzofurans, a member of pyrrolidines and a monocarboxylic acid amide. |
| Classification | Small molecule |
| Drug class | muscarinic receptor antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Br.NC(=O)C(c1ccccc1)(c1ccccc1)[C@@H]1CCN(CCc2ccc3c(c2)CCO3)C1 |
Identifiers
| PDB | — |
| CAS-ID | 133099-04-4 |
| RxCUI | 136198 |
| ChEMBL ID | CHEMBL1200935 |
| ChEBI ID | 31455 |
| PubChem CID | 444031 |
| DrugBank | DB00496 |
| UNII ID | APG9819VLM (ChemIDplus, GSRS) |
Target
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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2,700 adverse events reported
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