Darifenacin
Darifenacin, Emselex (darifenacin) is a small molecule pharmaceutical. Darifenacin 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. The pharmaceutical is active against muscarinic acetylcholine receptor M3. In addition, it is known to target muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M5, muscarinic acetylcholine receptor M1, and muscarinic acetylcholine receptor M4.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Darifenacin (discontinued: Darifenacin, Enablex)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| darifenacin | ANDA | 2024-04-19 |
| darifenacin 15 mg darifenacin 7.5 mg | ANDA | 2021-04-30 |
| enablex | New Drug Application | 2010-01-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| overactive urinary bladder | EFO_1000781 | D053201 | N32.81 |
| urge urinary incontinence | EFO_0006865 | D053202 | N39.41 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
28 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 | HP_0000020 | 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
No data
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 | HP_0007354 | 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 |
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 |
| 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) | NC(=O)C(c1ccccc1)(c1ccccc1)[C@@H]1CCN(CCc2ccc3c(c2)CCO3)C1 |
Identifiers
| PDB | — |
| CAS-ID | 133099-04-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1346 |
| ChEBI ID | 391960 |
| PubChem CID | 444031 |
| DrugBank | DB00496 |
| UNII ID | APG9819VLM (ChemIDplus, GSRS) |
Target
Agency Approved
Alternate
CHRM2
CHRM2
CHRM5
CHRM5
CHRM1
CHRM1
CHRM4
CHRM4
Variants
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Financial
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Estimated US medical usage
Darifenacin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,579 adverse events reported
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