Daklinza(daclatasvir)
Daklinza (daclatasvir) is a small molecule pharmaceutical. Daclatasvir was first approved as Daklinza on 2014-08-22. It is used to treat chronic hepatitis c and hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Daclatasvir dihydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
DAKLINZA | Bristol Myers Squibb | N-206843 DISCN | 2015-07-24 | 3 products, RLD |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
chronic hepatitis c | EFO_0004220 | D019698 | B18.2 |
hepatitis c | — | D006526 | B19.2 |
Agency Specific
FDA
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HCPCS
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Clinical
Clinical Trials
123 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hepatitis c | D006526 | B19.2 | 8 | 9 | 20 | 6 | 8 | 50 | |
Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 4 | 15 | 8 | 2 | 5 | 29 |
Covid-19 | D000086382 | U07.1 | — | 6 | 5 | 1 | — | 8 | |
Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 1 | 1 | 1 | 3 |
Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | 1 | 1 | — | 3 |
Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hepacivirus | D016174 | — | 6 | 4 | — | — | 10 | ||
Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | — | 2 | 4 | — | 1 | 5 |
Hepatitis b | D006509 | — | 2 | 3 | — | — | 5 | ||
Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 1 | 1 | — | 2 | 4 |
Hiv | D006678 | O98.7 | 1 | — | 1 | — | — | 2 | |
Hepatitis | D006505 | HP_0012115 | K75.9 | — | 1 | 1 | — | — | 1 |
Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | 1 | — | — | 1 |
Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | 1 | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Drug interactions | D004347 | 2 | — | — | — | — | 2 | ||
Hepatic insufficiency | D048550 | 2 | — | — | — | — | 2 | ||
Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | — | 1 |
Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Fibrosis | D005355 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | DACLATASVIR |
INN | daclatasvir |
Description | Daclatasvir is a member of the class of biphenyls that is a potent inhibitor of nonstructural protein 5A and is used (as its hydrochloride salt) for treatment of hepatitis C. It has a role as a nonstructural protein 5A inhibitor and an antiviral drug. It is a member of biphenyls, a member of imidazoles, a carbamate ester, a carboxamide and a valine derivative. It is a conjugate base of a daclatasvir(2+). |
Classification | Small molecule |
Drug class | antivirals: nonstructural protein 5A (NS5A) inhibitors |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1ncc(-c2ccc(-c3ccc(-c4cnc([C@@H]5CCCN5C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]4)cc3)cc2)[nH]1)C(C)C |
Identifiers
PDB | — |
CAS-ID | 1009119-64-5 |
RxCUI | 1606218 |
ChEMBL ID | CHEMBL2023898 |
ChEBI ID | 82977 |
PubChem CID | 25154714 |
DrugBank | DB09102 |
UNII ID | LI2427F9CI (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
Daklinza - Bristol Myers Squibb
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Trends
PubMed Central
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Additional graphs summarizing 3,820 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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74,389 adverse events reported
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