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Drug ReportsDaclatasvir
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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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
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
DAKLINZABristol Myers SquibbN-206843 DISCN2015-07-24
3 products, RLD
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FDA
EMA
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FDA
EMA
Agency Specific
FDA
EMA
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Patent Expiration
Patent
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FDA Information
Daclatasvir Dihydrochloride, Daklinza, Bristol-Myers Squibb
86291712031-06-13DS, DPU-1724
83291592029-07-24DP
86420252027-08-11DS, DPU-1724, U-1725
89005662027-08-08U-1724, U-1725
94211922027-08-08DPU-1724, U-1725
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AP: Antivirals for treatment of hcv infections
J05AP07: Daclatasvir
J05AP58: Daclatasvir, asunaprevir and beclabuvir
HCPCS
No data
Clinical
Clinical Trials
211 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 cD006526B19.21835371147142
HepatitisD006505K75.92222232973
Chronic hepatitis cD019698EFO_0004220B18.25191642865
Hepatitis aD006506EFO_0007305B152121422552
Covid-19D000086382U07.13851113
Liver cirrhosisD008103EFO_0001422K74.0211711
FibrosisD005355211610
Chronic hepatitis bD019694EFO_0004239B18.11651110
Chronic kidney failureD007676EFO_0003884N18.61124
Insulin resistanceD007333EFO_0002614E88.8191113
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitisD006521K73.91721018
HepacivirusD0161746511
Hiv infectionsD015658EFO_0000764B2022137
Hepatitis bD0065092327
InfectionsD007239EFO_00005441517
HivD006678O98.71113
Acquired immunodeficiency syndromeD000163EFO_0000765B201113
Directly observed therapyD023801111
Metabolic syndromeD024821EFO_0000195E88.810111
Hepatocellular carcinomaD006528C22.011
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Communicable diseasesD00314133
NeoplasmsD009369C80333
CoinfectionD060085112
GlioblastomaD005909EFO_0000515112
Hematologic neoplasmsD019337222
Lung neoplasmsD008175C34.90111
Small cell lung carcinomaD055752111
Severe acute respiratory syndromeD045169EFO_0000694J12.8111
Bronchiolitis obliterans syndromeD000092122D89.81111
RecurrenceD01200811
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients358
Drug interactionsD00434722
Hepatic insufficiencyD04855022
Type 2 diabetes mellitusD003924EFO_0001360E1111
Diabetes mellitusD003920EFO_0000400E08-E1311
Camurati-engelmann syndromeD003966Orphanet_1328Q78.311
Brain neoplasmsD001932EFO_0003833C7111
GliomaD005910EFO_000052011
Liver failureD017093K72.911
MelanomaD00854511
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Virus diseasesD014777B3422
Liver diseasesD008107EFO_0001421K70-K7722
HemoglobinopathiesD006453D58.211
Kidney diseasesD007674EFO_0003086N0811
Retinal diseasesD012164H35.911
Joint diseasesD007592M12.911
InflammationD007249MP_000184511
ThrombocytopeniaD013921HP_0001873D69.611
Non-hodgkin lymphomaD008228C85.911
HypersensitivityD006967EFO_0003785T78.4011
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDaclatasvir
INNdaclatasvir
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 classantivirals: nonstructural protein 5A (NS5A) inhibitors
Image (chem structure or protein)Loading
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-ID1009119-64-5
RxCUI
ChEMBL IDCHEMBL2023898
ChEBI ID82977
PubChem CID25154714
DrugBankDB09102
UNII IDLI2427F9CI (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
Daklinza Bristol Myers Squibb
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 7,636 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,803 adverse events reported
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