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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
No data
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
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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
210 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 cD006526B19.21945441355166
HepatitisD006505HP_0012115K75.9536341044123
Hepatitis aD006506EFO_0007305B153262273689
Chronic hepatitis cD019698EFO_0004220B18.25291953079
Chronic hepatitisD006521K73.919511428
InfectionsD007239EFO_00005441941417
Covid-19D0000863823851113
Liver cirrhosisD008103EFO_0001422K74.0111912
Chronic hepatitis bD019694EFO_0004239B18.11651110
Chronic kidney failureD007676EFO_0003884N18.91124
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HepacivirusD0161746511
Hiv infectionsD015658EFO_0000764B20232410
Hepatitis bD0065093428
Communicable diseasesD0031414126
FibrosisD0053551146
Virus diseasesD014777B34224
CoinfectionD0600852124
Acquired immunodeficiency syndromeD000163EFO_0000765B2011114
HivD0066781113
Hepatocellular carcinomaD006528C22.0112
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Indications Phases 2
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 mellitusD003920HP_0000819E08-E1311
Brain neoplasmsD001932EFO_0003833C7111
GliomaD005910EFO_000052011
Liver failureD017093HP_0001399K72.911
MelanomaD00854511
Breast neoplasmsD001943EFO_0003869C5011
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HemoglobinopathiesD006453D58.211
Retinal diseasesD012164HP_0000479H35.911
Joint diseasesD007592HP_0003040M12.911
InflammationD007249MP_000184511
ThrombocytopeniaD013921HP_0001873D69.611
Non-hodgkin lymphomaD008228C85.911
HypersensitivityD006967HP_0012393T78.4011
Surveys and questionnairesD01179511
Self reportD05756611
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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,171 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,786 adverse events reported
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