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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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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic hepatitis cEFO_0004220D019698B18.2
hepatitis cD006526B19.2
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
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
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 cD006526B19.289206850
Chronic hepatitis cD019698EFO_0004220B18.241582529
Covid-19D000086382U07.16518
Liver cirrhosisD008103EFO_0001422K74.01113
Chronic kidney failureD007676EFO_0003884N18.61113
Insulin resistanceD007333EFO_0002614112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HepacivirusD0161746410
Chronic hepatitis bD019694EFO_0004197B18.12415
Hepatitis bD006509235
Hiv infectionsD015658EFO_0000764B2011124
HivD006678O98.7112
HepatitisD006505HP_0012115K75.9111
Metabolic syndromeD024821EFO_0000195E88.81111
Liver neoplasmsD008113EFO_1001513C22.011
Male infertilityD007248EFO_0004248N46111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CoinfectionD06008511
Chronic hepatitisD006521K73.911
Renal insufficiencyD051437HP_0000083N1911
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD00434722
Hepatic insufficiencyD04855022
Healthy volunteers/patients22
Type 2 diabetes mellitusD003924EFO_0001360E1111
Diabetes mellitusD003920EFO_0000400E08-E1311
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
FibrosisD00535511
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)
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
RxCUI1606218
ChEMBL IDCHEMBL2023898
ChEBI ID82977
PubChem CID25154714
DrugBankDB09102
UNII IDLI2427F9CI (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Daklinza - Bristol Myers Squibb
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,820 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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74,389 adverse events reported
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