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Harvoni(ledipasvir)
Harvoni (ledipasvir) is a small molecule pharmaceutical. Ledipasvir was first approved as Harvoni on 2014-10-10. 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
Combinations
Harvoni
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ledipasvir
+
Sofosbuvir
Tradename
Company
Number
Date
Products
HARVONIGilead SciencesN-205834 RX2014-10-10
2 products, RLD, RS
HARVONIGilead SciencesN-212477 RX2019-08-28
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
harvoniNew Drug Application2021-03-26
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
chronic hepatitis cEFO_0004220D019698B18.2
hepatitis cD006526B19.2
Agency Specific
FDA
EMA
Expiration
Code
LEDIPASVIR / SOFOSBUVIR, HARVONI, GILEAD SCIENCES INC
2026-08-28ODE*, ODE-262, ODE-263, ODE-264
2024-10-07PED
2024-04-07ODE*, ODE-136
Patent Expiration
Patent
Expires
Flag
FDA Information
Ledipasvir / Sofosbuvir, Harvoni, Gilead Sciences Inc
100397792034-01-30DS, DPU-1470, U-2369, U-2370
93932562032-09-14U-1470
104564142032-09-14DP
86180762030-12-11DS, DPU-1470
92843422030-09-13DS, DPU-1470
80883682030-05-12DS, DP
82733412030-05-12U-1470
88224302030-05-12DS, DPU-1470
88412782030-05-12DPU-1470
95110562030-05-12DPU-1470
79645802029-03-26DS, DPU-1470
86333092029-03-26DS, DPU-1470
88891592029-03-26DPU-1470
83342702028-03-21DS, DPU-1470
85807652028-03-21DS, DPU-1470
87353722028-03-21U-1470
90855732028-03-21DS, DPU-1470
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AP: Antivirals for treatment of hcv infections
J05AP51: Sofosbuvir and ledipasvir
HCPCS
No data
Clinical
Clinical Trials
68 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 cD006526B19.22759527
Chronic hepatitis cD019698EFO_0004220B18.22934219
HivD006678O98.72114
Liver cirrhosisD008103EFO_0001422K74.01113
Covid-19D000086382U07.1112
Insulin resistanceD007333EFO_0002614112
Liver neoplasmsD008113EFO_1001513C22.0112
Beta-thalassemiaD017086Orphanet_848D56.1112
Liver diseasesD008107EFO_0001421K70-K7711
Gaucher diseaseD005776Orphanet_355E75.2211
Show 4 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B201314
Chronic hepatitis bD019694EFO_0004197B18.11213
Hepatitis bD0065091113
HepatitisD006505HP_0012115K75.91112
CryoglobulinemiaD003449EFO_0005846D89.1111
FibrosisD00535511
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hematologic neoplasmsD019337111
Porphyria cutanea tardaD017119E80.111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients22
PregnancyD011247EFO_0002950Z33.111
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Retinal diseasesD012164HP_0000479H35.911
HepacivirusD01617411
Chronic renal insufficiencyD051436N1811
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLEDIPASVIR
INNledipasvir
Description
Ledipasvir is a benzimidazole derivative that is used in combination with sofosbuvir (under the trade name Harvoni) for the treatment of chronic hepatitis C genotype 1 infection. It has a role as an antiviral drug and a hepatitis C protease inhibitor. It is a carbamate ester, a L-valine derivative, a bridged compound, a carboxamide, a benzimidazole, a member of fluorenes, an organofluorine compound, a member of imidazoles, a N-acylpyrrolidine and an azaspiro compound.
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)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Identifiers
PDB
CAS-ID1256388-51-8
RxCUI1591922
ChEMBL IDCHEMBL2374220
ChEBI ID85089
PubChem CID67505836
DrugBankDB09027
UNII ID013TE6E4WV (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Harvoni - Gilead Sciences
$
£
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,432 documents
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Safety
Black-box Warning
Black-box warning for: Harvoni
Adverse Events
Top Adverse Reactions
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1,182 adverse events reported
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