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Drug ReportsGlecaprevir
Mavyret, Maviret(glecaprevir)
Maviret, Mavyret (glecaprevir) is a small molecule pharmaceutical. Glecaprevir was first approved as Maviret on 2017-07-26. It is used to treat hepatitis c in the USA. It has been approved in Europe to treat chronic hepatitis c.
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Drug
Target
Variants
Financial
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Safety
Events Timeline
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1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Combinations
Mavyret
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Glecaprevir
+
Pibrentasvir
Tradename
Company
Number
Date
Products
MAVYRETAbbVieN-209394 RX2017-08-03
1 products, RLD, RS
MAVYRETAbbVieN-215110 RX2021-06-10
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
mavyretNew Drug Application2023-10-10
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatitis c—D006526B19.2
Agency Specific
FDA
EMA
Expiration
Code
GLECAPREVIR / PIBRENTASVIR, MAVYRET, ABBVIE
2028-12-10PED
2028-06-10ODE-372
2026-10-30PED
2026-04-30ODE-232, ODE-233
Patent Expiration
Patent
Expires
Flag
FDA Information
Glecaprevir / Pibrentasvir, Mavyret, Abbvie
112468662036-06-24DP
93218072035-06-05DP
RE489232035-05-08DP
102860292034-03-14U-3237, U-3238
114845342034-03-14U-3237
89371502032-05-18DS, DP
86480372032-01-19DS, DPU-2141, U-3237, U-3238
95869782030-11-06U-2141, U-3237, U-3238
100289372030-06-10U-2141, U-3237, U-3238
100397542030-06-10U-2141, U-3237, U-3238
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AP: Antivirals for treatment of hcv infections
— J05AP57: Glecaprevir and pibrentasvir
HCPCS
No data
Clinical
Clinical Trials
72 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 cD006526—B19.2—72531142
HepatitisD006505—K75.9—7253940
Hepatitis aD006506EFO_0007305B15—7242938
Renal insufficiencyD051437—N191——1—2
Chronic kidney failureD007676EFO_0003884N18.6———1—1
Heroin dependenceD006556EFO_0004240————1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis cD019698EFO_0004220B18.2—519—728
Chronic hepatitisD006521—K73.9—518—626
HepacivirusD016174———48——10
InfectionsD007239EFO_0000544——18——9
Liver cirrhosisD008103EFO_0001422K74.0—14—16
FibrosisD005355———14—16
Communicable diseasesD003141———14——5
Virus diseasesD014777—B34—14——5
Hepatitis bD006509————3—25
Hiv infectionsD015658EFO_0000764B20—13——4
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Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver diseasesD008107EFO_0001421K70-K771————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGlecaprevir
INNglecaprevir
Description
Glecaprevir (INN,) is a hepatitis C virus (HCV) nonstructural (NS) protein 3/4A protease inhibitor that was identified jointly by AbbVie and Enanta Pharmaceuticals. It is being developed as a treatment of chronic hepatitis C infection in co-formulation with an HCV NS5A inhibitor pibrentasvir. Together they demonstrated potent antiviral activity against major HCV genotypes and high barriers to resistance in vitro.
Classification
Small molecule
Drug classantivirals: serine protease inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)[C@@H]1NC(=O)O[C@@H]2CCC[C@H]2OC/C=C/C(F)(F)c2nc3ccccc3nc2O[C@@H]2C[C@@H](C(=O)N[C@]3(C(=O)NS(=O)(=O)C4(C)CC4)C[C@H]3C(F)F)N(C2)C1=O
Identifiers
PDB—
CAS-ID1365970-03-1
RxCUI—
ChEMBL IDCHEMBL3545363
ChEBI ID—
PubChem CID66828839
DrugBankDB13879
UNII IDK6BUU8J72P (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Mavyret – AbbVie
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,031 documents
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Safety
Black-box Warning
Black-box warning for: Mavyret
Adverse Events
Top Adverse Reactions
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12,366 adverse events reported
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