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Drug ReportsPibrentasvir
Mavyret, Maviret(pibrentasvir)
Maviret, Mavyret (pibrentasvir) is a small molecule pharmaceutical. Pibrentasvir 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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3M
6M
YTD
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2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion 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
76 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—B19.241228142071
HepatitisD006505HP_0012115K75.931228121765
Hepatitis aD006506EFO_0007305B152112781557
Chronic hepatitis cD019698EFO_0004220B18.2—62021035
Chronic kidney failureD007676EFO_0003884N18.921—4—6
Kidney diseasesD007674EFO_0003086N0811—4—5
Liver diseasesD008107HP_0002910K70-K771——124
Renal insufficiencyD051437HP_0000083N191——3—4
Chronic renal insufficiencyD051436—N18———2—2
HivD006678—————112
Show 4 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitisD006521—K73.9—618—829
HepacivirusD016174———58——11
InfectionsD007239EFO_0000544——19——10
Liver cirrhosisD008103EFO_0001422K74.0—14—27
FibrosisD005355———14—16
Communicable diseasesD003141———15——6
Hepatitis bD006509——113—26
Virus diseasesD014777—B34—14——5
Hiv infectionsD015658EFO_0000764B20—13——4
Acquired immunodeficiency syndromeD000163EFO_0000765B20——3——3
Show 6 more
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic insufficiencyD048550——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Retinal diseasesD012164HP_0000479H35.9————11
InflammationD007249MP_0001845—————11
Gastrointestinal diseasesD005767——————11
Rna virus infectionsD012327——————11
Digestive system diseasesD004066HP_0011024K92.9————11
Viral hepatitis humanD006525EFO_0004196—————11
Patient complianceD010349——————11
Opioid-related disordersD009293EFO_0005611F11————11
Risk reduction behaviorD040242——————11
Pregnancy complicationsD011248——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePibrentasvir
INNpibrentasvir
Description
Pibrentasvir is an NS5A inhibitor antiviral agent. In the United States and Europe, it is approved for use with glecaprevir as the combination drug glecaprevir/pibrentasvir (trade name Mavyret in the US and Maviret in the EU) for the treatment of hepatitis C. It is sold by Abbvie.
Classification
Small molecule
Drug classantivirals: nonstructural protein 5A (NS5A) inhibitors
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Structure (InChI/SMILES or Protein Sequence)
COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Identifiers
PDB—
CAS-ID1353900-92-1
RxCUI—
ChEMBL IDCHEMBL3545123
ChEBI ID—
PubChem CID58031952
DrugBankDB13878
UNII ID2WU922TK3L (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 1,818 documents
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Safety
Black-box Warning
Black-box warning for: Mavyret
Adverse Events
Top Adverse Reactions
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12,048 adverse events reported
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