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Tivicay(dolutegravir)
Dovato, Juluca, Tivicay, Triumeq (dolutegravir) is a small molecule pharmaceutical. Dolutegravir was first approved as Tivicay on 2013-08-12. It is used to treat HIV infections in the USA. It has been approved in Europe to treat HIV infections.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Tivicay
Combinations
Dovato, Juluca, Triumeq
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Abacavir sulfate
+
Dolutegravir sodium
+
Lamivudine
Tradename
Company
Number
Date
Products
TRIUMEQViiV HealthcareN-205551 RX2014-08-22
1 products, RLD, RS
TRIUMEQ PDViiV HealthcareN-215413 RX2022-03-30
1 products, RLD, RS
Dolutegravir sodium
Tradename
Company
Number
Date
Products
TIVICAYViiV HealthcareN-204790 RX2013-08-12
3 products, RLD, RS
TIVICAY PDViiV HealthcareN-213983 RX2020-06-12
1 products, RLD, RS
Dolutegravir sodium
+
Lamivudine
Tradename
Company
Number
Date
Products
DOVATOViiV HealthcareN-211994 RX2019-04-08
1 products, RLD, RS
Dolutegravir sodium
+
Rilpivirine hydrochloride
Tradename
Company
Number
Date
Products
JULUCAViiV HealthcareN-210192 RX2017-11-21
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dovatoNew Drug Application2021-03-23
julucaNew Drug Application2021-07-09
tivicay tivicay pdNew Drug Application2021-07-09
triumeqNew Drug Application2021-03-23
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
Agency Specific
FDA
EMA
Expiration
Code
DOLUTEGRAVIR SODIUM / LAMIVUDINE, DOVATO, VIIV HLTHCARE
2023-08-06I-839
Patent Expiration
Patent
Expires
Flag
FDA Information
Dolutegravir Sodium / Rilpivirine Hydrochloride, Juluca, Viiv Hlthcare
104267802031-01-24DS, DPU-257
71258792025-04-21DS, DPU-257
80805512023-04-11DS, DP
Dolutegravir Sodium / Lamivudine, Dovato, Viiv Hlthcare
112349852031-01-24DPU-257
Abacavir Sulfate / Dolutegravir Sodium / Lamivudine, Triumeq, Viiv Hlthcare
92429862029-12-08DS, DP
81293852027-10-05DS, DP
ATC Codes
J: Antiinfectives for systemic use
J05: Antivirals for systemic use
J05A: Direct acting antivirals
J05AJ: Integrase inhibitors, antiinfectives for systematic use
J05AJ03: Dolutegravir
J05AR: Antivirals for treatment of hiv infections, combinations
J05AR13: Lamivudine, abacavir and dolutegravir
J05AR21: Dolutegravir and rilpivirine
J05AR25: Lamivudine and dolutegravir
J05AR27: Lamivudine, tenofovir disoproxil and dolutegravir
HCPCS
No data
Clinical
Clinical Trials
196 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20121925201588
HivD006678O98.785419841
InfectionsD007239EFO_000054424391340
TuberculosisD014376EFO_0000774A15-A1933218
Hiv-associated lipodystrophy syndromeD039682EFO_100134833
Hepatic insufficiencyD048550213
Body weight changesD00183622
Acquired immunodeficiency syndromeD000163EFO_0000765B20112
ObesityD009765EFO_0001073E66.9112
Weight gainD015430HP_0004324112
Show 11 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Amyotrophic lateral sclerosisD000690EFO_0000253G12.211113
Pregnancy rateD01887322
PregnancyD011247EFO_0002950Z33.1111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Treatment outcomeD01689622
Pulmonary tuberculosisD014397EFO_1000049A15111
Htlv-ii infectionsD015491EFO_100134911
Metabolic bone diseasesD001851HP_000093811
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients1616
MalariaD008288EFO_0001068B5422
Medication adherenceD055118EFO_000634411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Contraception behaviorD00326811
Drug interactionsD00434711
Hiv-2D01549811
Hepatitis cD006526B19.211
Pediatric obesityD06376611
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDOLUTEGRAVIR
INNdolutegravir
Description
Dolutegravir is a monocarboxylic acid amide obtained by formal condensation of the carboxy group of (4R,12aS)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxylic acid with the amino group of 2,4-difluorobenzylamine. Used (as its sodium salt) for treatment of HIV-1. It has a role as a HIV-1 integrase inhibitor. It is a monocarboxylic acid amide, an organic heterotricyclic compound, a secondary carboxamide and a difluorobenzene. It is a conjugate acid of a dolutegravir(1-).
Classification
Small molecule
Drug classantivirals: integrase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@@H]1CCO[C@H]2Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N21
Identifiers
PDB
CAS-ID1051375-16-6
RxCUI1433868
ChEMBL IDCHEMBL1229211
ChEBI ID76010
PubChem CID54726191
DrugBankDB08930
UNII IDDKO1W9H7M1 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 5,741 documents
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Safety
Black-box Warning
Black-box warning for: Dovato, Triumeq
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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