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AboutPricing
Drug ReportsDolutegravir
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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5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Tivicay (discontinued: 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)
Dolutegravir sodium
Tradename
Company
Number
Date
Products
TIVICAY PDViiV HealthcareN-213983 RX2020-06-12
1 products, RLD, RS
TIVICAYViiV HealthcareN-204790 RX2013-08-12
1 products, RLD, RS
Show 1 discontinued
Abacavir sulfate
+
Dolutegravir sodium
+
Lamivudine
Tradename
Company
Number
Date
Products
TRIUMEQ PDViiV HealthcareN-215413 RX2022-03-30
1 products, RLD, RS
TRIUMEQViiV HealthcareN-205551 RX2014-08-22
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
dolutegravirExport only2021-03-05
dovatoNew Drug Application2024-04-18
julucaNew Drug Application2024-04-18
tivicayNew Drug Application2024-07-18
tivicay tivicay pdNew Drug Application2024-04-18
triumeqNew Drug Application2021-03-23
triumeq triumeq pdNew Drug Application2024-07-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
acquired immunodeficiency syndromeEFO_0000765D000163B20
hepatitis b—D006509—
Agency Specific
FDA
EMA
Expiration
Code
ABACAVIR SULFATE / DOLUTEGRAVIR SODIUM / LAMIVUDINE, TRIUMEQ, VIIV HLTHCARE
2026-12-15PED
2026-06-15M-294
ABACAVIR SULFATE / DOLUTEGRAVIR SODIUM / LAMIVUDINE, TRIUMEQ PD, VIIV HLTHCARE
2026-12-15PED
2026-06-15NPP
Patent Expiration
Patent
Expires
Flag
FDA Information
Dolutegravir Sodium / Rilpivirine Hydrochloride, Juluca, Viiv Hlthcare
104267802031-01-24DS, DPU-257
71258792025-04-21DS, DPU-257
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
378 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B203815321612110
Acquired immunodeficiency syndromeD000163EFO_0000765B20324154560
InfectionsD007239EFO_0000544—293151553
HivD006678—O98.74159220
Communicable diseasesD003141——3—81214
Immunologic deficiency syndromesD007153—D84.9——22—4
CoinfectionD060085————11—2
PapillomaviridaeD027383—————1—1
Cytomegalovirus infectionsD003586EFO_0001062B25———1—1
InflammationD007249MP_0001845————1—1
Show 4 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19112—15
Breast feedingD001942———11——1
PregnancyD011247EFO_0002950Z33.1—11——1
ArthralgiaD018771—M25.5——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———4————4
MalariaD008288EFO_0001068B541————1
Liver diseasesD008107EFO_0001421K70-K771————1
Hepatic insufficiencyD048550——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Persistent infectionD000088562——————11
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)Loading
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
RxCUI—
ChEMBL IDCHEMBL1229211
ChEBI ID76010
PubChem CID54726191
DrugBankDB08930
UNII IDDKO1W9H7M1 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Dovato, Triumeq, Triumeq triumeq pd
Adverse Events
Top Adverse Reactions
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20,977 adverse events reported
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