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
infections	D007239
urogenital diseases	D000091642
immune system diseases	D007154

Trade Name

FDA

EMA

Tivicay

Combinations

Dovato, Juluca, Triumeq

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Abacavir sulfate

Dolutegravir sodium

Lamivudine

Tradename	Company	Number	Date	Products
TRIUMEQ	ViiV Healthcare	N-205551 RX	2014-08-22	1 products, RLD, RS
TRIUMEQ PD	ViiV Healthcare	N-215413 RX	2022-03-30	1 products, RLD, RS

Dolutegravir sodium

Tradename	Company	Number	Date	Products
TIVICAY	ViiV Healthcare	N-204790 RX	2013-08-12	3 products, RLD, RS
TIVICAY PD	ViiV Healthcare	N-213983 RX	2020-06-12	1 products, RLD, RS

Dolutegravir sodium

Lamivudine

Tradename	Company	Number	Date	Products
DOVATO	ViiV Healthcare	N-211994 RX	2019-04-08	1 products, RLD, RS

Dolutegravir sodium

Rilpivirine hydrochloride

Tradename	Company	Number	Date	Products
JULUCA	ViiV Healthcare	N-210192 RX	2017-11-21	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
dovato	New Drug Application	2021-03-23
juluca	New Drug Application	2021-07-09
tivicay tivicay pd	New Drug Application	2021-07-09
triumeq	New Drug Application	2021-03-23

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
hiv infections	EFO_0000764	D015658	B20

Agency Specific

FDA

EMA

Expiration	Code
DOLUTEGRAVIR SODIUM / LAMIVUDINE, DOVATO, VIIV HLTHCARE
2023-08-06	I-839

Patent Expiration

Patent	Expires	Flag	FDA Information
Dolutegravir Sodium / Rilpivirine Hydrochloride, Juluca, Viiv Hlthcare
10426780	2031-01-24	DS, DP	U-257
7125879	2025-04-21	DS, DP	U-257
8080551	2023-04-11	DS, DP
Dolutegravir Sodium / Lamivudine, Dovato, Viiv Hlthcare
11234985	2031-01-24	DP	U-257
Abacavir Sulfate / Dolutegravir Sodium / Lamivudine, Triumeq, Viiv Hlthcare
9242986	2029-12-08	DS, DP
8129385	2027-10-05	DS, 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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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	12	19	25	20	15	88
Hiv	D006678		O98.7	8	5	4	19	8	41
Infections	D007239	EFO_0000544		24	3	9	1	3	40
Tuberculosis	D014376	EFO_0000774	A15-A19	3	3	—	2	1	8
Hiv-associated lipodystrophy syndrome	D039682	EFO_1001348		—	—	—	3	—	3
Hepatic insufficiency	D048550			2	—	—	1	—	3
Body weight changes	D001836			—	—	—	2	—	2
Acquired immunodeficiency syndrome	D000163	EFO_0000765	B20	—	—	—	1	1	2
Obesity	D009765	EFO_0001073	E66.9	—	—	—	1	1	2
Weight gain	D015430	HP_0004324		—	1	—	1	—	2

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Amyotrophic lateral sclerosis	D000690	EFO_0000253	G12.21	1	1	1	—	—	3
Pregnancy rate	D018873			—	—	2	—	—	2
Pregnancy	D011247	EFO_0002950	Z33.1	—	1	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Treatment outcome	D016896			—	2	—	—	—	2
Pulmonary tuberculosis	D014397	EFO_1000049	A15	1	1	—	—	—	1
Htlv-ii infections	D015491	EFO_1001349		—	1	—	—	—	1
Metabolic bone diseases	D001851	HP_0000938		—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Healthy volunteers/patients	—			16	—	—	—	—	16
Malaria	D008288	EFO_0001068	B54	2	—	—	—	—	2
Medication adherence	D055118	EFO_0006344		1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Contraception behavior	D003268		—	—	—	—	1	1
Drug interactions	D004347		—	—	—	—	1	1
Hiv-2	D015498		—	—	—	—	1	1
Hepatitis c	D006526	B19.2	—	—	—	—	1	1
Pediatric obesity	D063766		—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	DOLUTEGRAVIR
INN	dolutegravir
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 class	antivirals: 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-ID	1051375-16-6
RxCUI	1433868
ChEMBL ID	CHEMBL1229211
ChEBI ID	76010
PubChem CID	54726191
DrugBank	DB08930
UNII ID	DKO1W9H7M1 (ChemIDplus, GSRS)

Target

Agency Approved

No data

Alternate

No data

Variants

Clinical Variant

No data

Financial

No data

Trends

PubMed Central

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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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