Overview
Elvitegravir is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) used for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults. Because integrase is necessary for viral replication, inhibition prevents the integration of HIV-1 DNA into the host genome and thereby blocks the formation of the HIV-1 provirus and resulting propagation of the viral infection. Although available as a single dose tablet, elvitegravir must be used in combination with an HIV protease inhibitor coadministered with ritonavir and another antiretroviral drug. Elvitegravir was first licensed from Japan Tobacco in 2008 and developed by Gilead Sciences. It was FDA approved on August 27, 2012. On September 24, 2014, the FDA approved the single pill form of elvitegravir.
Indication
Elvitegravir in combination with an HIV protease inhibitor coadministered with ritonavir and with other antiretroviral drug(s) is indicated for the treatment of HIV-1 infection in antiretroviral treatment-experienced adults.
Associated Conditions
- Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/06/18 | Phase 1 | Completed | |||
2015/03/24 | Phase 3 | Completed | |||
2014/08/18 | Phase 1 | Completed | St Stephens Aids Trust | ||
2013/08/15 | Phase 2 | Terminated | |||
2008/07/02 | Phase 3 | Completed | |||
2007/03/08 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Avera McKennan Hospital | 69189-1201 | ORAL | 150 mg in 1 1 | 3/20/2017 | |
| State of Florida DOH Central Pharmacy | 53808-0887 | ORAL | 150 mg in 1 1 | 3/6/2014 | |
| Gilead Sciences, Inc. | 61958-1901 | ORAL | 150 mg in 1 1 | 1/13/2022 | |
| Gilead Sciences, Inc. | 61958-1201 | ORAL | 150 mg in 1 1 | 9/16/2021 | |
| Gilead Sciences, Inc. | 61958-1202 | ORAL | 150 mg in 1 1 | 11/24/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/19/2015 | ||
Authorised | 5/24/2013 | ||
Authorised | 5/24/2013 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GENVOYA FILM COATED TABLET 150 MG/150 MG/200 MG/10 MG | SIN15165P | TABLET, FILM COATED | 150.0mg | 1/20/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| STRIBILD tenofovir disoproxil fumarate 300mg, emtricitabine 200 mg, elvitegravir 150 mg, cobicistat 150 mg tablet bottle | 194081 | Medicine | A | 2/22/2013 | |
| GENVOYA elvitegravir (150mg), cobicistat (150mg), emtricitabine (200mg) and tenofovir alafenamide (as fumarate) (10mg) fixed dose combination tablets | 233398 | Medicine | A | 1/15/2016 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| VITEKTA | gilead sciences canada inc | 02411172 | Tablet - Oral | 85 MG | 4/21/2015 |
| STRIBILD | gilead sciences canada inc | 02397137 | Tablet - Oral | 150 MG | 12/20/2012 |
| GENVOYA | gilead sciences canada inc | 02449498 | Tablet - Oral | 150 MG | 2/3/2016 |
| VITEKTA | gilead sciences canada inc | 02411180 | Tablet - Oral | 150 MG | 4/21/2015 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| STRIBILD 150MG/150MG/200MG/245MG COMPRIMIDOS RECUBIERTOS CON PELICULA | 113830001IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized | |
| GENVOYA 150mg/150mg/200mg/10mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151061001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| STRIBILD 150mg/150mg/200mg/245mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 113830001 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Commercialized | |
| GENVOYA 150mg/150mg/200mg/10mg COMPRIMIDOS RECUBIERTOS CON PELICULA | 1151061001IP | COMPRIMIDO RECUBIERTO CON PELÍCULA | Uso Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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