Efavirenz

Overview

Efavirenz (brand names Sustiva® and Stocrin®) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) and is used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. For HIV infection that has not previously been treated, efavirenz and lamivudine in combination with zidovudine or tenofovir is the preferred NNRTI-based regimen. Efavirenz is also used in combination with other antiretroviral agents as part of an expanded postexposure prophylaxis regimen to prevent HIV transmission for those exposed to materials associated with a high risk for HIV transmission.

Indication

For use in combination treatment of HIV infection (AIDS)

Associated Conditions

Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Drug-Drug Interaction Potential of Mavorixafor	2025/04/06	NCT06914869	Phase 1	Completed	X4 Pharmaceuticals
The T Cell Activator of Cell Killing ("TACK") IT ON" STUDY	2025/02/12	NCT06823596	Not Applicable	Recruiting	University of Toronto
A Study of the Effect Efavirenz on the Plasma Levels of MK-7602 in Healthy Participants (MK-7602-005)	2025/01/28	NCT06797674	Phase 1	Completed	Merck Sharp & Dohme LLC
A Study of the Effect of Efavirenz on the Plasma Levels of Nemtabrutinib (MK-1026-014)	2024/11/20	NCT06698016	Phase 1	Completed	Merck Sharp & Dohme LLC
A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults	2023/08/16	NCT05995249	Phase 1	Completed	Takeda
An Open-label DDI Study of Omaveloxolone in Healthy Subjects	2023/06/18	NCT05909644	Phase 1	Completed	Biogen
A Trial of DDI Between SHR1459 and Efavirenz With Healthy Subjects	2022/09/29	NCT05560360	Phase 1	Completed	Jiangsu HengRui Medicine Co., Ltd.
Drug-drug Interaction Study of Ganaplacide and Lumefantrine With Efavirenz	2022/04/15	NCT05330273	Phase 1	Completed	Novartis Pharmaceuticals
Reverse Triple Negative Immune Resistant Breast Cancer	2021/10/13	NCT05076682	Phase 2	Recruiting	Fudan University
A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants	2021/10/05	NCT05067439	Phase 1	Completed	Pfizer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Efavirenz	Strides Pharma Science Limited	64380-705	ORAL	600 mg in 1 1	12/13/2023
SYMFI LO	Mylan Specialty L.P.	49502-425	ORAL	400 mg in 1 1	9/9/2019
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	Laurus Labs Limited	42385-929	ORAL	400 mg in 1 1	1/16/2019
efavirenz, emtricitabine and tenofovir disoproxil fumarate	Exelan Pharmaceuticals, Inc.	76282-678	ORAL	600 mg in 1 1	3/12/2021
Atripla	Physicians Total Care, Inc.	54868-5643	ORAL	600 mg in 1 1	5/3/2013
SUSTIVA	Physicians Total Care, Inc.	54868-4668	ORAL	600 mg in 1 1	1/2/2013
Efavirenz	Strides Pharma Inc.	42543-889	ORAL	600 mg in 1 1	1/23/2023
SYMFI	Mylan Specialty L.P.	49502-475	ORAL	600 mg in 1 1	10/15/2019
Efavirenz	Aurobindo Pharma Limited	65862-049	ORAL	600 mg in 1 1	12/29/2023
Efavirenz	Cipla USA Inc.	69097-301	ORAL	600 mg in 1 1	3/31/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan	Mylan Pharmaceuticals Limited,Damastown Industrial Park,Mulhuddart,Dublin 15,Ireland	Authorised	9/5/2017
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva	Zentiva k.s.,U kabelovny 130,Dolni Mecholupy,102 37 Prague 10,Czech Republic	Authorised	7/17/2017
Efavirenz/Emtricitabine/Tenofovir disoproxil Krka	KRKA, d.d., Novo mesto,Smarjeska cesta 6,8501 Novo mesto,Slovenia	Authorised	2/8/2018
Efavirenz Teva	Teva B.V.,Swensweg 5,2031GA Haarlem,The Netherlands	Authorised	1/9/2012
Stocrin	Merck Sharp & Dohme B.V.,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	5/28/1999

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
STOCRIN TABLET 600 mg	Zhejiang Huahai Pharmaceutical Co., Ltd.	SIN12064P	TABLET, FILM COATED	600 mg	9/5/2002
EFAVIRENZ SANDOZ FILM COATED TABLET 600MG	Sandoz Private Limited	SIN15719P	TABLET, FILM COATED	600mg	6/18/2019
STOCRIN® 200mg TABLET	Zhejiang Huahai Pharmaceutical Co., Ltd.	SIN13509P	TABLET	200.0 mg	7/31/2008

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
EFAVIRENZ ALPHAPHARM efavirenz 600 mg tablet blister pack	183898	Alphapharm Pty Ltd	Medicine	A	4/17/2013
EFAVIRENZ ALPHAPHARM efavirenz 600 mg tablet bottle	183899	Alphapharm Pty Ltd	Medicine	A	4/17/2013
TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ Viatris 300/200/600 tenofovir disoproxil maleate 300mg/emtricitabine 200mg/efavirenz 600mg tablet bottle	280721	Alphapharm Pty Ltd	Medicine	A	5/17/2018

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
AURO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR	auro pharma inc	02478404	Tablet - Oral	600 MG	3/18/2020
SUSTIVA 100MG	bristol-myers squibb canada	02239887	Capsule - Oral	100 MG	3/25/1999
MYLAN-EFAVIRENZ	Mylan Pharmaceuticals ULC	02381524	Tablet - Oral	600 MG	7/30/2013
JAMP-EFAVIRENZ	Jamp Pharma Corporation	02458233	Tablet - Oral	600 MG	6/14/2019
SUSTIVA 200MG	bristol-myers squibb canada	02239888	Capsule - Oral	200 MG	3/25/1999
RIVA-EFAVIRENZ/EMTRICITABINE/TENOFOVIR	laboratoire riva inc.	02518716	Tablet - Oral	600 MG	8/25/2021
AURO-EFAVIRENZ	auro pharma inc	02418428	Tablet - Oral	600 MG	3/3/2014
JAMP EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE	Jamp Pharma Corporation	02519461	Tablet - Oral	600 MG	12/14/2022
PMS-EFAVIRENZ-EMTRICITABINE-TENOFOVIR	Pharmascience Inc	02487284	Tablet - Oral	600 MG	10/29/2019
APO-EFAVIRENZ-EMTRICITABINE-TENOFOVIR	Apotex Inc	02468247	Tablet - Oral	600 MG	9/4/2018

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
EFAVIRENZ/EMTRICITABINA/TENOFOVIR DISOPROXILO KRKA 600 MG/200 MG/245 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Krka D.D. Novo Mesto	1171263001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
SUSTIVA 100 mg, CAPSULAS DURAS	Bristol-Myers Squibb Pharma Eeig	99110002	CÁPSULA DURA	Uso Hospitalario	Not Commercialized
EFAVIRENZ/EMTRICITABINA/TENOFOVIR DISOPROXILO TEVA 600 MG/200 MG/245 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Teva Pharma S.L.U.	81931	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
EFAVIRENZ MYLAN 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Mylan Pharmaceuticals S.L.	77176	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Not Commercialized
Efavirenz Teva 600 mg comprimidos recubiertos con pelicula EFG	Teva B.V.	111742001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
EFAVIRENZ/EMTRICITABINA/TENOFOVIR DISOPROXILO GLENMARK 600 MG/200 MG/245 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Glenmark Arzneimittel Gmbh	84409	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
EFAVIRENZ/EMTRICITABINA/TENOFOVIR DISOPROXILO MACLEODS 600 MG/200 MG/245 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Macleods Pharma Espana S.L.U.	84473	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
EFAVIRENZ/EMTRICITABINA/TENOFOVIR DISOPROXILO MYLAN 600 MG/200 MG/245 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Mylan Pharmaceuticals Limited	1171222001	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
EFAVIRENZ/EMTRICITABINA/TENOFOVIR DISOPROXILO SANDOZ 600 MG/200 MG/245 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Sandoz Farmaceutica S.A.	82517	COMPRIMIDO RECUBIERTO CON PELÍCULA	Uso Hospitalario	Not Commercialized
EFAVIRENZ/EMTRICITABINA/TENOFOVIR DISOPROXILO DR REDDYS 600 MG/200 MG/245 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Reddy Pharma Iberia S.A.	82626	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico 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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