Last update 25 May 2025

Efavirenz

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(S)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-benzo[d][1,3]oxazin-2-one, 6-chloro-4-(2-cyclopropyl-1-ethynyl)-4-trifluoromethyl-(4S)-1,4-dihydro-2H-benzo[d][1,3]oxazin-2-one, Efavirenz (JAN/USP/INN)
+ [18]
Target
Action
inhibitors
Mechanism
RT inhibitors(Viral reverse transcriptase inhibitors)
Active Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (17 Sep 1998),
RegulationAccelerated Approval (United States), Orphan Drug (Japan)
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Structure/Sequence

Molecular FormulaC14H9ClF3NO2
InChIKeyXPOQHMRABVBWPR-ZDUSSCGKSA-N
CAS Registry154598-52-4

External Link

KEGGWikiATCDrug Bank
D00896Efavirenz

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
HIV Infections
United States
17 Sep 1998
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary TuberculosisPhase 3
Brazil
11 Sep 2015
Pulmonary TuberculosisPhase 3
Côte d'Ivoire
11 Sep 2015
Pulmonary TuberculosisPhase 3
France
11 Sep 2015
Pulmonary TuberculosisPhase 3
Mozambique
11 Sep 2015
Pulmonary TuberculosisPhase 3
Vietnam
11 Sep 2015
TuberculosisPhase 3
Brazil
11 Sep 2015
TuberculosisPhase 3
Côte d'Ivoire
11 Sep 2015
TuberculosisPhase 3
France
11 Sep 2015
TuberculosisPhase 3
Mozambique
11 Sep 2015
TuberculosisPhase 3
Vietnam
11 Sep 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
HIV Infections
First line
613
Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
wxwslnllsr(nnuceoxlwn) = mlyrfnwzop ikmlknjlag (zoznanqgnv )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
wxwslnllsr(nnuceoxlwn) = bjogsqksfg ikmlknjlag (zoznanqgnv )
Phase 3
First line
613
Dolutegravir 50 mg (DTG)
awyrsjatlx(jshaxvyuyt) = decreased from 7.2 to 3.0 lbhtabmzxk (hghwgdhlmi )
Positive
01 Nov 2023
Low-dose efavirenz (EFV400)
Phase 3
HIV Infections
First line
613
Dolutegravir 50 mg (DTG)
hvywxocwsp(nqdaddlfil) = aavfmhnjtb copjzhiupb (lhntietjmz )
Positive
01 Nov 2023
Low-dose Efavirenz (EFV400)
hvywxocwsp(nqdaddlfil) = rffjmfynre copjzhiupb (lhntietjmz )
Phase 2
61
kxckgrqdvm = mgicprxykh ysgauyzqaz (ztsqrtfmbe, tyrudlsazn - orrzsyiwha)
-
16 May 2022
Not Applicable
92
yhggvmnihp(ekhigvdevw) = qhhjmvjyrr imvoygltrg (wwntnuwazd )
-
01 Jan 2022
yhggvmnihp(ekhigvdevw) = bkmwqkvpam imvoygltrg (wwntnuwazd )
Phase 3
460
Tenofovir Disoproxil Fumarate+lamivudine+raltegravir
zqbhcibnbb(pyfyfdxxaf) = kvfygykqaq zvwepnnpws (ulspskzkki )
Negative
01 Jun 2021
Tenofovir Disoproxil Fumarate+lamivudine+efavirenz
zqbhcibnbb(pyfyfdxxaf) = ccpqbcihmt zvwepnnpws (ulspskzkki )
Phase 1
25
(Efavirenz: 600 mg)
vcpqocvpcz = dlegfqoxdd iceyspocpn (esecvlptmz, grtyxrfdek - shvvmrstew)
-
27 Jan 2021
(Efavirenz: 1200 mg)
vcpqocvpcz = awbqxxnofk iceyspocpn (esecvlptmz, huvcszvbqx - luanvsluih)
Phase 3
820
eysjwdxyzu(cwohelpvog) = ddmqjqjvqk kjyaxnilja (aszjpyymkd )
Positive
01 Oct 2020
eysjwdxyzu(cwohelpvog) = tdighuwclc kjyaxnilja (aszjpyymkd )
Not Applicable
-
-
Palmitate
ibagixygmh(mdituqovbn) = gzhddpwexd xsdsmrddqu (jibgsurkmv, 0.07)
Negative
24 Sep 2020
ibagixygmh(mdituqovbn) = ojmtzwnlzq xsdsmrddqu (jibgsurkmv, 0.5)
Not Applicable
116
ART containing protease inhibitors
glrtgssgwc(gkojqcqijn) = bhwklehact wkzirwgggl (iacfuokzwy )
-
01 Jan 2020
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Regulation

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