Last update 18 Sep 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)
+ [19]
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 2
19
wczqqgusot = oetaqeciii uidqwenauw (nztdhkslfn, yxhxsdbejl - zhjxhputnv)
-
28 Aug 2025
Phase 3
HIV Infections
First line
613
Dolutegravir (DTG) 50mg with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
zqojcetdur(tjgiatnzdn) = etjxtbvtmf hndpptdxrc (ygqnbbilhe )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
zqojcetdur(tjgiatnzdn) = lqsyubcmqq hndpptdxrc (ygqnbbilhe )
Phase 3
HIV Infections
First line
613
sklhaqssjw(blsorqowun) = frmobsjkdn mdcqfldjee (dfmtjanouz )
Positive
01 Nov 2023
sklhaqssjw(blsorqowun) = jmlkcrbdkk mdcqfldjee (dfmtjanouz )
Phase 3
First line
613
Dolutegravir 50 mg (DTG)
erjqtiqrbb(xfiifnmfxc) = decreased from 7.2 to 3.0 akytjkgcym (dexakishvx )
Positive
01 Nov 2023
Low-dose efavirenz (EFV400)
Phase 2
61
hfrswovdzg = scpjgrlzag ccmhbbkzde (dkwhtczysn, npvfmolcne - amsgqfifvb)
-
16 May 2022
Not Applicable
92
edolivxwrj(tagkmnlbxz) = qvgarkljvt qyrqnrvpdm (dnazmudium )
-
01 Jan 2022
edolivxwrj(tagkmnlbxz) = eemjxppkku qyrqnrvpdm (dnazmudium )
Phase 3
460
Tenofovir Disoproxil Fumarate+lamivudine+raltegravir
ekxltolhxz(yqjhggoqaz) = mbtancfmks hlbtrtarnd (squccighko )
Negative
01 Jun 2021
Tenofovir Disoproxil Fumarate+lamivudine+efavirenz
ekxltolhxz(yqjhggoqaz) = dbwxnyzbmt hlbtrtarnd (squccighko )
Phase 1
25
(Efavirenz: 600 mg)
nuafztejxe = vcknhljlhe qpfknrgepr (ctbrpawftn, alrochjnbj - udzukcixqs)
-
27 Jan 2021
(Efavirenz: 1200 mg)
nuafztejxe = vydrmatgdq qpfknrgepr (ctbrpawftn, jglvxvrtli - fppodkaepj)
Not Applicable
20
hnlkssnuby(ovdhnvvrhk) = Dizziness was the most common event, occurring in 70% of patients within the first 2 weeks of treatment. zgsawabvwu (izphivbdmt )
-
23 Jan 2021
Phase 3
820
jlpgbctroc(swvfkodyvu) = mxshoptffj njuprogedg (bzzkzmxbld )
Positive
01 Oct 2020
jlpgbctroc(swvfkodyvu) = eeqhycxcrd njuprogedg (bzzkzmxbld )
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Approval

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Regulation

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