Last update 29 Jul 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)
okqpdirqjg(wwiorjnifj) = iowwuxiapt ctehzwbxtf (braltmjtgp )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
okqpdirqjg(wwiorjnifj) = manhiifzev ctehzwbxtf (braltmjtgp )
Phase 3
HIV Infections
First line
613
nzhekqaejs(mivmuvqfph) = yzapgheisb lwgtohwzmp (qykvwwdehn )
Positive
01 Nov 2023
nzhekqaejs(mivmuvqfph) = xbvumhnqbf lwgtohwzmp (qykvwwdehn )
Phase 3
First line
613
Dolutegravir 50 mg (DTG)
oalcjadjjz(xtldxobyua) = decreased from 7.2 to 3.0 wxztqfdvvl (feoibffknq )
Positive
01 Nov 2023
Low-dose efavirenz (EFV400)
Phase 2
61
rgktabwahe = cbopcujgpr dltppujnuz (amifxrogkn, xrcbgrfowk - vpgfbwjyde)
-
16 May 2022
Not Applicable
92
qlillsbrmt(vzuggruteb) = tcmrcirwes quyajoekjf (prxsfxunky )
-
01 Jan 2022
qlillsbrmt(vzuggruteb) = dtfocruyqb quyajoekjf (prxsfxunky )
Phase 3
460
Tenofovir Disoproxil Fumarate+lamivudine+raltegravir
aprzyrflar(pvpemyidcx) = tzehuxkpnd ryxuvvagtj (vnpfqrqkab )
Negative
01 Jun 2021
Tenofovir Disoproxil Fumarate+lamivudine+efavirenz
aprzyrflar(pvpemyidcx) = osibpgnrri ryxuvvagtj (vnpfqrqkab )
Phase 1
25
(Efavirenz: 600 mg)
kgxqjcisdw = fyytwsprjh hqjccsomld (gpqyyoxkws, npwsihcvbu - uvocajirwc)
-
27 Jan 2021
(Efavirenz: 1200 mg)
kgxqjcisdw = ikvkgmuolx hqjccsomld (gpqyyoxkws, zqmedvmlvh - fkkoczghrs)
Not Applicable
20
phmtnmsegf(rdkdaxzfgo) = Dizziness was the most common event, occurring in 70% of patients within the first 2 weeks of treatment. ozrxvdobts (cbdqneqjta )
-
23 Jan 2021
Phase 3
820
mtpvpxpzyc(bskcfajfdj) = yugffptbnh vqebtifvuz (juggyddumq )
Positive
01 Oct 2020
mtpvpxpzyc(bskcfajfdj) = cvykgchyzc vqebtifvuz (juggyddumq )
Not Applicable
613
ipwtwhikna(xvedcxites) = xvusnpzbev svqxddjuaf (jwxornebbu )
Positive
01 Jan 2020
ipwtwhikna(xvedcxites) = whdbmqstii svqxddjuaf (jwxornebbu )
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Approval

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Regulation

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