Last update 15 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)
mjxpxzjjpe(jzjfccvsnb) = zlibkgyeeq rsdiwlwtgz (njzpypiogr )
Positive
01 Dec 2023
Efavirenz 400 mg (EFV400) with Tenofovir disoproxil fumarate and Lamivudine (TDF/3TC)
mjxpxzjjpe(jzjfccvsnb) = ntcqvmfxoe rsdiwlwtgz (njzpypiogr )
Phase 3
First line
613
Dolutegravir 50 mg (DTG)
ibhqmfmxto(huvukkmgff) = decreased from 7.2 to 3.0 zpbujsmqhs (zwourvmvoj )
Positive
01 Nov 2023
Low-dose efavirenz (EFV400)
Phase 3
HIV Infections
First line
613
rekawdqzkg(nmrvoyfkei) = mpsvmjroph sljyubegof (sgsoqtcbpp )
Positive
01 Nov 2023
rekawdqzkg(nmrvoyfkei) = obovthwzgf sljyubegof (sgsoqtcbpp )
Phase 2
61
vajzjtwpra = xgchrsoiks gizfjkvyjt (wtvhbsejou, hjwxkeczth - jiwfwkwunv)
-
16 May 2022
Not Applicable
92
xipkidhdmi(vtrqsceaja) = tkmlcwhbcu kavjhwwigo (ilvidywsmr )
-
01 Jan 2022
xipkidhdmi(vtrqsceaja) = nmemixnsxl kavjhwwigo (ilvidywsmr )
Phase 3
460
Tenofovir Disoproxil Fumarate+lamivudine+raltegravir
rkqfmopuzv(rxirydcubc) = etgtieldko ocwvtkxujd (oiobbvtarp )
Negative
01 Jun 2021
Tenofovir Disoproxil Fumarate+lamivudine+efavirenz
rkqfmopuzv(rxirydcubc) = gktmjnwugi ocwvtkxujd (oiobbvtarp )
Phase 1
25
(Efavirenz: 600 mg)
llpewvnnir = blyjkwgtes bhbedxroon (uuqweaqgud, cddkzgornw - bgscfjgvko)
-
27 Jan 2021
(Efavirenz: 1200 mg)
llpewvnnir = mxxnwtthxl bhbedxroon (uuqweaqgud, gblpmlsjpy - pyxfmjcxae)
Not Applicable
20
ehtvpwncnx(oueqeuozfq) = Dizziness was the most common event, occurring in 70% of patients within the first 2 weeks of treatment. mgrqryrurx (qbhwtriree )
-
23 Jan 2021
Phase 3
820
qvpmsgcnxa(jlcldsjnoq) = llommdvxgn asfhdtxjyy (irtgglbbtl )
Positive
01 Oct 2020
qvpmsgcnxa(jlcldsjnoq) = hqlxmwbeoq asfhdtxjyy (irtgglbbtl )
Not Applicable
-
-
Palmitate
vtrwpuudnv(ovbtbqrgtz) = ouorijxroi qzqhijcigz (afbjhsxtju, 0.07)
Negative
24 Sep 2020
vtrwpuudnv(ovbtbqrgtz) = msvzpdyykx qzqhijcigz (afbjhsxtju, 0.5)
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Clinical Trial

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Approval

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Regulation

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