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Drug ReportsEfavirenz
Sustiva, Stocrin(efavirenz)
Efavirenz, Efavirenz / / Tenofovir Disoproxil, Stocrin, Sustiva, Symfi (efavirenz) is a small molecule pharmaceutical. Efavirenz was first approved as Sustiva on 1998-09-17. It is used to treat acquired immunodeficiency syndrome and HIV infections in the USA. It has been approved in Europe to treat HIV infections. It is known to target cytochrome P450 3A4.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Efavirenz (discontinued: Efavirenz, Sustiva)
Combinations
Efavirenz, emtricitabine, tenofovir disoproxil, Efavirenz, lamivudine tenofovir disoproxil, Symfi, Symfi lo (discontinued: Atripla, Efavirenz, lamivudine tenofovir disoproxil, Efavirenz; emtricitabine tenofovir disoproxil, Efavirenz; emtricitabine; tenofovir disoproxil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Efavirenz
+
Lamivudine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
SYMFI LOMylanN-208255 RX2018-02-05
1 products, RLD, RS
SYMFIMylanN-022142 RX2018-03-22
1 products, RLD, RS
Show 2 discontinued
Efavirenz
Tradename
Company
Number
Date
Products
SUSTIVABristol Myers SquibbN-020972 DISCN1998-09-17
3 products, RLD
SUSTIVABristol Myers SquibbN-021360 DISCN2002-02-01
2 products, RLD
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Efavirenz
+
Emtricitabine
+
Tenofovir disoproxil fumarate
Tradename
Company
Number
Date
Products
ATRIPLAGilead SciencesN-021937 DISCN2006-07-12
1 products, RLD
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Labels
FDA
EMA
Brand Name
Status
Last Update
atriplaNew Drug Application2024-07-09
atripla accessExport only2021-04-12
efavirenzANDA2024-09-05
efavirenz, emtricitabine and tenofovir disoproxil fumarateANDA2024-06-27
efavirenz, lamivudine and tenofovir disoproxil fumarateANDA2024-05-07
sustivaNew Drug Application2013-01-02
symfiNew Drug Application2019-10-15
symfi loNew Drug Application2019-10-15
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate, Atripla, Gilead Sciences
85981852029-04-28DP
90181922026-06-13U-750, U-1170
95454142026-06-13DPU-750, U-1170
85923972024-01-13DPU-750, U-1170
87162642024-01-13DPU-257
94570362024-01-13DPU-257
97441812024-01-13DPU-257
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AG: Non-nucleoside reverse transcriptase inhibitors
— J05AG03: Efavirenz
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR06: Emtricitabine, tenofovir disoproxil and efavirenz
— J05AR11: Lamivudine, tenofovir disoproxil and efavirenz
HCPCS
No data
Clinical
Clinical Trials
490 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2035761087871354
Acquired immunodeficiency syndromeD000163EFO_0000765B20111629152795
HivD006678——11129212371
InfectionsD007239EFO_0000544—9181491261
TuberculosisD014376EFO_0000774A15-A1959891040
Communicable diseasesD003141——6565627
Healthy volunteers/patients———18——4—22
Immunologic deficiency syndromesD007153HP_0002721D84.9—684219
Hepatitis cD006526—B19.25333619
HepatitisD006505HP_0012115K75.95235519
Show 34 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PregnancyD011247EFO_0002950Z33.1—12—13
Breast feedingD001942————1—12
Pregnancy rateD018873————1——1
Chronic hepatitisD006521—K73.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug-related side effects and adverse reactionsD064420—T88.711——23
ArteritisD001167EFO_0009011I77.6—2———2
LymphomaD008223—C85.911———2
Pulmonary tuberculosisD014397EFO_1000049A15—1———1
ParasitemiaD018512——11———1
Pancreatic neoplasmsD010190EFO_0003860C25—1———1
Prostatic neoplasmsD011471—C61—1———1
Aids-related lymphomaD016483EFO_1001365——1———1
Hepatitis b virusD006515———1———1
Breast neoplasmsD001943EFO_0003869C50—1———1
Show 2 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PharmacokineticsD010599——4———15
NeoplasmsD009369—C803————3
Type 2 diabetes mellitusD003924EFO_0001360E111————1
Diabetes mellitusD003920HP_0000819E08-E131————1
ToxoplasmosisD014123EFO_0007517B581————1
Substance-related disordersD019966EFO_0003890F131————1
Neoplasm metastasisD009362EFO_0009708—1————1
Alzheimer diseaseD000544EFO_0000249F031————1
Non-hodgkin lymphomaD008228—C85.91————1
Premature obstetric laborD007752—O601————1
Show 10 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep wake disordersD012893—G47————22
DepressionD003863—F33.9————22
Chronic hepatitis bD019694EFO_0004239B18.1————11
Penicillium chrysogenumD010408NCBITaxon_5076—————11
Biological availabilityD001682——————11
OsteoporosisD010024HP_0000939M81.0————11
Contraception behaviorD003268——————11
Sustained virologic responseD000072230——————11
Neurobehavioral manifestationsD019954EFO_0004364—————11
Medication adherenceD055118EFO_0006344—————11
Show 20 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEfavirenz
INNefavirenz
Description
Efavirenz is 1,4-Dihydro-2H-3,1-benzoxazin-2-one substituted at the 4 position by cyclopropylethynyl and trifluoromethyl groups (S configuration) and at the 6 position by chlorine. A non-nucleoside reverse transcriptase inhibitor with activity against HIV, it is used with other antiretrovirals for combination therapy of HIV infection. It has a role as a HIV-1 reverse transcriptase inhibitor and an antiviral drug. It is a benzoxazine, an acetylenic compound, an organochlorine compound, an organofluorine compound and a member of cyclopropanes.
Classification
Small molecule
Drug classFc fusion protein; antivirals: non-nucleoside reverse transcriptase inhibitors; benzoxazinone derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Identifiers
PDB—
CAS-ID154598-52-4
RxCUI—
ChEMBL IDCHEMBL223228
ChEBI ID119486
PubChem CID64139
DrugBankDB00625
UNII IDJE6H2O27P8 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
CYP3A4
CYP3A4
Organism
Homo sapiens
Gene name
CYP3A4
Gene synonyms
CYP3A3
NCBI Gene ID
Protein name
cytochrome P450 3A4
Protein synonyms
1,4-cineole 2-exo-monooxygenase, 1,8-cineole 2-exo-monooxygenase, Albendazole monooxygenase (sulfoxide-forming), Albendazole sulfoxidase, Cholesterol 25-hydroxylase, CYPIIIA3, CYPIIIA4, Cytochrome P450 3A3, Cytochrome P450 HLp, Cytochrome P450 NF-25, cytochrome P450, family 3, subfamily A, polypeptide 4, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 3, cytochrome P450, subfamily IIIA (niphedipine oxidase), polypeptide 4, Cytochrome P450-PCN1, glucocorticoid-inducible P450, Nifedipine oxidase, P450-III, steroid inducible, Quinine 3-monooxygenase, taurochenodeoxycholate 6-alpha-hydroxylase
Uniprot ID
Mouse ortholog
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—
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Atripla – Gilead Sciences
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Estimated US medical usage
Efavirenz
Total medical expenditures per year (USD, in millions)
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Efavirenz
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Emtricitabine
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Tenofovir
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 21,521 documents
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Safety
Black-box Warning
Black-box warning for: Atripla, Atripla access, Efavirenz, emtricitabine and tenofovir disoproxil fumarate, Efavirenz, lamivudine and tenofovir disoproxil fumarate, Symfi, Symfi lo
Adverse Events
Top Adverse Reactions
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33,228 adverse events reported
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