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AboutPricing
Drug ReportsRaltegravir
Isentress(raltegravir)
Dutrebis, Isentress (raltegravir) is a small molecule pharmaceutical. Raltegravir was first approved as Isentress on 2007-10-12. It is used to treat HIV infections in the USA. It has been approved in Europe to treat HIV infections.
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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
immune system diseasesD007154
Trade Name
FDA
EMA
Isentress, Raltegravir potassium
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Raltegravir potassium
Tradename
Company
Number
Date
Products
ISENTRESSMerck & CoN-205786 RX2013-12-20
1 products, RLD, RS
ISENTRESSMerck & CoN-203045 RX2011-12-21
2 products, RLD, RS
ISENTRESSMerck & CoN-022145 RX2007-10-12
1 products, RLD, RS
ISENTRESS HDMerck & CoN-022145 RX2017-05-26
1 products, RLD, RS
Lamivudine
+
Raltegravir potassium
Tradename
Company
Number
Date
Products
DUTREBISMerck & CoN-206510 DISCN2015-02-06
1 products
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Labels
FDA
EMA
Brand Name
Status
Last Update
isentressNew Drug Application2024-10-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hiv infectionsEFO_0000764D015658B20
acquired immunodeficiency syndromeEFO_0000765D000163B20
hepatitis b—D006509—
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Raltegravir Potassium, Isentress, Msd Sub Merck
107728882032-03-30U-1663
96493112030-10-21DP
87717332030-06-02DS, DPU-257
88526322028-01-28DS, DPU-257
Lamivudine / Raltegravir Potassium, Dutrebis, Merck Sharp Dohme
77547312029-03-11DS, DPU-257, U-1663
ATC Codes
J: Antiinfectives for systemic use
— J05: Antivirals for systemic use
— J05A: Direct acting antivirals
— J05AJ: Integrase inhibitors, antiinfectives for systematic use
— J05AJ01: Raltegravir
— J05AR: Antivirals for treatment of hiv infections, combinations
— J05AR16: Lamivudine and raltegravir
HCPCS
No data
Clinical
Clinical Trials
332 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_0000764B201417212033104
HivD006678——335141338
Acquired immunodeficiency syndromeD000163EFO_0000765B2034471129
InfectionsD007239EFO_0000544—4132818
Communicable diseasesD003141——3131513
Immunologic deficiency syndromesD007153HP_0002721D84.9121329
TuberculosisD014376EFO_0000774A15-A19—111—3
Metabolic syndromeD024821EFO_0000195E88.810———112
Fatty liverD005234EFO_0003934————2—2
Hiv seropositivityD006679—————112
Show 9 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Renal insufficiencyD051437HP_0000083N19—11——2
Virus diseasesD014777—B34——1—12
Chronic renal insufficiencyD051436—N18——1——1
HyperlipidemiasD006949HP_0003077E78.5——1——1
HypertriglyceridemiaD015228EFO_0004211———1——1
HyperlipoproteinemiasD006951HP_0010980———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatitis cD006526—B19.221———3
Liver cirrhosisD008103EFO_0001422K74.011———2
FibrosisD005355——11———2
HepatitisD006505HP_0012115K75.911———2
Hepatitis aD006506EFO_0007305B1511———2
LipodystrophyD008060HP_0009125E88.1—1——12
ViremiaD014766—B34.9—1———1
Liver diseasesD008107HP_0002910K70-K7711———1
End stage liver diseaseD058625EFO_1001311K72.111———1
Liver failureD017093HP_0001399K72.911———1
Show 9 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———2————2
Muscle spasticityD009128HP_0001257—1————1
Tropical spastic paraparesisD015493EFO_0007527G04.11————1
Htlv-i infectionsD015490EFO_0007316—1————1
ParaparesisD020335HP_0002385G82.21————1
Spastic paraparesisD020336HP_0002313—1————1
HypercholesterolemiaD006937HP_0003124—1————1
Papillomavirus infectionsD030361——1————1
DepressionD003863—F33.91————1
Cognitive dysfunctionD060825HP_0001268G31.841————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neurotoxicity syndromesD020258—G92————11
MorbidityD009017——————11
Organ transplantationD016377——————11
PregnancyD011247EFO_0002950Z33.1————11
ProteinuriaD011507HP_0000093R80————11
Hemophilia aD006467EFO_0007267D66————11
Hiv-associated lipodystrophy syndromeD039682EFO_1001348—————11
Nerve degenerationD009410HP_0002180—————11
AgingD000375GO_0007568R41.81————11
Neuroinflammatory diseasesD000090862——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRaltegravir
INNraltegravir
Description
Raltegravir is a pyrimidone that is pyrimidin-4(3H)-one in which the hydrogens at positions 2, 3, 5 and 6 are replaced by 2-[(5-methyl-1,3,4-oxadiazole-2-carbonyl)amino]propan-2-yl, methyl, hydroxy, and N-[(4-fluorophenyl)methyl]aminoacyl groups, respectively. It is an antiretroviral drug used for treatment of HIV infection. It has a role as an antiviral drug and a HIV-1 integrase inhibitor. It is a 1,2,4-oxadiazole, a dicarboxylic acid amide, a member of monofluorobenzenes, a pyrimidone, a hydroxypyrimidine and a secondary carboxamide.
Classification
Small molecule
Drug classantivirals: integrase inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Identifiers
PDB—
CAS-ID518048-05-0
RxCUI—
ChEMBL IDCHEMBL254316
ChEBI ID—
PubChem CID54671008
DrugBankDB06817
UNII ID22VKV8053U (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
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£
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Isentress – Merck & Co
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Estimated US medical usage
Raltegravir
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 8,635 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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14,516 adverse events reported
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