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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
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Financial
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Safety
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5D
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3M
6M
YTD
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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
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
333 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_0000764B202947604866237
HivD006678——11810232272
Acquired immunodeficiency syndromeD000163EFO_0000765B2041214111654
InfectionsD007239EFO_0000544—691341444
Communicable diseasesD003141——4482925
Hepatitis cD006526—B19.26435117
Immunologic deficiency syndromesD007153HP_0002721D84.91553315
HepatitisD006505HP_0012115K75.95434115
Healthy volunteers/patients———8——2212
Hepatitis aD006506EFO_0007305B153332110
Show 24 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ViremiaD014766—B34.9—11—13
Liver cirrhosisD008103EFO_0001422K74.0121——3
FibrosisD005355——121——3
Virus diseasesD014777—B34—12—13
PregnancyD011247EFO_0002950Z33.1—21—13
Renal insufficiencyD051437HP_0000083N19—11——2
Chronic hepatitisD006521—K73.9—11——1
Chronic renal insufficiencyD051436—N18——1——1
Treatment-resistant depressive disorderD061218————1——1
HyperlipidemiasD006949HP_0003077E78.5——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Adult t-cell leukemia-lymphomaD015459—C91.512———2
T-cell leukemiaD015458——12———2
Highly active antiretroviral therapyD023241———1——12
LipodystrophyD008060HP_0009125E88.1—1——12
LeukemiaD007938—C9511———1
LymphomaD008223—C85.911———1
Liver diseasesD008107HP_0002910K70-K7711———1
End stage liver diseaseD058625EFO_1001311K72.111———1
Liver failureD017093HP_0001399K72.911———1
Biliary liver cirrhosisD008105—K74.3—1———1
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DepressionD003863—F33.92———13
Htlv-i infectionsD015490EFO_0007316—2————2
HepacivirusD016174——1————1
Head and neck neoplasmsD006258——1————1
Squamous cell carcinomaD002294——1————1
Insulin resistanceD007333HP_0000855—1————1
Muscle spasticityD009128HP_0001257—1————1
Tropical spastic paraparesisD015493EFO_0007527G04.11————1
ParaparesisD020335HP_0002385G82.21————1
Spastic paraparesisD020336HP_0002313—1————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic hepatitis bD019694EFO_0004239B18.1————11
Female genital diseasesD005831EFO_0009549N85————11
Genital diseasesD000091662——————11
Neurotoxicity syndromesD020258—G92————11
Sleep wake disordersD012893—G47————11
Liver transplantationD016031EFO_0010682—————11
MorbidityD009017——————11
Organ transplantationD016377——————11
ProteinuriaD011507HP_0000093R80————11
Hemophilia aD006467EFO_0007267D66————11
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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 8,532 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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14,271 adverse events reported
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