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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
| immune system diseases | D007154 |
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 |
|---|---|---|---|---|
| ISENTRESS | Merck & Co | N-205786 RX | 2013-12-20 | 1 products, RLD, RS |
| ISENTRESS | Merck & Co | N-203045 RX | 2011-12-21 | 2 products, RLD, RS |
| ISENTRESS | Merck & Co | N-022145 RX | 2007-10-12 | 1 products, RLD, RS |
| ISENTRESS HD | Merck & Co | N-022145 RX | 2017-05-26 | 1 products, RLD, RS |
Lamivudine
+
Raltegravir potassium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUTREBIS | Merck & Co | N-206510 DISCN | 2015-02-06 | 1 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| isentress | New Drug Application | 2024-10-18 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
| acquired immunodeficiency syndrome | EFO_0000765 | D000163 | B20 |
| hepatitis b | — | D006509 | — |
Agency Specific
FDA
EMA
No data
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 infections | D015658 | EFO_0000764 | B20 | 29 | 47 | 60 | 48 | 66 | 237 |
| Hiv | D006678 | — | — | 11 | 8 | 10 | 23 | 22 | 72 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 4 | 12 | 14 | 11 | 16 | 54 |
| Infections | D007239 | EFO_0000544 | — | 6 | 9 | 13 | 4 | 14 | 44 |
| Communicable diseases | D003141 | — | — | 4 | 4 | 8 | 2 | 9 | 25 |
| Hepatitis c | D006526 | — | B19.2 | 6 | 4 | 3 | 5 | 1 | 17 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | 1 | 5 | 5 | 3 | 3 | 15 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 5 | 4 | 3 | 4 | 1 | 15 |
| Healthy volunteers/patients | — | — | — | 8 | — | — | 2 | 2 | 12 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 3 | 3 | 3 | 2 | 1 | 10 |
Show 24 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Viremia | D014766 | — | B34.9 | — | 1 | 1 | — | 1 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | 2 | 1 | — | — | 3 |
| Fibrosis | D005355 | — | — | 1 | 2 | 1 | — | — | 3 |
| Virus diseases | D014777 | — | B34 | — | 1 | 2 | — | 1 | 3 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 2 | 1 | — | 1 | 3 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | 1 | 1 | — | — | 2 |
| Chronic hepatitis | D006521 | — | K73.9 | — | 1 | 1 | — | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | — | 1 |
| Treatment-resistant depressive disorder | D061218 | — | — | — | — | 1 | — | — | 1 |
| Hyperlipidemias | D006949 | HP_0003077 | E78.5 | — | — | 1 | — | — | 1 |
Show 2 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 1 | 2 | — | — | — | 2 |
| T-cell leukemia | D015458 | — | — | 1 | 2 | — | — | — | 2 |
| Highly active antiretroviral therapy | D023241 | — | — | — | 1 | — | — | 1 | 2 |
| Lipodystrophy | D008060 | HP_0009125 | E88.1 | — | 1 | — | — | 1 | 2 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | 1 | — | — | — | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | 1 | — | — | — | 1 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | 1 | 1 | — | — | — | 1 |
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | 1 | — | — | — | 1 |
| Biliary liver cirrhosis | D008105 | — | K74.3 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 2 | — | — | — | 1 | 3 |
| Htlv-i infections | D015490 | EFO_0007316 | — | 2 | — | — | — | — | 2 |
| Hepacivirus | D016174 | — | — | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | 1 | — | — | — | — | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | 1 | — | — | — | — | 1 |
| Muscle spasticity | D009128 | HP_0001257 | — | 1 | — | — | — | — | 1 |
| Tropical spastic paraparesis | D015493 | EFO_0007527 | G04.1 | 1 | — | — | — | — | 1 |
| Paraparesis | D020335 | HP_0002385 | G82.2 | 1 | — | — | — | — | 1 |
| Spastic paraparesis | D020336 | HP_0002313 | — | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | — | — | — | — | 1 | 1 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Genital diseases | D000091662 | — | — | — | — | — | — | 1 | 1 |
| Neurotoxicity syndromes | D020258 | — | G92 | — | — | — | — | 1 | 1 |
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 1 | 1 |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | — | 1 | 1 |
| Morbidity | D009017 | — | — | — | — | — | — | 1 | 1 |
| Organ transplantation | D016377 | — | — | — | — | — | — | 1 | 1 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Raltegravir |
| INN | raltegravir |
| 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 class | antivirals: integrase inhibitors |
| Image (chem structure or protein) |  |
| 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-ID | 518048-05-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL254316 |
| ChEBI ID | — |
| PubChem CID | 54671008 |
| DrugBank | DB06817 |
| UNII ID | 22VKV8053U (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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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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Number of purchases
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Trends
PubMed Central
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Additional graphs summarizing 8,567 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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14,271 adverse events reported
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