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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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)
Lamivudine
+
Raltegravir potassium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUTREBIS | Merck Sharp & Dohme | N-206510 DISCN | 2015-02-06 | 1 products |
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Raltegravir potassium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ISENTRESS HD | Merck Sharp & Dohme | N-022145 RX | 2017-05-26 | 1 products, RLD, RS |
| ISENTRESS | Merck Sharp & Dohme | N-022145 RX | 2007-10-12 | 1 products, RLD, RS |
| ISENTRESS | Merck Sharp & Dohme | N-203045 RX | 2011-12-21 | 2 products, RLD, RS |
| ISENTRESS | Merck Sharp & Dohme | N-205786 RX | 2013-12-20 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| isentress | New Drug Application | 2023-03-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hiv infections | EFO_0000764 | D015658 | B20 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Raltegravir Potassium, Isentress, Msd Sub Merck | |||
| 10772888 | 2032-03-30 | U-1663 | |
| 9649311 | 2030-10-21 | DP | |
| 8771733 | 2030-06-02 | DS, DP | U-257 |
| 8852632 | 2028-01-28 | DS, DP | U-257 |
| Lamivudine / Raltegravir Potassium, Dutrebis, Merck Sharp Dohme | |||
| 7754731 | 2029-03-11 | DS, DP | U-257, U-1663 |
| 7169780 | 2023-10-03 | DS, DP | |
| 7820660 | 2023-04-25 | DP | |
HCPCS
No data
Clinical
Clinical Trials
238 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 | 23 | 30 | 33 | 37 | 32 | 149 |
| Hiv | D006678 | O98.7 | 9 | 6 | 9 | 18 | 11 | 52 | |
| Healthy volunteers/patients | — | 8 | — | — | 2 | 2 | 12 | ||
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 2 | 1 | 2 | 3 | 8 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 2 | 3 | 1 | 1 | — | 6 |
| Hepatitis c | D006526 | B19.2 | 1 | 1 | — | 3 | — | 5 | |
| Hiv seropositivity | D006679 | — | — | 2 | 1 | — | 3 | ||
| Metabolic bone diseases | D001851 | HP_0000938 | — | — | — | 2 | — | 2 | |
| Fatty liver | D005234 | — | — | — | 2 | — | 2 | ||
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | 2 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | 1 | 1 | 3 | — | — | 5 | |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | 2 | 1 | — | — | 2 |
| Chronic renal insufficiency | D051436 | N18 | — | — | 1 | — | — | 1 | |
| Viremia | D014766 | B34.9 | — | — | 1 | — | — | 1 | |
| Hyperlipidemias | D006949 | EFO_0003774 | E78.5 | — | — | 1 | — | — | 1 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | — | 1 |
| Adult t-cell leukemia-lymphoma | D015459 | C91.5 | 1 | 1 | — | — | — | 1 | |
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | 1 | — | — | — | 1 |
| Biliary liver cirrhosis | D008105 | K74.3 | — | 1 | — | — | — | 1 | |
| Relapsing-remitting multiple sclerosis | D020529 | EFO_0003929 | — | 1 | — | — | — | 1 | |
| Hiv-1 | D015497 | — | 1 | — | — | — | 1 | ||
| Lipodystrophy | D008060 | E88.1 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | F33.9 | 2 | — | — | — | — | 2 | |
| Htlv-i infections | D015490 | EFO_0007316 | 2 | — | — | — | — | 2 | |
| Hepacivirus | D016174 | 1 | — | — | — | — | 1 | ||
| Head and neck neoplasms | D006258 | 1 | — | — | — | — | 1 | ||
| Tropical spastic paraparesis | D015493 | EFO_0007527 | G04.1 | 1 | — | — | — | — | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | 1 | — | — | — | — | 1 | |
| Papillomavirus infections | D030361 | 1 | — | — | — | — | 1 | ||
| Cognitive dysfunction | D060825 | G31.84 | 1 | — | — | — | — | 1 | |
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep wake disorders | D012893 | G47 | — | — | — | — | 1 | 1 | |
| Liver transplantation | D016031 | EFO_0010682 | — | — | — | — | 1 | 1 | |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | — | — | 1 | 1 |
| Virus diseases | D014777 | B34 | — | — | — | — | 1 | 1 |
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 | 719872 |
| ChEMBL ID | CHEMBL254316 |
| ChEBI ID | — |
| PubChem CID | 54671008 |
| DrugBank | DB06817 |
| UNII ID | 22VKV8053U (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Isentress - Merck Sharp & Dohme
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Trends
PubMed Central
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Additional graphs summarizing 7,590 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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197 adverse events reported
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