NDAORALTABLETPriority Review
Approved
Oct 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
8/8 — Comprehensive
Priority Review
ISENTRESS (raltegravir) by Merck & Co. is hiv-1 antiviral drug [see ] . Approved for hiv-1 infection. First approved in 2007.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISENTRESS (raltegravir) is an oral HIV-1 integrase strand transfer inhibitor (INSTI) approved by the FDA in October 2007 for combination antiretroviral therapy. It is indicated for treatment of HIV-1 infection in adult and pediatric patients weighing at least 2 kg, working by blocking the HIV integrase enzyme to prevent viral replication. ISENTRESS represents a foundational drug class in modern HIV treatment and is widely used as a component of first-line and second-line regimens globally.
$0.1BPart D
5.9 years to LOEMechanism of Action
HIV-1 antiviral drug [see ] .
Indications (1)
Clinical Trials (20)
Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study
Started May 2019
50 enrolled
HIV Infections
Raltegravir One Thousand Two Hundred vs Darunavir-cb in Immnunosupressed Patients: ROTDIP Study
Started Apr 2019
75 enrolled
HIV Infections
Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)
Started Sep 2018
12 enrolled
Human Immunodeficiency Virus (HIV) Infection
Pharmacokinetics Distribution of Raltegravir by PET/MR
Started Apr 2018
10 enrolled
HIV-1-infection
Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir
Started Jan 2018
45 enrolled
HIV SeropositivityMetabolic SyndromeFatty Liver
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.