NDAORALTABLETPriority Review
Approved
Oct 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
ISENTRESS HD (raltegravir) by Merck & Co. is hiv-1 antiviral drug [see ] . Approved for hiv-1 infection, aids. First approved in 2007.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISENTRESS HD (raltegravir) is an oral HIV-1 integrase strand transfer inhibitor (INSTI) tablet approved by the FDA in October 2007 for use in combination with other antiretroviral agents. It is indicated for treatment of HIV-1 infection in adult patients and pediatric patients weighing at least 2 kg, functioning as a foundational component of modern antiretroviral regimens. Raltegravir works by inhibiting HIV integrase, preventing viral DNA integration into the host genome. ISENTRESS HD represents a higher-dose formulation of the standard ISENTRESS product, positioned for specific treatment scenarios within the contemporary HIV care landscape.
$0.0BPart D
5.9 years to LOEMechanism of Action
HIV-1 antiviral drug [see ] .
Indications (2)
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.