NDAORALTABLET, CHEWABLEPriority Review
Approved
Dec 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
ISENTRESS (raltegravir) by Merck & Co. is hiv-1 antiviral drug [see ] . Approved for hiv infection, aids. First approved in 2011.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISENTRESS (raltegravir) is an HIV-1 integrase strand transfer inhibitor (INSTI) approved in 2011 for treatment of HIV infection and AIDS. It works by blocking integrase, an enzyme required for HIV to replicate and infect CD4+ T cells. The drug is available as an oral tablet in both standard and chewable formulations.
Peak4.1 years to LOE
The product is at peak commercial maturity with 4.1 years of patent protection remaining; team focus is on maximizing market share before generic erosion accelerates.
Mechanism 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.