NDAORALTABLET, CHEWABLEPriority Review
Approved
Dec 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ISENTRESS (raltegravir) by Merck & Co. is hiv-1 antiviral drug [see ] . First approved in 2011.
Drug data last refreshed 13h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISENTRESS (raltegravir) is an oral HIV-1 integrase strand transfer inhibitor (INSTI) that blocks HIV replication by preventing viral DNA integration into the host genome. Approved in 2011, it is used as part of combination antiretroviral therapy in treatment-naive and treatment-experienced HIV-1 infected patients. The drug represents a key pillar of modern HIV treatment regimens.
Peak3.8 years to LOE
Product is at peak commercial maturity with established market presence; brand team focus is on maintaining market share and managing upcoming generic/competitive threats.
Mechanism of Action
HIV-1 antiviral drug [see ] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Worked on ISENTRESS at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
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.