NDAORALTABLETPriority Review
Approved
Oct 2007
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
ISENTRESS (raltegravir) by Merck & Co. is hiv-1 antiviral drug [see ] . First approved in 2007.
Drug data last refreshed 23h ago · AI intelligence enriched 3mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ISENTRESS (raltegravir) is an oral HIV-1 integrase strand transfer inhibitor approved in 2007 that blocks HIV replication by preventing viral DNA integration into host chromosomes. It is a foundational antiretroviral used in combination therapy for treatment-naive and treatment-experienced patients with HIV-1 infection. Raltegravir represents a pivotal shift to integrase inhibitor-based regimens, which have become standard-of-care in modern HIV treatment.
$0.131BPart D
PeakStable
5.5 years to LOEEstablished peak-stage product with sustained $131M annual Part D spending, indicating mature, stable commercial operations with consolidated field and marketing teams.
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
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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.