Last reviewed 2026-05-27 · How we verify

raltegravir (RAL)

raltegravir (RAL) is a Integrase strand transfer inhibitor (INSTI) Small molecule drug developed by Abbott. It is currently FDA-approved for HIV-1 infection in treatment-naïve adults and children, HIV-1 infection in treatment-experienced patients. Also known as: raltegravir, RAL, Isentress, MK-0518.

Raltegravir inhibits HIV integrase, preventing the virus from integrating its genetic material into the host cell's DNA.

Raltegravir (RAL) is a small molecule used to treat conditions such as Acquired Immune Deficiency Syndrome, AIDS, Human Immunodeficiency Virus, HIV Infections, and HIV Infection. It is used in combination with other treatments, including Atazanavir and Standard treatment regimens, as part of a regimen that may spare the use of NRTIs.

At a glance

Mechanism of action

Raltegravir is an integrase strand transfer inhibitor (INSTI) that binds to HIV integrase and blocks the catalytic activity required for viral DNA integration into the human genome. By preventing integration, the drug stops HIV replication at a critical step in the viral lifecycle. This mechanism is distinct from reverse transcriptase and protease inhibitors, offering an alternative pathway for antiretroviral therapy.

Approved indications

• HIV-1 infection in treatment-naïve adults and children
• HIV-1 infection in treatment-experienced patients

Common side effects

• Diarrhea
• Nausea
• Headache
• Insomnia
• Rash
• Elevated creatine kinase

Key clinical trials

• A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
• Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
• Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
• Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission (PHASE1, PHASE2)
• Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine (PHASE3)
• Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen (PHASE2, PHASE3)
• Raltegravir + Lamivudine/Abacavir in HIV/Tuberculosis Co-Infected Patients (PHASE4)
• The Influence of Concurrent Oral Calcium Carbonate Supplementation on Steady State Pharmacokinetics of Oral Raltegravir. (PHASE4)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• raltegravir (RAL) CI brief — competitive landscape report
• raltegravir (RAL) updates RSS · CI watch RSS
• Abbott portfolio CI

Frequently asked questions about raltegravir (RAL)

Related

• Drug class: All Integrase strand transfer inhibitor (INSTI) drugs
• Target: All drugs targeting HIV integrase
• Manufacturer: Abbott — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for HIV-1 infection in treatment-naïve adults and children
• Indication: Drugs for HIV-1 infection in treatment-experienced patients
• Also known as: raltegravir, RAL, Isentress, MK-0518

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing