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Isentress

(Raltegravir)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Raltegravir is used to treat HIV infection by helping to prevent the virus from multiplying in the body. It is typically used as part of a combination treatment with other HIV medications.[2] Isentress is currently approved and in use across 14 indications[4].[1]

Isentress is one of 195 small molecule programs targeting Concentration. It is currently in Approved.

14

Indications

148

Total Trials

1

Active Trials

194

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

7

Patents

Pipeline

Status by Indication[4][1]

Indication

ConcentrationCompleted

FemaleCompleted

Viral DiseaseActive, not recruiting

Human T-Lymphotropic Virus 1 Infectious DiseaseApproved

Primary Biliary CirrhosisApproved

Relapsing-Remitting Multiple SclerosisApproved

Head and Neck Malignant NeoplasiaApproved

LipodystrophyActive, not recruiting

WomenCompleted

BuprenorphineCompleted

ConcentrationPreclinical

Completed

FemalePreclinical

Completed

Viral DiseaseApproved

Active, not recruiting

Human T-Lymphotropic Virus 1 Infectious DiseaseApproved

Approved

Primary Biliary CirrhosisApproved

Approved

Relapsing-Remitting Multiple SclerosisApproved

Approved

Head and Neck Malignant NeoplasiaApproved

Approved

LipodystrophyPreclinical

Active, not recruiting

WomenPreclinical

Completed

BuprenorphinePreclinical

Completed

Showing 10 of 13 indications

Competition

Competitive Landscape

52 competitors in Viral Disease

#DrugCompanyPhaseTrials

Isentress

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Ziagen

Videx

Bristol-Myers Squibb

Selzentry

Incivek

Vertex Pharmaceuticals

Vistide

Viread

Vemlidy

Hepsera

Tyzeka

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2031

PreclinicalRecruiting

HIV Infection

NCT02140255

Clinical

Trials by Indication[1]

HIV10 trials

Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.

Completed·HHospital Clinic of Barcelona··NCT01258374·15 enrolled

Raltegravir Intensification in HIV-infected Patients

Completed·UUniversity of California, San Francisco·Phase 4·NCT00631449·30 enrolled

Evaluating the Effect of CHanging EnfuvirtidE to Raltegravir in HIV Infected Subjects

Completed·KKaiser Permanente·Phase 3·NCT00529243·52 enrolled

Show 7 more trials

Safety Study of Raltegravir in HIV/HCV Co-infected Patients

Withdrawn·UUniversity Hospital, Bonn·Phase 4·NCT01225705

Interferon Alfa Sensitivity in HIV/HCV Persons Before and After HIV Meds

Completed·JJohns Hopkins University·Phase 4·NCT01285050·20 enrolled

Abacavir Pharmacokinetic Study in the Absence/Presence of Darunavir/Ritonavir or Raltegravir in HIV-infected Subjects

Completed·SSt Stephens Aids Trust·Phase 1·NCT00765271·29 enrolled

RAL+ATV/r in Comparison With TDF/FTC (or 3TC) +ATV/r in HIV Infected Patients

Unknown status·PPedro Cahn·Phase 4·NCT01829802·50 enrolled

Pharmacokinetic Study of the HCV Protease Inhibitor Boceprevir and the HIV Integrase Inhibitor Raltegravir

Completed·RRadboud University Medical Center·Phase 1·NCT01288417·24 enrolled

Research In Viral Eradication of HIV Reservoirs

Completed·IImperial College London·Phase 2·NCT02336074·60 enrolled

A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers

Completed·HHelen Reynolds·Phase 1·NCT01784302·15 enrolled

Interaction8 trials

TMC278-TiDP6-C153 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC278 and Raltegravir

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01288755·24 enrolled

Drug Interaction Study Between Raltegravir And UK-453,061

Completed· Pfizer logo

Pfizer·Phase 1·NCT00784420·18 enrolled

A Study of Drug-Drug Interaction Between Danoprevir/Low-Dose Ritonavir and Raltegravir in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01531647·20 enrolled

Show 5 more trials

TMC435-TiDP16-C123 - A Study in Healthy Volunteers Investigating the Pharmacokinetic Interaction Between TMC435 and the Antiretroviral Agents Efavirenz and Raltegravir

Completed· Tibotec Pharmaceuticals, Ireland logo

Tibotec Pharmaceuticals, Ireland·Phase 1·NCT01241773·48 enrolled

Pharmacokinetic Drug-drug Interaction Study Between RaltEgravir and CITALopram in Healthy Subjects (RECITAL).

Completed·RRadboud University Medical Center·Phase 1·NCT01978782·24 enrolled

A Study To Evaluate An Interaction Between Maraviroc And Raltegravir In Healthy Subjects

Completed· GSK logo

GSK·Phase 4·NCT00666705·18 enrolled

A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers

Completed·SSt Stephens Aids Trust·Phase 1·NCT01841593·19 enrolled

A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs

Completed·RR-Pharm·Phase 1·NCT03537404·36 enrolled

Immunodeficiency8 trials

Evaluation of the Safety and Efficacy of Reformulated Raltegravir (MK-0518) 1200 mg Once Daily in Combination With TRUVADA™ in Human Immunodeficiency Virus (HIV)-1 Infected, Treatment-Naive Participants (MK-0518-292)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02131233·802 enrolled

A Pharmacokinetic Study to Evaluate the Effect of MAALOX on Raltegravir (MK-0518) in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-295)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01930045·18 enrolled

Safety and Pharmacokinetics (PK) of Raltegravir in HIV (Human Immunodeficiency Virus)-Infected Children and Adolescents

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00485264·153 enrolled

Show 5 more trials

HIV Attachment Inhibitor to Treat Human Immunodeficiency Virus 1 (HIV-1) Infections

Completed· GSK logo

GSK·Phase 2·NCT01384734·254 enrolled

A Study of the Safety, Tolerability, and Antiretroviral Activity of Raltegravir (MK-0518) in Combination With Other Antiretroviral Therapies in Russian Children and Adolescents Infected With Human Immunodeficiency Virus (HIV-1) (MK-0518-248)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01717287·32 enrolled

A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen)

Completed· Merck & Co. logo

Merck & Co.··NCT01213316·451 enrolled

The Effect of Antacids on the Pharmacokinetics (PK) of Raltegravir in Human Immunodeficiency Virus (HIV)-Infected Participants (MK-0518-824)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02473367·20 enrolled

Management of Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Antiretroviral (ARV) Combination Therapy Including Raltegravir (MK-0518-138)

Completed· Merck & Co. logo

Merck & Co.··NCT01048671·482 enrolled

Tics6 trials

Effect of Antacids on the Pharmacokinetics of Raltegravir

Completed·UUniversity of Colorado, Denver·Phase 1·NCT00944307·17 enrolled

Pharmacokinetics of Low Dose Raltegravir

Completed·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 2·NCT01159132·24 enrolled

Safety, Tolerability, and Pharmacokinetics of Raltegravir (MK-0518) in Healthy Japanese Male Participants (MK-0518-851)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT03667547·12 enrolled

Show 3 more trials

The Raltegravir and Ribavirin Pharmacokinetics (PK) Study

Completed·IImperial College London·Phase 1·NCT00982553·14 enrolled

Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500

Completed·VViriom·Phase 1·NCT02489487·24 enrolled

Investigation of Faldaprevir Effect on Pharmacokinetics of Raltegravir

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT01785160·25 enrolled

Pilot Study6 trials

Pilot Study of Adding Raltegravir (MK-0518) to Antiretroviral Therapy in Patients With Low Level Viremia

Completed·UUniversity of Pittsburgh·N/A·NCT00618371·10 enrolled

Pilot Study on the Effect of Adding Raltegravir +/- a Second Drug on HIV Levels in the Gut

Completed·UUniversity of California, San Francisco·N/A·NCT00884793·8 enrolled

A Pilot Study to Characterize the Pharmacokinetics of Raltegravir in the Cervicovaginal Fluids of HIV-infected Women

Completed·UUnknown Sponsor··NCT00774683·1 enrolled

Show 3 more trials

Pilot Study of a Raltegravir Based NRTI Sparing Regimen

Completed·YYale University·N/A·NCT00814879·60 enrolled

Pilot Study to Compare the Pharmacokinetics Parameters in Plasma and Intracellular of Raltegravir Administered Once a Day in Adult Patients Infected With HIV

Completed·GGermans Trias i Pujol Hospital·Phase 4·NCT00995241·5 enrolled

Pilot Study of Raltegravir/Truvada Versus Efavirenz/Truvada for Adults With Acute IV-1 Infection

Completed·UUniversity of Alabama at Birmingham·N/A·NCT00734344·18 enrolled

65 more indications

HIV-15 trials

Effect Of An Integrase Inhibitor On The Latency And Reservoir Of HIV-1

Completed·FFundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal·Phase 2·NCT00807443·10 enrolled

Standard Antiretroviral v. Multi-class Therapy in Acutely HIV-1 Infected Antiretroviral-Naïve Subjects (ADARC 2007-01)

Completed·RRockefeller University·N/A·NCT00525733·40 enrolled

Raltegravir (Isentress/MK-0518) and HIV-1 Infected CD4 Cells During Acute/Early HIV-1

Terminated·UUniversity of Washington·Phase 4·NCT00781287·10 enrolled

Show 2 more trials

Atazanavir/Ritonavir, Once Daily + Raltegravir, Twice Daily, Switch Study in HIV-1-Infected Patients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01332227·132 enrolled

Assess the Downregulation of HIV-1 When Raltegravir is Added to a Virologically Suppressed HAART Regimen

Completed·NNational Jewish Health·N/A·NCT00738569·30 enrolled

Treatment4 trials

Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

Terminated·GGeorge Washington University·Phase 4·NCT00632970·6 enrolled

Maraviroc (Celsentri) With Raltegravir and Darunavir/Ritonavir for the Treatment of Triple Class Failure in Adult HIV-1 Infected Patients

Unknown status·FFundación Huésped·Phase 4·NCT01013987·60 enrolled

Efficacy of Treatment Intensification With Maraviroc on HIV-1 Viral Latency in Recently Infected Hiv-1 naïve Patients Starting Raltegravir Plus Tenofovir/Emtricitabine

Completed·GGermans Trias i Pujol Hospital·Phase 3·NCT00808002·30 enrolled

Show 1 more trial

Optimizing Treatment for Treatment-Experienced, HIV-Infected People

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00537394·517 enrolled

HIV infection4 trials

Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection

Terminated·FFundação Bahiana de Infectologia·Phase 2/3·NCT01854762·33 enrolled

Safety Study of Isentress® + Truvada® in Post-exposure Treatment of HIV Infection

Completed·GGroupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux·Phase 3·NCT01114425·149 enrolled

Effects of Intensive cART During Acute/Early HIV Infection

Completed·UUniversity of Toronto·Phase 2/3·NCT01154673·32 enrolled

Show 1 more trial

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission: A Phase I/II Proof of Concept Study

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT02140255·1,120 enrolled

Trial4 trials

Pilot Opened Trial in HIV-infected Patients Including an Investigational Marketed Product

Completed·GGermans Trias i Pujol Hospital·Phase 4·NCT00773708·57 enrolled

A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen

Completed·KKirby Institute·Phase 4·NCT00931463·558 enrolled

Trial to Assess Effect of Raltegravir on HTLV-1 Proviral Load

Withdrawn·WWashington University School of Medicine·Phase 2·NCT01620736

Show 1 more trial

A Trial Comparing GSK1349572 50mg Once Daily to Raltegravir 400mg Twice Daily

Completed· GSK logo

GSK·Phase 3·NCT01227824·828 enrolled

Women4 trials

Raltegravir Therapy for Women With HIV and Fat Accumulation

Completed·UUniversity of California, Los Angeles·Phase 2·NCT00656175·39 enrolled

Comparing Raltegravir Genital Tract Distribution in HIV-infected Men and Women

Completed·UUniversity of Rochester·N/A·NCT00745368·28 enrolled

Changes in Lipids and Lipoproteins in HIV Infected Women After Switch From Protease Inhibitor to Raltegravir

Completed·AArbeitsgemeinschaft medikamentoese Tumortherapie·Phase 2·NCT02097108·11 enrolled

Show 1 more trial

A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas

Unknown status·TThe University of Texas Health Science Center, Houston··NCT02302950·254 enrolled

ART4 trials

A Pharmacokinetic Study to Evaluate the Effect of Antacids on Raltegravir (MK-0518) in HIV-Infected Participants (MK-0518-247)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01622673·27 enrolled

Effect of Addition of Raltegravir (MK-0518) to PI- or NNRTI-Based ART Regimens in HIV Infected Subjects With Undetectable Viral Load

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00515827·53 enrolled

A Study of the Neurological Effects of Adding Raltegravir to HAART Regimen in Patients With HIV

Terminated·SSt Vincent's Hospital, Sydney·Phase 4·NCT01448486·6 enrolled

Show 1 more trial

Comparative Study of Three NNRTI-Sparing HAART Regimens

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT00811954·1,814 enrolled

Pregnancy3 trials

Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission

Completed·WWestat·Phase 4·NCT01618305·408 enrolled

Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT00042289·1,578 enrolled

Pregnancy and Neonatal Outcomes Following Antenatal Exposure to Raltegravir: a Pooled Analysis From the European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC)

Unknown status·FFondazione Penta UK··NCT05751031·1,200 enrolled

Itching3 trials

Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM

Completed·JJudit Pich·Phase 3·NCT03311945·33 enrolled

Effect on Liver Fat and Metabolic Parameters When Switching a Protease Inhibitor or Efavirenz to Raltegravir

Completed·HHelsinki University Central Hospital·Phase 4·NCT03374358·45 enrolled

Switching From PI to RALtegravir in HIV Stable Patients

Completed·HHospital Clinic of Barcelona·Phase 3·NCT00528892·282 enrolled

Concentration3 trials

Comparison of Concentration-time Course of Plasma and Intracellular Raltegravir in Healthy Volunteers

Completed·—·Phase 1·NCT01027182·6 enrolled

Measurement of Plasma and Intracellular Concentrations of Raltegravir

Completed·UUniversity of Nebraska·N/A·NCT01214486·12 enrolled

Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

Completed·HHospitales Universitarios Virgen del Rocío·Phase 4·NCT01121809·16 enrolled

Adult Subject3 trials

A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects

Completed· GSK logo

GSK·Phase 1·NCT01101893·15 enrolled

An Interaction Study to Assess Drug Levels in Healthy Adult Subjects

Completed·GGarden State Infectious Disease Associates, PA·N/A·NCT00614991·44 enrolled

An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects

Completed·GGarden State Infectious Disease Associates, PA·N/A·NCT00802074·45 enrolled

Combination Therapy3 trials

Study of Options for Second-Line Effective Combination Therapy (SELECT)

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 3·NCT01352715·515 enrolled

Compare the Efficacy and Safety of Raltegravir Versus Efavirenz Combination Therapy in Treatment-naïve HIV-1 Patients

Completed·TTaipei Veterans General Hospital, Taiwan·Phase 4·NCT01989910·107 enrolled

A5288/MULTI-OCTAVE: Management Using Latest Technologies to Optimize Combination Therapy After Viral Failure

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 4·NCT01641367·545 enrolled

Recovery2 trials

Raltegravir Added to Stable HAART in HIV-1 Infected Subjects With Viral Suppression and Low CD4 Recovery

Terminated·PPedro Cahn·Phase 3·NCT00562510·20 enrolled

RAltegravir Switch STudy: Effects on Endothelial Recovery

Unknown status·UUMC Utrecht·Phase 4·NCT01453933·24 enrolled

Hepatitis C2 trials

Safety and Efficacy Study Comparing Raltegravir to a Protease Inhibitor in Treatment-naïve, HIV/Hepatitis C Drug Users

Unknown status·SSt. James's Hospital, Ireland·Phase 4·NCT01105611·40 enrolled

Raltegravir Switch Study to Reduce Liver Fibrosis Progression in HIV-Hepatitis C Co-infection

Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 2·NCT01231685·9 enrolled

Tenofovir Disoproxil Fumarate2 trials

Study of Viral Load Decay Rates in HIV Infected Participants Starting Treatment With Raltegravir (RAL) and Emtricitabine/Tenofovir Disoproxil Fumarate (TDF)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00660972·40 enrolled

Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)

Completed·AAbbott·Phase 3·NCT00711009·206 enrolled

HCV Coinfection2 trials

Hepatic Safety of Raltegravir Versus Efavirenz as HIV Therapy for Patients With HIV and HCV Coinfection

Completed·UUniversity of Hawaii·Phase 4·NCT01147107·80 enrolled

Changes in Liver Steatosis After Switching to Raltegravir in HIV/HCV Coinfection

Completed·JJuan Macías·Phase 4·NCT01900015·45 enrolled

Prophylaxis2 trials

Raltegravir Use as Nonoccupational Postexposure Prophylaxis (NPEP) in Men Who Have Sex With Men

Completed·AAndrew Carr·Phase 4·NCT01087840·120 enrolled

Truvada Plus Raltegravir for Nonoccupational Post-exposure Prophylaxis (nPEP)

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT01214759·103 enrolled

Gastrointestinal2 trials

Study to Characterize the Pharmacokinetics of Raltegravir in the Gastrointestinal (GI) Tract of Healthy Male Volunteers

Completed·AAngela Kashuba, PharmD·Phase 1·NCT01325051·15 enrolled

Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults

Completed·UUniversity of North Carolina, Chapel Hill··NCT02218320·20 enrolled

ESS2 trials

Addition of Raltegravir to Established Antiretroviral Suppressive Therapy

Terminated·UUniversity of Miami·Phase 4·NCT01245101·15 enrolled

Early Access of MK0518 in Combination With an Optimized Background Antiretroviral Therapy (0518-023)

Approved for marketing· Merck & Co. logo

Merck & Co.··NCT00377065

Tuberculosis2 trials

Efficacy and Safety of 2 Raltegravir Doses in Naive HIV-1-infected Patients Receiving Rifampin for Active Tuberculosis

Completed·AANRS, Emerging Infectious Diseases·Phase 2·NCT00822315·155 enrolled

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

Terminated·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT01601626·71 enrolled

Effectiveness1 trial

Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT00830804·113 enrolled

Infants1 trial

Evaluating the Safety and Pharmacokinetics of Raltegravir in Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT01828073·40 enrolled

Atorvastatin1 trial

Pharmacokinetic Drug Interaction Study Between Raltegravir and Atorvastatin.

Completed·RRadboud University Medical Center·Phase 1·NCT01779687·24 enrolled

Vascular Function1 trial

Effects of Switching Efavirenz to Raltegravir on Vascular Function and Bone Markers in HIV-infected Patients

Completed·IIndiana University·Phase 4·NCT01270802·30 enrolled

Cardiovascular1 trial

Impact of Antiretroviral Therapy on Metabolic, Skeletal, and Cardiovascular Parameters

Completed·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections··NCT00851799·334 enrolled

Cohort Study1 trial

Raltegravir in the Swiss HIV Cohort Study

Completed·UUniversity of Zurich··NCT00904644·200 enrolled

Menopausal Women1 trial

Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT00746499·7 enrolled

HIV-1 infection1 trial

Safety and Pharmacokinetics of Raltegravir in HIV-1-Exposed Newborn Infants at Risk of Acquiring HIV-1 Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01780831·52 enrolled

Mortality1 trial

Reduction of EArly mortaLITY in HIV-infected Adults and Children Starting Antiretroviral Therapy

Completed·AAnna Griffiths, MRC·Phase 3·NCT01825031·1,805 enrolled

Buprenorphine1 trial

Buprenorphine/Raltegravir Pharmacokinetic Interaction Study

Completed·YYale University·N/A·NCT00858962·12 enrolled

Multiple Sclerosis1 trial

Raltegravir (Isentress) Pilot Study in Relapsing Multiple Sclerosis

Completed·QQueen Mary University of London·Phase 2·NCT01767701·23 enrolled

HIV-Infected Individuals1 trial

Raltegravir Cerebrospinal Fluid Pharmacodynamic Study in HIV-Infected Individuals

Terminated·UUniversity of California, San Diego·N/A·NCT01293123·2 enrolled

CAR1 trial

Combination Antiretroviral Therapy (cART) for PBC

Completed·UUniversity of Alberta·Phase 2·NCT03954327·37 enrolled

Renal Transplantation1 trial

Renal Transplantation and Raltegravir in HIV-Infected Patients

Completed·AANRS, Emerging Infectious Diseases·Phase 3·NCT01453192·27 enrolled

Lipodystrophy1 trial

Pilot Study of Raltegravir Lipodystrophy IISP

Unknown status·SSouthern California Institute for Research and Education·N/A·NCT01164605·30 enrolled

Clinical Trial1 trial

Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME STUDY

Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 3·NCT03029689·61 enrolled

Outcome1 trial

BRAVO: Background Regimen of Raltegravir on Virologic Outcome

Completed·CCommunity Research Initiative of New England··NCT00751530·442 enrolled

T Cell1 trial

Antiretroviral Therapy Intensification With Raltegravir or Addition of Hyper-immune Bovine Colostrum in HIV-1 Infected Patients With Suboptimal CD4+ T Cell Response

Completed·KKirby Institute·Phase 4·NCT00772590·75 enrolled

Endothelial Function1 trial

Effect of Raltegravir on Endothelial Function in HIV-Infected Patients

Completed·UUniversity of California, San Francisco·Phase 4·NCT00843713·56 enrolled

Tolerance1 trial

Safety, Tolerance and Pharmacokinetics of Raltegravir-Containing Antiretroviral Therapy in Infants, Children Infected With HIV and TB

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT01751568·40 enrolled

Drug Interactions1 trial

Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen

Terminated·JJudit Pich·Phase 3·NCT03333083·17 enrolled

Impaired Renal Function1 trial

Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT02116660·11 enrolled

Adolescent1 trial

IMPAACT P1058A: Pharmacokinetic Effects of New Antiretroviral Drugs on Children, Adolescents and Young Adults

Completed·IInternational Maternal Pediatric Adolescent AIDS Clinical Trials Group··NCT00977756·168 enrolled

Efficacy1 trial

The Safety, Pharmacokinetic Profile and Efficacy of Raltegravir in HIV-infected Patients at Least 60 Years of Age

Completed·IImperial College London·Phase 4·NCT01335620·19 enrolled

Methadone1 trial

A Trial to Compare Raltegravir Versus Nevirapine as Anchor Drug for HIV+ Chinese IDUs on Methadone Maintenance

Unknown status·CCenters for Disease Control and Prevention, China·N/A·NCT01042652·60 enrolled

Phase II1 trial

Phase IIB Pilot of Atazanavir + Raltegravir

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00768989·167 enrolled

Adult1 trial

A Study of GSK1349572 Versus Raltegravir (RAL) With Investigator Selected Background Regimen in Antiretroviral-Experienced, Integrase Inhibitor-Naive Adults

Completed· GSK logo

GSK·Phase 3·NCT01231516·724 enrolled

TED1 trial

Effect of BI 201335 Mediated UGT1A1 (Uridine-diphosphate-glucuronosyltransferases) Inhibition in Healthy Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02182375·24 enrolled

Low Bone Mineral Density1 trial

Switch From Tenofovir to Raltegravir for Low Bone Mineral Density

Completed·SSt Vincent's Hospital, Sydney·Phase 4·NCT00939874·52 enrolled

Mitochondria1 trial

Effects of Raltegravir (Isentress®) on Lipid and Carbohydrate Metabolism and Mitochondrial Function in Healthy Volunteers

Unknown status·HHospital Clinic of Barcelona·Phase 1·NCT00772720·14 enrolled

LAM1 trial

Pharmacokinetic Study on Raltegravir and Lamotrigine

Completed·RRadboud University Medical Center·Phase 1·NCT00618241·24 enrolled

Bone1 trial

Bone and Body Comp: A Sub Study of the SECOND-LINE Study

Completed·KKirby Institute·Phase 4·NCT01513122·210 enrolled

Safety and Efficacy1 trial

Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir

Completed· Gilead logo

Gilead·Phase 3·NCT00708162·724 enrolled

Prevention1 trial

A Key Link for Transmission Prevention

Completed·UUniversity of North Carolina, Chapel Hill·N/A·NCT01450189·46 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Raltegravir (RAL) in Treatment-experienced HIV-1 Infected Adult Chinese Patients

Unknown status·SShanghai Public Health Clinical Center·Phase 4·NCT01201239·50 enrolled

Hyperlipidemia1 trial

Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy

Completed·TThe Miriam Hospital·Phase 3·NCT00887653·20 enrolled

Neuroimaging1 trial

Advanced Neuroimaging Evaluation of CNS Changes Associated With Efavirenz Therapy Switch to an Raltegravir-based Regimen

Completed·MMassachusetts General Hospital·N/A·NCT01978743·10 enrolled

Platelet Reactivity1 trial

Effects of Raltegravir Based Regimen on Platelet Reactivity, Platelet-monocyte Aggregation and Immune Activation

Completed·RRadboud University Medical Center·Phase 4·NCT02383355·40 enrolled

Female1 trial

Levels of Raltegravir in the Female Genital Tissue

Completed·UUniversity of Washington·N/A·NCT01327482·10 enrolled

Complication1 trial

Study of the Effect of Atorvastatin for Reducing Aging-related Complication in HIV-infected Patients Older Than 45 Years Receiving a Protease Inhibitor-based Regimen Versus a Raltegravir-based Regimen

Completed·FFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia·Phase 4·NCT02577042·42 enrolled

Leukemia1 trial

EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma

Completed·WWashington University School of Medicine·Phase 1/2·NCT01000285·18 enrolled

Statin1 trial

The Influence of Raltegravir on Pravastatin Pharmacokinetics(GRAPPA)

Completed·RRadboud University Medical Center·Phase 1·NCT00665717·24 enrolled

Children1 trial

Population Pharmacokinetics of Antiretroviral in Children

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03194165·65 enrolled

Immune1 trial

Pilot Project of Virologic and Immunologic Correlates of GALT Immune Reconstitution Following Raltegravir Therapy

Completed·UUniversity of California, Davis·N/A·NCT00661960·25 enrolled

Central Nervous System1 trial

Raltegravir Augmentation on Persistent Central Nervous System (CNS) Immunoactivation in Treated HIV-1 Patients

Completed·UUniversity of California, San Francisco·N/A·NCT00672932·18 enrolled

Unspecified9 trials

Genetic Predictors of Raltegravir Penetration Into Cerebrospinal Fluid

Completed·VVanderbilt University·Phase 2/3·NCT00729924·40 enrolled

Integrase Inhibitor (MK-0518) Viral Decay

Completed·CCanadian Immunodeficiency Research Collaborative·Phase 2·NCT00520897·24 enrolled

Simplification From Protease Inhibitors to Raltegravir

Unknown status·HHospital Carlos III, Madrid·Phase 4·NCT00941083·240 enrolled

Show 6 more trials

Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study

Unknown status·FFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud·Phase 4·NCT03732625·50 enrolled

Raltegravir And Darunavir Antiretroviral in Antiretroviral Naive Patients

Completed·—·Phase 4·NCT00677300·85 enrolled

DDI HV (ATV - Merck)

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00518297·22 enrolled

RAL-eve Study: Raltegravir Substitution Study

Completed·SStanford University·N/A·NCT00523237·14 enrolled

The Effect of Intermittent Rifampicin on Raltegravir

Completed·HHelen Reynolds·Phase 1·NCT01424826·18 enrolled

Raltegravir for HAM/TSP

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT01867320·19 enrolled

Regulatory

FDA Approval Timeline[5]

Oct 12, 2007

ISENTRESS

NDA NDA022145

Dec 21, 2011

ISENTRESS

NDA NDA203045

Dec 20, 2013

ISENTRESS

NDA NDA205786

Sources

References

[1]
ClinicalTrials.gov — 148 trial records for Raltegravir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Isentress drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Raltegravir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Raltegravir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA205786). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Isentress. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Integrase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[6]

Patent Cliff

Jan 28, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8852632Jan 28, 2028

7754731Mar 11, 2029

7754731*PEDSep 11, 2029

8771733Jun 2, 2030

9649311Oct 21, 2030

2 more patents

9649311*PEDApr 21, 2031

10772888Mar 30, 2032

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