Edurant Ped

(Rilpivirine)

ApprovedSmall molecule

Edurant Ped is a small molecule that works as a Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor.[2] It is being used across 9 indications, with its most advanced program in Approved.[1]

Edurant Ped is one of 196 small molecule programs targeting AIDS. It is currently in Approved.

Indications

Total Trials

Active Trials

195

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

AIDSApproved

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

HIV-1 InfectionActive, not recruiting

Oxidative StressActive, not recruiting

ImmunodeficiencyActive, not recruiting

HIV InfectionsNot yet recruiting

Human Immunodeficiency Virus Type 1Active, not recruiting

AIDSApproved

Approved

HIV InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

HIV-1 InfectionApproved

Active, not recruiting

Oxidative StressApproved

Active, not recruiting

ImmunodeficiencyPhase 3

Active, not recruiting

HIV InfectionsPhase 3

Not yet recruiting

Human Immunodeficiency Virus Type 1Phase 2

Active, not recruiting

Competition

Competitive Landscape

326 competitors in HIV Infection

#DrugCompanyPhaseTrials

Edurant Ped

WWim Janssens

Approved

39 2

Sunlenca

Gilead

Phase 3

1 3

Intron a

Merck & Co.

Phase 3

1 4

Megace

PEG-Intron

Betaseron

Foscavir

NNational Institute of Allergy and Infectious Diseases (NIAID)

Phase 3

1 8

TWINRIX™

GSK

Phase 3

1 9

Buprenorphine/naloxone

Astellas

Phase 3

1 10

F/TDF

Gilead

Phase 3

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

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Human Immunodeficiency Virus Type 1

NCT02494986

Q3 2027

Active, not recruiting

ART

NCT06518408

Q4 2029

Phase 3Active, not recruiting

Immunodeficiency

NCT03299049

Phase 3Active, not recruiting

Efficacy

NCT02938520

Phase 3Active, not recruiting

Infection, Human Immunodeficiency Virus

NCT02951052

Q1 2033

Phase 3Not yet recruiting

HIV Infections

NCT07682961

Clinical

Trials by Indication[1]

Immunodeficiency8 trials

A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00799864·54 enrolled

A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01266902·482 enrolled

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

Active, not recruiting· GSK logo

GSK·Phase 3·NCT03299049·1,049 enrolled

Show 5 more trials

A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

Completed· GSK logo

GSK·Phase 3·NCT04542070·687 enrolled

Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine

Completed· GSK logo

GSK·Phase 2·NCT01641809·244 enrolled

Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

Completed· GSK logo

GSK·Phase 3·NCT05896748·94 enrolled

A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03563742·58 enrolled

A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

Completed· GSK logo

GSK·Phase 3·NCT05896761·118 enrolled

Interaction3 trials

A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01719614·20 enrolled

Darunavir and Rilpivirine Interactions With Levonorgestrel Implant

Unknown status·MMakerere University·Phase 2·NCT03589027·60 enrolled

Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant

Unknown status·MMakerere University·Phase 2·NCT03589040·60 enrolled

Tics3 trials

A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01615614·20 enrolled

A Study to Evaluate the Pharmacokinetic Effects of Different Storage Conditions for a Long-Acting Nanosuspension of Rilpivirine on Pharmacokinetics

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02547870·61 enrolled

A Study to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03127189·110 enrolled

Children2 trials

Population Pharmacokinetics of Antiretroviral in Children

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

A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04012931·26 enrolled

Adolescent2 trials

Rilpivirine in Virologically Suppressed Adolescents

Unknown status·MMahidol University·Phase 2/3·NCT03033368·100 enrolled

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT03497676·168 enrolled

20 more indications

Efficacy2 trials

Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

Active, not recruiting· GSK logo

GSK·Phase 3·NCT02938520·631 enrolled

Efficacy of Rilpivirine-based Regimens as Switch Therapy From Nevirapine-based Regimens in HIV-infected Patients

Completed·MMahidol University·N/A·NCT03664440·106 enrolled

Antiretroviral Treatment1 trial

Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

Withdrawn·JJuan A. Arnaiz·Phase 4·NCT02470650

Acceptability1 trial

Phase II Safety and Acceptability of an Investigational Injectable Product, TMC278LA, for Pre-Exposure Prophylaxis

Completed·PPATH·Phase 2·NCT02165202·136 enrolled

Drug Interactions1 trial

Safety, Tolerability, Drug Interactions, and Antiviral Activity of Rilpivirine in Antiretroviral-Naive HIV-Infected Children Less Than 12 Years of Age

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT01975012

Pregnant Women1 trial

A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT00855335·77 enrolled

Medication1 trial

Effect on HIV Medications on EPC Cells

Completed·SSabyasachi Sen··NCT03782142·22 enrolled

Oxidative Stress1 trial

Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress

Completed·IIndiana University·Phase 4·NCT01585038·40 enrolled

Tenofovir Disoproxil Fumarate1 trial

A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01709084·426 enrolled

Pediatric1 trial

Relative Bioavailability of Three Oral Formulations Candidates of Rilpivirine for Potential Pediatric Use Compared to Oral Tablet

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02561936·32 enrolled

Pilot Study1 trial

Open Label, Pilot Study of Darunavir Boosted by Cobicistat in Combination With Rilpivirine to Treat HIV+ Naïve Subjects

Unknown status·TTherapeutic Concepts·Phase 4·NCT02404233·30 enrolled

Pregnancy1 trial

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

ART1 trial

A Real-life Study of the Use of Cabotegravir Plus Rilpivirine Long-acting in ART-experienced Pre-treated People With HIV

Active, not recruiting·UUniversity Hospital Virgen de las Nieves··NCT06518408·287 enrolled

Neurocognitive Function1 trial

Neurocognitive Function Improvement After Switching From Efavirenz to Rilpivirine

Unknown status·—·Phase 4·NCT03567304·28 enrolled

Treatment Failure1 trial

Cabotegravir Plus Rilpivirine Long-acting Regimen in the Swiss HIV Cohort Study:Uptake, Outcome, and Risk Factors for Treatment Failures

Recruiting·UUniversity of Zurich··NCT06405464·600 enrolled

Adult1 trial

Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants

Completed· GSK logo

GSK·Phase 1·NCT04371380·15 enrolled

Effectiveness1 trial

'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

Completed· GSK logo

GSK··NCT04019873·774 enrolled

Infection, Human Immunodeficiency Virus1 trial

A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

Active, not recruiting· GSK logo

GSK·Phase 3·NCT02951052·618 enrolled

Human Immunodeficiency Virus Type 11 trial

An Open-label, Roll-over Study With Rilpivirine in Combination With a Background Regimen Containing Other Antiretrovirals (ARVs) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Subjects Who Participated in Rilpivirine Pediatric Studies

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02494986·48 enrolled

HIV Infections1 trial

A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

Not yet recruiting· Gilead logo

Gilead·Phase 3·NCT07682961·590 enrolled

Unspecified1 trial

The Rilpivirine Cerebrospinal-fluid (CSF) Study

Completed·IImperial College London·Phase 1·NCT01562886·14 enrolled

Regulatory

FDA Approval Timeline[4]

May 20, 2011

EDURANT

NDA NDA202022

Mar 15, 2024

EDURANT PED

NDA NDA219016

Sources

References

[1]
ClinicalTrials.gov — 39 trial records for Rilpivirine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Rilpivirine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Rilpivirine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA219016). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Edurant Ped. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Wim Janssens company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Type 1 Reverse Transcriptase Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: WWim Janssens

Patent Landscape[5]

Patent Cliff

Oct 23, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11065198Oct 23, 2037

Edurant Ped

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q3 2027

Q4 2029

Q1 2033

Trials by Indication[1]

Immunodeficiency8 trials

Interaction3 trials

Tics3 trials

Children2 trials

Adolescent2 trials

Efficacy2 trials

Antiretroviral Treatment1 trial

Acceptability1 trial

Drug Interactions1 trial

Pregnant Women1 trial

Medication1 trial

Oxidative Stress1 trial

Tenofovir Disoproxil Fumarate1 trial

Pediatric1 trial

Pilot Study1 trial

Pregnancy1 trial

ART1 trial

Neurocognitive Function1 trial

Treatment Failure1 trial

Adult1 trial

Effectiveness1 trial

Infection, Human Immunodeficiency Virus1 trial

Human Immunodeficiency Virus Type 11 trial

HIV Infections1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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