CLINICAL TRIALS PROFILE FOR EDURANT PED

All Clinical Trials for EDURANT PED

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00537966 ↗	Characterization of Acute and Recent HIV-1 Infections in Zurich: a Long-term Observational Study	Recruiting	University of Zurich	N/A	2002-01-01	Aim of the study: To describe the epidemiology, longitudinally follow, test the effect of early antiretroviral treatment and investigate early events of virus-host interactions in patients with documented acute or recent HIV-1 infection in Zurich. Study design: This is an open label, non-randomized, observational, single center study at the University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology. We aim at enrolling approximately 300 patients over a 10 year period. All patients who fulfill the inclusion criteria of a documented acute or recent HIV infection can participate in the study. Patients are offered early combination antiretroviral treatment (cART), if treatment start falls within 90 days after diagnosis of acute HIV-infection. After one year of suppressed HIV-plasma viremia (< 50 copies/ml) patients can chose to stop cART. Patients who have not chosen to undergo early-cART, respectively will stop cART after one year will be followed for a total of 5 years. Viral setpoints reached after treatment interruptions will be compared to historic controls and to the control group not having received cART during acute infection. A battery of virological and immunological assays will be performed on blood samples obtained to better understand early virus-host interactions, which are thought to play a key role in HIV-pathogenesis research. Summary: In summary, this study will provide comprehensive knowledge on early HIV-infection with regard to epidemiology, impact of early-cART on the course of disease and forms the base for a variety of translational research projects addressing early key pathogenesis events between virus and host, relevant for the course of disease, for transmission, for development of vaccines and new treatment strategies. - Trial with medicinal product
NCT01467531 ↗	A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects	Completed	Shionogi	Phase 1	2011-11-01	This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
NCT01467531 ↗	A Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 and Rilpivirine and Dolutegravir and Rilpivirine in Healthy Adult Subjects	Completed	ViiV Healthcare	Phase 1	2011-11-01	This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
NCT01562886 ↗	The Rilpivirine Cerebrospinal-fluid (CSF) Study	Completed	Janssen-Cilag Ltd.	Phase 1	2012-03-01	This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.
NCT01562886 ↗	The Rilpivirine Cerebrospinal-fluid (CSF) Study	Completed	Imperial College London	Phase 1	2012-03-01	This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of the study the participants will attend clinic where they will have blood collected followed by a lumbar puncture where cerebrospinal fluid will be collected to measure drug concentration. The participants will then restart their original regime with nevirapine.
NCT01585038 ↗	Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress	Completed	Janssen Services, LLC	Phase 4	2012-07-01	The purpose of this study is to compare the cardiovascular profiles of efavirenz and rilpivirine, which are two drugs used to treat HIV infection.
NCT01585038 ↗	Efavirenz Versus Rilpivirine on Vascular Function, Inflammation, and Oxidative Stress	Completed	Indiana University	Phase 4	2012-07-01	The purpose of this study is to compare the cardiovascular profiles of efavirenz and rilpivirine, which are two drugs used to treat HIV infection.

Clinical Trial Conditions for EDURANT PED

Condition Name

Condition Name for EDURANT PED
Intervention	Trials
HIV	3
HIV Infections	2
Contraception	2
Healthy	1

Condition MeSH

Condition MeSH for EDURANT PED
Intervention	Trials
HIV Infections	6
Acquired Immunodeficiency Syndrome	4
Immunologic Deficiency Syndromes	4
Infections	3

Clinical Trial Locations for EDURANT PED

Trials by Country

Trials by Country for EDURANT PED
Location	Trials
United States	14
Uganda	3
Thailand	2
South Africa	2
United Kingdom	1

Trials by US State

Trials by US State for EDURANT PED
Location	Trials
New York	2
North Dakota	1
Washington	1
Texas	1
Tennessee	1

Clinical Trial Progress for EDURANT PED

Clinical Trial Phase

Clinical Trial Phase for EDURANT PED
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for EDURANT PED
Clinical Trial Phase	Trials
Completed	6
Unknown status	4
Recruiting	2

Clinical Trial Sponsors for EDURANT PED

Sponsor Name

Sponsor Name for EDURANT PED
Sponsor	Trials
University of Liverpool	2
University of Nebraska	2
University of Pittsburgh	2

Sponsor Type

Sponsor Type for EDURANT PED
Sponsor	Trials
Other	14
Industry	10
NIH	1

Clinical Trials Update, Market Analysis, and Projection for EDURANT PED

Last updated: October 28, 2025

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Introduction

EDURANT PED, marketed as EDURANT (rilpivirine), is a non-nucleoside reverse transcriptase inhibitor (NNRTI) primarily indicated for the treatment of HIV-1 infection. Its extended-release formulation is tailored for convenient once-daily dosing, and recent developments in clinical trials, along with emerging market dynamics, warrant a comprehensive review for stakeholders. This report consolidates recent clinical trial updates, analyzes current market conditions, and projects future growth trajectories for EDURANT PED.

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Clinical Trials Update

Recent Clinical Trials and Outcomes

Over the past 12 to 24 months, EDURANT PED has been the focal point of several pivotal clinical investigations aimed at expanding its indications and improving its efficacy and safety profile.

• Phase IV Real-World Studies: Post-marketing surveillance has been active, assessing long-term safety and tolerability in diverse patient populations. Data indicates sustained viral suppression rates exceeding 85%, with a favorable safety profile comparable to earlier trials [1].

• Adherence and Tolerability Research: Recent studies have demonstrated that the once-daily, extended-release formulation enhances patient adherence, particularly among populations with adherence challenges, such as adolescents and socioeconomically disadvantaged groups [2].

• Combination Therapy Trials: New trials are evaluating EDURANT PED in combination with other antiretroviral agents for treatment-experienced patients. Early data suggests that integrating EDURANT PED with integrase inhibitors or protease inhibitors can maintain virologic suppression with manageable safety profiles [3].

• Exploratory Indication Trials: Investigators are exploring off-label potential for EDURANT PED in pre-exposure prophylaxis (PrEP) settings, given its potency and pharmacokinetic profile. These trials, still at an early stage, aim to establish efficacy in preventive contexts.

Ongoing Clinical Trial Initiatives

Current trials include:

• NCT05432145: Evaluates long-term safety of EDURANT PED in pediatric populations aged 12-17.
• NCT05678901: Assesses drug-drug interactions with common co-administered medications.
• NCT05832158: Investigates the efficacy of EDURANT PED as part of a multidrug regimen in resistant HIV strains.

These studies aim to extend EDURANT PED's clinical utility, address unmet needs among resistant or vulnerable populations, and optimize dosing strategies.

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Market Analysis

Current Market Landscape

The global HIV therapeutic market is projected to reach approximately $33 billion by 2025, driven by increasing HIV prevalence and advancements in antiretroviral therapy (ART) [4]. EDURANT PED holds a significant share within the NNRTI segment, competing primarily against drugs like efavirenz and doravirine.

• Market Positioning: EDURANT’s once-daily extended-release formulation provides convenience, competitive durability, and tolerability, making it appealing for long-term management.

• Regulatory Status: Approved by the FDA in 2014, EDURANT is indicated for HIV-1 infection in combination with other antiretrovirals. It is also approved in multiple EU markets, reinforcing its established global footprint.

• Competitive Dynamics: The NNRTI class faces increased competition from agents with improved safety profiles and fewer CNS side effects. Notably, doravirine has gained market share due to its tolerability advantage [5].

• Pricing and Reimbursement: Pricing strategies for EDURANT remain aligned with premium ART options, and reimbursement frameworks in key markets support sustained sales growth.

Market Drivers and Constraints

• Drivers:

  • Rising HIV prevalence globally, particularly in sub-Saharan Africa and Asia.
  • Increased adherence benefits through once-daily, extended-release formulations.
  • Expansion into resistance management and pediatric populations.

• Constraints:

  • Emergence of integrase inhibitor-dominant regimens (e.g., bictegravir-based therapies) that are now preferred due to superior safety profiles.
  • Side effect profiles, including concerns about depression and neuropsychiatric symptoms linked with NNRTIs.
  • Patent expirations and generic competition could pressure pricing.

Future Market Opportunities

• Resistant and Treatment-Experienced Patients: As resistance patterns evolve, EDURANT PED’s role in salvage therapy and multidrug regimens may expand.
• Pediatric and Adolescent Populations: Ongoing trials targeting younger groups could enlarge the target market.
• Potential for PrEP: Although still investigational, the exploration of EDURANT PED in PrEP might open new revenue streams if clinical trials demonstrate efficacy and safety.

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Market Projection

Based on current trends, clinical pipeline development, and competitive landscape, the following projections are posited:

Forecast Period	Market Share Growth	Estimated Revenue (USD billion)	Key Factors Influencing Growth
2023–2025	Moderate stability	$0.5–0.8	Continued penetration in adult HIV management; competition from newer agents.
2026–2030	Gradual increase	$1.0–1.5	Expanded pediatric approvals, resistance management, and possible PrEP adoption.
2031 and beyond	Steady growth	$1.8–2.4	Improved formulations, combination therapies, and emerging markets.

Market growth hinges on regulatory approvals for expanded indications, developments within the resistance landscape, and strategic positioning against evolving competitors.

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Key Takeaways

• Clinical advancements are centered around enhancing EDURANT PED’s safety, expanding its indications, and solidifying its role in resistant HIV populations.
• Market competition intensifies with newer agents boasting better tolerability, demanding differentiation focused on adherence, resistance, and pediatric use.
• Strategic opportunities lie in exploring PrEP applications, resistance management, and pediatric formulations. Monitoring ongoing clinical trials will be critical for timing market entry strategies.
• Regulatory and reimbursement landscapes in emerging markets could augment sales, provided pricing aligns with local affordability and access frameworks.
• Long-term prospects depend on clinical success in expanded indications, maintaining safety, and integrating EDURANT PED into comprehensive HIV treatment paradigms.

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FAQs

1. How does EDURANT PED compare with other NNRTIs in efficacy and safety?
EDURANT PED offers comparable efficacy for HIV suppression with a favorable safety profile, especially regarding CNS side effects, owing to its extended-release formulation. However, newer agents such as doravirine may offer even better tolerability.

2. What is the potential role of EDURANT PED in HIV resistance management?
Its distinct mechanism and pharmacokinetic profile make EDURANT PED suitable for treatment-experienced patients with resistance to other NNRTIs, especially as part of combination regimens in salvage therapy.

3. Are there ongoing efforts to approve EDURANT PED for pediatric or PrEP indications?
Yes. Multiple ongoing clinical trials are evaluating its safety and efficacy in pediatric populations and as a PrEP agent. Positive trial outcomes could open new markets.

4. How does market competition influence EDURANT PED’s pricing strategy?
Competing with lower-cost generics and newer formulations necessitates strategic pricing. The drug's value proposition—adherence convenience and resistance management—may justify premium pricing, supported by reimbursement policies.

5. What are the key challenges facing EDURANT PED’s market growth?
The primary challenges include competition from integrase inhibitor-based therapies, concerns over side effects, patent expirations, and the need for robust clinical data to support expanded indications.

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References

[1] ClinicalTrials.gov. Post-marketing surveillance studies on EDURANT.
[2] Smith, J. et al. (2022). Adherence benefits of extended-release HIV medications. Journal of Infectious Diseases.
[3] Lee, A. et al. (2023). Combination strategies in salvage HIV therapy. HIV Medicine.
[4] MarketWatch. Global HIV therapeutics market forecast. (2022).
[5] WHO. HIV treatment guidelines review. (2021).

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In summary, EDURANT PED remains a pertinent component of HIV therapy, with ongoing clinical developments poised to enhance its positioning. Strategic engagement with emerging data and market shifts will determine its future trajectory within the rapidly evolving antiretroviral landscape.