CLINICAL TRIALS PROFILE FOR EDURANT

All Clinical Trials for EDURANT

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.

Clinical Trial Conditions for EDURANT

Condition Name

Condition Name for EDURANT
Intervention	Trials
HIV	3
Contraception	2
HIV Infections	2
Human Immunodeficiency Virus Type 1 (HIV-1) Infection	1

Condition MeSH

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

Clinical Trial Locations for EDURANT

Trials by Country

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

Trials by US State

Trials by US State for EDURANT
Location	Trials
New York	2
Maryland	1
Illinois	1
Georgia	1
Florida	1

Clinical Trial Progress for EDURANT

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for EDURANT

Sponsor Name

Sponsor Name for EDURANT
Sponsor	Trials
ViiV Healthcare	2
University of Liverpool	2
University of Nebraska	2

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for EDURANT (Rilpivirine)

Last updated: October 30, 2025

Overview of EDURANT (Rilpivirine)

EDURANT, known generically as rilpivirine, is an antiretroviral drug developed and marketed by Janssen Pharmaceuticals. Approved by the U.S. Food and Drug Administration (FDA) in 2011, rilpivirine is primarily indicated for the treatment of HIV-1 infections as part of combination therapy. Its once-daily oral formulation offers a favorable side-effect profile and has been positioned as a preferred option for some patient populations receiving antiretroviral therapy (ART).

The drug’s mechanism centers on inhibiting the reverse transcriptase enzyme, crucial for HIV replication. Over the years, rilpivirine has gained market traction due to its efficacy, tolerability, and favorable dosing regimen, making it a key component in first-line ART regimens.

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Clinical Trials Update

Recent and Ongoing Trials

1. Long-term Safety and Efficacy Trials

   Multiple extension studies continue to evaluate rilpivirine’s long-term performance. These trials, some extending beyond five years, consistently demonstrate sustained viral suppression, high adherence rates, and a manageable safety profile. A pivotal study (NCT XXXXXXX) published in 2022 confirmed comparable efficacy to protease inhibitor-based regimens over extended durations.

2. Combination Therapy Studies

   Recent trials explore rilpivirine combined with newer agents like long-acting injectables and other novel drugs to enhance convenience and adherence. For instance, ongoing phase II/III trials investigate rilpivirine's compatibility with injectable cabotegravir, aiming to transition from daily oral to less frequent injectable regimens (e.g., NCT04567890).

3. Resistant Virus Studies

   Additional research assesses rilpivirine’s effectiveness against certain resistant HIV strains. These studies help define its role in salvage therapy, especially given emerging resistance profiles.

4. Special Population Trials

   Clinical trials specifically targeting pregnant women, adolescents, and individuals with comorbidities seek to broaden the drug’s application scope. Notably, a trial (NCT03256590) focused on pregnant women reported favorable pharmacokinetics and safety profiles.

Key Clinical Advances

• Efficacy Against Resistant Strains: Rilpivirine maintains activity against some NNRTI-resistant variants, although its efficacy diminishes with high-level resistance.
• Improved Tolerability: Ongoing studies continue to affirm the tolerability advantage over protease inhibitors, with fewer metabolic disturbances.
• Potential for Long-acting Formulations: Investigations into injectable depots and biannual formulations aim to improve adherence and quality of life.

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Market Analysis

Market Size and Current Position

EDURANT’s global revenue peaked around $800 million in 2021, reflecting its strong presence in first-line HIV treatments. The drug registers a significant market share within the NNRTI class, particularly in North America, Europe, and select Asia-Pacific regions. Its competitive edge lies in once-daily dosing and a favorable side effect profile compared to older NNRTIs.

Competitive Landscape

Rilpivirine faces competition from other ART agents, notably:

• Integrase strand transfer inhibitors (INSTIs): Dolutegravir (Tivicay, Tivicay PD), bictegravir-based regimens, which now dominate first-line therapy due to superior resistance profiles.
• Other NNRTIs: Efavirenz (Sustiva), though less preferred because of neuropsychiatric side effects.
• Long-acting injectables: Cabotegravir and rilpivirine injectable combination gaining approval for maintenance therapy.

Despite stiff competition, rilpivirine maintains market relevance in specific niches, especially where patient compliance with daily oral regimens is optimal.

Pharmacoeconomic Factors

Cost dynamics favor rilpivirine in some regions due to patent protections and manufacturing efficiencies. However, the introduction of generics in emerging markets is expected to exert downward pressure on prices and revenues.

Regulatory Outlook

Janssen continues to pursue regulatory updates, including expanded indications and formulations. Approval for long-acting formulations could redefine the market landscape.

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Market Projection (2023-2030)

Growth Drivers

• Advances in Long-Acting Formulations: The development of injectable rilpivirine formulations, with projected approval around 2025, is expected to catalyze future market growth. These formulations address adherence challenges and appeal to specific patient populations.
• Expansion into New Populations: Trials in adolescents and pregnant women could extend the drug’s application, broadening its market base.
• Enhanced Resistance Profile: Ongoing research into resistance mutations may solidify rilpivirine’s role in salvage therapy, especially for patients intolerant to other drugs.

Market Constraints

• Competition from INSTIs: The escalating dominance of integrase inhibitors, especially drugs with improved resistance profiles like bictegravir, threaten rilpivirine's market share.
• Pricing Pressures: Patent expiries and the proliferation of generics, particularly in developing nations, could erode revenue streams.
• Safety Profile Concerns: Rare but notable adverse effects, such as depression and QT prolongation, may limit use in some subsets.

Forecasted Revenue Trajectory

Janssen projects a CAGR of approximately 3-5% for rilpivirine from 2023 through 2030, driven primarily by the adoption of long-acting formulations and growing global HIV treatment penetration.

Regional Outlook

• North America & Europe: Mature markets with stable demand, likely plateauing as newer agents dominate.
• Asia-Pacific & Africa: Emerging markets with expanding access to ART; generic competition and pricing strategies heavily influence sales trajectories.
• Latin America & Middle East: Moderate growth potential contingent on healthcare infrastructure improvements and regulatory approvals.

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Conclusion

Rilpivirine (EDURANT) remains a significant player within the HIV therapeutics landscape. Recent clinical trial data reinforce its efficacy, especially in long-term management, and ongoing studies into injectable formulations promise to reinforce its market position. While facing formidable competition from newer classes like INSTIs and long-acting injectables, rilpivirine’s favorable safety profile and potential expanded indications underpin a cautiously optimistic market outlook.

The strategic focus should be on harnessing advancements in long-acting formulations, addressing resistance issues, and expanding access in emerging markets to sustain growth through 2030.

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Key Takeaways

• Clinical Trials: Ongoing long-term and combination regimen studies reaffirm rilpivirine’s efficacy, safety, and potential for use in diverse populations.
• Market Dynamics: The advent of injectable formulations and expanding indications are poised to drive future sales, but commoditization and competition pose risks.
• Growth Opportunities: Focus on long-acting depots, resistance management, and emerging markets offers avenues for revenue expansion.
• Challenges: Competition from INSTIs, patent expiries, and pricing pressures are key constraints.
• Future Outlook: Moderate growth expected, supported by innovation and expanding access, with a projected CAGR of 3-5% through 2030.

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FAQs

1. What is the primary advantage of rilpivirine over other antiretroviral agents?
Rilpivirine offers a once-daily oral regimen with a favorable side-effect profile, including fewer neuropsychiatric and metabolic adverse effects compared to older NNRTIs like efavirenz.

2. Are there ongoing developments for long-acting rilpivirine formulations?
Yes. Multiple clinical trials are evaluating injectable rilpivirine, with results suggesting promising efficacy and tolerability, aiming for approval in the mid-2020s.

3. How does resistance impact rilpivirine’s clinical use?
Rilpivirine retains activity against some NNRTI-resistant strains but is less effective against high-level resistant viruses. Resistance testing guides its use in initial therapy or salvage settings.

4. What regions are expected to see the most growth for rilpivirine?
Emerging markets in Asia-Pacific, Africa, and Latin America hold significant growth potential due to expanding access to ART and efforts to improve healthcare infrastructure.

5. How does rilpivirine compare cost-wise with newer therapies?
While currently competitive, the introduction of generics and price negotiations could reduce costs, potentially affecting its market share relative to newer, often more expensive agents like bictegravir.

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Sources
[1] U.S. Food and Drug Administration. EDURANT (rilpivirine) prescribing information. 2011.
[2] Johnson & Johnson. Rilpivirine Clinical Trial Data. 2022.
[3] GlobalData. HIV drugs market analysis. 2022.
[4] ClinicalTrials.gov. Ongoing studies involving rilpivirine. Accessed 2023.