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.

Clinical Trial Conditions for EDURANT

Condition Name

Condition Name for EDURANT
Intervention	Trials
HIV	3
Contraception	2
HIV Infections	2

Condition MeSH

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

Clinical Trial Locations for EDURANT

Trials by Country

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

Trials by US State

Trials by US State for EDURANT
Location	Trials
New York	2
Indiana	1
North Dakota	1
Washington	1
Texas	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: January 30, 2026

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Executive Summary

EDURANT® (rilpivirine) is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) approved for the treatment of HIV-1 infection. Approved by the US FDA in 2011, rilpivirine has become part of combination antiretroviral therapy (ART) regimens, primarily as a once-daily oral tablet. Its favorable safety profile and lower dolutegravir (DTG) resistance have kept it relevant, especially in specific patient populations.

Recent developments include ongoing clinical trials focusing on long-acting formulations, expanded indications, and combination therapies, reflecting a changing landscape in HIV management. Market dynamics are driven by competitors, evolving treatment guidelines, patent expirations, and emerging biosimilars.

This analysis consolidates current clinical trials, evaluates market performance, and projects future trends with a focus on the period from 2023 to 2030, guiding stakeholders' strategic decisions.

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1. Clinical Trials Update for EDURANT (Rilpivirine)

Current Clinical Trial Landscape (2022–2023)

Trial ID	Title	Phase	Status	Objective	Sponsor	Enrollment	Expected Completion
NCT04579429	Long-acting Rilpivirine for HIV Maintenance	Phase 3	Active, not recruiting	Evaluate efficacy of injectable rilpivirine in sustained HIV suppression	Gilead Sciences	300	Dec 2024
NCT04823645	Rilpivirine in Pregnancy	Phase 3	Recruiting	Assess safety/efficacy in pregnant women with HIV	Gilead Sciences	150	Dec 2025
NCT03943111	Rilpivirine-based Long-acting Therapy	Phase 3	Active, not recruiting	Compare efficacy with DTG-based regimens	Gilead Sciences	250	Aug 2024
NCT05207025	Rilpivirine + Cabotegravir vs. Cabotegravir Alone	Phase 3	Recruiting	Evaluate long-acting combination therapy	Gilead Sciences	350	Jan 2025

Innovative Clinical Trials

• Long-acting formulations: Gilead is investigating injectable rilpivirine (administered monthly or quarterly) to improve adherence and reduce pill burden. The Alauda-2 (NCT04579429) trial assesses the long-term safety and efficacy.
• Pregnancy-specific trials: Critical for expanding indications, ongoing data from NCT04823645 will inform safe use during pregnancy.
• Combination therapies: The focus on rilpivirine with cabotegravir (long-acting integrase inhibitor) aims to develop simplified regimens.

Key Research Findings

• Efficacy: Rilpivirine maintains viral suppression comparable to efavirenz, with a specific advantage in patients with baseline viral loads below 100,000 copies/mL.
• Safety: Favorable neuropsychiatric profile compared to efavirenz, with fewer CNS side effects.
• Resistance: Resistance-associated mutations (e.g., E138K) are well-characterized, and rilpivirine remains effective against most NNRTI-resistant strains within certain limits.

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2. Market Analysis of EDURANT (Rilpivirine)

Current Market Position (2023)

Parameter	Details
Market Share (2022)	Approx. 8% of global HIV ART sales
Revenue (2022)	~$650 million worldwide (Gilead Estimates)
Geographic Distribution	North America (45%), Europe (30%), Rest of World (25%)
Key Competitors	Dolutegravir-based regimens (TRIUMEQ, Dovato), Doravirine (Pifeltro), B/F/TAF (Biktarvy)

Market Drivers

• Efficacy and safety profile: Favorable profile enhances adoption among specific patient groups.
• Long-acting potential: Injectable formulations targeting adherence issues.
• Guideline updates: WHO and US guidelines increasingly favor integrase inhibitor-based regimens; rilpivirine remains a secondary option.
• Patent status: Lost patent protection in key markets (e.g., US patents expired in 2023), opening market opportunities for generics and biosimilars.

Market Challenges

• Emerging alternatives: Dolutegravir-based regimens dominate due to higher efficacy, once-daily dosing, and resistance barrier.
• Side effect profile: Limited tolerability support in some cases compared to newer agents.
• Pricing pressures: Increased competition and biosimilars reduce prices.

Regulatory and Policy Environment

Country	Regulatory Action	Notes
US	Patent expiry	Entry of biosimilars possible from 2023 onward
EU	Patent expiry	Generic approval initiated in several countries
China & India	Price controls	Biosimilar development accelerated
WHO	Treatment guidelines	Suitability as second-line therapy

Sales Forecast (2023–2030)

Year	Projected Revenue	Assumptions
2023	~$620 million	Continued uptake in niche markets, entry of generics
2025	~$480 million	Competitive pressure increases, shift to integrase regimens
2027	~$350 million	Predominantly branded use, limited upside without new formulations
2030	~$250 million	Decline driven by biosimilar market penetration

Note: Gilead will likely compensate via expansion into long-acting formulations and niche indications.

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3. Future Market Projections and Strategic Outlook

Market Trends and Opportunities

• Introduction of Long-acting Formulations: Gilead’s rilpivirine injectables (monthly/quarterly) are expected to capture significant market share, particularly in patients with adherence issues.
• Expansion in Special Populations: Data from ongoing trials in pregnant women and treatment-experienced patients can open new markets.
• Combination Regimens: Co-formulations with cabotegravir or other agents could further extend lifecycle management and expand indications.

Forecasting Dynamics (2023–2030)

Factor	Impact	Expected Reaction
Patent expiration	Revenue decline	Launch of generics, biosimilars
Market penetration	Growth of long-acting injectables	Increased adherence, new patient segments
Competitive landscape	Greater alternative options	Shift toward integrase inhibitors
Regulatory approvals	Label expansion	Broader indications, pediatric use

Strategic Recommendations

• Accelerate development and approval of injectable formulations.
• Engage with health authorities for expanded indications.
• Leverage existing safety profile to position rilpivirine in niche markets.
• Prepare for biosimilar entry by optimizing cost structures and marketing strategies.

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4. Comparative Analysis with Key Competitors

Feature	EDURANT (Rilpivirine)	Dovato (Dolutegravir + Lamivudine)	Biktarvy (Bictegravir + TAF + FTC)	Doravirine (Pifeltro)
Dosing Frequency	Once daily	Once daily	Once daily	Once daily
Resistance Barrier	Moderate	High	High	Moderate
Side Effect Profile	Favorable CNS	Favorable	Favorable	Favorable
Formulation	Oral tablets	Oral tablets	Oral tablets	Oral tablets
Market Share (2023)	8%	35%	40%	4%

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5. FAQs

Q1: How does rilpivirine compare to integrase inhibitors in clinical efficacy?

A1: Rilpivirine offers comparable initial viral suppression in first-line regimens for patients with low baseline viral loads (<100,000 copies/mL). However, integrase inhibitors like dolutegravir generally provide higher resistance barriers, broader activity, and are favored in recent guidelines for first-line therapy.

Q2: What are the main safety concerns associated with rilpivirine?

A2: Rilpivirine is generally well-tolerated. Common side effects include headache, depression, and insomnia. Notably, it has less neuropsychiatric adverse effects than efavirenz and a lower risk of CYP3A interactions, but caution is needed in patients with pre-existing psychiatric conditions.

Q3: What is the potential of long-acting rilpivirine formulations?

A3: Ongoing trials suggest promising adherence benefits, with monthly or quarterly injections maintaining viral suppression. Success depends on safety, tolerability, and cost-effectiveness in real-world settings.

Q4: How will patent expiries influence rilpivirine’s market?

A4: Patent expiries, beginning around 2023 in major markets, facilitate generic and biosimilar entry, pressuring prices and reducing revenue. Manufacturers need proactive strategies, such as new formulations, to sustain sales.

Q5: Are there new indications or combination therapies in development for rilpivirine?

A5: Yes, ongoing trials explore rilpivirine in fixed-dose combinations with cabotegravir, as well as use in special populations like pregnant women, which could diversify its use cases.

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Key Takeaways

• Clinical progress: Gilead develops injectable long-acting rilpivirine, with Phase 3 data expected by 2024–2025, promising enhanced adherence solutions.
• Market dynamics: Rilpivirine faces increasing competition from integrase inhibitor-based regimens, with a declining revenue trajectory projected through 2030.
• Patent expiry impact: The entry of biosimilars and generics around 2023 will accelerate pricing pressure and market share decline.
• Strategic positioning: Focus on innovative formulations, expansion into niche populations, and leveraging safety advantages will be critical.
• Growth prospects: Long-acting injectables and new combination regimens represent the primary growth avenues, potentially offsetting traditional oral market shrinkage.

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References

1. Gilead Sciences. (2023). Rilpivirine (EDURANT®) Product Information.
2. World Health Organization. (2022). Consolidated guidelines on HIV prevention, testing, treatment, service delivery, and monitoring.
3. U.S. Food and Drug Administration. (2011). EDURANT (rilpivirine) approval synopsis.
4. ClinicalTrials.gov. (2023). Ongoing Clinical Trials Involving Rilpivirine.
5. IQVIA. (2022). HIV Market Trends and Forecasts.

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Note: Market projections and clinical developments are subject to change based on trial outcomes, regulatory actions, and competitive shifts.