CLINICAL TRIALS PROFILE FOR RILPIVIRINE HYDROCHLORIDE

All Clinical Trials for rilpivirine hydrochloride

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
NCT00799864 ↗	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	Recruiting	Janssen Sciences Ireland UC	Phase 2	2011-01-07	The purpose of this study is to evaluate the pharmacokinetics, safety and antiviral activity of rilpivirine (TMC278) 25 milligram (mg) or adjusted dose once daily in combination with an investigator-selected background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) (zidovudine [AZT], abacavir [ABC], or tenofovir disoproxil fumarate [TDF] in combination with lamivudine [3TC] or emtricitabine [FTC] in antiretroviral (ARV) treatment-naïve adolescents and children aged greater than or equal to (>=) 6 to less than (
NCT00855335 ↗	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	Janssen Scientific Affairs, LLC	Phase 3	2009-04-09	The purpose of this study is to study how changes in the body during pregnancy influence the blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study will examine how these drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time. Any pregnant woman who is currently receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll. Patients must be willing to remain on study medication during the course of their pregnancy, and 12 weeks postpartum. The information collected may help answer questions about how to best prescribe these three drugs for pregnant women.
NCT00959894 ↗	Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection	Completed	Janssen Pharmaceuticals	Phase 2	2009-09-01	The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.
NCT00959894 ↗	Evaluating Once Daily Etravirine in Treatment-Naive Adults With HIV Infection	Completed	University of North Carolina, Chapel Hill	Phase 2	2009-09-01	The main study is a single arm, open-label, prospective study to assess antiretroviral activity and tolerability of etravirine (TMC-125) 400 mg once daily, given with fixed-dose tenofovir/emtricitabine, in treatment-naïve HIV-1-infected men and women. There are also a genital secretions pharmacokinetic (PK) sub-study and a metabolic sub-study. The purpose of the genital secretions PK sub-study is to gain information about drug levels and HIV-1 RNA in genital secretions when subjects are taking etravirine. The purpose of the metabolic sub-study is to learn about the effects of etravirine on body composition, as well as lipid and glucose levels.
NCT01049932 ↗	Pre-Exposure Prophylaxis Using TMC278LA	Terminated	St Stephens Aids Trust	Phase 1/Phase 2	2010-03-01	Pre-exposure prophylaxis (PrEP) is an experimental HIV-prevention strategy using antiretroviral (ARV) agents to protect HIV negative individuals from HIV infection.TMC278 is a new drug being developed for this type of HIV treatment. It is hoped that this drug may be used to help prevent HIV transmission in future. A 'long acting' formulation of TMC278 has been developed. Long acting means that the drug will be present in the blood for longer. It is this formulation of the drug that will be investigated in this study. Subjects will receive the drug by injection. The purpose of this study is to investigate the safety of the drug and how well it is tolerated by the body. The study will look at the levels of the study drug in the subjects blood over the duration of the study.

Clinical Trial Conditions for rilpivirine hydrochloride

Condition Name

Condition Name for rilpivirine hydrochloride
Intervention	Trials
HIV Infections	29
HIV	16
HIV-1-infection	15
HIV-1 Infection	10

Condition MeSH

Condition MeSH for rilpivirine hydrochloride
Intervention	Trials
HIV Infections	44
Acquired Immunodeficiency Syndrome	26
Immunologic Deficiency Syndromes	21
Infections	13

Clinical Trial Locations for rilpivirine hydrochloride

Trials by Country

Trials by Country for rilpivirine hydrochloride
Location	Trials
United States	418
Canada	60
Germany	40
Italy	32
Spain	28

Trials by US State

Trials by US State for rilpivirine hydrochloride
Location	Trials
California	29
Texas	26
Georgia	25
Florida	24
New York	23

Clinical Trial Progress for rilpivirine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for rilpivirine hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	3
PHASE2	4

Clinical Trial Status

Clinical Trial Status for rilpivirine hydrochloride
Clinical Trial Phase	Trials
Completed	44
RECRUITING	17
Active, not recruiting	13

Clinical Trial Sponsors for rilpivirine hydrochloride

Sponsor Name

Sponsor Name for rilpivirine hydrochloride
Sponsor	Trials
ViiV Healthcare	29
Gilead Sciences	12
GlaxoSmithKline	12

Sponsor Type

Sponsor Type for rilpivirine hydrochloride
Sponsor	Trials
Industry	95
Other	77
NIH	13

Rilpivirine Hydrochloride Clinical Trials Update and Market Outlook: Exclusivity, Generic/Biosimilar Risk, and Forecast Scenarios

Last updated: July 24, 2026

Rilpivirine hydrochloride is an established antiretroviral in HIV therapy, marketed as oral rilpivirine (commonly co-packaged with other agents or used in fixed-dose regimens). Public clinical-development activity is limited versus newer HIV drug classes, and the near-term commercial outlook is driven by (1) ongoing uptake in combination therapy, (2) regimen guideline persistence, and (3) patent and exclusivity timelines that govern generic competition in key markets.

What is rilpivirine hydrochloride and where is it used in HIV treatment?

Rilpivirine hydrochloride is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It is used in adult HIV-1 infection as part of combination antiretroviral therapy (cART).

What clinical positions does rilpivirine occupy in guidelines and practice?

Key practical attributes shaping market share include: once-daily oral dosing, NNRTI class tolerability profile, and historical use in switch and simplification strategies where viral suppression is stable. Rilpivirine is also associated with drug-drug interaction considerations driven by CYP and acid-reducing co-medications, which can constrain use.

Which formulations exist for rilpivirine hydrochloride?

The market is primarily oral solid dosage forms (including strengths and combinations as commercialized in major markets). Coverage and access vary by country through local brand and generic labeling.

What clinical trials for rilpivirine are ongoing or recently completed?

A complete, up-to-the-minute trials inventory requires an authoritative registry pull (ClinicalTrials.gov, EU CTR, ISRCTN) with status filters. Without registry-level inputs in this workspace, a definitive “ongoing vs. completed vs. terminated” table cannot be produced without risking factual errors.

When do rilpivirine patents and regulatory exclusivity expire?

Rilpivirine is an older compound, so the principal exclusivity in most jurisdictions is typically exhausted for the drug substance and basic oral compositions. Residual protection, where present, tends to come from:

• Specific fixed-dose combinations (FDCs) and co-formulations
• Method-of-use patents tied to patient subgroups or clinical regimens
• Formulation/process patents (e.g., stability, polymorph, manufacturing steps)

Without a jurisdiction-mapped Orange Book / patent-listing dataset and dossier references, it is not possible to state exact expiration or exclusivity end dates.

What patents protect rilpivirine hydrochloride and which are likely composition vs method-of-use?

Patent estates for established HIV products split across three buckets:

1. Composition claims (rilpivirine drug substance or oral dosage forms)
2. Formulation/process claims (manufacturing methods, polymorph/salt form improvements, dissolution and stability)
3. Method-of-use claims (treatment regimens, dosing strategies, combinations, and biomarker-defined use)

A precise enumeration of protecting patents, including publication numbers, assignees, claim scope, and remaining life, cannot be generated without patent database inputs.

What is the Orange Book status of rilpivirine-containing products?

Orange Book status is specific to each FDA-approved NDA and listed patent family (including use-code mapping and patent expiration). A generic entry assessment depends on the exact product-label NDA and the listed patent set.

In the absence of NDA-level identity and Orange Book listing extraction, producing a correct Orange Book table for “rilpivirine hydrochloride” would be unreliable.

What generic entry risks exist for rilpivirine hydrochloride?

Given rilpivirine’s age, the largest generic risk vectors are not “whether generics can exist,” but “what residual patents still block specific products,” especially:

• Fixed-dose combinations where co-formulation patents remain active
• Pediatric exclusivity that might delay certain label expansions in specific markets
• ETAs for specific dosage forms and strengths

A credible risk matrix requires active patent-to-product mapping.

How does rilpivirine market performance compare with other NNRTIs in HIV therapy?

Market share is influenced by regimen preference and switching dynamics versus competing NNRTIs and newer classes. The comparative commercial impact generally depends on:

• Guideline recommendations and evidence depth of each NNRTI
• Tolerability and interaction profile
• Formulary placement and payer economics
• Availability of fixed-dose combinations

A quantified comparison requires product-level revenue or prescription data that is not available in this workspace.

What formulation patents are protected for rilpivirine oral products?

Formulation patent coverage typically targets:

• Stability and shelf-life improvements
• Bioavailability enhancement via dissolution control
• Polymorph control and manufacturing constraints
• Excipient and tablet architecture changes

A formulation-patent landscape cannot be stated accurately without patent record retrieval by jurisdiction and by specific marketed NDC/dose form.

What clinical endpoint data matter most for rilpivirine and how do they affect commercial durability?

Commercial durability for an NNRTI is supported by long-term virologic suppression endpoints and low discontinuation rates. In practice, clinicians weigh:

• Proportion achieving and maintaining HIV-1 RNA suppression
• Resistance emergence rates on failure
• Tolerability and adherence under once-daily regimens
• Switch outcomes from other suppressive regimens

A trials-results update (with numeric endpoints by study) cannot be compiled safely without trial identifiers and result tables from registries or publications.

Which companies manufacture rilpivirine hydrochloride and how does the competitive landscape look?

Competition includes:

• Originator and branded supply channels (varies by country)
• Generic manufacturers for oral NNRTI products and FDCs
• Potential entrants for combination products tied to remaining patents

A current manufacturer roster needs current market authorizations or sales share inputs not present here.

What patent litigation affects rilpivirine products and settlements?

Patent litigation and Paragraph IV challenges are product- and patent-listing-specific. Settlement terms can materially affect launch timing and market share. A litigation update requires:

• Case dockets (e.g., FDA Orange Book triggers and Hatch-Waxman filings)
• Court case numbers, litigants, and settlement dates

No docket-level inputs are available here, so a “litigation status” section cannot be produced without factual risk.

How do FDA approvals and label restrictions impact rilpivirine uptake?

Rilpivirine use is sensitive to acid-reducing agents and certain drug-drug interactions due to formulation-dependent absorption characteristics. This can reduce eligible patient populations and shift prescriber behavior toward regimens with fewer interaction constraints.

A regulator-driven uptake analysis requires label text review and real-world utilization or prescribing telemetry not available in this workspace.

Market projection for rilpivirine hydrochloride: base case, bull case, bear case

A quantified market forecast requires a baseline (revenue or units), geography split, and scenario drivers. Without market sizing inputs, producing numerical projections would be speculative.

Below is a driver-based projection framework that can be converted into numbers once product revenue baselines and forecast horizons are supplied internally:

Base case drivers (slow erosion)

• Continued guideline inclusion for appropriate patient subsets
• Ongoing generics availability where patents and exclusivity have lapsed
• Moderate share pressure from integrase inhibitor-dominant regimens

Bear case drivers (faster erosion)

• Payer/formulary substitution toward newer regimens with better resistance/interaction profiles
• Label-constrained patient pools due to interaction limitations
• Intensified generic price competition in key markets

Bull case drivers (resilience)

• Increased use in simplified once-daily options or specific switch populations
• Stable pricing via managed formularies
• Residual patent protection delaying direct competition for select combinations

Key data tables (to populate with registry and patent extraction)

No authoritative dataset is present in this workspace to fill these tables without risk of inaccuracy.

Asset type	Table fields needed	Status in this response
Clinical trials	NCT/EudraCT ID, phase, design, arms, enrollment, primary endpoints, topline results, status	Not generated
Patent estate	Patent numbers, assignees, jurisdictions, claim type, filing/grant dates, expiration, Orange Book use codes	Not generated
FDA regulatory	NDA/BLA identifiers, listed patents, exclusivity codes, approval dates, labeling restrictions	Not generated
Litigation	Court, case number, parties, asserted patents, filing dates, settlement terms, launch date impacts	Not generated
Market sizing	Revenue/units by geography, channel, time series, forecast method	Not generated

Key Takeaways

• Rilpivirine hydrochloride is an established NNRTI in HIV therapy, but its development pipeline visibility is typically lower than for newer antiretroviral classes.
• Commercial trajectory is dominated by patent-by-product residual protection, regimen preference shifts toward integrase inhibitor-based therapy, and price competition from generics.
• A defensible “clinical trials update” and “market projection” for rilpivirine requires registry-level trial status extraction and NDA/patent-listing mapping; those sources are not available in this workspace to produce validated tables or numeric forecasts.

FAQs

1. Which HIV guidelines still recommend rilpivirine-containing regimens for treatment-naïve and switch patients?
2. Does rilpivirine use depend on avoiding PPIs or H2 blockers, and how does that affect prescribing?
3. What are the typical barriers for generic rilpivirine fixed-dose combinations in the US and EU?
4. How does NNRTI resistance impact long-term cost of care compared with integrase inhibitor regimens?
5. What signals indicate whether remaining formulation patents could delay generic launches?

References

No cited sources are available because no registry, Orange Book, patent database, or market sizing datasets were provided or retrievable within this workspace.