CLINICAL TRIALS PROFILE FOR PREZCOBIX

All Clinical Trials for PREZCOBIX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02499978 ↗	Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity	Withdrawn	Janssen Scientific Affairs, LLC	Phase 2/Phase 3	2016-05-01	This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.
NCT02499978 ↗	Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity	Withdrawn	University of Colorado, Denver	Phase 2/Phase 3	2016-05-01	This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.
NCT02499978 ↗	Darunavir/Cobicistat and Dolutegravir to Maintain Virologic Suppression and Reduce NRTI-associated Toxicity	Withdrawn	Stanford University	Phase 2/Phase 3	2016-05-01	This is a clinical research study to see if switching to Darunavir/Cobicistat ((PREZCOBIX™, DRV/COBI ) and Dolutegrivir (Tivicay®, DTG) in HIV-infected individuals with undetectable HIV viral load on nucleos(t)ide reverse transcriptase inhibitor (NRTI)-containing therapy will be effective in maintaining virologic suppression at 48 weeks of treatment.
NCT02603107 ↗	Study to Evaluate the Safety and Efficacy of Switching From Regimens Consisting of Boosted Atazanavir or Darunavir Plus Either Emtricitabine/Tenofovir or Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppres	Completed	Gilead Sciences	Phase 3	2015-11-20	The primary objective of this study is to evaluate the efficacy of switching to a fixed-dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing on a regimen consisting of boosted atazanavir (ATV) or darunavir (DRV) plus either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) in HIV-1 infected adults who are virologically suppressed.
NCT02625207 ↗	THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC	Completed	Pfizer	Phase 1	2015-11-06	This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).
NCT02625207 ↗	THE EFFECT OF CYP3A5 GENOTYPE ON THE PHARMACOKINETICS OF MARAVIROC	Completed	ViiV Healthcare	Phase 1	2015-11-06	This will be an open-label, parallel group, multiple dose study in approximately 48 healthy male or female subjects of African American and Caucasian self-reported race, to assess the effect of CYP3A5 genotype on the PK of MVC and CYP3A5-derived metabolites. Maraviroc and CYP3A5-derived metabolite PK will also be compared between African-Americans and Caucasians in subjects carrying two copies of the dysfunctional CYP3A5 alleles (*3, *6, and/or *7).

Clinical Trial Conditions for PREZCOBIX

Condition Name

Condition Name for PREZCOBIX
Intervention	Trials
Healthy	1
Healthy Subjects	1
HIV-1 Infection	1
HIV/AIDS	1

Condition MeSH

Condition MeSH for PREZCOBIX
Intervention	Trials
HIV Infections	1
Acquired Immunodeficiency Syndrome	1

Clinical Trial Locations for PREZCOBIX

Trials by Country

Trials by Country for PREZCOBIX
Location	Trials
United States	26
Australia	3
Canada	3
Italy	2
Germany	2

Trials by US State

Trials by US State for PREZCOBIX
Location	Trials
Colorado	2
California	2
Massachusetts	1
Louisiana	1
Kentucky	1

Clinical Trial Progress for PREZCOBIX

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for PREZCOBIX
Clinical Trial Phase	Trials
Completed	3
Withdrawn	1

Clinical Trial Sponsors for PREZCOBIX

Sponsor Name

Sponsor Name for PREZCOBIX
Sponsor	Trials
Janssen Scientific Affairs, LLC	1
University of Colorado, Denver	1
Stanford University	1

Sponsor Type

Sponsor Type for PREZCOBIX
Sponsor	Trials
Industry	5
Other	2

Clinical Trials Update, Market Analysis, and Projection for PREZCOBIX (Darunavir)

Last updated: October 28, 2025

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Introduction

PREZCOBIX (darunavir), developed by Johnson & Johnson, is an antiretroviral therapy (ART) used primarily for the treatment of HIV-1 infection. Approved in 2010, PREZCOBIX is a protease inhibitor, often part of combination therapy recommended by global health authorities such as the CDC and WHO. This analysis provides an update on ongoing clinical trials, a comprehensive market landscape, and the projected trajectory of PREZCOBIX within the competitive HIV treatment sector.

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Clinical Trials Update

Ongoing and Recent Trials

Despite its initial approval in 2010, PREZCOBIX continues to be evaluated through various clinical investigations aimed at expanding its efficacy profile, optimizing dosing regimens, and assessing long-term safety.

• Combination Regimen Trials: Recent Phase IV studies focus on combining PREZCOBIX with newer agents such as tenofovir alafenamide (TAF) and emtricitabine, assessing their efficacy and tolerability in treatment-naïve and treatment-experienced patients. These studies aim to optimize dosing schedules, reduce side effects, and improve adherence.

• Long-term Safety and Resistance: Several observational studies evaluate resistance development and side-effect profile over extended periods. For instance, a trial registered under NCT04556544 evaluates the virologic suppression sustainability over five years.

• Pediatric and Special Populations: Clinical trials targeting pediatric populations are ongoing. These include NCT03252231, assessing safety and pharmacokinetics among adolescents aged 12-17.

• Innovative Delivery Methods: While not the focus of current trials, efforts are underway to explore long-acting formulations of protease inhibitors. Although PREZCOBIX itself is not yet formulated as a long-acting injectable, its molecular structure makes it a candidate for future development.

Regulatory and Intellectual Property

The patent landscape suggests impending expirations in key markets, notably the U.S. and Europe, by 2030[1]. Johnson & Johnson has actively protected its formulations via secondary patents extending exclusivity, which influences ongoing clinical development and market strategies.

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Market Overview

Global HIV Treatment Market Context

The HIV therapeutics market was valued at approximately USD 26 billion in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.2% through 2027[2].

• Market Share of PREZCOBIX: As of 2022, PREZCOBIX holds an estimated 7-9% share of the HIV protease inhibitor segment, competing directly with drugs like darunavir, atazanavir, and fosamprenavir. Its positioning is heavily influenced by efficacy, side-effect profile, dosing convenience, and formulary inclusion.

• Prescribing Trends: The shift toward integrase strand transfer inhibitors (INSTIs) such as dolutegravir is impacting the protease inhibitor segment's growth. However, PREZCOBIX remains relevant for patients with resistance to other classes or those intolerant to INSTIs.

• Geographic Distribution: The drug’s primary markets include the U.S., Europe, and parts of Asia-Pacific. The U.S. accounts for nearly 50% of prescriptions due to advanced healthcare infrastructure and higher HIV prevalence rates.

• Pricing and Reimbursement: Prices range from USD 2,300 to USD 2,800 per month per treatment regimen in developed markets. Reimbursement policies and insurance coverage significantly influence patient access.

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Market Dynamics and Competitive Landscape

• Emerging Alternatives: The advent of fixed-dose combination pills, such as Genvoya and Biktarvy, offers simpler regimens with fewer side effects, eroding protease inhibitor market share. Nonetheless, PREZCOBIX retains a niche due to its efficacy in resistant cases.

• Patent Expiry Impact: Anticipated patent expirations in 2030 could open opportunities for generic manufacturers, potentially reducing prices and expanding accessibility in low- and middle-income economies[1].

• Regulatory Strategies: Johnson & Johnson is exploring new formulations and indications to extend market exclusivity, including potential pediatric approvals and long-acting injectable versions.

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Market Projection and Future Outlook

Growth Drivers

• Patient Population Expansion: Despite improvements, increasing diagnosis rates and lifelong treatment needs sustain demand.

• Resistance Management: As resistance to other ART classes grows, protease inhibitors like PREZCOBIX will remain vital for salvage therapy.

• Innovation in Delivery: Long-acting formulations, currently in development for other protease inhibitors, could eventually include PREZCOBIX, boosting its market potential.

Challenges

• Competitive Pressure: Dominance of INSTI-based regimens, particularly Genvoya and Biktarvy, may limit growth unless PREZCOBIX develops unique advantages.

• Pricing Pressures: Cost containment efforts and price negotiations in public health markets threaten profitability.

• Regulatory Barriers: Any delays in approval for new formulations or indications could hinder expansion efforts.

Projection (2023-2030)

The global market share of PREZCOBIX is expected to decline marginally from 7-9% to roughly 4-6% by 2030, primarily owing to patent expiries and competitive dynamics[2].

However, in niche areas—such as resistant HIV cases and pediatric populations—it may sustain steady demand. Strategic investments in trialing new delivery methods and combination regimens could prolong its lifecycle.

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Key Takeaways

• Clinical development of PREZCOBIX continues, emphasizing combination therapies, resistance management, and formulations suited for special populations.

• Market share faces pressure from emerging INSTI-based therapies, yet the drug remains relevant for resistant cases and specific demographics.

• Patent expiries by 2030 pose risks but also open opportunities for generics and biosimilars, particularly in emerging markets.

• Innovation in delivery systems, including long-acting injectables, could revitalize PREZCOBIX’s market position.

• Strategic positioning in treatment-resistant HIV and pediatric indications will determine long-term viability.

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FAQs

1. What are the recent developments in clinical trials involving PREZCOBIX?
Recent trials focus on combining PREZCOBIX with newer agents like TAF, assessing long-term safety, and expanding its use in pediatric populations. Trials also aim to evaluate resistance patterns and optimize dosing regimens.

2. How does PREZCOBIX compare with other protease inhibitors in the market?
PREZCOBIX offers high efficacy, especially in resistant cases, with a favorable side-effect profile. However, newer INSTI-based regimens often dominate due to simpler dosing and fewer drug interactions, leading to a shift in prescribing patterns.

3. What is the impact of patent expiration on PREZCOBIX’s market?
Patent expiries, expected around 2030, will likely lead to increased generic competition, reducing prices and expanding access in lower-income countries, though it may also decrease Johnson & Johnson’s revenue from the drug.

4. Are there any upcoming regulatory approvals or formulations that could impact PREZCOBIX?
While current development efforts are concentrated on combination therapies and pediatric approvals, long-acting formulations are in preclinical or early clinical stages and could influence its future market position.

5. What strategies can Johnson & Johnson adopt to sustain PREZCOBIX’s relevance?
Developing innovative formulations, expanding indications, and targeting treatment-resistant populations will be crucial. Continued investment in clinical research and exploring long-acting injectable versions can prolong the drug’s lifecycle.

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References

[1] Johnson & Johnson Patent Portfolio and Market Exclusivity Data, 2022.
[2] Grand View Research, “HIV Therapeutics Market Size, Share & Trends Analysis,” 2022.