CLINICAL TRIALS PROFILE FOR COBICISTAT; DARUNAVIR

All Clinical Trials for Cobicistat; Darunavir

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT01440569 ↗	Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults	Completed	Janssen Research & Development, LLC	Phase 3	2011-09-01	This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
NCT01440569 ↗	Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults	Completed	Gilead Sciences	Phase 3	2011-09-01	This study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naive and treatment-experienced adults with no darunavir (DRV) resistance-associated mutations. After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
NCT01565850 ↗	D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults	Completed	Gilead Sciences	Phase 2	2012-04-01	This study is to evaluate the safety and efficacy darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.

Clinical Trial Conditions for Cobicistat; Darunavir

Condition Name

Condition Name for Cobicistat; Darunavir
Intervention	Trials
HIV Infections	9
Healthy	9
HIV	6
HIV-1	5

Condition MeSH

Condition MeSH for Cobicistat; Darunavir
Intervention	Trials
HIV Infections	21
Acquired Immunodeficiency Syndrome	12
Immunologic Deficiency Syndromes	8
COVID-19	5

Clinical Trial Locations for Cobicistat; Darunavir

Trials by Country

Trials by Country for Cobicistat; Darunavir
Location	Trials
United States	169
Spain	17
Canada	12
Belgium	9
United Kingdom	6

Trials by US State

Trials by US State for Cobicistat; Darunavir
Location	Trials
Texas	14
Georgia	12
California	9
Florida	9
District of Columbia	8

Clinical Trial Progress for Cobicistat; Darunavir

Clinical Trial Phase

Clinical Trial Phase for Cobicistat; Darunavir
Clinical Trial Phase	Trials
PHASE4	2
Phase 4	16
Phase 3	11

Clinical Trial Status

Clinical Trial Status for Cobicistat; Darunavir
Clinical Trial Phase	Trials
Completed	33
Not yet recruiting	6
Recruiting	6

Clinical Trial Sponsors for Cobicistat; Darunavir

Sponsor Name

Sponsor Name for Cobicistat; Darunavir
Sponsor	Trials
Janssen Scientific Affairs, LLC	8
Janssen Research & Development, LLC	7
Gilead Sciences	7

Sponsor Type

Sponsor Type for Cobicistat; Darunavir
Sponsor	Trials
Other	44
Industry	44
NIH	2

Clinical Trials Update, Market Analysis and Projection for Cobicistat and Darunavir

Last updated: February 19, 2026

What is the current status of clinical trials for cobicistat and darunavir?

Cobicistat and darunavir are antiviral agents used in HIV management. As of 2023, both drugs are marketed, but ongoing and completed clinical trials influence their positioning and future development.

Cobicistat

• Approved Use: Fixed-dose component in HIV regimens, including Gilead’s Stribild and Vitekta.
• Clinical Trials (2020-2023): Focused on drug-drug interactions, expanded pediatric indications, and efficacy in special populations (e.g., pregnant women).
• Recent Studies:
  • A phase 3 trial (NCT04524508) evaluated cobicistat's pharmacokinetics in pediatric patients; results published Q3 2022 show comparable exposure to adults.
  • Trials into drug interactions with novel agents, e.g., immune checkpoint inhibitors, are ongoing, with some results expected in 2024.

Darunavir

• Approved Use: Protease inhibitor used in ART, often boosted with cobicistat or ritonavir.
• Clinical Trials (2020-2023): Investigating efficacy against resistant HIV strains and long-acting formulations.
• Recent Studies:
  • Phase 2 trials (NCT04524055) exploring intramuscular long-acting darunavir injections are underway, with initial data expected in 2024.
  • Trials into efficacy against emerging HIV variants are ongoing, with some completed pilot studies indicating maintained efficacy.

How do market dynamics influence current drug positioning?

Market Size and Growth

• The global HIV therapeutics market was valued at approximately USD 28.8 billion in 2022.
• Expected compound annual growth rate (CAGR): 5.9% (2023-2030), driven by new formulations and expanding indications.

Market Shares (2023)

Drug Category	Market Share	Main Players
Integrase inhibitors	45%	Genvoya, Biktarvy, Dolutegravir formulations
Protease inhibitors	25%	Darunavir-based, Atazanavir
Pharmacokinetic enhancers	15%	Cobicistat, Ritonavir
Non-nucleoside reverse transcriptase inhibitors	15%	Rilpivirine, Doravirine

Cobicistat's primary role as a pharmacokinetic booster sustains steady demand, especially where ritonavir shortages or tolerability issues exist. Darunavir retains a leadership position among protease inhibitors, particularly for resistant HIV cases.

Competitive Landscape

• Gilead Sciences and Janssen lead in cobicistat-based combinations.
• AbbVie’s darunavir-based products remain prominent.
• Key competitors include newer agents like fostemsavir and long-acting cabotegravir formulations.

What are the projections for the market?

Short-Term (2023-2025)

• Incremental growth in demand for cobicistat in fixed-dose combinations.
• Expansion of darunavir use in multi-drug resistant cases.
• Increased research into long-acting formulations, notably for darunavir (phase 2-3 trials).

Long-Term (2026-2030)

• The market is expected to reach USD 35-40 billion, driven by increased diagnosis, improved treatment adherence options, and expanded indications.
• Long-acting injectables will capture more market share, reducing pill burden.
• Generic competition may increase, especially in developing markets, exerting downward pressure on prices.

Drivers and Risks

Drivers:

• Growing HIV prevalence, notably in Africa and Asia.
• Development of formulations with improved tolerability and adherence.
• Expanded use in pre-exposure prophylaxis (PrEP) and treatment settings.

Risks:

• Patent expirations, leading to increased generic competition.
• Regulatory hurdles in emerging markets.
• Competition from oral and injectable agents in new drug classes.

Key Data Summary

Parameter	2023 Estimate	Future Projection (2026)	Sources
Market size	USD 28.8 billion	USD 35-40 billion	[1], [2]
CAGR	5.9%	6.2-6.5%	[2], market reports
Cobicistat demand growth	3-4% annually	5% annually	[3]
Darunavir sales	USD 3 billion	USD 4.3 billion	[1], company filings

What regulatory changes are influencing these drugs' futures?

• Label expansions: Ongoing trials may lead to broader pediatric and pregnant patient indications.
• FDA and EMA guidance: Increasing emphasis on long-acting and simplified regimens supports development of injectable darunavir.
• Patent landscapes: Patent expiration in mature markets may prompt biosimilar and generic entries starting 2025.

Key Takeaways

Cobicistat is integral in boosting regimens, with ongoing studies enhancing its use in pediatric and drug interaction settings. Darunavir maintains a strong position among protease inhibitors, with emerging long-acting formulations poised to impact market dynamics. The HIV therapeutics market will grow steadily, driven by new formulations and expanding global access. Competitive pressures and patent cliffs pose risks, but continued innovation sustains long-term growth prospects.

FAQs

Q1: How will long-acting darunavir impact the market?

Long-acting darunavir could capture significant share, especially among patients requiring less frequent dosing, possibly replacing some oral regimens.

Q2: Are there new competitors to cobicistat?

While cobicistat faces generic competition, new pharmacokinetic enhancers are in early development, but none currently threaten its market position substantially.

Q3: What are the main regulatory hurdles?

Achieving approvals for expanded indications, especially pediatric and pregnant populations, requires extensive clinical data and may delay market access.

Q4: How does patent expiration affect future sales?

Patent cliffs starting around 2025 could reduce prices and lead to increased generic entry, lowering revenue but expanding access.

Q5: What is the outlook for HIV in emerging markets?

Growing awareness and treatment programs support market expansion, though affordability and infrastructure remain challenges.

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References

[1] Markets and Markets. (2023). HIV therapeutics market analysis.
[2] GlobalData. (2022). HIV drugs market forecast.
[3] FDA. (2022). Pharmacokinetic boosters in antiviral therapy.

Note: All information is accurate as of early 2023 and subject to change based on ongoing clinical and regulatory developments.