CLINICAL TRIALS PROFILE FOR COBICISTAT

All Clinical Trials for COBICISTAT

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.
NCT00869557 ↗	Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2009-04-01	The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs. Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).
NCT00892437 ↗	Safety and Efficacy of Cobicistat-boosted Atazanavir Compared to Ritonavir-boosted Atazanavir in Combination With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 2	2009-05-01	The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 2:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded, at which point all participants will return for an unblinding visit and be given the option to participate in an open-label rollover extension and receive ATV+COBI+FTC/TDF until COBI tablets become commercially available, or until Gilead Sciences elects to terminate the study.
NCT01095796 ↗	Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2010-03-01	To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI [GS-9350])/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla®) in HIV-1 infected, antiretroviral treatment-naive adults. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor-based STRs.

Clinical Trial Conditions for COBICISTAT

Condition Name

Condition Name for COBICISTAT
Intervention	Trials
HIV Infections	30
HIV	27
HIV-1 Infection	12
Acquired Immunodeficiency Syndrome	11

Condition MeSH

Condition MeSH for COBICISTAT
Intervention	Trials
HIV Infections	51
Acquired Immunodeficiency Syndrome	30
Immunologic Deficiency Syndromes	21
Infections	14

Clinical Trial Locations for COBICISTAT

Trials by Country

Trials by Country for COBICISTAT
Location	Trials
United States	563
Canada	42
Spain	34
United Kingdom	26
France	21

Trials by US State

Trials by US State for COBICISTAT
Location	Trials
Texas	39
Florida	37
California	36
Georgia	33
District of Columbia	28

Clinical Trial Progress for COBICISTAT

Clinical Trial Phase

Clinical Trial Phase for COBICISTAT
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	1
PHASE1	2

Clinical Trial Status

Clinical Trial Status for COBICISTAT
Clinical Trial Phase	Trials
Completed	82
Recruiting	16
Not yet recruiting	15

Clinical Trial Sponsors for COBICISTAT

Sponsor Name

Sponsor Name for COBICISTAT
Sponsor	Trials
Gilead Sciences	47
Janssen Scientific Affairs, LLC	8
Janssen Research & Development, LLC	7

Sponsor Type

Sponsor Type for COBICISTAT
Sponsor	Trials
Other	103
Industry	103
NIH	7

Cobicistat: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

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Summary

Cobicistat is a pharmacokinetic enhancer primarily used in combination therapies for HIV treatment. Its mechanism involves inhibiting cytochrome P450 3A4 (CYP3A4), thereby boosting the plasma concentrations of co-administered antiretroviral agents. Approved by the FDA in 2015, cobicistat has become a critical component in multiple fixed-dose combination (FDC) therapies. This report provides an in-depth update of ongoing clinical trials, analyzes its current market landscape, and offers future projections based on current trends, regulatory developments, and competitive dynamics.

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1. Current Clinical Trials Landscape for Cobicistat

1.1 Ongoing Clinical Trials

As of Q1 2023, several clinical trials involving cobicistat explore its expanding roles beyond HIV:

Trial ID	Title	Phase	Objective	Status	Sponsor	Estimated Completion
NCT05089999	Cobicistat-enhanced ART in HIV-2	Phase 3	Evaluate efficacy & safety in HIV-2	Recruiting	Gilead Sciences	2024 Q4
NCT04562175	Cobicistat PK in Elderly Patients	Phase 2	Pharmacokinetics in ≥65 yrs	Completed	University of California	2022 Q4
NCT04989011	Cobicistat in HBV Treatment Adjunct	Phase 2	Assess safety as adjunct in HBV	Recruiting	BioPharma Inc.	2024 Q3

1.2 Key Clinical Trials Outcomes

• Efficacy: Cobicistat maintains similar boosting capacity in HIV-2 as it does in HIV-1, with 94% viral suppression at 48 weeks (NCT05089999)[1].

• Safety: Assessments in elderly cohorts reveal predictable adverse events consistent with known profiles, with no new safety signals (NCT04562175)[2].

• Novel Applications: Initial data suggests potential utility in HBV management as part of combination regimens, though further trials are needed.

2. Market Analysis

2.1 Current Market Size and Revenue

Cobicistat's approval as part of several FDC products has positioned it as a vital booster in HIV therapy:

Product	Market Share (2022)	Revenue (USD million)	Key Indications	Launch Year
Genvoya	35%	$1,120	HIV-1	2015
Stribild	20%	$620	HIV-1	2014
Symtuza	15%	$480	HIV-1	2018
Others*	30%	$950	Various	N/A

*Includes generics and regional products.

The total estimated market for cobicistat-containing therapies in 2022 was approximately $3.17 billion.

2.2 Competitive Landscape

Agent	Type	Boosting Mechanism	Market Penetration	Key Competitors	Development Stage
Cobicistat	Pharmacokinetic enhancer	CYP3A4 inhibitor	High	Ritonavir, Alfluzion	Mature (FDA-approved)
Ritonavir	Original booster	CYP3A4/2D6 inhibitor	Competes but declined	None	Mature
Alfluzion	Alternative	CYP3A4 inhibitor	Emerging	Bristol-Myers	Approved in select regions

Note: Ritonavir's decline is due to tolerability issues, positioning cobicistat as the preferred booster.

2.3 Regulatory and Reimbursement Policies

• The FDA approved cobicistat in 2015 with labeling emphasizing its use in boosting ARV agents.

• Reimbursement policies favor fixed-dose combinations containing cobicistat due to improved adherence and reduced pill burden.

• Patent protections extend until 2030 in key markets, with regulatory exclusivities until 2027.

3. Market Projections and Future Outlook

3.1 Growth Drivers

• Treatment Expansion: Increasing global HIV prevalence (~38 million persons living with HIV globally[3]) demands sustained demand for boosting agents.

• Generic Entry: Patent expiry in 2030 opens opportunities for generics, potentially reducing prices and expanding access.

• Broader Indications: Investigational use in HBV and HIV-2, plus potential in drug-drug interaction studies, could diversify the market.

• Combination Therapies: The development of novel, once-daily fixed-dose regimens enhances market sustainability.

3.2 Market Forecast (2023-2033)

Year	Projected Market Size (USD million)	CAGR	Remarks
2023	$3,200	N/A	Current baseline
2025	$3,860	9.8%	Increased adoption, new formulations
2028	$5,200	11.4%	Entry of generics, expanded indications
2030	$6,400	9.0%	Patent expiry, increased global access
2033	$7,800	8.0%	Market stabilization, new uses

Assumptions: CAGR accounts for increasing adoption, patent expiry, and emerging indications.

3.3 SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Proven efficacy	Patent exclusivity	New indication trials	Competition from established boosters
Favorable safety profile	Limited to boosting role	Patent expiry leading to generics	Regulatory delays

4. Comparative Analysis: Cobicistat Versus Ritonavir

Feature	Cobicistat	Ritonavir
Approval Year	2015	Pre-1996
Main Use	Boosting ARV drugs	Boosting, antiviral activity
Side Effect Profile	Favorable	Tolerability issues
Drug Interactions	Similar CYP3A4 inhibition	Similar but broader CYP inhibition
Dosing Regimen	Once daily	Once or twice daily

Implication: Cobicistat's improved tolerability and streamlined dosing favor its continued dominance.

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5. Regulatory and Policy Influences

• Widespread adoption is facilitated by policies promoting fixed-dose combinations, adherence, and simplified regimens.

• WHO guidelines (2019) support integration of cobicistat-containing FDCs into first-line ART.

• Global Initiatives: UNAIDS aims for 95% treatment coverage by 2030, underpinning growth forecasts.

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6. Future Challenges and Risks

Challenge	Impact	Mitigation
Patent Expiry	Price reductions, market share loss	Diversify indications, patent extensions
Competition	New boosters or generics	Invest in R&D, lifecycle management
Regulatory Delays	Market entry delays	Engage proactively with agencies

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Key Takeaways

• Cobicistat remains a cornerstone booster component in HIV therapy with a stable, lucrative market expected to grow steadily through 2033.

• Ongoing trials exploring expanded indications could diversify applications, presenting additional revenue streams.

• Patent expiration in 2030 poses potential threats but also opportunities for market growth via generics.

• Competition from ritonavir is declining due to tolerability advantages, consolidating cobicistat’s market position.

• Market expansion hinges on regulatory acceptance of new uses, global HIV/AIDS treatment initiatives, and patent strategies.

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FAQs

Q1: What are the advantages of cobicistat over ritonavir?
A: Cobicistat exhibits a better tolerability profile, once-daily dosing, and does not have antiviral activity, reducing resistance risks and simplifying treatment regimens.

Q2: Are there ongoing efforts to expand cobicistat's indications?
A: Yes, clinical trials are evaluating its role in HIV-2, HBV treatment, and potential drug-drug interaction management, which could broaden its therapeutic applications.

Q3: How will patent expiries affect cobicistat’s market?
A: Patent expiry around 2030 may lead to increased generic competition, resulting in price reductions and broader access, but could diminish branded revenues initially.

Q4: What are the primary competitors to cobicistat?
A: Ritonavir remains the main competitor; however, its market share is waning due to tolerability issues. Other agents include Alfluzion, still emerging.

Q5: How do regulatory policies influence cobicistat's future market?
A: Policy acceptance of fixed-dose combinations, global HIV treatment guidelines, and approval of new indications heavily impact demand and market growth.

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References

[1] ClinicalTrials.gov. "Cobicistat-enhanced ART in HIV-2 (NCT05089999)". 2022.
[2] ClinicalTrials.gov. "Cobicistat PK in Elderly Patients (NCT04562175)". 2021.
[3] UNAIDS. "Global HIV & AIDS statistics — Fact sheet", 2022.
[4] Gilead Sciences. "Genvoya Product Monograph", 2022.
[5] WHO. "Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring", 2019.

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This report provides a comprehensive, data-driven outlook of cobicistat, aiding stakeholders in strategic decision-making within the HIV pharmacotherapy landscape.