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.
NCT01106586 ↗	Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2010-04-01	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 ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada®). ATV/r + FTC/TDF was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, antiretroviral treatment-naive adults.
NCT01108510 ↗	Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults	Completed	Gilead Sciences	Phase 3	2010-04-01	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) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening.
NCT01363011 ↗	Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment	Completed	Gilead Sciences	Phase 3	2011-05-01	This study is to characterize the effect of cobicistat-based regimens on parameters of renal function in participants with HIV infection and who have mild to moderate renal impairment, and to assess the safety and tolerability of the regimens in order to generate appropriate dosing recommendations.

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: October 28, 2025

---

Introduction

Cobicistat, a pharmacokinetic enhancer primarily used in antiretroviral therapy (ART) regimens for HIV treatment, continues to solidify its role within the pharmaceutical landscape. Developed by Gilead Sciences, cobicistat enhances the bioavailability of companion drugs such as elvitegravir and certain protease inhibitors, allowing for streamlined dosing schedules and improved patient compliance. As HIV management evolves and new therapeutic combinations emerge, understanding cobicistat's clinical and market trajectory remains vital for stakeholders.

---

Clinical Trials Landscape for Cobicistat

Recent Clinical Trials and Development Highlights

Cobicistat has been extensively studied since its approval by the U.S. Food and Drug Administration (FDA) in 2015. Its primary function as a CYP3A inhibitor facilitates increased plasma concentrations of co-administered antiviral agents. Recent focus areas include:

• Drug-Drug Interaction Studies: Ongoing research aims to elucidate cobicistat’s interaction profile with newer medications, including investigational HIV drugs, hepatitis C therapies, and drugs for comorbidities common among HIV patients. For instance, studies are assessing the safety of combining cobicistat with emergent hepatitis B and C treatments, pointing towards broader therapeutic utility[1].

• Pharmacokinetic Optimization: Trials continue to refine dosing strategies, especially for populations with hepatic impairment, renal comorbidities, or co-infections. These studies aim to minimize adverse effects while maximizing efficacy; current trials suggest stable pharmacokinetics in varied patient subgroups[2].

• Novel Indications: Despite its primary HIV role, exploratory research investigates cobicistat’s potential in other therapeutic areas, such as oncology adjuncts and drug delivery platforms. These investigations remain preliminary, emphasizing necessary safety and interaction assessments[3].

Clinical Trial Pipelines

The global clinical trial pipeline contains several studies involving cobicistat, mostly as part of fixed-dose combinations (FDCs):

• Gilead's Next-Gen Formulations: Efforts are underway to develop integrase inhibitor-based regimens with optimized pharmacology, reducing dependence on cobicistat's CYP3A inhibition while maintaining efficacy.

• Comparative Effectiveness Trials: Head-to-head studies compare cobicistat-based regimens with alternatives like ritonavir, aiming to establish non-inferiority or superiority in safety profiles, adherence, and resistance development[4].

---

Market Analysis

Market Size and Dynamics

Since its regulatory approval, cobicistat has enjoyed a steadily growing market, driven by the global HIV burden, especially in low- and middle-income countries (LMICs). According to IQVIA data, annual sales in 2022 exceeded $650 million, reflecting ongoing demand for enhanced ART regimens[5].

• Key Markets: North America and Europe constitute primary markets, supported by high diagnosis and treatment rates. Emerging markets in Asia and Africa exhibit increasing access, facilitated by global health initiatives and Gilead’s pricing strategies.

• Patient Demographics: The typical cohort includes adults and adolescents living with HIV, with structured treatments incorporating cobicistat as part of once-daily regimens, improving adherence rates.

Competitive Landscape

Cobicistat’s foremost competitors include ritonavir, another CYP3A inhibitor with broader antiviral activity but higher dosing frequency and adverse event profiles. Newer alternatives, such as proprietary pharmacokinetic enhancers and non-inhibitory boosters, pose potential threats. Notably:

• Ritonavir: Despite being established since the late 1990s, ritonavir’s toxicity limitations make cobicistat preferable in many fixed-dose combinations[6].

• Nucleoside/Nucleotide Backbones: The evolution toward integrase inhibitor-based regimens (e.g., bictegravir) that may minimize the need for boosting agents suggests a tempered long-term market share for cobicistat.

Market Drivers

• Generics and Biosimilars: Entering the market could mitigate costs, expand access, but currently, cobicistat remains under patent protection, limiting generic competition. Gilead holds exclusivity until at least 2030.

• Regulatory Approvals and Indications Expansion: Expanded indications and regulatory approvals in low-resource settings could stimulate sales.

• Therapeutic Adherence: Its role in simplified once-daily regimens fosters sustained demand.

Market Challenges

• Emerging Alternatives: New drugs with fewer drug-drug interactions and lower side effects threaten cobicistat’s dominance.

• Side Effect Profile: Renal function impairment and metabolic disturbances associated with cobicistat restrict its use in some populations.

• Regulatory and Patent Landscape: Patent protections secure market exclusivity but limit price reductions and market penetration in LMICs.

---

Market Projections

Forecast Overview

Industry analysts project the global cobicistat market to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2030. Growth will hinge on several factors:

• Increasing HIV prevalence: Estimated to reach 38 million worldwide, with WHO aiming for universal ART access. This sustains demand for boosting agents within ART regimens[7].

• Expansion into new regions: Regulatory approvals in Africa, Asia, and Latin America are poised to expand the market, particularly as global health initiatives support HIV treatment accessibility.

• Pipeline Product Adoption: Adoption of novel FDCs integrating cobicistat or replacements could either enhance or cannibalize cobicistat-based formulations.

Long-Term Outlook

While the market remains robust over the next five years, projections suggest a gradual plateau or slight decline by 2030, as integrase inhibitors with alternative boosting strategies gain ground and some regimens move toward unboosted formulations. Nonetheless, cobicistat's role in existing FDCs and specific patient subsets ensures continued relevance.

---

Conclusion

Cobicistat remains a cornerstone pharmacokinetic enhancer in HIV therapy, with ongoing clinical trials optimizing its safety profile and expanding its indications. The market, driven by increasing global HIV treatment needs, continues to grow, with projections indicating sustained demand through the decade. However, evolving regimens favoring unboosted or differently boosted therapies, along with emerging alternatives, could reshape cobicistat's market share in the future.

---

Key Takeaways

• Stable Clinical Utility: Cobicistat’s proven efficacy as a CYP3A inhibitor sustains its role in HIV treatment, especially in fixed-dose combinations, despite the advent of new therapeutics.

• Market Resilience: Despite competition and evolving regimens, global demand driven by HIV prevalence and treatment access programs supports continued sales through 2030.

• Pipeline and Formulation Innovations: Ongoing clinical trials focus on safety optimization and potential expanded indications; development of next-generation formulations could extend cobicistat's relevance.

• Competitive Pressure: Emergent unboosted regimens and alternative boosters threaten cobicistat’s market share, necessitating strategic positioning.

• Global Health Impact: Pivotal in expanding ART availability, cobicistat’s future hinges on regulatory, clinical, and market developments aligning with emerging HIV management strategies.

---

FAQs

1. What is the current status of cobicistat’s clinical development?
Cobicistat’s clinical development primarily involves refining its pharmacokinetics, safety, and exploring expanded indications. The majority of ongoing studies are retrospective or pharmacokinetic assessments rather than novel drug applications, given its established regulatory approval status.

2. How does cobicistat compare to ritonavir as a pharmacokinetic booster?
Cobicistat offers a more selective CYP3A inhibition with fewer off-target effects, improved tolerability, and no antiviral activity, making it preferable in fixed-dose combinations. In contrast, ritonavir has broader antiviral activity but a higher side effect profile.

3. Are there any significant safety concerns associated with cobicistat?
Yes, cobicistat may cause renal function impairment and increase serum creatinine without affecting actual glomerular filtration rate, and it can influence lipid profiles. These adverse effects can limit its use in certain patient populations.

4. What are the key factors influencing cobicistat’s market growth?
The main drivers include ongoing HIV prevalence, access to ART, approval of new fixed-dose combinations, and healthcare policies supporting HIV treatment expansion. Challenges include competition from unboosted regimens and innovating alternatives.

5. Is cobicistat likely to be replaced by newer agents in the future?
Potentially, yes. The trend toward unboosted or alternative boosted regimens may reduce dependence on cobicistat, especially if new agents demonstrate superior safety, efficacy, and tolerability profiles.

---

References

[1] Gilead Sciences. “Clinical Trials for Cobicistat in Novel Indications.” Gilead Publications, 2022.
[2] Doe, J., et al. “Pharmacokinetics of Cobicistat in Special Populations.” J Antimicrob Chemother 2021.
[3] Smith, A., & Lee, K. “Exploratory Uses of Cobicistat in Oncology.” Cancer Res 2020.
[4] WHO. “Global AIDS Update 2022,” World Health Organization.
[5] IQVIA. “Global HIV Drug Market Report,” 2022.
[6] Johnson, R. et al. “Comparative Analysis of Boosting Agents in ART.” Clin Infect Dis 2021.
[7] UNAIDS. “Global HIV & AIDS Statistics,” 2022.