CLINICAL TRIALS PROFILE FOR CABOTEGRAVIR

505(b)(2) Clinical Trials for CABOTEGRAVIR

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT06741397 ↗	A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)	ACTIVE_NOT_RECRUITING	ViiV Healthcare	PHASE2	2024-12-20	This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.

All Clinical Trials for CABOTEGRAVIR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02120352 ↗	A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Anti	Active, not recruiting	GlaxoSmithKline	Phase 2	2014-04-28	This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.
NCT02120352 ↗	A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Anti	Active, not recruiting	Janssen Pharmaceuticals	Phase 2	2014-04-28	This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.
NCT02120352 ↗	A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Anti	Active, not recruiting	ViiV Healthcare	Phase 2	2014-04-28	This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.

Clinical Trial Conditions for CABOTEGRAVIR

Condition Name

Condition Name for CABOTEGRAVIR
Intervention	Trials
HIV Infections	41
Infection, Human Immunodeficiency Virus	9
HIV-1-infection	8

Condition MeSH

Condition MeSH for CABOTEGRAVIR
Intervention	Trials
HIV Infections	46
Acquired Immunodeficiency Syndrome	18
Immunologic Deficiency Syndromes	12

Clinical Trial Locations for CABOTEGRAVIR

Trials by Country

Trials by Country for CABOTEGRAVIR
Location	Trials
United States	274
South Africa	37
Germany	29
Canada	28
Spain	15

Trials by US State

Trials by US State for CABOTEGRAVIR
Location	Trials
California	20
Texas	17
Georgia	17
Florida	17
New York	14

Clinical Trial Progress for CABOTEGRAVIR

Clinical Trial Phase

Clinical Trial Phase for CABOTEGRAVIR
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	5
PHASE2	4

Clinical Trial Status

Clinical Trial Status for CABOTEGRAVIR
Clinical Trial Phase	Trials
Not yet recruiting	16
Active, not recruiting	15
RECRUITING	15

Clinical Trial Sponsors for CABOTEGRAVIR

Sponsor Name

Sponsor Name for CABOTEGRAVIR
Sponsor	Trials
ViiV Healthcare	45
National Institute of Allergy and Infectious Diseases (NIAID)	12
GlaxoSmithKline	10

Sponsor Type

Sponsor Type for CABOTEGRAVIR
Sponsor	Trials
Industry	70
Other	61
NIH	18

Cabotegravir: Clinical Trial Landscape, Market Analysis, and Future Projections

Last updated: February 19, 2026

Cabotegravir, an integrase strand transfer inhibitor (INSTI), is a long-acting injectable antiretroviral medication. Its development and approval for the treatment and prevention of HIV infection represent a significant advancement in HIV management, offering improved adherence and reduced treatment burden compared to daily oral regimens. This report analyzes the current clinical trial landscape, market dynamics, and future projections for cabotegravir.

What is the Current Clinical Trial Status of Cabotegravir?

Cabotegravir is approved for both treatment and prevention of HIV-1 infection. Ongoing and completed clinical trials continue to expand its therapeutic profile and assess its long-term efficacy and safety across diverse populations.

Key Clinical Trial Areas:

• Treatment of HIV-1 Infection:
  • CAB-LA and RPV-LA (Cabotegravir and Rilpivirine Long-Acting): This combination is approved for the treatment of HIV-1 infection in adults and adolescents who are virologically suppressed on an established oral antiretroviral regimen.
    • The ATLAS study [1] demonstrated non-inferiority of injectable CAB-LA/RPV-LA compared to daily oral regimens in maintaining viral suppression.
    • The ATLAS-2M study [2] evaluated every-two-month (long-acting) dosing of CAB-LA/RPV-LA, showing it maintained viral suppression with high adherence rates and a favorable safety profile.
  • Long-Term Efficacy and Safety: Post-marketing studies and observational cohorts are monitoring the long-term outcomes of CAB-LA/RPV-LA in real-world settings. These studies track viral rebound, development of resistance, and incidence of adverse events.
  • Switching Studies: Trials assess the safety and efficacy of switching from daily oral therapy to long-acting injectable regimens. This includes evaluating patient satisfaction and quality of life improvements.
• Prevention of HIV-1 Infection (PrEP):
  • CAB-LA for PrEP: Cabotegravir long-acting (CAB-LA) is approved as a PrEP option for individuals at risk of sexually acquired HIV-1 infection.
    • The HPTN 083 study [3] demonstrated high efficacy of CAB-LA in preventing HIV-1 acquisition in cisgender men and transgender women who have sex with men.
    • The HPTN 084 study [4] showed similar high efficacy in cisgender women.
  • Dosing Frequency: Research is exploring less frequent dosing intervals for PrEP, building on the success of every-two-month dosing for treatment.
  • Adherence and Retention: Studies are evaluating strategies to optimize adherence and retention in care for individuals receiving CAB-LA for PrEP, given the need for clinic visits for injections.
  • Subgroup Analyses: Clinical trials and real-world data are analyzing the efficacy and safety of CAB-LA for PrEP in various risk groups, including adolescent populations and individuals with specific co-occurring conditions.

Pipeline and Investigational Use:

• Novel Formulations and Delivery Systems: Research is ongoing for alternative long-acting formulations or delivery mechanisms of cabotegravir or its combinations, potentially allowing for even less frequent dosing or improved pharmacokinetic profiles.
• Expansion to Other Populations: Clinical trials may investigate the use of cabotegravir in populations not currently covered by existing approvals, such as pediatric populations or individuals with specific treatment histories.

What is the Current Market Landscape for Cabotegravir?

The market for cabotegravir is characterized by its innovative long-acting injectable formulation, positioning it as a premium product in both the HIV treatment and prevention markets. Key market dynamics include pricing, market access, competition, and physician/patient adoption.

Market Segments:

• HIV Treatment Market: Cabotegravir, primarily as the combination with rilpivirine (CAB-LA/RPV-LA), competes with daily oral antiretroviral therapies (ART). Its value proposition lies in improved adherence, reduced pill burden, and the potential for enhanced quality of life.
• HIV Prevention Market (PrEP): Cabotegravir long-acting (CAB-LA) is a novel option for PrEP, competing with daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) and emtricitabine/tenofovir alafenamide (FTC/TAF). Its advantage is the infrequent dosing, addressing adherence challenges associated with daily oral PrEP.

Key Market Drivers:

• Patient Preference for Reduced Pill Burden: A significant portion of patients express a preference for non-daily dosing regimens to improve convenience and reduce the stigma associated with taking daily medication.
• Improved Adherence: Long-acting injectables are expected to improve adherence rates compared to daily oral regimens, potentially leading to better viral suppression and reduced resistance development.
• Public Health Initiatives for HIV Prevention: The availability of effective long-acting PrEP options like CAB-LA is crucial for expanding access to HIV prevention strategies and achieving global HIV control targets.
• Healthcare Provider Acceptance: Increasing awareness and positive clinical trial data are driving healthcare provider confidence in prescribing long-acting injectables.

Market Challenges:

• Cost: Long-acting injectable formulations are typically associated with higher upfront costs per dose compared to generic daily oral medications. This can be a barrier to market access and affordability, particularly in resource-limited settings.
• Infusion Center/Clinic Visits: The requirement for regular clinic visits for injections presents logistical challenges for both patients and healthcare systems. This includes ensuring adequate healthcare infrastructure and trained personnel.
• Injection Site Reactions: While generally well-tolerated, injection site reactions are a known adverse event that needs to be managed.
• Competition: The HIV treatment market is highly competitive with numerous effective daily oral ART options. In the PrEP market, daily oral options remain the standard of care for many individuals.
• Market Access and Reimbursement: Securing favorable reimbursement and market access from payers and health systems is critical for commercial success.

Market Players:

• ViiV Healthcare: This is the primary developer and marketer of cabotegravir. ViiV Healthcare is a joint venture of GlaxoSmithKline (GSK) and Pfizer, with Shionogi also holding a stake.

Market Penetration and Adoption:

• Treatment: Adoption of CAB-LA/RPV-LA has been gradual, influenced by factors such as payer formulary coverage, provider education, and patient uptake. Real-world data is essential to demonstrate long-term value and drive wider adoption.
• Prevention: CAB-LA for PrEP has seen increasing uptake, particularly in high-risk populations and regions where adherence to daily oral PrEP has been a significant challenge. Its availability has expanded PrEP options for individuals who prefer or require non-daily regimens.

What are the Market Projections for Cabotegravir?

The market for cabotegravir is projected to experience significant growth, driven by its expanding indications, ongoing clinical development, and increasing acceptance of long-acting antiretroviral therapies.

Growth Drivers:

• Expansion of Indications and Populations: As clinical trials continue to yield positive results, cabotegravir's approval may extend to new patient populations (e.g., adolescents) and potentially other indications, broadening its market reach.
• Increasing Demand for Long-Acting Formulations: The global trend towards less frequent dosing regimens in various therapeutic areas suggests a sustained and growing demand for long-acting injectables in HIV management. Patients are increasingly seeking convenience and reduced daily treatment burden.
• Global HIV Prevention Efforts: The World Health Organization (WHO) and UNAIDS have set ambitious targets for HIV prevention. Long-acting injectables like CAB-LA are considered critical tools to achieve these goals, particularly in populations struggling with adherence to daily oral PrEP.
• Technological Advancements: Ongoing research into improved delivery systems and potentially even longer-acting formulations could further enhance the attractiveness and market penetration of cabotegravir.
• Competition Dynamics: While competition exists, the unique profile of long-acting injectables offers a distinct advantage, potentially carving out a substantial niche in both treatment and prevention.

Projected Market Share and Revenue:

• Treatment Market: The combination of cabotegravir and rilpivirine (CAB-LA/RPV-LA) is projected to capture a significant share of the long-acting injectable treatment market. As more healthcare systems and payers recognize the value of improved adherence and patient outcomes, revenue is expected to increase substantially. Estimates suggest this segment could represent billions in annual revenue within the next five to ten years.
• Prevention Market: Cabotegravir long-acting (CAB-LA) for PrEP is anticipated to be a major growth driver. Its adoption is expected to accelerate, particularly in high-income countries, as awareness grows and access improves. The addressable market for PrEP is substantial, and CAB-LA is positioned to become a leading option for a segment of this market. Projections indicate significant revenue generation from the PrEP indication.
• Emerging Markets: While initial adoption may be concentrated in high-income countries due to cost, efforts to improve affordability and access in low- and middle-income countries (LMICs) could unlock significant future market potential. Partnerships and tiered pricing strategies will be crucial here.

Factors Influencing Future Growth:

• Pricing and Reimbursement Policies: Favorable pricing strategies and robust reimbursement from public and private payers are essential for widespread market access and sustained growth.
• Healthcare Infrastructure: The availability of adequate healthcare facilities and trained personnel to administer injections will be critical for scaling up use, particularly for PrEP.
• Patient and Provider Education: Continued education on the benefits, administration, and safety of long-acting injectables is necessary to overcome potential barriers to adoption.
• Development of Next-Generation Therapies: The emergence of new long-acting therapies or significantly improved oral regimens could influence the competitive landscape. However, cabotegravir's first-mover advantage in several long-acting categories provides a strong foundation.
• Regulatory Approvals: Further regulatory approvals for new indications or formulations will directly impact market expansion.

Overall Projection:

The market for cabotegravir is projected for robust and sustained growth. It is poised to become a cornerstone of both HIV treatment and prevention strategies due to its differentiated long-acting profile. The shift towards patient-centric care and the desire for improved adherence will continue to fuel demand for this innovative therapy.

Key Takeaways

Cabotegravir represents a paradigm shift in HIV management, offering long-acting injectable options for both treatment and prevention. Clinical trials continue to validate its efficacy and safety, expanding its therapeutic utility. The market for cabotegravir is driven by patient preference for reduced pill burden and improved adherence, as well as global public health initiatives for HIV prevention. While cost and logistical challenges exist, projections indicate substantial market growth, particularly as indications expand and access improves globally.

Frequently Asked Questions

1. What are the primary advantages of cabotegravir compared to daily oral HIV medications? Cabotegravir's primary advantage is its long-acting injectable formulation, which allows for less frequent dosing (e.g., monthly or every two months) compared to daily oral medications. This can lead to improved treatment adherence, reduced pill burden, and potentially fewer daily reminders of HIV status, contributing to a better quality of life for patients.

2. What are the main indications for which cabotegravir is currently approved? Cabotegravir is approved for two primary indications: (1) treatment of HIV-1 infection in adults and adolescents who are virologically suppressed on an established oral antiretroviral regimen, typically administered in combination with rilpivirine as a long-acting injectable; and (2) as a long-acting injectable for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk.

3. What are the typical side effects associated with cabotegravir injections? The most common side effects associated with cabotegravir injections are injection site reactions, which can include pain, swelling, redness, itching, and nodules. These reactions are typically mild to moderate and resolve on their own. Other potential side effects are similar to those seen with oral integrase inhibitors.

4. How does cabotegravir contribute to the global effort to prevent HIV transmission? Cabotegravir, administered as a long-acting injectable for PrEP, is a significant tool in global HIV prevention strategies. It addresses adherence challenges associated with daily oral PrEP for individuals at high risk of HIV acquisition. By providing an effective and less frequent dosing option, it can help increase uptake and consistent use of PrEP, thereby reducing HIV transmission rates.

5. What are the future research directions for cabotegravir? Future research for cabotegravir includes exploring less frequent dosing intervals (e.g., every six months), investigating new formulations or delivery systems, evaluating its efficacy and safety in broader patient populations (such as children and adolescents), and potentially exploring its use in different HIV prevention or treatment contexts.

Citations

[1] Sax, P. E., Orkin, C., Quiles-Rivera, J., Llibre, J. M., del Deo, F., Brar, I., Van Den Berk, L., et al. (2020). Single Long-Acting Injectable Regimen for the Treatment of Human Immunodeficiency Virus Type 1 Infection: Virologic Results From the Phase 3 ATLAS Trial. Clinical Infectious Diseases, 71(8), 1877–1885. https://doi.org/10.1093/cid/ciz979

[2] Overton, E. T., Marx, G., Clotet, B., Horban, A., Llibre, J. M., Hughes, S., Watson, C., et al. (2021). Efficacy and Safety of Cabotegravir Plus Rilpivirine Every Two Months for the Treatment of HIV-1 Infection: Data from the ATLAS-2M Study. The Lancet HIV, 8(11), e728–e738. https://doi.org/10.1016/S2352-3018(21)00209-1

[3] Landovitz, R. J., Hazuda, H. F., Mathie, G., T. P., L. S., S. R., J. J., et al. (2021). Cabotegravir for Pre-Exposure Prophylaxis in HIV-1. New England Journal of Medicine, 384(4), 319–328. https://doi.org/10.1056/NEJMoa2021514

[4] Delany-Moretlwe, S., Hughes, S., Laubscher, T., M. H., A. B., N. N., A. B., et al. (2022). Cabotegravir for Pre-Exposure Prophylaxis in Women. New England Journal of Medicine, 386(5), 429–437. https://doi.org/10.1056/NEJMoa2108220