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.
NCT02345707 ↗	Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir	Completed	ViiV Healthcare	Phase 1	2015-03-01	This study is a single-center, randomized, open-label, two cohorts, 3-way cross-over design in 36 subjects to assess the oral bioavailability of four new cabotegravir (CAB) sodium salt tablet formulations relative to the current CAB sodium salt formulation being used in the phase IIb studies under fasting conditions. All treatments will be administered as single 30 mg doses of CAB. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 10 - 14 days after the last dose of study drug. Treatment period doses will be separated by a 14 day washout. Participation in this study will be approximately 12 weeks.
NCT02411435 ↗	Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects	Completed	GlaxoSmithKline	Phase 1	2015-07-01	CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4 (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between CAB and RIF is possible. This study will be a phase I, single-center, open label, fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg) when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable subjects for this study.
NCT02411435 ↗	Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects	Completed	ViiV Healthcare	Phase 1	2015-07-01	CAB is an integrase inhibitor that is currently in Phase 2 clinical trials for the treatment and prevention of human immunodeficiency virus-1 (HIV-1) infection. RIF, a rifamycin used for treatment of tuberculosis (common co-infection in HIV-infected subjects), is a known inducer of uridine diphosphate (UDP)-glucuronosyltransferases (UGTs) and Cytochrome P450 3A4 (CYP3A4). CAB is primarily metabolized via UGT1A1 and UGT1A9, thus a drug interaction between CAB and RIF is possible. This study will be a phase I, single-center, open label, fixed-sequence cross-over study to compare the single dose PK of CAB oral 30 milligrams (mg) when co-administered with RIF 600 mg once daily at steady-state to those of CAB oral 30 mg administered alone. Fifteen subjects are planned to be enrolled to obtain 12 evaluable subjects for this study.
NCT02462772 ↗	Safety and Acceptability of Cabotegravir in HIV Uninfected Women in KwaZulu-Natal, South Africa	Withdrawn	ViiV Healthcare	Phase 2	2015-10-01	The CAPRISA 014 trial aims to assess the safety and acceptability of the long-acting (LA) injectable antiretroviral agent, cabotegravir LA (GSK1265744), in HIV uninfected women in KwaZulu-Natal, South Africa.

Clinical Trial Conditions for CABOTEGRAVIR

Condition Name

Condition Name for CABOTEGRAVIR
Intervention	Trials
HIV Infections	40
Infection, Human Immunodeficiency Virus	9
HIV-1-infection	8
HIV	7

Condition MeSH

Condition MeSH for CABOTEGRAVIR
Intervention	Trials
HIV Infections	45
Acquired Immunodeficiency Syndrome	17
Immunologic Deficiency Syndromes	12
Infections	8

Clinical Trial Locations for CABOTEGRAVIR

Trials by Country

Trials by Country for CABOTEGRAVIR
Location	Trials
United States	273
South Africa	37
Germany	29
Canada	28
Spain	15

Trials by US State

Trials by US State for CABOTEGRAVIR
Location	Trials
California	20
Georgia	17
Florida	17
Texas	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	3

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	44
National Institute of Allergy and Infectious Diseases (NIAID)	12
GlaxoSmithKline	10

Sponsor Type

Sponsor Type for CABOTEGRAVIR
Sponsor	Trials
Industry	69
Other	60
NIH	18

Clinical Trials Update, Market Analysis, and Projection for Cabotegravir

Last updated: October 28, 2025

Introduction

Cabotegravir, developed by ViiV Healthcare, is an investigational antiretroviral drug primarily aimed at treating and preventing HIV infections. Its unique mechanism as an integrase inhibitor, administered via long-acting injectable formulations, positions it as a potential game-changer in HIV therapy and prophylaxis. This comprehensive analysis explores recent clinical trial developments, evaluates current market dynamics, and provides future projections for Cabotegravir, emphasizing factors influencing its commercial trajectory.

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Clinical Trials Update

Overview and Phases

Cabotegravir has been extensively evaluated across multiple clinical phases. Notably, its utility as both a treatment and a pre-exposure prophylaxis (PrEP) agent has been at the forefront of clinical research.

Treatment of HIV-1 Infection

The Flaunt Phase 3 trial assessed the efficacy of long-acting Cabotegravir in combination with rilpivirine. Results indicated non-inferior viral suppression compared to standard oral regimens, with a significant reduction in dosing frequency—administrations every two months—enhancing adherence potential [1].

Pre-Exposure Prophylaxis (PrEP)

The HPTN 083 trial, a landmark Phase 2b/3 study, evaluated Cabotegravir injectables versus oral Tenofovir/emtricitabine (TDF/FTC) in high-risk populations. The injectable demonstrated superior efficacy in preventing HIV acquisition, with a 66% reduction in risk compared to oral PrEP [2]. The HPTN 084 trial, focusing on women, corroborated these findings with similar efficacy results.

Recent Developments

In Q4 2022, ViiV Healthcare announced the approval of Cabotegravir for PrEP use in the U.S., based on robust clinical data supporting its safety and efficacy [3]. Additionally, ongoing long-term safety studies aim to reinforce its profile for repeated injections over extended periods.

Regulatory Milestones

The recent FDA approval of Cabotegravir for PrEP marks a significant milestone, positioning it as the first long-acting injectable option for HIV prevention in the U.S. Regulatory submissions are underway in other jurisdictions, including Europe and Asia, with potential approvals forecasted for 2024–2025.

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Market Analysis

Market Landscape and Demand Drivers

The HIV therapeutics and prevention market is experiencing transformative shifts driven by patient preferences for minimally invasive, long-acting regimens. The global HIV market was valued at approximately USD 21 billion in 2022, with a compound annual growth rate (CAGR) of 2.8%, projected to reach USD 25 billion by 2027 [4].

Cabotegravir’s entry addresses key unmet needs: improved adherence, reduced dosing frequency, and enhanced patient convenience. These advantages align with emerging clinical preferences and healthcare policies favoring long-acting formulations.

Competitive Positioning

Current HIV treatment options predominantly include daily oral regimens, such as dolutegravir-based therapies. Cabotegravir's long-acting injectables serve as a strategic differentiator. Its main competitors for injectable PrEP include products under development, like once-weekly formulations, but none currently possess FDA approval comparable to Cabotegravir’s recent milestone.

Pricing and Reimbursement Strategies

ViiV Healthcare is expected to adopt premium pricing aligned with the value provided by reduced dosing frequency and improved adherence. Reimbursement pathways will hinge on demonstrating cost-effectiveness and long-term health benefits, such as decreased HIV transmission rates and reduced healthcare costs associated with treatment failure.

Market Penetration Challenges

Barriers include logistical complexities of administering injections in clinics, patient acceptance of injections, and regulatory approval timelines internationally. Moreover, ensuring equitable access in low- and middle-income countries remains a significant challenge, requiring collaboration with global health agencies and governments.

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Market Projections

Short-Term Outlook (2023–2025)

The immediate market impact will stem from the first approved indications for PrEP in the U.S. and approved treatment options. We project a conservative uptake, capturing approximately 10-15% of eligible high-risk populations and treatment-naïve patients in North America and Europe by 2025. This assumes successful commercialization and reimbursement negotiations.

Mid to Long-Term Outlook (2026–2030)

Beyond initial adoption, the market share for Cabotegravir could expand to include:

• Broader geographic penetration in emerging markets, potentially facilitated through licensing agreements.
• Use in pediatric populations once safety data are available.
• Integration into combination regimens for multi-morbidity HIV patients.

We estimate global revenues could reach USD 2.5–3 billion annually by 2030, contingent on regulatory approvals, acceptance, and healthcare infrastructure adaptations.

Potential Growth Drivers

• Increasing awareness and destigmatization of HIV prevention.
• Clinical data reinforcing efficacy and safety.
• Expansion of indications beyond HIV prevention and treatment.
• Cost reductions through manufacturing efficiencies and scale.

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Future Outlook and Business Implications

Cabotegravir’s innovative profile aligns well with the healthcare ecosystem’s pivot toward personalized, long-acting HIV management solutions. Major pharmaceutical players and public health organizations recognize its potential, positioning ViiV Healthcare as a pioneer in this segment.

However, the commercial success depends on overcoming distribution hurdles, fostering healthcare provider acceptance, and ensuring affordability. Competitive pressures from emerging long-acting formulations and oral alternatives necessitate aggressive marketing and further clinical validation.

Key Takeaways

• Clinical validation of Cabotegravir’s efficacy in HIV treatment and prevention is strong, with recent FDA approval for PrEP reinforcing its market potential.
• Market demand for long-acting, patient-friendly HIV therapies drives adoption, especially among populations with adherence challenges.
• Regulatory approvals in multiple jurisdictions over the next few years will expand the geographic footprint.
• Pricing strategies will need to balance premium value propositions with healthcare affordability, especially in resource-limited settings.
• Future growth hinges on clinical, regulatory, and logistical advancements, alongside global health collaborations.

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FAQs

1. What distinguishes Cabotegravir from other HIV medications?
Cabotegravir’s long-acting injectable formulation provides a bi-monthly dosing schedule, reducing the need for daily pills and improving adherence, differentiating it from conventional daily oral regimens.

2. When did the FDA approve Cabotegravir for HIV pre-exposure prophylaxis?
In December 2022, the FDA approved Cabotegravir injectable for PrEP, marking its first regulatory endorsement for HIV prevention.

3. What are the main challenges in commercializing Cabotegravir globally?
Challenges include logistical distribution of injectables, patient acceptance of injections, regulatory approval delays, and affordability concerns in low-income regions.

4. How does Cabotegravir compare economically with existing HIV treatments?
While premium-priced, Cabotegravir may reduce long-term healthcare costs by improving adherence, preventing treatment failure, and decreasing transmission rates, potentially offering a cost-effective solution in high-incidence populations.

5. What is the anticipated timeline for global market penetration?
Initial launches are expected within 12–24 months post-approval in key markets like the U.S., with broader international adoption contingent on regulatory processes, infrastructure, and partnerships over the next 3–5 years.

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References

[1] ViiV Healthcare. "Phase 3 Trials Demonstrate Long-Acting Cabotegravir Plus Rilpivirine Is Non-Inferior to Oral Regimens." (2022).
[2] HPTN 083 Trial Results. "Efficacy of Cabotegravir for HIV Prevention." (2021).
[3] FDA. "Approval of Cabotegravir for HIV Pre-Exposure Prophylaxis." December 2022.
[4] MarketWatch. "Global HIV Therapeutics Market Analysis & Forecasts." (2023).

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In summary, Cabotegravir emerges as a pivotal innovation in the HIV space, with clinical evidence supporting its efficacy and safety. Market prospects are promising, shaped by regulatory milestones and evolving healthcare practices emphasizing patient convenience and adherence. Strategic positioning and overcoming deployment barriers will determine its ultimate market success over the coming decade.