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.

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
HIV	7

Condition MeSH

Condition MeSH for Cabotegravir
Intervention	Trials
HIV Infections	46
Acquired Immunodeficiency Syndrome	18
Immunologic Deficiency Syndromes	12
Infections	8

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 trials update, market analysis and exclusivity/patent-driven generic risk forecast (2026-2035)

Last updated: May 24, 2026

Cabotegravir (as oral cabotegravir and in combination with rilpivirine as long-acting Cabenuva) is in late-stage phase for additional line expansions and duration/dosing refinements, while near-term commercial growth depends on execution in virologically suppressed switching, treatment-naïve positioning where supported by evidence, and retention after injection. Patent and regulatory timing shape the risk window for generic or biosimilar-like entry (cabotegravir is small molecule, so the risk is generic entry).

What is cabotegravir and how is it positioned in HIV treatment markets?

Cabotegravir is an integrase strand transfer inhibitor (INSTI). Market demand is driven by sustained-release, long-acting intramuscular delivery when paired with rilpivirine (single-brand regimen Cabenuva). Oral cabotegravir supports bridging and initial dosing strategies.

Key commercial framing by use case

• Switch therapy in virologically suppressed patients (core Cabenuva growth engine).
• Treatment initiation approaches where clinical evidence supports operational simplicity and adherence outcomes versus daily ART.
• Dosing optimizations (injection interval, loading/bridging protocols) intended to improve persistence and reduce clinic burden.
• Regional formulary placement influenced by contracting, payer criteria, and evidence packages for prior regimens.

What clinical trials for cabotegravir are most relevant right now?

High-intent clinical-trials monitoring for cabotegravir generally clusters around:

• switching vs continuation strategies,
• long-acting maintenance durability,
• treatment initiation studies,
• injection schedule optimization and real-world implementation proxies,
• resistance emergence assessments.

What pivotal evidence underpins Cabenuva adoption

• LATTE program (oral lead-in and injectable transition strategies in studies of cabotegravir + rilpivirine).
• ATLAS (treatment-naïve initiation in randomized design).
• FLAIR (switch in virologically suppressed participants).
• Phase 3 follow-on data supporting durability, safety, and injection adherence models.

These trials inform endpoints payers and guideline committees use for switch coverage and injection-transition policy.

What to track in 2025-2027 trial readouts

For decision-grade monitoring, focus on:

• Durability of viral suppression beyond 48 to 96 weeks.
• Safety signals tied to injection-site reactions and tolerability in extended use.
• Resistance profiles in the event of virologic failure and adherence gaps.
• Protocol simplification outcomes: reduced need for oral lead-in, optimized loading, and injection schedule flexibility.

(Clinical trial updates and market impact link strongly to these endpoints because they determine guideline weight, payer coverage criteria, and persistence rates.)

How does cabotegravir’s clinical pipeline compare with other long-acting HIV options?

Cabotegravir’s competitive set is long-acting ART strategies, mostly in the same adherence-motivation segment:

• long-acting NNRTI combinations,
• long-acting INSTI approaches (where available),
• and pipeline-stage long-acting cohorts versus oral-only regimens.

Differentiation factors that affect market share

• Injection interval flexibility and clinic workflow compatibility.
• Evidence strength for switching and durability.
• Resistance barrier and failure salvage options.
• Real-world persistence, including missed-dose management protocols.

Cabotegravir’s market position depends on matching these differentiators to guideline adoption and payer contracting.

What patents protect cabotegravir and what is the strength of the patent estate?

Cabotegravir’s IP landscape for the US typically includes:

• drug substance and composition-of-matter patents covering cabotegravir and/or combinations (cabotegravir with rilpivirine),
• formulation and sustained-release delivery patents for long-acting injection,
• method-of-treatment claims for dosing regimens and adherence/maintenance protocols.

How the estate usually segments for long-acting products

• Composition of matter: active ingredient identity and defined chemical forms.
• Formulation: suspension characteristics and particle engineering enabling long-acting pharmacokinetics.
• Combination and dosing regimens: claims tied to injection schedules, loading/bridging, and patient selection.

Practical patent impact for entry strategy

For generics, entry typically faces:

• legal barriers tied to combination regimen claims and formulation coverage,
• expiration timing across multiple patents and listed Orange Book entries,
• and Paragraph IV litigation risk if a generic challenges remaining patents.

When does cabotegravir lose exclusivity in the US and what are the likely generic entry risks?

For long-acting HIV regimens, exclusivity and patent timing drive:

• when generic can submit an ANDA and attempt a Paragraph IV,
• when it can launch absent injunction,
• and how long market will remain insulated by formulation and method claims.

Cabotegravir commercial protection is not a single-date story. It is a portfolio of patent expiration events plus regulatory exclusivities that often extend protection against direct generic substitution.

Paragraph IV risk framework for cabotegravir

• If multiple patents cover active ingredients and long-acting formulations, a generic must either wait out all relevant expirations or win a challenge against the asserted patents.
• If formulation or method-of-treatment patents remain, even “same API” products can face injunction risk or design-around costs.

What is the Orange Book status of cabotegravir-related products?

US Orange Book coverage for cabotegravir will be determined by:

• listed drug products (oral cabotegravir if applicable, and the long-acting combination product),
• listed patents (active ingredient, formulation, and method-of-use),
• and expiry dates associated with each listing.

A complete Orange Book-driven table must list patent numbers, listed expiration dates, and status (expired, pending, delisted). Without the product-specific Orange Book record(s) and patent identifiers in the provided context, a complete, accurate status table cannot be produced.

What cabotegravir formulation patents could block generic or “design-around” approaches?

Long-acting injectables typically have the highest formulation/IP leverage:

• suspension stability,
• particle size distribution,
• excipient system and buffering,
• and injection-ready presentation enabling consistent plasma exposure.

Generic oral-only entry is not a substitute for Cabenuva’s market positioning, and formulation patents can control long-acting suspension manufacturing and release characteristics.

Likely design-around difficulty areas

• If claims tie directly to defined particle/solvent systems and sustained-release performance thresholds, generic suspension development needs more than routine equivalence studies.
• Injection-site and PK profile constraints increase development time because regulatory comparability must be demonstrated at clinically meaningful exposures.

What cabotegravir method-of-use patents could restrict clinical protocol substitution?

Method-of-use patents can restrict:

• specific dosing schedules,
• initiation approaches like oral lead-in bridging,
• and patient-selection claims (for example, virologically suppressed switching criteria in defined populations).

If method-of-use patents remain in force, generics may still be able to market a product only if it does not infringe claimed regimens, which often means protocol restrictions or carve-outs that are commercially unattractive.

What patent litigation affects cabotegravir and what settlements matter for launch timing?

Cabotegravir’s litigation risk depends on:

• whether challengers filed Paragraph IV ANDAs (or other regulatory submissions),
• the identity of asserted patents,
• and settlement terms that set launch dates or market carve-outs.

A decision-grade litigation map requires docket-level identification of cases, asserted patent numbers, and settlement dates. Without case-specific inputs, an accurate litigation-status summary cannot be generated.

What FDA regulatory milestones apply to cabotegravir and Cabenuva?

Commercial uptake is sensitive to:

• label expansions (line of therapy, switching criteria, loading/oral lead-in requirements),
• safety updates (injection-site reaction labeling, hypersensitivity guidance),
• and any required post-marketing studies that affect clinician confidence.

A complete milestone table requires the specific FDA approval dates, supplements, and label-change dates tied to the product(s) relevant to cabotegravir and its long-acting combination regimen.

How big is the cabotegravir opportunity: market analysis and revenue projections?

Market size for cabotegravir is best analyzed through:

• patient addressable base for long-acting injectable ART,
• adoption rate driven by payer coverage and clinician workflow,
• persistence and switching conversion rates,
• and competitive substitution risk (other long-acting regimens and oral INSTI/NNRTI regimens).

Demand drivers shaping projections (2026-2030)

• Continued guideline and payer acceptance of long-acting switching in virologically suppressed populations.
• Expanded evidence and label language supporting initiation strategies where adopted.
• Clinic adoption and injection appointment availability.
• Net price and contracting structures that determine whether payers reimburse broadly or restrict to narrow subgroups.

Supply and operational considerations affecting realized revenue

• Manufacturing capacity and drug product lead times for long-acting suspensions.
• Dose logistics (loading and injection scheduling).
• Global distribution readiness in major markets (US, EU5, UK, key LATAM and Asia markets).

Competitive landscape that constrains upside

• Oral INSTI backbones remain default options in many markets due to lower administrative overhead.
• Alternative long-acting combinations can take share where they are covered with better net pricing or have smoother clinic integration.
• Clinical inertia can slow switching uptake even when evidence supports it.

Projection structure investors and planners use

A robust forecast usually models:

1. Addressable population by country and line of therapy.
2. Share shift to long-acting injectables (conversion to Cabenuva).
3. Annual persistence and missed-dose recovery.
4. Price/net revenue after rebates and contracting.
5. Patent/regulatory timing for generic entry or biosimilar-like competition (not applicable; small molecule uses generic).

In absence of product-specific base-year sales, label date history, and country-by-country uptake rates, a numerically precise revenue projection cannot be completed in a defensible way.

How do exclusivity timelines translate into market risk for cabotegravir (2026-2035)?

For a small-molecule long-acting regimen, market risk is dominated by:

• earliest relevant patent expiration across substance, combination, formulation, and method-of-use,
• exclusivity periods (regulatory exclusivity and pediatric exclusivity if applicable),
• and the time to resolve Paragraph IV litigation or to obtain design-around approvals.

Scenario framework for planning

• Base case: slower-than-expected generic pressure due to multi-patent coverage and litigation timelines.
• Downside case: faster than expected resolution of key formulation or method claims.
• Upside case: additional label expansions and regimen optimizations expand addressable base faster than adoption curve risk.

A legally anchored scenario requires a complete patent list and expiration timeline per jurisdiction, which cannot be produced from the provided input.

Key takeaways

• Cabotegravir’s near-term commercial trajectory is driven by long-acting Cabenuva adoption in switching and any label expansion tied to initiation or dosing simplification.
• IP protection for long-acting HIV products typically spans substance, formulation, and method-of-use claims; generic entry risk depends on which patent types expire first and whether litigation blocks launch.
• Market projections must be built from country-specific adoption, persistence, and net pricing assumptions, anchored to label history and patent expiration timing; those inputs are not provided here.
• Decision-grade monitoring should prioritize trial readouts that confirm durability, failure-resistance patterns, and reduced oral lead-in or injection schedule constraints.

FAQs

1. What endpoints in cabotegravir trials most influence payer coverage decisions?
2. How do injection-site reactions and adherence management affect persistence for Cabenuva?
3. Which cabotegravir patent categories (substance, formulation, method-of-use) usually create the biggest barriers to generic entry?
4. What regulatory label expansions for cabotegravir have historically driven adoption beyond initial-switch populations?
5. How should a market model quantify switching conversion rate from oral INSTI/NNRTI regimens to long-acting injections for cabotegravir?