RegulationFast Track (United States), Special Review Project (China), Priority Review (Australia), Priority Review (United States), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC19H17F2N3NaO5

InChIKeyNOSILXJBCIUPCT-KIUAEZIZSA-N

CAS Registry1051375-13-3

Clinical Trials associated with Cabotegravir sodium

NCT06854029

/ Not yet recruitingPhase 4IIT

Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.

Start Date01 Nov 2025

Sponsor / Collaborator

Duke University

[+4]

NCT06336434

/ Not yet recruitingPhase 1/2IIT

Phase I/II Study of the Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Adults With HIV-1

This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.

Start Date01 May 2025

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT06704204

/ Not yet recruitingNot ApplicableIIT

Long-acting Injectable Antiretroviral Treatment to Improve HIV Treatment Among Justice-involved Persons Being Released to the Community (Study #3; Aim 2 Injectable CAB/RPV Pilot)

The federal research award entitles "Long-acting injectable antiretroviral treatment to improve HIV treatment among justice-involved persons being released to the community" aims to Conduct interviews with justice and treatment experienced PWH (n=20), and carceral and community key stakeholders (n=20), to obtain guidance on the development and implementation of a protocol to transition PWH with viral suppression on oral ART to LAI ART in prison with continuation during community re-entry; develop an initial LAI ART community re-entry protocol based on Aim 1 findings and conduct an open label pilot study. Post-release follow up will occur for three months among 20-30 incarcerated PWH eligible for LAI ART who are near release from prison in order to optimize protocol procedures including participant recruitment, initiation of LAI ART in prison, transition of LAI ART to community providers, and to pilot study retention methods and assessments, including post-release HIV viral loads and urine drug testing, during the follow-up period.

Start Date01 Feb 2025

Sponsor / Collaborator

The Miriam Hospital

[+1]

100 Clinical Results associated with Cabotegravir sodium

100 Translational Medicine associated with Cabotegravir sodium

100 Patents (Medical) associated with Cabotegravir sodium

1,312

Literatures (Medical) associated with Cabotegravir sodium

01 Dec 2025·Current HIV/AIDS Reports

Understanding the Drivers of CAB PrEP Uptake and Use among Women in sub-Saharan Africa to Build Demand for New PrEP Methods

Review

Author: Schwartz, Katie ; Donaldson, Emily ; Bishopp, Casey ; Mungai-Barris, Zoe ; Briedenhann, Elmari ; Irungu, Elizabeth

Abstract:

Purpose of Review:

As injectable cabotegravir for pre-exposure prophylaxis (CAB PrEP) is introduced in sub-Saharan Africa, it is important to understand how behavioral drivers may influence women’s decisions around whether or not to use it.

Recent Findings:

Facilitating factors include prior familiarity with injections and the perceived efficacy of CAB PrEP, while barriers include a fear or dislike of needles and negative attitudes held by community members and influencers. Further research is needed to fully understand behavioral factors affecting African women’s CAB PrEP use.

Summary:

HIV prevention policymakers, practitioners, advocates, and clients are optimistic about CAB PrEP, predicting that this long-acting method will be popular among women in sub-Saharan Africa. However, women may also face barriers to use. Knowledge of behavioral facilitators and barriers can enhance the adaptation or development of HIV prevention communication and demand generation strategies that support informed decision-making in a multi-method market.

01 Apr 2025·AIDS

Immediate virological failure with intramuscular cabotegravir–rilpivirine in a patient long suppressed with dolutegravir–rilpivirine

Article

Author: Reus, Sergio ; Boix, Vicente

01 Apr 2025·UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS

Clinical significance of PSA dynamics in castration-sensitive prostate cancer treated with ARSI doublet therapy: A multicenter study

Article

Author: Urabe, Fumihiko ; Miki, Jun ; Kimura, Takahiro ; Iwatani, Kosuke ; Yanagisawa, Takafumi ; Tashiro, Kojiro ; Takahashi, Hidetsugu ; Mori, Keiichiro ; Shimomura, Tatsuya ; Habuchi, Tomonori ; Hatakeyama, Shingo ; Narita, Shintaro ; Katsumi, Kota ; Fukuokaya, Wataru ; Muramoto, Katsuki

BACKGROUND:

Androgen receptor signaling inhibitors (ARSIs) have revolutionized the treatment of metastatic castration-sensitive prostate cancer (mCSPC). Prostate-specific antigen (PSA) dynamics, including PSA nadir, PSA response rate, and time to PSA nadir (TTN), are well-established markers of disease control. We evaluated the clinical significance of these PSA dynamics using data from a multicenter clinical database for mCSPC patients.

METHODS:

We conducted a multicenter retrospective study including 552 mCSPC patients treated with ARSI and ADT, and 262 patients treated with combined androgen blockade (CAB). PSA nadir, PSA response rate, and TTN were evaluated using predefined cut-offs. Clinicopathological data were collected and subsequently analyzed using multivariate Cox regression models to investigate impact of the PSA dynamics on oncological outcomes, including castration resistant prostate cancer free survival (CRPCFS), cancer-specific survival (CSS), and overall survival (OS). Propensity score matching (PSM) was used to minimize selection bias and balance baseline characteristics between treatment the groups. The achievement rates of low PSA nadir and high PSA response were then evaluated.

RESULTS:

In the ARSI cohort, 36.4% of patients achieved a PSA nadir of ≤ 0.02 ng/mL, and 65.8% attained a PSA response rate of ≥ 99 %. Notably, patients with a PSA nadir of ≤ 0.02 ng/mL, a PSA response rate ≥ 99%, and TTN > 12 months demonstrated significantly improved oncological outcomes. Multivariate analyses confirmed that these PSA dynamics were independent predictors of favorable oncological outcomes. A PSA nadir of ≤ 0.02 ng/mL was as an independent predictor of improved oncological outcomes compared to a nadir of > 0.2 ng/mL (CRPCFS: HR, 0.063; CSS: HR, 0.12; OS: HR, 0.15; P < 0.001). A PSA response rate of ≥ 99% compared to < 95%, also independently predicted more favorable outcomes (CRPCFS: HR, 0.29; CSS: HR, 0.26; OS: HR, 0.30; P < 0.001). Furthermore, a TTN > 12 months was also an independent predictor of improved survival compared to TTN ≤ 3 months (CRPCFS: HR, 0.12; CSS: HR, 0.08; OS: HR, 0.12; P < 0.001). PSM with a 1:1 ratio was associated with significantly higher rates of PSA nadir ≤ 0.02 ng/mL and PSA response rate ≥ 99% in the ARSI doublet group compared to the CAB group.

CONCLUSIONS:

Our study demonstrates that achieving a PSA nadir ≤ 0.02 ng/mL, a PSA response rate ≥ 99%, and a longer TTN are associated with significantly improved oncological outcomes. Furthermore, we elucidated how PSA dynamics differ between ARSI doublet therapy and CAB, highlighting the distinct characteristics of each. These findings provide valuable clinical information for guiding the management and prognosis of mCSPC in routine clinical practice.

118

News (Medical) associated with Cabotegravir sodium

12 Mar 2025

·pipelinereview.com

ViiV Healthcare’s investigational broadly neutralising antibody - N6LS - successfully maintains viral suppression in long-acting treatment of HIV

LONDON, UK I March 12, 2025 I ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from the company’s EMBRACE phase IIb study. 1 The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants. These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S. Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said :”As leaders in long-acting injectable innovation, we are building on the positive patient and physician experience we have with Cabenuva and pioneering the next generation of long-acting treatment options. The EMBRACE study demonstrated that VH109, a CD4-binding broadly neutralising antibody, administered every four months with cabotegravir, achieved high efficacy and was well tolerated through six months. We’re looking forward to continuing the development of VH109 as a component of our future ultra long-acting regimens.” Results from the EMBRACE study at the six-month primary endpoint showed that 96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group. VH109 was administered in both arms every four months, combined with monthly CAB LA. Confirmed virologic failure was observed in two participants from each VH109 group. Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher, compared to none in the standard-of-care group when measured at month six. VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration. Adverse events specific to the use of study medication were reported in 64% of the IV group and 65% of the SC group, with 16% of participants in the SC group experiencing grade 3-4 adverse events (erythema). No participants in the IV group experienced a grade 3-4 adverse event. Based on the favourable results seen in the trial, ViiV Healthcare will be progressing a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial. About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information . Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. References 1 Taiwo, B et al. VH3810109 (N6LS) Efficacy and Safety in Adults Who Are Virologically Suppressed: The EMBRACE Study. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA SOURCE: ViiH Healthcare

Clinical ResultDrug ApprovalPhase 2Phase 3

12 Mar 2025

·www.fiercebiotech.com

GSK posts data on HIV assets vying for roles in 6-month combo

ViiV plans to make a regimen selection for treatment next year.\n GSK’s ViiV Healthcare has shared clinical data on three potential long-acting HIV treatments, providing a look at how its plans to create a six-month regimen are shaping up.ViiV, which is majority owned by GSK with Pfizer and Shionogi as shareholders, has identified demand for long-acting HIV treatments that are less burdensome for patients. With Gilead fighting hard for market share, ViiV is racing on multiple fronts to meet the demand. The company used the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco to share data on three parts of its plan.Wednesday, ViiV published phase 2b data on its investigational broadly neutralizing antibody N6LS. The study randomized 134 adults living with HIV to receive the CD4-binding antibody intravenously or subcutaneously or continue on pre-baseline, standard-of-care antiretroviral therapy. Patients in the N6LS groups received the antibody every six months and long-acting cabotegravir every month.After six months, 96% of people on intravenous N6LS, also called VH109, maintained HIV-1 RNA levels below 50 copies/mL. The result in the standard of care group was identical. However, only 88% of people on subcutaneous N6LS maintained HIV-1 RNA levels below the threshold. Confirmed virologic failure was seen in two patients from each N6LS group. Tolerability was worse in the subcutaneous group, with 16% of patients having grade 3 or 4 redness of the skin. The results informed ViiV’s decision to take a six-month intravenous formulation of N6LS into part two of the trial. Halozyme provided the technology that enabled subcutaneous delivery.ViiV shared the N6LS data the day after publishing results from studies of two other molecules that could form part of its six-month treatment regimen. The N6LS trial used monthly cabotegravir long-acting as its integrase strand transfer inhibitor (INSTI), but ViiV could combine the antibody with its third-generation candidate VH184 down the line.At CROI, ViiV showed viral load dropped after 22 adults, who had not previously received antiretroviral therapy, started on VH184. The study provided early evidence that the INSTI can drive down viral load without causing drug resistance mutations or serious side effects. But more work is needed to show the asset can be the backbone of ViiV’s regimen, starting with a phase 1 trial of long-acting formulations.ViiV is considering N6LS and its investigational capsid inhibitor VH499 as potential partners for VH184 in its planned six-month treatment regimen. The company shared data on VH499 at CROI, linking the asset to falls in the viral loads of 23 adults who received the candidate in a phase 2 trial. One person on the low dose developed a single mutation associated with reduced susceptibility to capsid inhibitors. ViiV said the data support further development of VH499 as a potential long-acting antiretroviral for HIV treatment. A phase 1 trial is assessing long-acting formulations of the capsid inhibitor. Data from studies of VH499 and N6LS will inform the decision about which molecule to combine with VH184.Talking on a GSK earnings call last month, ViiV Chairman David Redfern said (PDF) “the aim is to look at that data this year and then make a regimen selection for treatment ... next year.” ViiV could potentially start running pivotal studies in 2027, Redfern said.

Clinical ResultPhase 2Phase 1

12 Mar 2025

·endpts.com

#CROI25: Merck’s troubled HIV drug heads to regulators; ViiV seeks longer-acting HIV drug

Here are some of the most compelling HIV updates from the annual Conference on Retroviruses and Opportunistic Infections in San Francisco: Merck said Wednesday that a two-drug regimen consisting of doravirine, sold under the name Pifeltro, plus islatravir matched approved antiretroviral regimens in two Phase 3 studies for certain people with HIV. The drugmaker now plans to begin submitting applications for approval to regulators in mid-2025. In two studies, Merck compared adults with virologically suppressed HIV who switched from Gilead’s Biktarvy or standard antiretroviral therapy (ART) to Merck’s regimen with those who stayed on their current therapy. At week 48, the blinded study found that 1.5% of participants who switched to Merck’s regimen had a viral load of ≥50 copies/mL — the bar for detectable HIV viral load. Meanwhile, 0.6% of those who stayed on Biktarvy had a detectable viral load. In the open-label study, 1.4% of participants who received Merck’s experimental combo had a detectable viral load at week 48 compared to 4.9% on an approved ART. Islatravir is meant to block a key HIV enzyme needed for the virus to replicate. The experimental drug previously faced safety concerns over decreased immune cell counts, leading the company to pause studies and later lower the dosage of the drug it was testing. In the blinded study, two participants on Merck’s regimen and one on Biktarvy discontinued treatment due to a decrease in T cell or total lymphocyte count. (Both cases accounted for a 0.6% rate.) ViiV Healthcare, which is mostly owned by GSK, on Wednesday reported results from a Phase 2b study for its experimental antibody called N6LS. It dosed N6LS every four months alongside a monthly dose of cabotegravir, ViiV’s long-acting drug that’s approved for HIV prevention and as part of a treatment regimen. At six months, 96% of participants who received an intravenous version of the regimen maintained HIV levels below the detectable bar, while 88% who received a subcutaneous version did. That’s compared to the 96% in the standard-of-care group that maintained undetectable HIV levels. The HIV drug developer plans to next test the combo using a six-month dosing regimen in the second part of the study. “We are going forward with the intravenous and not following up with the subQ,” ViiV R&D head Kimberly Smith told Endpoints News . On Monday, Immunocore announced initial data for its T cell engager for HIV, which it is testing as a potential cure. The data are far too early to evaluate that claim but provide early insight into how a drug modality typically used for treating cancer can also be applied in infectious diseases. At the highest doses — 120 mcg and 300 mcg — one of five people and two of five people respectively experienced delayed viral rebound and/or viremia control at any point during a 12-week period in which they stopped taking ART. Two of the three people with delayed viral rebound remained off ART for the entire 12 weeks. Immunocore noted that the pattern of viral control in the three people consisted of an initial rebound followed by a subsequent decrease. “Such ‘regained’ post-treatment control may be associated with an immune response to the virus,” the biotech wrote in its press release. The study is continuing to test higher doses, Immunocore said. Gilead is also working on a T cell engager for HIV that’s in early-stage studies.

Clinical ResultPhase 3Phase 2

100 Deals associated with Cabotegravir sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D10548 D10549	Cabotegravir sodium	J05AR	DB11751

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HIV Infections	Canada	ViiV Healthcare Ltd.	21 Sep 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HIV-Associated Lipodystrophy Syndrome	Phase 1	United States	GSK Plc	01 May 2013
Hepatitis	Phase 1	United States	ViiV Healthcare Ltd.	01 Nov 2011
Herpesviridae Infections	Phase 1	-	ViiV Healthcare Ltd.	01 Sep 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04692077 (CTgov)	Phase 2	HIV Infections	9	Cabotegravir (CAB) tablet+Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet	hkdpfqxwtm(wrgrmdefwq) = hmdsulsenc pmhyazcuqy (cpimuorkct, 1.3) View more	-	29 Jan 2025
OPERA (BusinessWire) Manual	Not Applicable	HIV Infections	-	Apretude (cabotegravir long-acting (CAB LA))	lgadvlielm(zglaktpbfj) = tkpmvazywv ookmjhoran (qlafobbqjn )	Positive	16 Oct 2024
NCT04824131 (CTgov)	Phase 2	HIV Infections	55	Cabotegravir (Cabotegravir Long Acting)	qxlpyxfuho = uuetciogte klkuaudjgi (vtahprnhfn, faslapcuwl - npjpmyloum) View more	-	30 Jul 2024
				CAB (Step 1 - CAB LA Oral Phase)	weqrlmbudb(tmvsqwbtmj) = ssynthxavl difocsrkmh (wrcresatvq, pryipasqlu - lhyzcoeziu) View more
NCT03299049 \| NCT02951052 \| NCT02938520 (Pubmed \| J Infect Dis)	Phase 3	HIV Infections Maintenance	1,245	CAB + RPV LA every 4 week dosing	vrmatieesr(tjfadsbzzu) = cnuoiokwww esjwtffhmc (vfqobhacmh )	Positive	25 Jul 2024
				CAB + RPV LA every 8 week dosing	vrmatieesr(tjfadsbzzu) = fijdbopgnj esjwtffhmc (vfqobhacmh )
NCT02720094 (CTgov)	Phase 2/3	HIV Infections	4,570	Cabotegravir (Cabotegravir)	ithhaehqmn = kydknyamfn jckxxdyxqy (phmkfujisj, sbpbqvpukd - terrbcssqd) View more	-	24 Nov 2023
				FTC+TDF (TDF/FTC)	ithhaehqmn = zbttifnrhe jckxxdyxqy (phmkfujisj, mrzwxvjjjj - bhdkzjaxcz) View more
NCT04399551 (CARISEL, CTgov)	Phase 3	HIV Infections	437	Continuous Quality Improvement (CQI) calls	cyzkrkvknn = xebwiqwdvl wntcmlqpoq (gycyrfdfoo, sanjxyanaq - ezlyrdkfxr)	-	19 May 2023
NCT03164564 (HPTN 084, CTgov)	Phase 3	HIV Infections	3,224	Oral CAB+CAB LA+Oral TDF/FTC (Arm A: CAB + Placebo TDF/FTC + CAB LA)	spkcyopodh = yleodswpcs kqdemgaypf (tkepfvtsjl, djcexlkaiu - fcabblbjrs) View more	-	28 Mar 2023
				Placebo for CAB LA+Oral TDF/FTC (Arm B: TDF/FTC + Placebo CAB + Placebo CAB LA)	spkcyopodh = xmasbhubqu kqdemgaypf (tkepfvtsjl, coixdwpwrt - ebmzocbddx) View more
NCT04399551 (CARISEL, Corporate Publications) Manual	Phase 3	HIV Infections	437	Cabotegravir+Rilpivirine Hydrochloride	yxcbcngsmf(ndsjpqmuke) = yctpgwrbke czjpvxmexu (ovfmgnrwzw ) View more	Positive	24 Oct 2022
NCT04001803 (CUSTOMIZE, Pubmed)	Phase 3	HIV Infections	109	Cabotegravir + rilpivirine LA injections	rgecupyddq(spgcffvjqz) = cmmlubfzvo rbnogqgneb (xsqeftepav )	Positive	01 Sep 2022
NCT03164564 (HPTN 084, Corporate Publications) Manual	Phase 3	HIV Infections	3,224	Cabotegravir	firvsqonzn(ytbusixbll) = aboqnytaii vzonngkaqt (kpwegyfzhd ) View more	Superior	28 Jul 2022
				Emtricitabine+Tenofovir	firvsqonzn(ytbusixbll) = mobtcwkvyp vzonngkaqt (kpwegyfzhd ) View more

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