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

NCT06646562

/ RecruitingPhase 4IIT

Long Acting Cabotegravir Plus Rilpivirine in People Living with HIV-1 Aged ≥ 60 Years for 24 Months.

People Living with HIV-1 (PLHIV) are an important group of patients attending their specialist's and continue growing thanks to efficacy antiretroviral treatment (ART), allowing them to stabilize the HIV-infection and to live a normal life despite the infection. The present study is encouraged to demonstrate that efficacy and security of CAB LA + RPV LA treatment's on this population remains the same compared to younger population of patients. This study also registers some metabolic and hepatic parameters to observe a hypothetical improvement on these parameters, as the population may suffer more comorbidities than younger population and therefore tolerability and convenience gains a huge importance on them. Psychosocial aspects are also very important in these patients as these patients may suffer social stigma, and therefore suffering certain psychological disorders.

Start Date03 Mar 2025

Sponsor / Collaborator

ViiV Healthcare Ltd.

TCTR20250218001

/ RecruitingPhase 3IIT

Changes in sleep quality following a switch of antiretroviral regimen from three to two drugs: A comparative study between dolutegravir and lamivudine (DTG + 3TC) and dolutegravir and rilpivirine (DTG + RPV)

Start Date04 Feb 2025

Sponsor / Collaborator-

100 Clinical Results associated with Rilpivirine Hydrochloride

100 Translational Medicine associated with Rilpivirine Hydrochloride

100 Patents (Medical) associated with Rilpivirine Hydrochloride

1,991

Literatures (Medical) associated with Rilpivirine Hydrochloride

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Treatment persistence among treatment-experienced people with HIV switching to integrase strand transfer inhibitor–based antiretroviral regimens

Article

Author: Chen, Megan ; de Boer, Melanie ; Trom, Cassidy ; Chuo, Ching-Yi ; Christoph, Mary J. ; Zachry, Woodie

AIMS:

Low rates of persistence are associated with poor outcomes in people with HIV (PWH). This retrospective cohort study assessed treatment persistence as measured by time to treatment switch in treatment-experienced (TE) PWH initiating integrase strand transfer inhibitor (INSTI)-based regimens.

METHODS:

United States prescription claims and medical history data from the IQVIA Longitudinal Access and Adjudication Dataset between January 1, 2018, and August 31, 2023, were analyzed. TE PWH with ≥1 prescription claim for initiation of an INSTI-based antiretroviral regimen during the index period (January 1, 2020, to December 31, 2022) were included. Descriptive analyses of demographic and comorbidity variables were performed, stratified by regimen. Kaplan-Meier analysis was used to evaluate time to subsequent treatment switch in the overall population and among PWH aged ≥50 years, those receiving Medicare, and those with mental health conditions or substance use disorders.

RESULTS:

Overall, 29,348 TE PWH were included. The majority of INSTI-based regimen initiations were for bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (61%; n = 17,917), followed by dolutegravir/lamivudine (27.4%; n = 8034) and cabotegravir + rilpivirine (7.4%; n = 2186). A subsequent switch occurred in 3341 (11.4%) PWH. Risk factors for switch included female sex, Medicare/Medicaid coverage, and higher Charlson Comorbidity Index scores. B/F/TAF was associated with the fewest subsequent switches (9.2%; n = 1656) and was significantly less likely than any other regimen to lead to a subsequent switch, either in the overall population or in the three at-risk subgroups.

LIMITATIONS:

No data are available to determine the underlying reasons for initial treatment choice or subsequent treatment switch.

CONCLUSIONS:

This study provides evidence for greater treatment persistence with B/F/TAF versus other INSTI-based regimens. Unlike prior studies that focused on treatment-naïve individuals, this analysis uniquely evaluates persistence among treatment-experienced PWH initiating newer INSTI-based regimens.

01 Dec 2025·Current HIV/AIDS Reports

Long-Acting Injectable Antiretroviral Therapy for Treatment of Human Immunodeficiency Virus: A Review

Review

Author: Brotherton, Amy L ; Rossi, Michael R ; Beckwith, Curt G ; Sanchez, Martha C ; Johnson, Jennie E

PURPOSE OF REVIEW:

Long-acting injectable (LAI) antiretroviral therapy (ART) for treatment of HIV-1 are approved both as a complete treatment regimen (cabotegravir/rilpivirine) and as an additional treatment option (lenacapavir) for those with multidrug resistant HIV-1. Here, we review the data supporting these approvals, pharmacokinetics, and additional patient populations that many benefit from LAI ART.

RECENT FINDINGS:

Persons with HIV and adherence challenges as well as those in low-and-middle income countries have high rates of adherence and viral suppression with LAI ART. LAI cabotegravir/rilpivirine (CAB/RPV) offers an alternative treatment approach to daily oral ART for people with HIV-1 infection that is associated with high rates of patient satisfaction when compared to daily oral ART. LAI CAB/RPV is currently only approved in those with HIV-1 viral suppression, however recent data support the use of LAI ART in populations with adherence challenges. Furthermore, given high rates of NNRTI resistance globally, CAB/RPV is not recommended in low-and-middle income countries presently, although this recommendation is likely to change based on recently published data. More research is needed among groups that may benefit from long-acting treatments for HIV-1.

01 Nov 2025·BIOORGANIC & MEDICINAL CHEMISTRY

Synthesis and biological evaluation of N-acyl diaryl pyrimidines (NDAPYs) as novel reverse transcriptase inhibitors

Article

Author: Shaikh, Taslim B ; Alli, Vidya Jyothi ; Yadav, Pawan ; Grée, René ; Sule, Swapnil Anil ; Ahsan, Mohammed Jawed ; Jadav, Surender Singh ; Andugulapati, Sai Balaji

Diaryl pyrimidines (DAPYs) are privileged structures for Non-Nucleosidic Reverse Transcriptase Inhibitors (NNRTIs), and they are considered as one of the fundamental scaffolds of existing anti-HIV agents. In this study, we designed novel molecules by the addition of a N-acyl group to the C4-position of Rilpivirine/Etravirine basic scaffold, a well-known class of DAPYs, in order to provide more interactions with K103 and E138 in Reverse Transcriptase. This was leading, as expected, to better in vitro RT inhibition, and the compounds 12c (56 %) and 12 k (49 %) demonstrated three-fold higher potency than Doravirine (17 %). Additionally, compound 12c was identified as a strong and 12k as a moderate HIV reverse transcriptase enzyme inhibitor in the in vitro experiments. DAPYs are also crucial in the development of novel anti-cancer agents targeting several kinases, and our compounds, 12d and 12j, exhibited moderate cytotoxicity with IC₅₀ values of 14.21 and 10.16 μM, respectively, against PC-3 cells and caused cell cycle arrest at G2/M checkpoint. The compound 12d induced apoptosis and reduced angiogenesis in PC-3 cells. Additionally, preliminary kinase screening against a panel of eight human kinases demonstrated only low PIM1 inhibition. However, the absence of correlation with cytotoxicity advocates an alternative mode of action that ought to be determined. Altogether, these studies indicate that the C4-position of diaryl pyrimidines could be important and warrants further investigated towards optimization of potential reverse transcriptase inhibitors.

127

News (Medical) associated with Rilpivirine Hydrochloride

18 Aug 2025

·www.prnewswire.com

RedHill Received Talicia® Licensing Payments Totaling $1.1 Million

RedHill has received its first Talicia sales milestone payment as well as royalties and other payments, totaling $1.1 million, following the first ex-U.S. commercial launch of Talicia in 2024 Talicia is the first FDA-approved rifabutin-based product specifically designed to treat Helicobacter pylori (H. pylori), a bacterial infection with high and rising resistance rates that affects over 50% of the world's adult population[1] and is the strongest risk factor for gastric cancer and peptic ulcer disease Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists[2] for treatment of H. pylori infection and was granted a Qualified Infectious Disease Product (QIDP) designation by the FDA, providing eligibility for a total of eight years of U.S. market exclusivity; Talicia is patent protected through 2042 RALEIGH, N.C., Aug. 18, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has received its first Talicia[3] ex-U.S. sales milestone, royalties and other payments totaling approximately $1.1 million. "The presence of H. pylori infection is the strongest risk factor for gastric cancer and peptic ulcer disease and there is a significant global medical need for a highly effective first-line H. pylori therapy," said Rick Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer. "H. pylori is a major public health concern, with over 50% of the world's adult population infected. Talicia offers the best hope for patients and physicians in an era of increased resistance with clarithromycin-based therapies[4],[5]. As we work to bring Talicia to more patients globally, we continue our discussions with potential partners and expect to secure additional non-dilutive ex-US licensing revenue streams. Clarithromycin-based triple therapy continues to wane in effectiveness. A 2021 study demonstrated only 68.5% eradication with traditional clarithromycin-based triple therapy, which declined further to 32% in patients harboring resistant H. pylori organisms[6]. Clarithromycin-based treatment efficacy has also been reported to be negatively impacted by patient obesity or diabetic status, neither of which impacts Talicia's safety or efficacy, according to data from post-approval post-hoc analysis [7],[8]. In contrast, in the pivotal Phase 3 study, Talicia demonstrated up to 90% eradication of H. pylori infection in adherent patients (p<0.0001) with minimal to zero antibiotic resistance to rifabutin, a key component of Talicia, detected[9]. About H. pylori H. pylori is a bacterial infection that affects approximately 35%[10] of the U.S. population, with an estimated 1.6 million patients treated annually[11]. Worldwide, more than 50% of the population has H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[12] and a major risk factor for peptic ulcer disease[13] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[14]. More than 27,000 Americans are diagnosed with gastric cancer annually[15]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[16]. About Talicia Talicia is the only low-dose rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria seen with other antibiotics. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG and FDA in recent years. Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm. Talicia is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2042 with additional patents and applications pending and granted in various territories worldwide. Talicia is approved and commercialized in the United States and the United Arab Emirates. TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATION Talicia is a three-drug combination of omeprazole, a proton pump inhibitor, amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial, indicated for the treatment of Helicobacter pylori infection in adults. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs, Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION Talicia contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycin. Talicia is contraindicated in patients receiving rilpivirine-containing products. Talicia is contraindicated in patients receiving delavirdine or voriconazole. Serious and occasionally fatal hypersensitivity reactions have been reported with omeprazole, amoxicillin and rifabutin. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Severe cutaneous adverse reactions (SCAR) (e.g., Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)) have been reported with rifabutin, amoxicillin, and omeprazole. Additionally, drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with rifabutin. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis. Talicia may cause fetal harm. Talicia is not recommended for use in pregnancy. Talicia may reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia. Talicia should not be used in patients with hepatic impairment or severe renal impairment. Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs. These events have occurred as both new onset and exacerbation of existing autoimmune disease. The most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma INC. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or . Full prescribing information for Talicia is available at About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults3. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements, including, but not limited to, statements regarding the intended use of net proceeds from the offering, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the risk that the Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, non-dilutive development funding from RHB-107 and its inclusion in a key platform study. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, market and other conditions, the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for opaganib for any indication, the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107, the risk that HB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required, as well as risks and uncertainties associated with the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia® and Aemcolo®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Logo: Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma [email protected] +972-54-6543-112 Category: Commercial 1. Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 2. IQVIA XPO Data on file. 3. Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . 4. Savoldi, A., et al., Prevalence of Antibiotic Resistance in Helicobacter pylori: A Systematic Review and Meta-analysis in World Health Organization Regions. Gastroenterology, 2018. 155(5): p. 1372-1382 e17. 5. Park, J.Y., et al., Helicobacter pylori Clarithromycin Resistance and Treatment Failure Are Common in the USA. Dig Dis Sci, 2016. 61(8): p. 2373-2380. 6. Chey, W.D., et al., Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology, 2022. 163(3): p. 608-619. 7. Diabetes Data on File. 8. Kao, J.Y., Helicobacter pylori eradication by low-dose rifabutin triple therapy (RHB-105) is unaffected by high body mass index. GastroHep, 2021. 3(7): p. 426-434. 9. Graham DY, Canaan Y, Maher J, Wiener G, Hulten KG, Kalfus IN. Rifabutin-based triple therapy (RHB-105) for Helicobacter pylori eradication: a double-blind, randomized, controlled trial. Ann Intern Med. 2020;172(12):795-802. 10. Hooi JKY et al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. 11. IQVIA Custom Study for RedHill Biopharma, 2019. 12. Lamb A et al. Role of the Helicobacter pylori–Induced inflammatory response in the development of gastric cancer. J Cell Biochem 2013;114.3:491-497. 13. NIH – Helicobacter pylori and Cancer, September 2013. 14. Hu Q et al. Gastric mucosa-associated lymphoid tissue lymphoma and Helicobacter pylori infection: a review of current diagnosis and management. Biomarker research 2016;4.1:15. 15. National Cancer Institute, Surveillance, Epidemiology, and End Results Program (SEER). 16. Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report, Gut 2012;61:646-664; O'Connor A. et al. Treatment of Helicobacter pylori Infection 2015, Helicobacter 20 (S1) 54-61; Venerito M. et al. Meta-analysis of bismuth quadruple therapy versus clarithromycin triple therapy for empiric primary treatment of Helicobacter pylori infection. Digestion 2013;88(1):33-45. SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultPhase 2Drug ApprovalLicense out/in

24 Jul 2025

·www.shionogi.com

ViiV Healthcare’s Presentation on the VOLITION Study of Long-Acting Injectable Cabenuva in HIV Treatment

• 89% of people living with HIV expressed a preference to switch from daily oral therapy to long-acting injectable Cabenuva OSAKA, Japan, July 24, 2025 - Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that ViiV Healthcare Ltd. (“ViiV”), in which Shionogi holds equity alongside GlaxoSmithKline plc and Pfizer Inc., has presented results from the Phase IIIb VOLITION study of Cabenuva at the 13th International AIDS Society Conference (IAS 2025). The VOLITION study was conducted in treatment-naïve adults living with HIV. Following rapid viral suppression with daily oral Dovato (dolutegravir and lamivudine), participants were offered the choice to either continue with Dovato or switch to the long-acting injectable Cabenuva (cabotegravir and rilpivirine). Results showed that 89% (n=129/145) of participants chose to switch to Cabenuva. The most commonly cited reasons were “Not having to worry about missing a dose each day” (80%) and “Not having to carry medication” (68%). These findings highlight the potential of long-acting regimens to improve adherence and overall treatment satisfaction among people living with HIV. Shionogi has positioned “Protect people from the threat of infectious diseases” as one of its key material issues and is committed to addressing the three major infectious diseases—HIV, tuberculosis, and malaria—through comprehensive initiatives. With over 60 years of experience in infectious disease research and development, Shionogi will continue to work in partnership with ViiV Healthcare to contribute to global health by advancing both treatment and prevention strategies for HIV. Reference: About Dovato (marketed in Japan as Dovato Combination Tablets) Dovato is a daily oral two-drug regimens containing dolutegravir 50 mg and lamivudine 300 mg. It is approved for the treatment of HIV-1 infection in adults who are either treatment-naïve or virologically suppressed on antiretroviral therapy, with no known resistance to dolutegravir or lamivudine. About Cabenuva (marketed in Japan as Vocabria Intramuscular Suspension and Rekambys® Intramuscular Suspension) Cabenuva is the world’s first long-acting injectable for HIV treatment. It is approved in major markets including Japan, the U.S., Europe, and China as a treatment option administered once every two months.1 In addition to the results of this study, multiple real-world data led by ViiV Healthcare—including COMBINE-2, CARLOS, BEYOND, and OPERA—have demonstrated high efficacy, tolerability, and improved adherence, contributing to enhanced treatment satisfaction across a broad range of patient populations.2 1. ViiV Healthcare Press Release: February 26, 2024 LATITUDE PHASE III INTERIM TRIAL DATA INDICATES ViiV HEALTHCARE’S LONG-ACTING INJECTABLE HIV TREATMENT CABENUVA (CABOTEGRAVIR + RILPIVIRINE) HAS SUPERIOR EFFICACY COMPARED TO DAILY THERAPY IN INDIVIDUALS LIVING WITH HIV WHO HAVE ADHERENCE CHALLENGES 2. ViiV Healthcare Press Release: July 14, 2025 ViiV HEALTHCARE DATA SHOW 89% OF TREATMENT-NAÏVE PEOPLE WITH HIV CHOOSE TO SWITCH TO LONG-ACTING INJECTABLE VOCABRIA + REKAMBYS FROM DAILY PILLS AFTER ACHIEVING RAPID VIRAL SUPPRESSION Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. For Further Information, Contact: SHIONOGI Website Inquiry Form: https://www.shionogi.com/global/en/contact.html

Phase 3Clinical ResultDrug Approval

15 Jul 2025

·www.fiercepharma.com

GSK expands Medicines Patent Pool deal to allow generic production of cabotegravir for HIV treatment

Through the Medicines Patent Pool, GSK will allow generic drugmakers to produce and supply their versions of long-acting injectable cabotegravir as part of a treatment to HIV patients in poorer nations. GSK has expanded its voluntary licensing agreement with the United Nations-backed Medicines Patent Pool (MPP) for cabotegravir, allowing it to be produced by three generic drugmakers and supplied to patients in poorer nations for HIV treatment.The adjustment comes the same day that the World Health Organization (WHO) updated its guidance, recommending the long-acting injectable combo treatment of Cabenuva, or cabotegravir and rilpivirine, as an alternative to daily oral therapy for patients who are virally suppressed.Rilpivirine, which was developed by Johnson & Johnson and is known commercially in its oral formulation as Edurant, was approved by the FDA as an HIV treatment in 2011 and already has generic versions available outside the U.S.“This step is closely aligned with WHO’s new recommendation of long-acting injectable antiretrovirals as an alternative for people who are virologically suppressed but face adherence challenges with daily oral regimens,” Meg Doherty, the director of the WHO’s global HIV, hepatitis and STI programs, said in a release.The agreement comes on top of a licensing deal in 2022, which allowed specified generic drugmakers to produce their versions of cabotegravir for pre-exposure prophylaxis (PrEP). The long-acting drug, injected every two months, earned an FDA approval in 2021 under the brand name Apretude as a single agent for HIV prevention. The MPP licensing deal allows generic drugmakers Aurobindo, Cipla and Viatris to produce and supply their version of the treatment to all countries in Sub-Saharan Africa, as well as those in the world classified as low-income and lower-middle-income. The deal covers 133 nations.“Expanding access to long-acting options like this supports a more person-centered, choice- and needs-driven approach, which is exactly what an equitable and effective HIV response requires,” Charles Gore, the executive director of the MPP, added in a release. The agreement comes a week after Gilead signed on to provide its newly approved long-acting, injected PrEP drug Yeztugo at a not-for-profit rate to poorer nations around the world. The deal was struck with the Global Fund to Fight AIDS, Tuberculosis and Malaria and is designed to provide coverage for up to 2 million people over three years. Before that, Gilead had inked agreements with six generic drug manufacturers to make and sell Yeztugo across 120 high-incidence, resource-limited countries.Last month, the FDA signed off on Yeztugo as a twice-yearly alternative to Apretude.

License out/inDrug Approval

100 Deals associated with Rilpivirine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D09720 D09958	Rilpivirine Hydrochloride	J05AG05	DB08864

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Janssen Products LP	20 May 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pregnancy	Phase 3	United States	Janssen Scientific Affairs LLC	09 Apr 2009
Pregnancy	Phase 3	Puerto Rico	Janssen Scientific Affairs LLC	09 Apr 2009
Hepatitis	Phase 1	United States	ViiV Healthcare Ltd.	01 Nov 2011
Hepatitis C	Phase 1	-	Tibotec Pharmaceuticals	01 Nov 2010
Contraception	Phase 1	-	Tibotec Pharmaceuticals	01 Jul 2008
Contraception Behavior	Phase 1	-	Tibotec Pharmaceuticals	01 Jul 2008
Acquired Immunodeficiency Syndrome	Phase 1	-	Tibotec Pharmaceuticals	01 Jun 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03635788 (LATITUDE , CTgov)	Phase 3	HIV Infections	456	CAB-LA Maintenance Dose+Oral CAB+RPV-LA Loading Dose (Step 2 Arm A: LA ART)	tjhhkeisyk = sxgldvdcsn dagshkgnfk (xgqgpjfsqa, fdatyngdml - ramteeisvk) View more	-	24 Apr 2025
				Standard of Care (SOC) Oral ART (Step 2 Arm B: SOC)	tjhhkeisyk = jdsnhpktgu dagshkgnfk (xgqgpjfsqa, otarpuszvv - tcbggdexvm) View more
NCT03497676 (IMPAACT 2017/MOCHA, Pubmed \| Lancet HIV)	Phase 1/2	HIV Infections	139	Long-acting Injectable Cabotegravir 600 mg + Long-acting Injectable Rilpivirine 900 mg	rwqdjbwgff(qpnydjaioe) = 10.8% [95% CI 6.2-17.2] of all 139 participants in the evaluable analysis population had at least one adverse event of grade 3 or above by week 24 hsrgxubrrq (kyygfnwnju ) View more	Positive	01 Mar 2025
NCT00799864 (PAINT, CTgov)	Phase 2	HIV Infections	54	Rilpivirine (Cohort 1 Adolescents: Rilpivirine 25 mg)	tntkzybktt(jiqosiplob) = rirxbvlwtk gxryqswsba (mzcqzrospq, 38.0) View more	-	25 Jun 2024
				Rilpivirine (Cohort 2 Children (>=25 kg): Rilpivirine 25 mg)	tntkzybktt(jiqosiplob) = mrawpsainz gxryqswsba (mzcqzrospq, 52.2) View more
NCT04012931 (CTgov)	Phase 2	HIV Infections	26	Rilpivirine (Rilpivirine 12.5 Milligrams (mg) (<20 kg))	ljduqqxurd(ycblueiesu) = timjmiqtan bqkhafqmcx (vsgybnnmvg, NA) View more	-	02 May 2024
				Rilpivirine (Rilpivirine 15 mg (<20 kg))	ekkqwtcvxa(vnzkdqsuhg) = ryoaoyebvu xicbgdorjq (lyfztypgri, NA) View more
NCT00543725 \| NCT00540449 (THRIVE, FDA) Manual	Phase 3	HIV Infections	-	EDURANT + BR	oodkchhmgb(audaogwdbo) = bfigacjdnv dukrhedbrn (qmmbjutunv ) View more	Superior	15 Mar 2024
				Efavirenz + BR	oodkchhmgb(audaogwdbo) = ivvxfcmeqx dukrhedbrn (qmmbjutunv ) View more
TMC278-C213 (FDA) Manual	Phase 2	HIV Infections	-	EDURANT+BR (HIV RNA ≤100,000)	hlgtchavpy(vniesjwqxe) = bbljgovjxh wharljiodh (vlcteagmew ) View more	Superior	15 Mar 2024
				EDURANT+BR (HIV RNA >100,000)	hlgtchavpy(vniesjwqxe) = ntexfyvswu wharljiodh (vlcteagmew ) View more
NCT04399551 (CARISEL, CTgov)	Phase 3	HIV Infections	437	Continuous Quality Improvement (CQI) calls	xcpekxbptw = udkkrlcwrt maphybmykc (nyoopaleii, acgnazexuv - gzwnwmldky)	-	19 May 2023
NCT04399551 (CARISEL, Corporate Publications) Manual	Phase 3	HIV Infections	437	Cabotegravir+Rilpivirine Hydrochloride	jljyucwrlq(enjrllsxvv) = nubvvytkqw gwxlpeqrci (kggyvkzdhl ) View more	Positive	24 Oct 2022
NCT03639311 (Pubmed) Manual	Phase 2	HIV Infections	97	CAB+RPV long-acting	tuagzqsgpx(muktuzugeu) = lxyrkdcspa iiljjxkrry (zwlbcnrvaa ) View more	Positive	01 Feb 2022
				dolutegravir/RPV	tuagzqsgpx(muktuzugeu) = gjimhuuidn iiljjxkrry (zwlbcnrvaa ) View more
NCT04001803 (CUSTOMIZE, CTgov)	Phase 3	HIV Infections	115	CAB+RPV LA (Staff Study Participants)	trtwsrsvfn(beqwyufmto) = vdtrdoluvw txgjcakvwa (ccamefnzft, 0.42) View more	-	10 Jan 2022
				long-acting (LA)+CAB LA+Rilpivirine (RPV) (Participants With HIV Infection)	kxcuplykpz(qhcgwubxkt) = uiggfialyt mspjjydzqs (mjplyliuhq, 0.74) View more

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