Efficacy and Safety of EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal Carcinoma: a Single-center, Single-arm Phase II Trial

Nearly all undifferentiated nasopharyngeal carcinoma (NPC) are associated with the Epstein-Barr Virus (EBV), which typically remains in a latent, non-immunogenic state within tumor cells. By combining EBV lytic induction strategy with standard chemo-immunotherapy, this study aims to create a synergistic anti-tumor effect and improve clinical outcomes for patients with recurrent/metastatic NPC (r/m NPC). This is a phase II, single-center, single-arm clinical trial designed to evaluate the efficacy and safety of a novel combination therapy in patients with r/m EBV-positive NPC.

Start Date19 Aug 2025

Sponsor / Collaborator

Sun Yat-Sen University

NCT06798909

/ RecruitingPhase 3IIT

Kidney Transplant Preemptive Therapy or Prophylaxis (KPoP) for CMV Prevention in D+R- Recipients

This is a prospective, randomized multicenter trial of preemptive therapy (PET) vs. antiviral prophylaxis (AP) for prevention of cytomegalovirus (CMV) disease in adult D+R- kidney transplant recipients (KTR). Patients meeting study eligibility criteria and who have provided informed consent will be randomized (1:1) within 7 days of transplant to receive, in an open label design, either AP with valganciclovir 900 mg orally once daily or letermovir 480 mg orally once daily [both dose adjusted per Food and Drug Administration (FDA) label] for 200 days post-transplant), or PET (central lab weekly plasma polymerase chain reaction (PCR) monitoring for CMV deoxyribonucleic acidemia (DNAemia)) for 100 days post-transplant, with oral valganciclovir 900mg orally twice daily (or renally dosed per FDA label) at onset of CMV DNAemia at any level and continued until plasma CMV DNAemia is negative or below the level of quantitation in two consecutive weekly plasma samples. Study participants will be followed for pre-specified outcomes (clinical, laboratory, immunologic, safety) until withdrawal, death, or study closure, up to a maximum of 5.5 years post-transplant. Approximately 360 participants (180 participants in each group) will be randomized into the study.
Estimated Time to Complete Enrollment: 4 years

Start Date22 Jul 2025

Sponsor / Collaborator

The University of California, San Francisco

[+1]

CTRI/2025/06/088638

/ Not yet recruitingNot Applicable

Open-label, prospective, multi-center, single-arm, academic clinical trial of oral Valganciclovir (VGCV) as pre-emptive therapy for low-risk cytomegalovirus reactivation following alloHCT in children - VALOR

Start Date01 Jul 2025

Sponsor / Collaborator-

100 Clinical Results associated with Valganciclovir Hydrochloride

100 Translational Medicine associated with Valganciclovir Hydrochloride

100 Patents (Medical) associated with Valganciclovir Hydrochloride

1,366

Literatures (Medical) associated with Valganciclovir Hydrochloride

01 Jan 2026·ANNALS OF VASCULAR SURGERY

A Case Series of Ruptured Fungal Mycotic Pseudoaneurysms in Renal Transplant Patients

Article

Author: Kabutey, Nii-Kabu ; Hegazi, Mennatalla ; Delgadillo, Daniel ; Chen, Samuel L ; Chau, Anthony H ; Fujitani, Roy M

Mycotic pseudoaneurysms (MPs) occur in <1% of renal transplant patients, with rupture being even rarer. We present clinical symptoms, surgical techniques, and postoperative courses of four transplant patients with MPs who presented with acute bleeding. All patients presented within 3 weeks of transplant. All patients underwent immunosuppression induction with rabbit anti-thymocyte globulin and high-dose steroids, and following transplant, were managed with a triple therapy immunosuppression regimen of mycophenolate sodium, a prednisone taper, and tacrolimus, as well as an infection prophylaxis regimen of valganciclovir, clotrimazole, and sulfamethoxazole-trimethoprim. All patients presented with bleeding originating from the iliac or transplant renal artery. Despite the antifungal prophylaxis, all four patients were found to have candida infections at the transplant site. Hemorrhage control was obtained using different techniques in each case, including open and endovascular techniques. Endovascular balloon occlusion was used for immediate stabilization, followed by open arterial resection, extra-anatomic bypass, or patch repair. One allograft was salvaged while three required nephrectomy. MPs in immunocompromised transplant patients may not present with infectious symptoms before rupture, but infection should be considered in acutely bleeding transplant patients. Open and endovascular approaches can be employed to control hemorrhage; however, infection risk must be considered with prosthetics.

01 Dec 2025·Blood Research

CMV infections after HSCT: prophylaxis and treatment

Review

Author: Chung, Haerim

Abstract:

Cytomegalovirus (CMV) infection remains a major complication in recipients of hematopoietic stem cell transplantation (HSCT) and contributes significantly to morbidity and mortality. Effective CMV prevention and management are essential for improving transplant outcomes. Preventive strategies include antiviral prophylaxis and preemptive treatments (PET). Letermovir, a terminase complex inhibitor, has become the standard of care for primary prophylaxis in CMV-seropositive recipients because of its efficacy and favorable safety profile. PET involves regular monitoring of CMV DNAemia via polymerase chain reaction (PCR) and initiation of antiviral therapy, most commonly ganciclovir or valganciclovir, upon detection of early viral reactivation. Refractory or resistant CMV infections present a significant therapeutic challenge and often require switching to a different antiviral class while awaiting genotypic resistance testing. Maribavir, a UL97 kinase inhibitor, has demonstrated superior efficacy and improved tolerability compared to conventional therapies in the phase 3 SOLSTICE trial, making it a promising therapy for refractory or resistant CMV. Optimal CMV management requires a risk-adapted, individualized approach that integrates prophylaxis, early detection, and timely intervention to reduce CMV-related complications.

01 Nov 2025·JOURNAL OF MEDICAL VIROLOGY

Valganciclovir Underdosing Is Associated With Cytomegalovirus DNAemia During Universal Prophylaxis: A Real‐Life Case Control Retrospective Study

Article

Author: Moal, Valérie ; Solignac, Justine ; Gully, Marion ; Brunet, Philippe ; Legris, Tristan ; Resseguier, Noémie ; Zandotti, Christine ; Rigon, Pierre‐Antonin

ABSTRACT:

Universal prophylaxis or a preemptive strategy with valganciclovir (VGCV) is recommended for prevention of cytomegalovirus (CMV) infections after kidney transplantation. We combined both strategies during the first 3 months post‐transplantation. The objectives were to define the incidence of CMV DNAemia and identify the associated factors during universal prophylaxis in a retrospective monocentric case‐control study. Cases presenting CMV DNAemia during the first 3 months post‐transplantation were matched to four controls each regarding sex, age, donor and recipient CMV serostatus, and induction treatment. We collected the rates of visits with VGCV underdosing, comparing the adjusted daily dosage to the kidney function and the received daily dosage. Despite prophylaxis, the incidence of CMV DNAemia was 5.1% between 2017 and 2020 in 300 patients. Rates of visits with VGCV underdosing during follow‐up were significantly higher in the cases group than in the controls group. In the cases group, the rate was higher when using estimated creatinine clearance rather than estimated glomerular filtration rate. VGCV underdosing was the only factor associated with CMV DNAemia in the multivariate analysis (OR: 1.04 95% CI: 1.011–1.061, p = 0.003), regardless of the formula used to estimate kidney function. Resistance to GCV was observed in 4 out of 15 cases, two of which had VGCV underdosing. In our study, CMV DNAemia was associated with VGCV underdosing that could be related to the absence of systematic adjustment during post‐transplantation follow‐up or to the use of inadequate kidney function assessment formulas to adjust VGCV dosages.

105

News (Medical) associated with Valganciclovir Hydrochloride

07 Nov 2025

·www.globenewswire.com

GenVivo to Present Phase 1 Trial Results for GEN2, A Personalizing Systemic Cancer Immunotherapy, at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting

GEN2 was evaluated in adult patients with advanced solid tumors in an intravenous dose escalation Phase 1 study GEN2 is well-tolerated, with no Dose Limiting Toxicity or treatment-related discontinuations Dose dependent increases in immunocytokines and vector persistence in peripheral blood mononuclear cells at the two highest dose levels support GEN2 transgene expression and mechanism of action SAN MARINO, Calif., Nov. 07, 2025 (GLOBE NEWSWIRE) -- GenVivo, Inc., a clinical-stage biopharmaceutical company pioneering a patented, off-the-shelf vector platform to combat cancer by activating the patient’s immune system against the entire repertoire of their own tumor antigens, announces the presentation of GEN2 Phase 1 clinical trial results in adult patients with advanced solid tumors (NCT06391918), at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 7-9, in National Harbor, MD. Poster Abstract Title: “Phase 1 Study of GEN2, A Personalizing Systemic Cancer Immunotherapy, in Adult Patients with Advanced Solid Tumor Malignancies”Session Date and Time for Poster Presentation: Friday, Nov. 7, 2025Abstract Number: 573Presenter: Anthony El-Khoueiry, MD GEN2, an off-the-shelf non-replicating mRNA vector, delivers two payload genes that provide dual-mechanisms of action: an enhanced prodrug-activator enzyme (HSV-eTK) and an immunostimulatory cytokine (GM-CSF). After valganciclovir (VGCV) prodrug administration, GEN2 triggers the local release of tumor-specific antigens (including neoantigens) to stimulate an immune response. This novel therapy enables faster treatment, as it does not require tumor biopsies or tumor-specific genomic sequencing to identify patient-specific neoantigens and create an individualized therapy prior to commencing treatment. GEN2 was dosed intravenously (IV) across five dose levels (3.4 × 10⁶ to 2 × 10⁸ TU/kg) in combination with VGCV in 23 patients in this Phase 1 dose-escalation trial. GEN2 was administered on Days 1, 3, and 8, followed by VGCV on days 12 to 21 during the four-week cycle. GEN2 demonstrated tolerability and minimal toxicity, with no Dose Limiting Toxicity (DLT) observed and no treatment-related discontinuations. Treatment-related adverse events included diarrhea (22%), nausea (17%), vomiting and fatigue (13% each), all Grade 1–2. Stable disease >24 weeks was observed. GEN2’s mechanism of action was supported through pharmacodynamic and biomarker data (including cytokines and other plasma proteins). Dose-dependent increases in GM-CSF were observed with intravenous GEN2 administration. Levels of IL-2, IFNγ, CCL4 and CCL3 also showed increasing trends, further indicating GEN2 induced biological activity. Vector persistence in peripheral blood mononuclear cells (PBMCs) confirmed GEN2’s transgene expression; elimination of the signal after VGCV administration demonstrated the effectiveness of the pro-drug activated enzyme, HSV-eTK. Cycle 2 Day 1 data showed a lower exposure than for Cycle 1 at the higher dose levels. This was coincident with the development of neutralizing antibodies; alternate dosing schedules, and premedication strategies to mitigate neutralizing antibody generation are under evaluation. A parallel intratumoral (IT) cohort continues in cutaneous malignancies. “GEN2 represents a unique systemic treatment modality employing an ‘off-the-shelf’ gene delivery vector that exerts immunotherapeutic effects through multiple mechanisms of action,” said Dr. Anthony El-Khoueiry, Chief of the Section of Developmental Therapeutics and Verna R. Richter Chair in Cancer Research at the University of Southern California (USC) Norris Comprehensive Cancer Center in Los Angeles, CA. “These data verified GEN2's gene transduction, consistent with its putative mechanism of action, resulting in increased cytokine and immunomodulatory protein biomarkers, and creating the potential to promote an anti-tumor immune response.” “The GEN2’s pharmacokinetic, pharmacodynamic, and safety data together with the demonstration of the effectiveness of the ‘off’-switch provide clinical validation of GenVivo’s G-VolveTM vector platform, the basis for GEN2,” said Dr. Robert G. Johnson, Chief Operating Officer of GenVivo, Inc. “The GEN2 data provide a solid foundation for advancing our G-VolveTM platform, including IL-12 and in vivo CAR-T vector programs.” GEN2’s IV administration represents a major advancement over alternative therapies limited by IT or Intralesional (IL) approaches, as local administration is usually restricted to readily accessible tumors. While clinical trials of oncolytic viruses or replication-deficient vectors have demonstrated encouraging results in skin, bladder, prostate, pancreatic, and lung cancers (sometimes showing abscopal effects in both injected and non-injected tumors), there are practical limitations to IT or IL administration. By contrast, GEN2’s IV administration enables treatment of advanced disease with distant metastases. About GenVivoGenVivo (GVO) is a private, vertically integrated, clinical-stage biotechnology company founded to develop innovative gene delivery and immune stimulation therapies, which activate the patient’s immune system to treat cancer and autoimmune disease. GenVivo is committed to developing and manufacturing products that are rapidly deployed, and easily administered, personalizing, and yet off-the-shelf, with the goal of increasing cancer patient survival and improving quality of life for them and patients with autoimmune disease. GEN2, GVO’s first clinical candidate, is currently in a Phase 1 clinical trial in the US (NCT06391918). GenVivo’s pre-clinical pipeline includes GEN-1013, an IL-12 encoding therapy, and an in vivo CAR-T vector program. For more information, visit https://genvivoinc.com/ Forward-Looking StatementsThis press release contains forward-looking statements of GenVivo, Inc. (“GenVivo”) that involve substantial risks and uncertainties. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are based on current scientifically based mechanisms, understandings, and expectations and are not guarantees of future performance. GenVivo may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. In addition, the forward-looking statements included in this press release represent GenVivo’s views as of the date of this press release. GenVivo anticipates that subsequent events and developments will cause its views to change. However, while GenVivo may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. “GenVivo,” the GenVivo logo and other trademarks, trade names or service marks of GenVivo appearing in this press release are the property of GenVivo. All other trademarks, trade names and service marks appearing in this press release are the property of their respective owners and are used for reference purposes only. Such use should not be construed as an endorsement of such products or companies. Contact Brian Korb Managing Director Brian.korb@partners.com Victor Constantinescu Head of Business Development BD@genvivoinc.com 626-768-5162

Phase 1ImmunotherapyClinical ResultASCOGene Therapy

26 Jun 2025

·www.echemi.com

Merck’s New CMV Drug Approved in China Targets Nearly 40000 HSCT Patients

On June 23, 2025, Merck announced that its novel non-nucleoside cytomegalovirus (CMV) inhibitor, Letermovir, in both tablet and injectable forms, has been approved by the National Medical Products Administration (NMPA) for use in children aged 6 months and above, weighing ≥6kg. The newly approved indication covers the prevention of CMV infection and disease in allogeneic hematopoietic stem cell transplant (HSCT) recipients who are CMV-seropositive (R+), including adults and children. According to Merck, Letermovir is the first and only CMV prevention therapy in China available for both pediatric and adult HSCT patients. CMV, a prevalent herpes virus, poses a severe threat to transplant recipients, significantly increasing transplant-related mortality rates. In China, CMV infection is widespread, with 60%-80% of infants testing positive for antibodies. Children, who lack fully developed immune systems, face an increased risk of CMV reactivation after transplantation. Data shows that in 2022 and 2023, there were 39,918 HSCT recipients in China, of which 9,860 were children—accounting for 1 in every 4 transplant patients. The approval of Letermovir addresses a critical unmet need in CMV prevention for this vulnerable group. Previously approved CMV inhibitors in China include Roche’s ganciclovir and valganciclovir, while domestic companies such as Zhejiang Asia-Pacific Pharmaceutical and Shanghai Pharma have also entered the market with generic versions. However, Letermovir offers a novel mechanism of action, making it a game-changing option for CMV prevention in HSCT patients, particularly children.

Drug ApprovalImmunotherapyCell Therapy

14 May 2025

·www.prnewswire.com

Akeso's Penpulimab Approval Intensifies the Competition Among the Other Pharmaceutical Companies Active in the Nasopharyngeal Carcinoma Market | DelveInsight

The FDA has approved Akeso's PD-1 monoclonal antibody, penpulimab-kcqx, for the treatment of recurrent or metastatic non-keratinising nasopharyngeal carcinoma in adults. The approval includes its use as a first-line treatment in combination with platinum-based chemotherapy, as well as a monotherapy option for later-stage metastatic disease. This marks the first FDA approval for a biologic developed in-house by Akeso, signifying the Hong Kong-based company's debut in the US nasopharyngeal carcinoma market. LAS VEGAS, May 14, 2025 /PRNewswire/ -- Nasopharyngeal carcinoma is a rare type of cancer that originates in the nasopharynx, the upper part of the throat behind the nose. It is strongly associated with Epstein-Barr virus (EBV) infection. Unlike many other head and neck cancers, NPC has distinct genetic, viral, and environmental risk factors. As per DelveInsight's analysis, in 2023, there were around 67K incident cases of head and neck cancer and around 2,300 cases of nasopharyngeal cancer in the United States. Due to their location and extent of spread, nasopharyngeal cancers are often not suitable for surgical removal. These cancers are usually managed with a combination of chemotherapy and radiation therapy, often followed by additional chemotherapy. If the cancer recurs, it may be treated with another round of radiation, frequently using brachytherapy. In carefully selected cases, skull base resection may be considered as an alternative to radiation. LOQTORZI (toripalimab-tpzi) is an advanced anti-PD-1 monoclonal antibody that inhibits PD-L1 from binding to the PD-1 receptor at a distinct, high-affinity site, thereby enhancing antitumor immune responses and improving overall survival across multiple cancer types. In October 2023, the FDA approved LOQTORZI in combination with cisplatin and gemcitabine as a first-line treatment for adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. Additionally, the FDA approved toripalimab-tpzi as a monotherapy for adults with recurrent, unresectable, or metastatic nasopharyngeal carcinoma that has progressed following platinum-based chemotherapy. The combination therapy's efficacy was demonstrated in the JUPITER-02 clinical trial. Learn more about the nasopharyngeal carcinoma treatment options @ Nasopharyngeal Carcinoma Treatment Market In April 2025, the FDA approved penpulimab-kcqx, a distinct PD-1 monoclonal antibody, for use alongside cisplatin or carboplatin and gemcitabine as a first-line treatment for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma. Additionally, the FDA authorized penpulimab-kcqx as a standalone treatment for adults with metastatic non-keratinizing NPC who have experienced disease progression following platinum-based chemotherapy and at least one other prior therapy. Penpulimab-kcqx was independently developed by Akeso, with further development and commercialization carried out through its joint venture with Chia Tai-Tianqing Pharmaceutical Group. This approval marks the first time an innovative biologic developed internally by Akeso has received FDA clearance, signifying a major milestone. It reflects the strength of the clinical data supporting penpulimab-kcqx and signifies Akeso's successful entry into the US regulatory landscape. The achievement showcases Akeso's innovation in drug development and its dedication to meeting high global standards in pharmaceutical quality. The FDA's decision affirms Akeso's international development and expansion strategy and provides a solid platform for the company to advance its clinical programs in the global therapeutics arena. In China, penpulimab-kcqx is already approved for two uses: as a first-line treatment and as a second-line or later therapy for advanced NPC. The recent US approval introduces a new immunotherapy option for American patients with advanced NPC. This regulatory approval was based on findings from the global Phase III AK105-304 trial and the pivotal AK105-202 study, both of which supported the Biologics License Applications (BLA) for penpulimab-kcqx. These trials confirmed the drug's clinical efficacy and favorable safety profile across different stages of metastatic NPC treatment. AK105-304, a randomized, double-blind international Phase III trial, enrolled patients from various ethnic backgrounds. The results will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Previously, penpulimab-kcqx had received Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) from the FDA, emphasizing the urgent need for effective NPC treatments. To know more about the new treatment for nasopharyngeal carcinoma, visit @ FDA-approved Drugs for Nasopharyngeal Carcinoma Triggered by promising advances in immunotherapy, there has been growing interest in the use of immune checkpoint inhibitors (ICI), specifically anti-programmed death-1 or programmed death-1 ligand (PD-1/PD-L1) therapies in the treatment of nasopharyngeal carcinoma. Some of the drugs in the pipeline include Nana-val (Viracta Therapeutics), Tislelizumab (BeiGene), PRO1160 (Genmab/ProfoundBio), and others. Discover which therapies are expected to grab major nasopharyngeal carcinoma drug market share @ New Medicine for Nasopharyngeal Carcinoma TEVIMBRA is a humanized IgG4 monoclonal antibody targeting PD-1, engineered to reduce its interaction with Fc-gamma (Fcγ) receptors on macrophages. This design supports the immune system's ability to recognize and combat tumors. Preclinical research has shown that when PD-1 antibodies bind to Fcγ receptors on macrophages, it can reduce their anti-tumor efficacy by triggering macrophage-driven destruction of T-effector cells. Nanatinostat, developed by Viracta, is an orally administered histone deacetylase (HDAC) inhibitor with selectivity for certain Class I HDAC isoforms. These isoforms are crucial for reactivating viral genes that are epigenetically suppressed in cancers associated with Epstein-Barr virus (EBV). Nanatinostat is being evaluated as part of an all-oral regimen called Nana-val, in combination with the antiviral valganciclovir, for the treatment of various EBV-related cancers. Discover more about drugs for nasopharyngeal carcinoma in development @ Nasopharyngeal Carcinoma Clinical Trials Market The anticipated launch of these emerging nasopharyngeal carcinoma treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the nasopharyngeal carcinoma market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for nasopharyngeal carcinoma in the 7MM is expected to grow at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. DelveInsight's latest published market report titled N asopharyngeal Carcinoma Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the nasopharyngeal carcinoma country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The nasopharyngeal carcinoma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Incident Cases of Nasopharyngeal Carcinoma Gender-specific Incident Cases of Nasopharyngeal Carcinoma Age-specific Incident Cases of Nasopharyngeal Carcinoma Stage-specific Incident Cases of Nasopharyngeal Carcinoma Treated Cases of Nasopharyngeal Carcinoma The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM nasopharyngeal carcinoma market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this nasopharyngeal carcinoma market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the nasopharyngeal carcinoma market. Also, stay abreast of the mitigating factors to improve your market position in the nasopharyngeal carcinoma therapeutic space. Related Reports Head and Neck Cancer Market Head and Neck Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key HNC companies, including CEL-SCI, Junshi Biosciences, Coherus, Exelixis, Immutep S.A.S., Merck Sharp & Dohme LLC, Iovance Biotherapeutics, BeiGene, Akeso, Chia Tai-Tianqing, Kura Oncology, Hoffmann-La Roche, Eli Lilly and Company, among others. Head and Neck Cancer Pipeline Head and Neck Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key HNC companies, including Debiopharm, Merck, GlaxoSmithKline, QBiotics Group Limited, Memgen, Inc., BioNTech, Alentis Therapeutics AG, Beijing CorreGene Biotechnology, Coordination Pharmaceuticals, Inc., Regeneron Pharmaceuticals, Sichuan Baili Pharmaceutical Co., Ltd., TILT Biotherapeutics Ltd., Coherus Biosciences, Inc., among others. Head and Neck Squamous Cell Carcinoma Market Head and Neck Squamous Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key HNSCC companies, including VCN Biosciences, Moderna Therapeutics, Exelixis, MacroGenics, Nykode Therapeutics, Tizona Therapeutics, Totus Medicines, Turnstone Biologics, Hoffmann-La Roche, Hookipa Pharma, Zenith Epigenetics, HiFiBiO, Nanobiotix, GSK, AstraZeneca, Merus, PureTech Health, Rakuten Medical, Jacobio Pharmaceuticals , among others. Recurrent Head and Neck Squamous Cell Carcinoma Pipeline Recurrent Head and Neck Squamous Cell Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key recurrent HNSCC companies, including AstraZeneca, Astellas, GlaxoSmithKline, Boehringer Ingelheim, Merck, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Drug ApprovalFast TrackOrphan Drug

100 Deals associated with Valganciclovir Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D03256	Valganciclovir Hydrochloride	J05AB14	DB01610

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Virus Diseases	China	Roche Pharma (Schweiz) AG	13 Dec 2005
Acquired Immunodeficiency Syndrome	Japan	Mitsubishi Tanabe Pharma Corp.	05 Nov 2004
Cytomegalovirus Infections	Australia	Pharmaco (NZ) Ltd.	17 Jun 2002
Cytomegalovirus Retinitis	United States	CHEPLAPHARM Arzneimittel GmbH	29 Mar 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hematopoietic stem cell transplantation	Phase 3	United States	Roche Pharma AG	01 Nov 2001
HIV Infections	Phase 3	Canada	Hoffmann-La Roche, Inc.	01 Jan 1997
Hearing Loss, Sensorineural	Phase 2	United States	Genentech, Inc.	31 Aug 2018
Chronic Lymphocytic Leukemia	Phase 2	United States	Roche Pharma AG	01 Sep 2003
Human herpesvirus 8 infection	Phase 2	United States	Hoffmann-La Roche, Inc.	01 Dec 2002
Idiopathic Pulmonary Fibrosis	Phase 1	United States	Genentech, Inc.	03 Jan 2018
Cystic Fibrosis	Phase 1	United States	Hoffmann-La Roche, Inc.	01 Dec 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EURETINA2025	Not Applicable	Cytomegalovirus Retinitis	1	Intravitreal Foscarnet + Systemic Ganciclovir/Valganciclovir + Anti-VEGF (Aflibercept) + Topical Corticosteroids	ylcwuwhmek(vlhujwnliq) = Transient ocular hypertension (IOP: 25 mmHg) post- injection, managed with topical timolol. Cystoid macular edema in OS (GMC: 242 μm) resolved after 3 monthly aflibercept injections. zpvlvvhoie (spmnamqdhg ) View more	Positive	04 Sep 2025
NCT01329185 (Pubmed) Manual	Phase 2	EBV viremia \| Cytomegalovirus viremia	137	Valganciclovir	mfqthwbhmi(svqgeoqpni) = advsyagzru kmcqrkjzls (pdbspdivfo ) View more	Positive	01 Jun 2024
				Valganciclovir	mfqthwbhmi(svqgeoqpni) = zzhqepzpjz kmcqrkjzls (pdbspdivfo ) View more
NCT02927067 (AURORA, Pubmed)	Phase 3	Cytomegalovirus Infections	-	Valganciclovir (dose-adjusted for renal clearance)	memelsvdpf(xfiauwgqge) = yqxzmcyxsn zlqnwgkkkn (jidwprdkvr ) View more	Negative	30 Nov 2023
ERA2023	Not Applicable	Cytomegalovirus Infections	33	Low-dose oral valganciclovir (450 mg twice daily)	bvdljrqvll(ncbyjtacpl) = pchcjedjyz hlwzfwwbhq (rroopteqix, 311.24–826.25)	-	15 Jun 2023
AACR2023 Manual	Phase 1	Recurrent Prostate Carcinoma	15	Ad5-yCD/mutTKSR39rep-hIL-12+5-fluorocytosine+Valganciclovir	gcvfxgvqae(djmnxfkbah) = dgwhxbmwfj jqifjmkjug (dkmcfcynlb ) View more	Positive	14 Apr 2023
ACTRN12613000554763 (Pubmed \| J Am Soc Nephrol)	Not Applicable	Renal transplant rejection	140	Valganciclovir prophylaxis	iifvvfnyfc(qxpmmmgmfo) = kfysyckxde rstfzohhia (yyvmxnznye ) View more	-	02 Feb 2023
				Preemptive therapy	iifvvfnyfc(qxpmmmgmfo) = lcodhgwekh rstfzohhia (yyvmxnznye ) View more
NCT03301415 (CTgov)	Phase 2	Cytomegalovirus Infections	7	Valganciclovir	nsfsncvpkn = vnlxvzccof nncsiqgomb (mkphmehbnf, lzgysbzbci - vbulxrlbrr) View more	-	26 Jan 2023
NCT02871401 (CTgov)	Phase 1	Idiopathic Pulmonary Fibrosis	31	Valganciclovir (Valganciclovir)	ccytfgzqmr = etrungqysm kxqmvbnaie (qemdbupzal, lihtnqjkmt - akupmhrxlt) View more	-	29 Apr 2022
				Placebo (Placebo)	ccytfgzqmr = ownrgyqcat kxqmvbnaie (qemdbupzal, wxirshbxcb - ftausfdwdn) View more
NCT01649869 (CTgov)	Phase 2	Hearing Loss \| Cytomegalovirus Infections \| Hearing Loss, Sensorineural	54	Placebo (Placebo)	gmgyxigbby = jkhmtzobyg fetplrpumx (quwmqtelgq, wscevtbouz - splnarikev) View more	-	02 Jun 2021
				Valganciclovir (Active)	gmgyxigbby = bpgrqyctue fetplrpumx (quwmqtelgq, ywiddpjdel - vkldtykndp) View more
NCT02871401 (Pubmed)	Phase 1	Idiopathic Pulmonary Fibrosis Add-on	31	Valganciclovir 900 mg	xficpafqzf(wyfxosvzbd) = ezecdfapxp cjyjrnukeq (jrkcaowrph )	-	19 Mar 2021
				Placebo	xficpafqzf(wyfxosvzbd) = ovlqzqjrva cjyjrnukeq (jrkcaowrph )

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