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 Date28 Apr 2025

Sponsor / Collaborator

The University of California, San Francisco

[+2]

IRCT20210519051345N67

/ RecruitingNot ApplicableIIT

In vivo Fasted-state bioequivalence study of Valgancilovir 450 mg tablet manufactured by Avicenna Co. compared with innovator product

Start Date20 Nov 2024

Sponsor / Collaborator-

CTR20243562

/ CompletedNot Applicable

盐酸缬更昔洛韦片人体生物等效性研究

[Translation] Study on the bioequivalence of valganciclovir hydrochloride tablets in healthy volunteers

主要研究目的：研究空腹/餐后状态下单次口服受试制剂盐酸缬更昔洛韦片【规格：0.45g（以缬更昔洛韦计），武汉人福利康药业有限公司生产】与参比制剂盐酸缬更昔洛韦片【商品名：万赛维/Valcyte，规格：450mg（以缬更昔洛韦计）；Roche Pharma (Schweiz)Ltd.持证】在健康受试者体内的药代动力学，评价空腹/餐后状态口服两种制剂的生物等效性。次要研究目的：评价受试制剂盐酸缬更昔洛韦片0.45g和参比制剂盐酸缬更昔洛韦片（商品名：万赛维/Valcyte）450mg在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of a single oral administration of the test preparation valganciclovir hydrochloride tablets [Specification: 0.45g (in terms of valganciclovir), produced by Wuhan Renfu Likang Pharmaceutical Co., Ltd.] and the reference preparation valganciclovir hydrochloride tablets [trade name: Valcyte, specification: 450mg (in terms of valganciclovir); Roche Pharma (Schweiz) Ltd. licensed] in healthy subjects in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary purpose of the study: to evaluate the safety of the test preparation valganciclovir hydrochloride tablets 0.45g and the reference preparation valganciclovir hydrochloride tablets (trade name: Valcyte) 450mg in healthy subjects.

Start Date11 Oct 2024

Sponsor / Collaborator

Yichang Humanwell Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Valganciclovir Hydrochloride

100 Translational Medicine associated with Valganciclovir Hydrochloride

100 Patents (Medical) associated with Valganciclovir Hydrochloride

2,158

Literatures (Medical) associated with Valganciclovir Hydrochloride

01 Jul 2025·PEDIATRIC BLOOD & CANCER

Comparison of Letermovir Versus Ganciclovir for Cytomegalovirus Prophylaxis in Pediatric Hematopoietic Stem Cell Transplant Recipients

Article

Author: Kohorst, Mira A. ; Dinnes, Laura M. ; Ferdjallah, Asmaa ; Martin, Catherine E. ; Madigan, Theresa ; Kuhn, Alexis K.

ABSTRACT:

Background:

Patients at high risk for cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplant (HCT) should receive CMV prophylaxis. Historically, ganciclovir has been the preferred agent. However, its side effect profile, particularly myelosuppression, is undesirable. Letermovir is a newer agent that is not myelosuppressive and has replaced ganciclovir as the preferred agent for CMV prophylaxis in high‐risk adult patients.

Methods:

The primary objective was to compare the incidence of dose modifications or discontinuation of CMV prophylaxis between pediatric patients who received ganciclovir versus letermovir. Secondary objectives included comparing the use of granulocyte colony‐stimulating factor (G‐CSF) support and the incidence of CMV DNAemia. We reviewed records of all pediatric patients who received an HCT at our institution between 2000 and 2024 and received either ganciclovir/valganciclovir or letermovir for CMV prophylaxis.

Results:

Between 2000 and 2024, 65 pediatric patients receiving prophylactic ganciclovir, valganciclovir, or letermovir were evaluated. The median age at transplant was 12.2 years. No patients receiving letermovir required dose modification or discontinuation as opposed to 14 (29.2%) patients receiving ganciclovir (p = 0.014). After engraftment, 12 (25%) patients receiving ganciclovir required G‐CSF support compared to seven (41.2%) patients receiving letermovir (p = 0.23). In the ganciclovir group, 10 (20.8%) patients experienced CMV infection versus one (5.9%) patient receiving letermovir (p = 0.26).

Conclusion:

Compared with those receiving letermovir, a significantly higher proportion of patients in the ganciclovir/valganciclovir group experienced dose modifications or discontinuation of CMV prophylaxis due to adverse effects. Letermovir shows great promise as a CMV prophylactic agent in pediatric HCT patients due to its favorable side effect profile.

01 Jun 2025·THERAPEUTIC DRUG MONITORING

Pharmacokinetic and Pharmacodynamic Assessment of Valganciclovir in Infants With Congenital Cytomegalovirus Infection

Article

Author: Yano, Ikuko ; Fujioka, Kazumichi ; Tamura, Naoki ; Omura, Tomohiro ; Itohara, Kotaro ; Hashimoto, Mari ; Yamamoto, Kazuhiro ; Fujinaka, Shunsuke ; Kitahiro, Yumi

Background::

Valganciclovir (VGCV) is administered at a dose of 16 mg/kg 2 times daily for 6 months to treat symptomatic congenital cytomegalovirus (CMV) infections. During the treatment period, approximately 20% of the patients developed grade 3 or higher neutropenia. Currently, information on the pharmacokinetics and pharmacodynamics of ganciclovir, an active metabolite of VGCV, in infants is limited. In the current study, the relationship between ganciclovir concentration and neutropenia was investigated, and a population pharmacokinetic (PPK) model of ganciclovir in infants with symptomatic congenital CMV infection was developed.

Methods::

Japanese infants who were prescribed oral VGCV for symptomatic congenital CMV infections between July 2017 and January 2021 were included. The relationship between the observed trough ganciclovir concentrations and neutrophil counts was examined. PPK analysis was performed to evaluate the covariates affecting the pharmacokinetics of ganciclovir.

Results::

Twenty-seven ganciclovir serum samples from 8 patients were analyzed. A moderate negative correlation was observed between the observed trough ganciclovir concentration and neutrophil count. PPK model analysis showed that postmenstrual age (PMA) affected the total body clearance of ganciclovir after correcting for the empirical allometric scaling of body weight. Based on PMA and body weight, a nomogram to achieve the target area under the concentration–time curve from 0 to 24 hours of 40–60 mcg·h·mL−1 of ganciclovir was calculated.

Conclusions::

The relationship between neutrophil count and ganciclovir trough concentration in infants was clarified. The PPK model showed that the dose of VGCV should be reduced in patients with a low PMA to achieve target exposure.

01 Jun 2025·PEDIATRIC TRANSPLANTATION

Association of Neutropenia With Valganciclovir Prophylaxis Dosing Practices Within Pediatric Solid Organ Transplant Recipients

Article

Author: Darland, Leanna ; Yasechko, Stephanie ; Danziger‐Isakov, Lara ; Hambrick, H. Rhodes ; Crooker, Anna ; Gerthoffer, Emma ; Pozderac, Amber

ABSTRACT:

Background:

Prophylactic dosing of valganciclovir for cytomegalovirus prophylaxis in the pediatric solid organ transplant (SOT) population is highly variable among institutions. The purpose of this study was to assess the impact of valganciclovir dosing strategy on neutropenia in SOT recipients at a pediatric academic medical center utilizing a novel method of GFR estimation.

Methods:

A retrospective chart review was conducted to identify differences between patients with and without neutropenia. Regression modeling was used to determine whether valganciclovir dosing strategy could predict posttransplant neutropenia.

Results:

Of 80 patients included in the study, 32.5% were neutropenic while prescribed valganciclovir. Most patients were receiving concomitant myelosuppressive medications (sulfamethoxazole‐trimethoprim [87.5%] and mycophenolate [66.3%]). Fourteen (53.8%) and 21 (38.9%) patients' doses were determined using their cystatin C‐based estimated GFR in the neutropenic and non‐neutropenic groups, respectively (p = NS). Rates of CMV DNAemia were < 5% in both groups. Valganciclovir dose was not predictive of the rate, odds, or degree of neutropenia. However, a higher valganciclovir dose adjusted for kidney function was associated with a higher log odds of neutropenia.

Conclusions:

At our institution, where BSA‐based dosing using a novel GFR method and appropriate upper limits of GFR for age is used, the rate of neutropenia was lower than previous reports in the literature. Furthermore, valganciclovir dose in milligrams per kilogram was not associated with an increased odds or degree of neutropenia. However, dose accounting for BSA and kidney function was. It is crucial to consider kidney function and the exposure to valganciclovir (vs. dose alone) when determining the risk of neutropenia.

102

News (Medical) associated with Valganciclovir Hydrochloride

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

05 Mar 2025

·www.pharmaindustrial-india.com

Zydus Lifesciences Introduces ANVIMO for Kidney and HSCT Transplant Patients

Zydus has developed ANVIMO (Letermovir), a breakthrough in the prevention of Cytomegalovirus (CMV) infection for haematopoietic stem cell transplant (HSCT) and kidney transplant patients. ANVIMO will be available in dosages of 240 mg and 480 mg. CMV infection remains one of the most serious complications in transplant patients, often leading to graft failure, decreased survival and prolonged hospital stays. Traditional CMV treatments, such as ganciclovir and valganciclovir, have notable limitations, including toxicity and bone marrow suppression. Letermovir provides a safer, well-tolerated, and effective alternative, offering superior safety and reduced side effects while improving transplant outcomes. Transplantation is a life-saving but financially burdensome procedure in India. The high cost of post-transplant care, particularly CMV prophylaxis, adds to the burden. Until now, innovator Letermovir 240 mg was imported at INR 5+ lakh per month, severely limiting access. With the launch of ANVIMO, Zydus has significantly reduced the cost by 91 percent of the innovator price, making treatment of CMV prophylaxis significantly more affordable for Indian patients. ANVIMO has established bioequivalence with the reference drug, ensuring quality at a fraction of the cost. Speaking on the launch, Dr. Sharvil Patel, MD of Zydus Lifesciences, said, "The introduction of ANVIMO marks a new era in bone marrow transplant and kidney transplant care in India. By making this critical therapy affordable and accessible, we are reinforcing our commitment to delivering world-class healthcare solutions. Our mission is to ensure that transplant patients get access to affordable, life-saving treatment." With ANVIMO, Zydus Lifesciences is transforming CMV prophylaxis in India, ensuring that more transplant patients receive timely, effective, and affordable care, ultimately improving survival rates and quality of life.

Drug ApprovalCell Therapy

05 Mar 2025

·pharma.economictimes.indiatimes.com

Zydus launches Merck’s CMV generic in India

New Delhi: Indian pharma major, Zydus Lifesciences announces the launch of ANVIMO (Letermovir), a breakthrough in the prevention of Cytomegalovirus (CMV) infection for haematopoietic stem cell transplant (HSCT) and kidney transplant patients. Anvimo has established bioequivalence with the reference drug, which will be available in 240 mg and 480 mg dosages. Letermovir tablets are an innovation of MNC pharma giant MSD (Merck Sharp & Dohme) indicated to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received a bone marrow transplant or kidney transplant. The patent for the drug was expired in 2023 and the Indian drug maker secured the tentative marketing approval from FDA in 2024. In its official release the company said that, “Traditional CMV treatments, such as ganciclovir and valganciclovir, have notable limitations, including toxicity and bone marrow suppression. Letermovir provides a safer, well-tolerated, and effective alternative, offering superior safety and reduced side effects while improving transplant outcomes. Earlier, the drug was imported at more than ₹5 lakh per month, but post this announcement, the drug cost will be reduced significantly by 91 per cent of the innovator price, it added. “The introduction of ANVIMO marks a new era in bone marrow transplant and kidney transplant care in India. Our mission is to ensure that transplant patients get access to affordable, life-saving treatment,” Dr Sharvil Patel, MD of Zydus Lifesciences, said. CMV infection is a major complication in transplant patients, often leading to graft failure, decreased survival and prolonged hospital stays. By Online Bureau ,

Drug Approval

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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01329185 (Pubmed) Manual	Phase 2	EBV viremia \| Cytomegalovirus viremia	137	Valganciclovir	rpfhoayuqd(ierytwoavu) = tvbqsomzga xejorvojtf (lymphtabky ) View more	Positive	01 Jun 2024
				Valganciclovir	rpfhoayuqd(ierytwoavu) = nltsvgnphx xejorvojtf (lymphtabky ) View more
NCT02927067 (AURORA, Pubmed)	Phase 3	Cytomegalovirus Infections	-	Valganciclovir (dose-adjusted for renal clearance)	qcgbqbknkx(epofeagsto) = cuhqmxibfe hbtwvavweo (nvuhbxkguz ) View more	Negative	30 Nov 2023
P11.80.A (EANO2023)	Not Applicable	Glioblastoma Add-on MGMT methylation status \| IDH1 wt	220	Valganciclovir	hymbtqslbo(uvgcurliqn) = Five patients showed reversible hematological side effects grade 3-4, always with the initial high dose and concomitant to radiochemotherapy. No patient stopped the study due to side effects. zdffqcckdd (rlsrsfahyd )	Positive	08 Sep 2023
				Placebo
ERA2023	Not Applicable	Cytomegalovirus Infections	33	Low-dose oral valganciclovir (450 mg twice daily)	wakedbvzzc(rzsjysfmpj) = wshzmqfgig tnzlqpjnea (pechvnvqfc, 311.24–826.25)	-	15 Jun 2023
AACR2023 Manual	Phase 1	Recurrent Prostate Carcinoma	15	Ad5-yCD/mutTKSR39rep-hIL-12+5-fluorocytosine+Valganciclovir	uzshnwmbyf(djdlznfkoe) = pjoshzknev ohtvjkfdbj (duxcfltdqm ) View more	Positive	14 Apr 2023
ISN WCN2023	Not Applicable	Cytomegalovirus Infections CMV IgG \| CMV IgM \| CMV DNA	32	Valganciclovir prophylaxis	pdmdufeaeh(fqoerdrtqh) = keylcvdlqe rboruncjet (rzqcwcudkb )	Negative	01 Mar 2023
				VALGANCICLOVIR (No prophylaxis)	pdmdufeaeh(fqoerdrtqh) = dcporjgcrq rboruncjet (rzqcwcudkb )
ACTRN12613000554763 (Pubmed \| J Am Soc Nephrol)	Not Applicable	Renal transplant rejection	140	Valganciclovir prophylaxis	ojfqexgkgw(mwztvkxfwm) = wzrwltxqch ctgglgidpm (bqfoohfhpa ) View more	-	02 Feb 2023
				Preemptive therapy	ojfqexgkgw(mwztvkxfwm) = gpypzojhib ctgglgidpm (bqfoohfhpa ) View more
NCT03301415 (CTgov)	Phase 2	Cytomegalovirus Infections	7	Valganciclovir	eopgrgmjpe = bgjgkcgjjb vxjmlnaloq (vmvarhagba, rjdiwhtslm - tfooznsxbm) View more	-	26 Jan 2023
ASN2022	Not Applicable	Renal transplant rejection	-	Valganciclovir (Neutropenic KTRs)	wkyxspvgrz(cscjoehxbr) = cvsiywvxpk oubojzaqau (iwkwlgjefh ) View more	-	04 Nov 2022
NCT02871401 (CTgov)	Phase 1	Idiopathic Pulmonary Fibrosis	31	Valganciclovir (Valganciclovir)	pxhynsanyz = xmuxtadpqv tgsfxjmnta (jtnlbnozex, ftohwxnoua - jhxxocdxoq) View more	-	29 Apr 2022
				Placebo (Placebo)	pxhynsanyz = wdnggxnckw tgsfxjmnta (jtnlbnozex, egsguvdkfd - dlqudnynfj) View more

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