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Valcyte

(valganciclovir)

ApprovedSmall molecule

EEngelhard Arzneimittel GmbH & Co.KG

Valganciclovir is used to treat cytomegalovirus (CMV) infections, particularly in people with weakened immune systems such as those with HIV/AIDS or organ transplant recipients. It works by slowing or stopping the growth of the virus.[2] Valcyte is currently approved and in use across 24 indications[4].[1]

Valcyte is one of 633 small molecule programs targeting HIV infection. It is currently in Approved.

24

Indications

82

Total Trials

14

Active Trials

632

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

2

Patents

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

Nasopharyngeal CarcinomaActive, not recruiting

Liver TransplantActive, not recruiting

LymphomaActive, not recruiting

MortalityActive, not recruiting

Cytomegalovirus InfectionApproved

Kidney TransplantApproved

Hearing LossActive, not recruiting

DeafnessActive, not recruiting

HIV InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Nasopharyngeal CarcinomaPhase 1

Active, not recruiting

Liver TransplantPreclinical

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

MortalityPhase 2

Active, not recruiting

Cytomegalovirus InfectionApproved

Approved

Kidney TransplantApproved

Approved

Hearing LossPhase 2

Active, not recruiting

DeafnessPhase 2/Phase 3

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Valcyte

EEngelhard Arzneimittel GmbH & Co.KG

Tykerb

Prolia

Gemzar

GGynecologic Oncology Group

MS Contin

Blenoxane

Bristol-Myers Squibb

Adenocard

Lupron

EEastern Cooperative Oncology Group

Spravato

Zinecard

CChildren's Oncology Group

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Lung Transplant Recipient

NCT05708755

Q4 2026

Phase 2Active, not recruiting

Lymphoproliferative Disorder

NCT00092222

Post-ApprovalRecruiting

Cytomegalovirus Infection

NCT07266467

Active, not recruiting

Cytomegalovirus (CMV) Infection

NCT01199562

Phase 1/2Recruiting

Depression

NCT04724447

Q2 2027

Phase 2Not yet recruiting

Advanced

NCT07379203

Clinical

Trials by Indication[1]

Cytomegalovirus Infection8 trials

A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

Completed· Takeda logo

Takeda·Phase 3·NCT02927067·553 enrolled

Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection

Completed·MMedical University of South Carolina·Phase 4·NCT01509404·40 enrolled

The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University··NCT02973464·450 enrolled

Show 5 more trials

Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients

Recruiting·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT07266467·290 enrolled

Trial of Preemptive Treatment With Oral Valganciclovir Compared With Intravenous (IV) Ganciclovir for Cytomegalovirus Infection After Bone Marrow or Peripheral Blood Stem Cell Transplant

Terminated·WWashington University School of Medicine·Phase 3·NCT00241345·39 enrolled

Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation

Completed·FFred Hutchinson Cancer Center·Phase 3·NCT00016068·184 enrolled

Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT06334497·80 enrolled

Valganciclovir to Prevent Cytomegalovirus Infection in Kidney and Kidney/Pancreas Transplant Recipients

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 4·NCT00034385·12 enrolled

Kidney Transplant8 trials

Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

Completed·MMedical University of South Carolina·Phase 4·NCT06034925·70 enrolled

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

Recruiting·NNational Taiwan University Hospital·N/A·NCT07294547·80 enrolled

A Study of Oral Valcyte (Valganciclovir) in Pediatric Kidney Transplant Recipients

Completed· Roche logo

Roche·Phase 4·NCT01376804·57 enrolled

Show 5 more trials

Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R Recipients

Recruiting·UUniversity of California, San Francisco·Phase 3·NCT06798909·360 enrolled

Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03443869·601 enrolled

ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

Completed·UUniversity of Minnesota·Phase 2·NCT01972035·137 enrolled

WP16302 A Bioequivalence Study Comparing Ganciclovir From the Valganciclovir Syrup Formulation and the Commercial Valganciclovir 450mg Tablet (Valcyte®) at a Dose of 900mg in Kidney Transplant Recipients

Terminated·UUniversity of Pittsburgh·Phase 3·NCT00275314·5 enrolled

Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients

Completed·PPiedmont Healthcare··NCT05238220·37 enrolled

Cytomegalovirus Disease3 trials

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease

Terminated· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 3·NCT02439970·5 enrolled

Certican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients

Unknown status·MMarcus Saemann·Phase 2·NCT00828503·40 enrolled

IMPACT Study: A Study of Valcyte (Valganciclovir) for Prevention of Cytomegalovirus Disease (CMV) in Kidney Allograft Recipients

Completed· Roche logo

Roche·Phase 3·NCT00294515·326 enrolled

Cytomegalovirus (CMV)3 trials

Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00006145·350 enrolled

A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes

Completed· Roche logo

Roche·Phase 3·NCT00002377

A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS

Completed· Roche logo

Roche·N/A·NCT00002222·200 enrolled

Congenital Cmv2 trials

Asymptomatic Congenital CMV Treatment

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03301415·7 enrolled

Valganciclovir in Congenital CMV Infants

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00031434·24 enrolled

49 more indications

Lung Transplantation2 trials

Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation

Completed·—·Phase 3·NCT00227370·136 enrolled

Letermovir for CMV Prevention After Lung Transplantation

Completed·FFernanda P Silveira, MD, MS·Phase 2·NCT05041426·16 enrolled

GAN2 trials

Study of Prophylactic Vs Preemptive Valganciclovir

Completed·WWashington University School of Medicine·N/A·NCT00374686·120 enrolled

Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease

Withdrawn·UUniversity of Washington·Phase 4·NCT00361933

Solid Organ Transplant Recipients2 trials

VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients

Completed· Roche logo

Roche·Phase 4·NCT00431353·325 enrolled

A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

Completed· Roche logo

Roche·Phase 2/3·NCT00090766·63 enrolled

Glioblastoma2 trials

A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients

Active, not recruiting·CCecilia Soderberg-Naucler·Phase 2·NCT04116411·220 enrolled

Efficacy and Safety of Valcyte® as an add-on Therapy in Patients With Malignant Glioblastoma and Cytomegalovirus (CMV) Infection

Completed·KKarolinska Institutet·N/A·NCT00400322·42 enrolled

Transplant Recipient2 trials

A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age

Completed· Roche logo

Roche·Phase 1·NCT01165580·17 enrolled

(Val)Ganciclovir TDM in Transplant Recipients

Unknown status·UUniversity Medical Center Groningen··NCT03698435·100 enrolled

Lung Transplant Recipient2 trials

Clinical Trial of Efficacy and Safety of the Combination of Reduced Duration Prophylaxis Followed by Immuno-guided Prophylaxis in Lung Transplant Recipients.

Completed·MMaimónides Biomedical Research Institute of Córdoba·Phase 3·NCT03699254·150 enrolled

CMV Immunity Monitoring in Lung Transplant Recipients

Recruiting·NNYU Langone Health·Phase 2·NCT05708755·50 enrolled

Oral2 trials

Oral Valganciclovir Versus Valacyclovir

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00562770·46 enrolled

Suppression of Oral HHV8 Shedding With Valganciclovir

Completed·UUniversity of Washington·Phase 2·NCT00194467·32 enrolled

Cytomegalovirus (CMV) Infection2 trials

Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant

Active, not recruiting·—··NCT01199562·153 enrolled

Efficacy and Safety Study of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

Completed· Takeda logo

Takeda·Phase 3·NCT02931539·352 enrolled

Randomized Controlled Trial2 trials

Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

Terminated·—·Phase 3·NCT01655212·2 enrolled

Randomized Controlled Trial of Valganciclovir for Cytomegalovirus Infected Hearing Impaired Infants

Active, not recruiting·AAlbert Park·Phase 2·NCT03107871·52 enrolled

Mortality1 trial

Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial.

Completed·NNational Institute of Cancerología·Phase 2·NCT03296553·40 enrolled

Hearing Loss1 trial

Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01649869·54 enrolled

Relapsed or Refractory1 trial

Phenylbutyrate and Valganciclovir in Treating Patients With Relapsed or Refractory Epstein-Barr Virus-Positive Cancer

Withdrawn·UUniversity of California, San Diego·Phase 2·NCT00387530

Allogeneic Stem Cell Transplantation1 trial

Study Comparing Valganciclovir Versus Ganciclovir in Patients Following Allogeneic Stem Cell Transplantation

Terminated·PPierrel Research Europe GmbH·Phase 3·NCT01185223·212 enrolled

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Nasopharyngeal Carcinoma1 trial

Study of Cytolytic Viral Activation Therapy (CVAT) for Recurrent/Metastatic Nasopharyngeal Carcinoma

Unknown status·—·Phase 1·NCT02761291·18 enrolled

Inflammatory Bowel Disease1 trial

MICI-CMV:Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

Terminated·UUniversity Hospital, Grenoble·Phase 3·NCT00237653·40 enrolled

CMV Infection1 trial

The Study is Being Done to See if Taking the Drug Valganciclovir Can Prevent CMV Infection.

Completed·MMayo Clinic·Phase 3·NCT00275665·20 enrolled

Prevention1 trial

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus

Terminated· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 3·NCT02439957·6 enrolled

Castleman disease1 trial

Tocilizumab for KSHV-Associated Multicentric Castleman Disease

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01441063·8 enrolled

Tuberculosis1 trial

Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia

Completed·HHospital Universitario 12 de Octubre·Phase 2/3·NCT03915366·563 enrolled

Lymphoproliferative Disorders1 trial

Study of HQK-1004 and Valganciclovir to Treat Epstein-Barr Virus (EBV) - Positive Lymphoid Malignancies or Lymphoproliferative Disorders

Terminated·HHemaQuest Pharmaceuticals Inc.·Phase 2·NCT00992732·1 enrolled

Cystic Fibrosis1 trial

A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.

Completed· Roche logo

Roche·Phase 1·NCT00377741·31 enrolled

Renal Transplantation1 trial

A Study of Valcyte (Valganciclovir) CMV Prophylaxis After Renal Transplantation

Completed· Roche logo

Roche·Phase 3·NCT00372229·299 enrolled

Chronic Fatigue Syndrome1 trial

Valganciclovir (Valcyte) for Chronic Fatigue Syndrome Patients Who Have Elevated Antibody Titers Against Human Herpes Virus 6 (HHV-6)and Epstein-Barr Virus (EBV)

Completed·SStanford University·Phase 1/2·NCT00478465·30 enrolled

Congenital CMV Infection1 trial

Short-Term vs. Long-Term Valganciclovir Therapy for Symptomatic Congenital CMV Infections

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00466817·109 enrolled

Kidney1 trial

Treating Kidney Donors With Valganciclovir to Reduce Viral Transmission to Recipients

Completed·UUniversity of Minnesota·Phase 2·NCT01329185·17 enrolled

Tics1 trial

Pharmacokinetics of Mmf and Valganciclovir

Completed·UUniversity of Michigan·Phase 4·NCT00189150·16 enrolled

Advanced1 trial

ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse

Not yet recruiting·WWits Health Consortium (Pty) Ltd·Phase 2·NCT07379203·130 enrolled

Retinitis1 trial

Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection

Unknown status· Roche logo

Roche·Phase 3·NCT00017784·500 enrolled

Lymphoid Malignancies1 trial

Study of Arginine Butyrate and Ganciclovir/Valganciclovir in EBV(+) Lymphoid Malignancies

Terminated·HHemaQuest Pharmaceuticals Inc.·Phase 2·NCT00917826·1 enrolled

Pembrolizumab1 trial

Nanatinostat Plus Valganciclovir in Advanced EBV+ Solid Tumors and in Combination With Pembrolizumab in EBV+ RM-NPC

Terminated·VViracta Therapeutics, Inc.·Phase 1·NCT05166577·26 enrolled

Lymphoma1 trial

Bortezomib and Antiviral Therapy Followed By Effusion Drainage, Bevacizumab, and Combination Chemotherapy in Treating Patients With Primary Effusion Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00217503·15 enrolled

Stem Cell Transplantation1 trial

Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)

Completed·HHadassah Medical Organization·Phase 3·NCT00330018·40 enrolled

Islet Transplantation1 trial

B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure

No longer available·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT01049633

Breast Cancer1 trial

Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection

Recruiting·TThe Methodist Hospital Research Institute·Phase 2·NCT07383649·28 enrolled

Treatment1 trial

Congenital Cytomegalovirus: Efficacy of Antiviral Treatment

Completed·—·Phase 3·NCT02005822·37 enrolled

Renal Transplant Recipients1 trial

A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls

Completed· Roche logo

Roche·Phase 4·NCT01663740·59 enrolled

Ulcerative Colitis1 trial

Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy

Terminated·—·Phase 3·NCT04064697·6 enrolled

Chronic Lymphocytic Leukemia1 trial

Antiviral Treatment of Chronic Lymphocytic Leukemia

Completed·MMedical University of Vienna·Phase 4·NCT01255644·20 enrolled

Idiopathic Pulmonary Fibrosis1 trial

A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)

Completed·VVanderbilt University Medical Center·Phase 1·NCT02871401·31 enrolled

POI1 trial

TAMOVALCIR in Allogenic Hematopoietic Progenitors Transplant

Completed·PPETHEMA Foundation·Phase 2·NCT00386412·132 enrolled

Kaposi's sarcoma1 trial

Valganciclovir in Treating Patients With Classic Non-HIV-Associated Kaposi's Sarcoma

Completed·MMemorial Sloan Kettering Cancer Center·N/A·NCT00096538·6 enrolled

Liver Transplant1 trial

CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT01552369·205 enrolled

Depression1 trial

ANTIVIRAL TREATMENT OF CYTOMEGALOVIRUS IN DEPRESSION

Recruiting·LLaureate Institute for Brain Research, Inc.·Phase 1/2·NCT04724447·24 enrolled

HIV infection1 trial

Valganciclovir to Reduce T Cell Activation in HIV Infection

Completed·UUniversity of California, San Francisco·Phase 4·NCT00264290·30 enrolled

Heart Transplant1 trial

Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant

Recruiting·—·Phase 2/3·NCT07079735·150 enrolled

Deafness1 trial

Evaluation of the Benefit of Antiviral Treatment With Valganciclovir on Congenital CMV Infection-related Deafness on Hearing and Balance

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT02606266·1 enrolled

Immunosuppression1 trial

Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00141037·130 enrolled

Lymphoproliferative Disorder1 trial

Targeted Oncolytic Virotherapy and Natural History Study of KSHV-Associated Multicentric Castleman's Disease With Laboratory and Clinical Correlates of Disease Activity

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT00092222·75 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 29, 2001

VALCYTE

NDA NDA021304

Aug 28, 2009

VALCYTE

NDA NDA022257

Sources

References

[1]
ClinicalTrials.gov — 82 trial records for valganciclovir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Valcyte drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — valganciclovir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for valganciclovir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022257). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Valcyte. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Engelhard Arzneimittel GmbH & Co.KG company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Human Herpesvirus 1 DNA Polymerase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: EEngelhard Arzneimittel GmbH & Co.KG

Patent Landscape[6]

Patent Cliff

Dec 11, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9642911Dec 11, 2027

8889109Dec 11, 2027

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