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Cytovene

(Ganciclovir)

ApprovedSmall molecule

EExela Pharma Sciences, LLC.

Ganciclovir is used to treat serious viral infections caused by cytomegalovirus (CMV), particularly in people with weakened immune systems like those with HIV/AIDS. It works by stopping the virus from multiplying in the body.[2] Cytovene is currently approved and in use across 15 indications[4].[1]

Cytovene is one of 406 small molecule programs targeting HIV infection. It is currently in Approved.

15

Indications

87

Total Trials

6

Active Trials

405

Competitors

5

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

Eye InfectionActive, not recruiting

Viral DiseaseActive, not recruiting

Liver TransplantActive, not recruiting

Cutaneous MelanomaApproved

Central Nervous System NeoplasmApproved

Anterior UveitisActive, not recruiting

Kidney TransplantActive, not recruiting

Allergic RhinitisActive, not recruiting

KeratitisActive, not recruiting

HIV InfectionApproved

Active, not recruiting

Eye InfectionApproved

Active, not recruiting

Viral DiseaseApproved

Active, not recruiting

Liver TransplantPreclinical

Active, not recruiting

Cutaneous MelanomaApproved

Approved

Central Nervous System NeoplasmApproved

Approved

Anterior UveitisPreclinical

Active, not recruiting

Kidney TransplantPreclinical

Active, not recruiting

Allergic RhinitisPreclinical

Active, not recruiting

KeratitisPreclinical

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Cytovene

EExela Pharma Sciences, LLC.

Mecobalamin

Tegoprazan

SShandong Luoxin Pharmaceutical Group Stock Co., Ltd.

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Becotatug Vedotin

FFudan University

TLL-018

HHangzhou Highlightll Pharmaceutical Co., Ltd

Zvs101e

CChigenovo Co., Ltd

Imlifidase

HHansa Biopharma AB

INZ-701

IInozyme Pharma

Ralinepag

United Therapeutics

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

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Cytomegalovirus (CMV) Infection

NCT01199562

PreclinicalRecruiting

Rhinitis, Allergic

NCT06436534

Q2 2028

Phase 2Recruiting

CMV Infection

NCT06853184

Q4 2032

Phase 2Not yet recruiting

Cytomegalovirus (CMV)

NCT07513623

Clinical

Trials by Indication[1]

Treatment9 trials

High-dose Intravitreal Injection of Ganciclovir for the Treatment of CMVR in HIV-negative Patients

Completed·—·N/A·NCT03598452·33 enrolled

CMV Retinitis Retreatment Trial

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000766·300 enrolled

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Large Intestine in Patients With AIDS

Completed· Roche logo

Roche·N/A·NCT00002273

Show 6 more trials

A Phase I/II Pilot Treatment Study Of CSF Penetration And Response To Ganciclovir And Foscarnet In CMV Neurologic Disease.

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000856

A Study of Foscarnet Plus Ganciclovir in the Treatment of Cytomegalovirus of the Eye in Patients With AIDS Who Have Already Been Treated With Ganciclovir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000970·30 enrolled

Kinetics of Response of Cytomegalovirus With Ganciclovir Treatment Using Quantitative Real-Time PCR

Unknown status·NNational Center for Research Resources (NCRR)·N/A·NCT00004573

PTH - Preemptive Treatment for Herpesviridae

Completed·AAssistance Publique Hopitaux De Marseille·Phase 4·NCT02152358·317 enrolled

A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001062·25 enrolled

Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001061·167 enrolled

Cytomegalovirus Infection9 trials

A Pharmacokinetic and Tolerance Study of Oral Ganciclovir in HIV-Infected Children With Asymptomatic Cytomegalovirus Infection and Low CD4 Cell Counts or Quiescent Cytomegalovirus Disease

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000805·32 enrolled

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

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

Evaluation of the Prophylactic Use of Letermovir in Kidney Transplant Recipients at Risk of Cytomegalovirus Infection

Not yet recruiting·HHospital do Rim e Hipertensão·Phase 3·NCT06341686·100 enrolled

Show 6 more trials

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

Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

Completed· Roche logo

Roche·N/A·NCT00002024

Measuring Changes in Blood in Patients at High Risk of Cytomegalovirus Infection After Undergoing Donor Bone Marrow Transplant or Peripheral Blood Stem Cell Transplant

Completed·—·N/A·NCT00716911·100 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

T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant

Unknown status·UUniversity Hospital Birmingham·Phase 2·NCT00986557·78 enrolled

Phase III Randomized, Controlled Study of Ganciclovir for Symptomatic Congenital Cytomegalovirus Infection

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004278·130 enrolled

Cytomegalovirus (CMV)7 trials

Determining a Viral Load Threshold for Treating Cytomegalovirus (CMV)

Completed·UUniversity College, London·Phase 4·NCT00947141·165 enrolled

The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001034·850 enrolled

A Study of Two Forms of Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Completed· Roche logo

Roche·N/A·NCT00002330·280 enrolled

Show 4 more trials

The Safety and Effectiveness of Ganciclovir Plus Interferon Beta in Preventing the Return of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Completed· Roche logo

Roche·N/A·NCT00002299

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

Completed· Roche logo

Roche·Phase 3·NCT00002377

The Safety and Effectiveness of Ganciclovir Used Alone or in Combination With Granulocyte-Macrophage Colony Stimulating Factor in the Treatment of Cytomegalovirus (CMV) of the Eye in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000989·50 enrolled

Systemic and Topical Antiviral Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes - Trials I and II

Not yet recruiting·UUniversity of California, San Francisco·Phase 2·NCT07513623·117 enrolled

Cytomegalovirus Retinitis7 trials

A Randomized Study Comparing the Safety and Efficacy of Two Regimens of Oral Ganciclovir to Intravenous Ganciclovir Maintenance Therapy for Cytomegalovirus Retinitis in People With AIDS Who Have Received Prior Ganciclovir Therapy

Completed· Roche logo

Roche·N/A·NCT00002247·225 enrolled

A Randomized Controlled Study of the Efficacy and Safety of Maintenance Treatment With Oral Ganciclovir for Newly Diagnosed Cytomegalovirus Retinitis in People With AIDS

Completed· Roche logo

Roche·N/A·NCT00002257·150 enrolled

A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 2·NCT00002156·194 enrolled

Show 4 more trials

A Randomized, Controlled Study of Intravenous Ganciclovir Therapy for Peripheral Cytomegalovirus Retinitis in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000688·180 enrolled

A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS

Completed· Roche logo

Roche·N/A·NCT00002034·100 enrolled

A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis

Completed· Roche logo

Roche·N/A·NCT00002134·450 enrolled

Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 3·NCT00000134·279 enrolled

Cytomegalovirus (CMV) Infection4 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

A Phase III Study to Evaluate the Safety and Efficacy of Ganciclovir (Dihydroxypropoxymethyl Guanine [DHPG]) Treatment of Symptomatic Central Nervous System (CNS) Congenital Cytomegalovirus (CMV) Infections.

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001100·130 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

Show 1 more trial

A Study of AZT Plus Ganciclovir in Patients With AIDS and Cytomegalovirus (CMV) Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000995·60 enrolled

45 more indications

Keratitis2 trials

Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

Unknown status·CChunxiao Wang·N/A·NCT03217474·100 enrolled

Topical Ganciclovir Versus Systemic Aciclovir in the Treatment of Herpetic Keratitis

Completed·—·N/A·NCT06757907·20 enrolled

CMV Infection2 trials

CMV-CTL for the Treatment of CMV Infection After HSCT

Completed·SShanghai General Hospital, Shanghai Jiao Tong University School of Medicine·Phase 4·NCT03004261·5 enrolled

Phase 2, Randomized, Open-label, Active Comparator, Dose-ranging Study Evaluating the Efficacy and Safety of Artesunate for Injection in Combination With Ganciclovir or Valganciclovir for the Treatment of Cytomegalovirus Infection in Solid Organ Transplant Recipients

Recruiting·AAmivas Inc.·Phase 2·NCT06853184·90 enrolled

Complication2 trials

Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 3·NCT00000136·234 enrolled

Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000665·240 enrolled

Retinitis2 trials

Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis

Completed·SSchering-Plough·Phase 3·NCT00002070

Comparison of Two Drugs, Cidofovir and Ganciclovir, in Treating Patients With AIDS Who Have CMV Retinitis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 4·NCT00000894·300 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia

Not yet recruiting·PPeking University People's Hospital·Phase 2·NCT06971913·100 enrolled

A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS

Completed·AAmerican National Red Cross·N/A·NCT00001999

Allogeneic Stem Cell Transplantation2 trials

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

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

Cytomegalovirus (CMV) Viremia and Disease Occurrence in Pediatric Allogeneic Stem Cell Transplantation Recipients

Completed·NNew York Medical College··NCT04478474·100 enrolled

Gastrointestinal Disease1 trial

A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000768·24 enrolled

Ovarian Cancer1 trial

A Study of an Infectivity Enhanced Suicide Gene Expressing Adenovirus for Ovarian Cancer in Patients With Recurrent Ovarian and Other Selected Gynecologic Cancers

Completed·UUniversity of Alabama at Birmingham·Phase 1·NCT00964756·11 enrolled

Renal Replacement Therapy1 trial

Ganciclovir Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy

Terminated·UUniversity of Oslo School of Pharmacy·Phase 4·NCT00264368·6 enrolled

Kidney Transplant1 trial

Pediatric Kidney Transplant Without Calcineurin Inhibitors

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00023231·35 enrolled

Renal Allograft Recipients1 trial

Prophylaxis With Ganciclovir Improves Graft Survival in Renal Allograft Recipients

Completed·LLower Saxony Center for Nephrology·Phase 4·NCT00373165·150 enrolled

Systemic Therapy1 trial

A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000673·38 enrolled

Children1 trial

An Open Label Evaluation of the Safety and Pharmacokinetics of Ganciclovir in Children

Completed· Roche logo

Roche·N/A·NCT00002015·20 enrolled

Congenital Cmv1 trial

Valganciclovir in Congenital CMV Infants

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

Tolerance1 trial

A Phase I Pharmacokinetic and Tolerance Study of 28-Day Regimens of Oral Ganciclovir

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000668·48 enrolled

Tics1 trial

Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid

Completed·GGene Surgery LLC·Phase 1·NCT05578820·21 enrolled

Transplant Recipient1 trial

(Val)Ganciclovir TDM in Transplant Recipients

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

Antibiotic Therapy1 trial

Optimized Antibiotic Therapy in Patients With Subarachnoid Haemorrhage (ES) and Cerebral Haemorrhage (EC)

Unknown status·AAzienda Sanitaria-Universitaria Integrata di Udine··NCT04132115·104 enrolled

Solid Organ Transplant Recipients1 trial

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

Anterior Uveitis1 trial

Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis

Completed·SSingapore National Eye Centre·N/A·NCT01647529·29 enrolled

Lymphoproliferative Disorders1 trial

Ganciclovir Plus Arginine Butyrate in Treating Patients With Cancer or Lymphoproliferative Disorders Associated With the Epstein Barr Virus

Completed·—·Phase 1·NCT00006340

Type 1 Diabetes1 trial

Islet Transplantation for Type 1 Diabetes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00014911·36 enrolled

Hepatocellular Carcinoma1 trial

Preliminary Results for the Double-dose Adenovirus-mediated Adjuvant Therapy Improving Outcome of Liver Transplantation in Patients With Advanced Hepatocellular Carcinoma

Completed·HHuazhong University of Science and Technology·Phase 2·NCT02202564·81 enrolled

Lymphoid Malignancies1 trial

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

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

Lung Transplant Recipient1 trial

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

Renal Transplantation1 trial

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

Completed· Roche logo

Roche·Phase 3·NCT00372229·299 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

Conjunctivitis1 trial

Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus

Unknown status·AAdapt Produtos Oftalmológicos Ltda.·Phase 3·NCT01600365·22 enrolled

Maintenance Treatment1 trial

An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access

Completed· Roche logo

Roche·N/A·NCT00002135

Intravenous1 trial

A Treatment Protocol for the Use of Intravenous Ganciclovir in AIDS Patients With Immediately Sight-Threatening CMV Retinitis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000698

Absorption1 trial

A Multiple Dose Crossover Pharmacokinetics Study to Evaluate the Effects of Food on the Absorption of Oral Ganciclovir

Completed· Roche logo

Roche·N/A·NCT00002251·20 enrolled

Neuroblastoma1 trial

Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma

Completed·FFred Hutchinson Cancer Center·Phase 1·NCT00006480

Bone Marrow Transplant1 trial

Ganciclovir by Infusion and by Mouth in Treating Patients With Cytomegalovirus After Donor Bone Marrow Transplant

Completed·—·Phase 2·NCT00530218·61 enrolled

Central Nervous System Lymphoma1 trial

Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma

Completed·AAIDS Malignancy Consortium·Phase 2·NCT00006264

Mesothelioma1 trial

Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma

Unknown status·LLouisiana State University Health Sciences Center in New Orleans·Phase 1·NCT00006216

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

Oral1 trial

A Phase I Pharmacokinetic Study in HIV-Positive Subjects of Oral Ganciclovir and Concomitant Antiretroviral Zidovudine and Didanosine

Completed· Roche logo

Roche·Phase 1·NCT00002096·24 enrolled

Primary Brain Tumor1 trial

Gene Therapy in Treating Patients With Primary Brain Tumors

Completed·—·Phase 1·NCT00002824

Melanoma1 trial

Gene Therapy and Ganciclovir in Treating Patients With Stage IV Melanoma

Completed·NNational Human Genome Research Institute (NHGRI)·Phase 1·NCT00005057

Fallopian Tube Cancer1 trial

Gene Therapy in Treating Women With Refractory or Relapsed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer

Unknown status·JJohn Stoddard Cancer Center at Iowa Methodist Medical Center·Phase 2·NCT00005025

Liver Transplant1 trial

Maribavir Versus Oral Ganciclovir For The Prevention of Cytomegalovirus (CMV) Disease in Liver Transplant Recipients

Completed· Takeda logo

Takeda·Phase 3·NCT00497796·307 enrolled

Adenovirus1 trial

Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis

Completed·FFederal University of São Paulo·N/A·NCT01349452·33 enrolled

Immunodeficiency1 trial

A Randomized, Double-Blind Study of the Efficacy and Safety of Oral Ganciclovir for the Prevention of CMV Disease in People Infected With the Human Immunodeficiency Virus

Completed· Roche logo

Roche·N/A·NCT00002095·700 enrolled

Cytomegalovirus Disease1 trial

Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient

Completed· Roche logo

Roche·N/A·NCT00002025

Rhinitis, Allergic1 trial

A Randomized, Double-blind, Placebo-controlled, Single-center Clinical Trial of Ganciclovir Capsules in the Treatment of Refractory Moderate-to-severe Allergic Rhinitis

Recruiting·UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology·Preclinical·NCT06436534·50 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 23, 1989

CYTOVENE

NDA NDA019661

Dec 22, 1994

CYTOVENE

NDA NDA020460

Mar 4, 1996

VITRASERT

NDA NDA020569

Sep 15, 2009

ZIRGAN

NDA NDA022211

Feb 17, 2017

GANZYK-RTU

NDA NDA209347

Sources

References

[1]
ClinicalTrials.gov — 87 trial records for Ganciclovir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cytovene drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Ganciclovir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Ganciclovir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209347). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Cytovene. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Exela Pharma Sciences, LLC. 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: EExela Pharma Sciences, LLC.

Patent Landscape[6]

Patent Cliff

Sep 2, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9486530Sep 2, 2034

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