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Vistide

(Cidofovir)

ApprovedSmall molecule

Cidofovir is used to treat cytomegalovirus (CMV) infection of the eye, particularly in people with weakened immune systems such as those with HIV/AIDS. It works by stopping the virus from multiplying.[2] Vistide is currently approved and in use across 15 indications[4].[1]

Vistide is one of 280 small molecule programs targeting HIV infection. It is currently in Approved.

15

Indications

28

Total Trials

2

Active Trials

279

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionActive, not recruiting

Herpes Simplex InfectionApproved

Viral DiseaseActive, not recruiting

Cytomegalovirus RetinitisActive, not recruiting

Dysplasia of CervixApproved

Inborn Error of ImmunityActive, not recruiting

Cytomegalovirus InfectionActive, not recruiting

Kidney DiseaseApproved

Cervical CancerActive, not recruiting

Common WartApproved

HIV InfectionPhase 2

Active, not recruiting

Herpes Simplex InfectionApproved

Approved

Viral DiseaseApproved

Active, not recruiting

Cytomegalovirus RetinitisPhase 2

Active, not recruiting

Dysplasia of CervixApproved

Approved

Inborn Error of ImmunityApproved

Active, not recruiting

Cytomegalovirus InfectionApproved

Active, not recruiting

Kidney DiseaseApproved

Approved

Cervical CancerPhase 1

Active, not recruiting

Common WartApproved

Approved

Showing 10 of 14 indications

Competition

Competitive Landscape

380 competitors in Cervical Cancer

#DrugCompanyPhaseTrials

Taxol

Paraplatin

Keytruda

Vistide

Avastin

BBio-Thera Solutions

Gemzar

Johnson & Johnson

Camptosar

Imfinzi

Trexall

Alnylam Pharmaceuticals

Theraplaza

BBiotech Pharmaceutical Co., Ltd.

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

Timeline

Expected Milestones

Q1 2028

Phase 2Active, not recruiting

Cystitis

NCT01295645

Q2 2028

Phase 3Recruiting

Adenovirus Infection

NCT07387367

Clinical

Trials by Indication[1]

Cytomegalovirus (CMV)3 trials

The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Completed· Gilead logo

Gilead·Phase 2·NCT00002437·48 enrolled

A Study of Cidofovir in HIV-Infected Children With Cytomegalovirus (CMV) Disease

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000881

A Study of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients With AIDS

Unknown status· Gilead logo

Gilead·N/A·NCT00002384

Cystitis3 trials

Intravesical Cidofovir for Hemorrhagic Cystitis

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01816646·6 enrolled

Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis

Withdrawn·MM.D. Anderson Cancer Center·N/A·NCT00956176

Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01295645·27 enrolled

Papilloma3 trials

Bevacizumab Versus Cidofovir for the Treatment of Recurrent Respiratory Papillomatosis

Unknown status·CCentro de Investigación en. Enfermedades Infecciosas, Mexico·Phase 2·NCT02555800·36 enrolled

Use of Cidofovir for Recurrent Respiratory Papillomatosis

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT00205374·19 enrolled

Treatment With Cidofovir for Children With Laryngeal Papillomatosis (Warts in the Throat)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00001126·36 enrolled

Retinitis2 trials

HPMPC (Cidofovir) Peripheral CMV Retinitis Trial Protocol

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000799·100 enrolled

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

Cytomegalovirus Retinitis2 trials

An Open-Label Study of the Safety and Efficacy of Cidofovir for the Treatment of Relapsing Cytomegalovirus Retinitis in Patients With AIDS

Completed· Gilead logo

Gilead·N/A·NCT00002142·100 enrolled

Phase II Randomized Study of Cidofovir for Peripheral Cytomegalovirus Retinitis

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004794·90 enrolled

14 more indications

Complication2 trials

Studies of the Ocular Complications of AIDS (SOCA)--HPMPC Peripheral CMV Retinitis Trial (HPCRT)

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 2/3·NCT00000142·64 enrolled

Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

Completed·JJohns Hopkins Bloomberg School of Public Health·Phase 3·NCT00000143·61 enrolled

Efficacy1 trial

A Prolongation of a Clinical Study to Evaluate the Efficacy of an Aqueous Gel Containing 2% (w/w) of Cidofovir, Directly Applied on the Cervix Exhibiting High Grade Squamous Intraepithelial Lesions.

Completed·—·Phase 2·NCT02976987·36 enrolled

HIV infection1 trial

Antiviral Therapy in Treating Patients With Kaposi's Sarcoma With or Without HIV Infection

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00019240

High-Grade Squamous Intraepithelial Lesions1 trial

Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus

Completed·AAIDS Malignancy Consortium·Phase 2·NCT00550589·33 enrolled

Treatment1 trial

Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.

Withdrawn·UUniversity of Minnesota·Phase 2·NCT02567149

Cytomegalovirus (CMV) Infection1 trial

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

Renal Transplant Recipients1 trial

Cidofovir in Renal Transplant Recipients With BKVN

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00138424·22 enrolled

Herpes Simplex1 trial

Cidofovir as a Treatment for Herpes Simplex in Patients With AIDS

Completed· Gilead logo

Gilead·N/A·NCT00002181

Progressive Multifocal Leukoencephalopathy1 trial

A Study to Evaluate the Use of Cidofovir (an Experimental Drug) for the Treatment of Progressive Multifocal Leukoencephalopathy (PML) in AIDS Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000945·24 enrolled

Adenovirus Infection1 trial

A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT

Recruiting·SSymBio Pharmaceuticals·Phase 3·NCT07387367·180 enrolled

Safety and Efficacy1 trial

A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

Completed· Gilead logo

Gilead·Phase 1·NCT00002116·30 enrolled

Effectiveness1 trial

The Safety and Effectiveness of Cidofovir in the Treatment of Venereal Warts in HIV-Infected Patients

Completed· Gilead logo

Gilead·Phase 1·NCT00002327·40 enrolled

Cervical Cancer1 trial

Cidofovir in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Receiving Chemotherapy and Radiation Therapy

Unknown status·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1·NCT00811408·24 enrolled

Unspecified1 trial

Safety and Tolerability of Cidofovir Gel Applied on Cervix Squamous Lesions

Completed·MMithra Pharmaceuticals·Phase 1·NCT00989443·6 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 26, 1996

VISTIDE

NDA NDA020638

Sources

References

[1]
ClinicalTrials.gov — 28 trial records for Cidofovir. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vistide drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cidofovir compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cidofovir. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020638). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Gilead 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: Gilead

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