CIDOFOVIR
Cidofovir treats CMV retinitis in patients living with AIDS. It is used specifically to manage this viral eye infection, though it has not been established for other types of CMV diseases or for patients who are not HIV-positive. This medication helps prevent the progression of the virus in the eye to protect the patient's vision.
How CIDOFOVIR Works
This medication works by selectively blocking the synthesis of viral DNA, which prevents the cytomegalovirus from replicating. Its active form inhibits the viral DNA polymerase much more effectively than it affects human DNA polymerases. When the drug is incorporated into the growing viral DNA chain, it slows down the overall rate of viral production.
Details
- Status
- Prescription
- First Approved
- 2012-06-27
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
CIDOFOVIR Approval History
What CIDOFOVIR Treats
2 indicationsCIDOFOVIR is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cytomegalovirus Retinitis
- Acquired Immunodeficiency Syndrome
CIDOFOVIR Boxed Warning
WARNING RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF CIDOFOVIR INJECTION. CASES OF ACUTE RENAL FAILURE RESULTING IN DIALYSIS AND/OR CONTRIBUTING TO DEATH HAVE OCCURRED WITH AS FEW AS ONE OR TWO DOSES OF CIDOFOVIR INJECTION. TO REDUCE POSSIBLE NEPHROTOXICITY, INTRAVENOUS PREHYDRATION WITH NORMAL SALINE AND ADMINISTRATION OF PROBENECID MUST BE USED WITH EACH CIDOFOVIR INJECTION INFUSION. RENAL FUNCTION (SERUM CREATININE AND URINE PROTEIN) MUST BE MONITORED WITHIN 48 HOURS PRIOR TO EACH DOSE OF CIDOFO...
WARNING RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF CIDOFOVIR INJECTION. CASES OF ACUTE RENAL FAILURE RESULTING IN DIALYSIS AND/OR CONTRIBUTING TO DEATH HAVE OCCURRED WITH AS FEW AS ONE OR TWO DOSES OF CIDOFOVIR INJECTION. TO REDUCE POSSIBLE NEPHROTOXICITY, INTRAVENOUS PREHYDRATION WITH NORMAL SALINE AND ADMINISTRATION OF PROBENECID MUST BE USED WITH EACH CIDOFOVIR INJECTION INFUSION. RENAL FUNCTION (SERUM CREATININE AND URINE PROTEIN) MUST BE MONITORED WITHIN 48 HOURS PRIOR TO EACH DOSE OF CIDOFOVIR INJECTION AND THE DOSE OF CIDOFOVIR INJECTION MODIFIED FOR CHANGES IN RENAL FUNCTION AS APPROPRIATE (SEE DOSAGE AND ADMINISTRATION ). CIDOFOVIR INJECTION IS CONTRAINDICATED IN PATIENTS WHO ARE RECEIVING OTHER NEPHROTOXIC AGENTS. NEUTROPENIA HAS BEEN OBSERVED IN ASSOCIATION WITH CIDOFOVIR INJECTION TREATMENT. THEREFORE, NEUTROPHIL COUNTS SHOULD BE MONITORED DURING CIDOFOVIR INJECTION THERAPY. CIDOFOVIR INJECTION IS INDICATED ONLY FOR THE TREATMENT OF CMV RETINITIS IN PATIENTS WITH ACQUIRED IMMUNODEFICIENCY SYNDROME. IN ANIMAL STUDIES CIDOFOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED HYPOSPERMIA (SEE CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY ).
CIDOFOVIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to CIDOFOVIR
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07387367 ENOVIA | BCV-PA02 | Ph 3 | recruiting | A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT |
| NCT01295645 | 2010-0518 NCI-2011-00250 | Ph 2 | active not recruiting | Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis |
| NCT02931539 results posted | SHP620-303 2015-004725-13 | Ph 3 | completed | 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 |
| NCT02567149 | Version 1.0 | Ph 2 | withdrawn | Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population. |
| NCT01816646 | 2012-0903 NCI-2013-02184 | Ph 1 | completed | Intravesical Cidofovir for Hemorrhagic Cystitis |
| NCT02976987 | CHUB-POST-Colvir II | Ph 2 | completed | 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. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CIDOFOVIR FDA Label Details
Indications & Usage
CIDOFOVIR is indicated for the treatment of Cytomegalovirus Retinitis; Acquired Immunodeficiency Syndrome.
WARNING RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF CIDOFOVIR INJECTION. CASES OF ACUTE RENAL FAILURE RESULTING IN DIALYSIS AND/OR CONTRIBUTING TO DEATH HAVE OCCURRED WITH AS FEW AS ONE OR TWO DOSES OF CIDOFOVIR INJECTION. TO REDUCE POSSIBLE NEPHROTOXICITY, INTRAVENOUS PREHYDRATION WITH NORMAL SALINE ...
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VISTIDE
Full clinical data, patents, trials, and competitive landscape for cidofovir.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.