Numerous clinical trials across all phases have evaluated cidofovir for cytomegalovirus retinitis, herpes simplex virus infection, high-grade cervical epithelial neoplasia, and viral complications associated with blood and marrow transplantation. These studies are supported by government bodies like the National Institute of Allergy and Infectious Diseases, academic research hospitals, and biopharmaceutical firms including Gilead Sciences and SymBio Pharmaceuticals. Current registry records reflect varying recruitment statuses, encompassing completed, active, recruiting, and terminated protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT01295645 | ACTIVE_NOT_RECRUITING | Transplantation Infection |
M.D. Anderson Cancer Center |
2011-03-17 | PHASE2 |
| NCT07387367 | RECRUITING | Adenovirus Infections |
SymBio Pharmaceuticals |
2026-03-17 | PHASE3 |
| NCT06439342 | RECRUITING | Cytomegalovirus (CMV) |
Takeda |
2024-12-16 | PHASE3 |
| NCT04706923 | COMPLETED | Adenovirus Infections; Cytomegalovirus Infection |
SymBio Pharmaceuticals |
2021-08-16 | PHASE2 |
| NCT04055142 | COMPLETED | High-grade Anal Intraepithelial Neoplasia |
Hospital Universitari Vall d'Hebron Research Institute |
2020-09-18 | PHASE3 |
| NCT04542252 | Completed | Drug Drug Interaction |
SymBio Pharmaceuticals |
2020-11-09 | Phase 1 |
| NCT02931539 | COMPLETED | Cytomegalovirus (CMV) |
Shire |
2016-12-22 | PHASE3 |
| NCT03532035 | WITHDRAWN | Adenovirus |
Jazz Pharmaceuticals |
2018-12-15 | PHASE2 |
| NCT03339401 | TERMINATED | Adenovirus |
Jazz Pharmaceuticals |
2017-12-22 | PHASE2 |
| NCT01816646 | COMPLETED | Blood And Marrow Transplantation |
M.D. Anderson Cancer Center |
2013-09 | PHASE1 |
| NCT02555800 | UNKNOWN | Recurrent Respiratory Papillomatosis |
Centro de Investigación en. Enfermedades Infecciosas, Mexico |
2014-12 | PHASE2 |
| NCT02567149 | WITHDRAWN | Warts |
University of Minnesota |
2016-06 | PHASE2 |
| NCT02976987 | COMPLETED | High Grade Cervical Epithelial Neoplasia (CIN2+) |
Brugmann University Hospital |
2013-02 | PHASE2 |
| NCT01610765 | Withdrawn | Herpes Simplex Virus |
University of Alabama at Birmingham |
2016-01 | Phase 1|Phase 2 |
| NCT01769170 | COMPLETED | CMV |
Jazz Pharmaceuticals |
2013-08 | PHASE3 |
| NCT01946009 | COMPLETED | HIV |
Fundacion SEIMC-GESIDA |
2013-09 | |
| NCT01816646 | Completed | Blood And Marrow Transplantation |
M.D. Anderson Cancer Center|Gilead Sciences |
2013-09 | Phase 1 |
| NCT00948506 | COMPLETED | Prevention of Hair Growth |
University of Pennsylvania |
2009-07 | PHASE2 |
| NCT00989443 | COMPLETED | Uterine Cervical Neoplasms; Cervix Intraepithelial Neoplasia |
Mithra Pharmaceuticals |
2010-05 | PHASE1 |
| NCT00138424 | TERMINATED | BK Virus (Nephropathy) |
National Institute of Allergy and Infectious Diseases (NIAID) |
2006-05 | PHASE1; PHASE2 |
| NCT00550589 | COMPLETED | Anal Cancer; Precancerous Condition |
AIDS Malignancy Consortium |
2007-09 | PHASE2 |
| NCT00205374 | COMPLETED | Recurrent Respiratory Papillomatosis |
University of Wisconsin, Madison |
1999-11 | PHASE4 |
| NCT00811408 | UNKNOWN | Cervical Cancer; Precancerous Condition |
Gustave Roussy, Cancer Campus, Grand Paris |
2008-04 | PHASE1 |
| NCT00780182 | COMPLETED | Healthy |
Jazz Pharmaceuticals |
2008-10 | PHASE1 |
| NCT00780182 | Completed | Healthy |
Chimerix|National Institutes of Health (NIH) |
2008-10 | Phase 1 |
| NCT01866397 | COMPLETED | Cytomegalovirus Retinitis; Acute Renal Failure |
Medical University of Vienna |
2002-03 | PHASE4 |
| NCT00000143 | COMPLETED | Cytomegalovirus Retinitis; HIV Infections |
Johns Hopkins Bloomberg School of Public Health |
1997-05 | PHASE3 |
| NCT00000894 | COMPLETED | Cytomegalovirus Retinitis; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE4 | |
| NCT00000142 | COMPLETED | HIV Infections; CMV Cytomegalovirus Retinitis |
Johns Hopkins Bloomberg School of Public Health |
1994-04 | PHASE2; PHASE3 |
| NCT00000799 | COMPLETED | Cytomegalovirus Retinitis; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00002116 | COMPLETED | Herpes Simplex; HIV Infections |
Gilead Sciences |
PHASE1 | |
| NCT00001126 | COMPLETED | Papilloma |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00002327 | COMPLETED | HIV Infections; Condyloma Acuminata |
Gilead Sciences |
PHASE1 | |
| NCT00002142 | COMPLETED | Cytomegalovirus Retinitis; HIV Infections |
Gilead Sciences |
||
| NCT00000881 | WITHDRAWN | Cytomegalovirus Infections; Cytomegalovirus Retinitis; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00002181 | COMPLETED | Herpes Simplex; HIV Infections |
Gilead Sciences |
||
| NCT00002437 | COMPLETED | Cytomegalovirus Retinitis; HIV Infections |
Gilead Sciences |
PHASE2 | |
| NCT00004794 | COMPLETED | Cytomegalovirus Retinitis; Acquired Immunodeficiency Syndrome |
National Center for Research Resources (NCRR) |
1995-03 | PHASE2 |
| NCT00002384 | UNKNOWN | Cytomegalovirus Retinitis; HIV Infections |
Gilead Sciences |
||
| NCT00019240 | COMPLETED | Sarcoma |
National Cancer Institute (NCI) |
1996-11 | PHASE2 |
| NCT00000945 | COMPLETED | HIV Infections; Leukoencephalopathy, Progressive Multifocal |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00956176 | WITHDRAWN | Cystitis; Bladder Diseases |
M.D. Anderson Cancer Center |
(data from https://clinicaltrials.gov, updated on 2026-03-06)
Check the
Cidofovir
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.