Multiple clinical trials spanning Phase 1 through Phase 3 have evaluated the therapeutic utility, safety, and pharmacokinetics of brincidofovir in treating viral infections—such as cytomegalovirus, adenovirus, herpes simplex virus, and Ebola virus—as well as relapsed or refractory lymphoma. Sponsored by pharmaceutical companies (including Chimerix, Jazz Pharmaceuticals, and SymBio Pharmaceuticals) alongside academic and government entities like the NIH and NINDS, studies range from early-phase pharmacokinetic assessments to advanced efficacy trials. Across this research landscape, trial recruitment statuses encompass completed, active, terminated, suspended, and withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07511049 | RECRUITING | Progressive Multifocal Leukoencephalopathy |
National Institute of Neurological Disorders and Stroke (NINDS) |
2026-06-05 | PHASE2 |
| NCT07387367 | RECRUITING | Adenovirus Infections |
SymBio Pharmaceuticals |
2026-03-17 | PHASE3 |
| NCT06761677 | SUSPENDED | Relapsed or Refractory Lymphoma Including ENKL |
SymBio Pharmaceuticals |
2025-06-09 | PHASE1; PHASE2 |
| NCT04706923 | COMPLETED | Adenovirus Infections; Cytomegalovirus Infection |
SymBio Pharmaceuticals |
2021-08-16 | PHASE2 |
| NCT05935917 | COMPLETED | Smallpox |
Emergent BioSolutions |
2023-05-30 | PHASE1 |
| NCT05511779 | TERMINATED | BK Virus Infection; Nephropathy; Kidney Transplantation |
SymBio Pharmaceuticals |
2022-10-14 | PHASE2 |
| NCT04542252 | Completed | Drug Drug Interaction |
SymBio Pharmaceuticals |
2020-11-09 | Phase 1 |
| NCT03532035 | WITHDRAWN | Adenovirus |
Jazz Pharmaceuticals |
2018-12-15 | PHASE2 |
| NCT03339401 | TERMINATED | Adenovirus |
Jazz Pharmaceuticals |
2017-12-22 | PHASE2 |
| NCT02087306 | COMPLETED | Adenovirus Infection |
Jazz Pharmaceuticals |
2014-03 | PHASE3 |
| NCT02439957 | TERMINATED | Cytomegalovirus Disease; Kidney Transplant Infection |
Jazz Pharmaceuticals |
2015-09 | PHASE3 |
| NCT02439970 | TERMINATED | Cytomegalovirus Disease |
Jazz Pharmaceuticals |
2015-09 | PHASE3 |
| NCT01610765 | Withdrawn | Herpes Simplex Virus |
University of Alabama at Birmingham |
2016-01 | Phase 1|Phase 2 |
| NCT01769170 | COMPLETED | CMV |
Jazz Pharmaceuticals |
2013-08 | PHASE3 |
| NCT04268966 | WITHDRAWN | Ebola Virus Disease |
Jazz Pharmaceuticals |
2014-10 | PHASE2 |
| NCT02271347 | WITHDRAWN | Ebola Virus |
Jazz Pharmaceuticals |
2014-10 | PHASE2 |
| NCT01241344 | COMPLETED | Adenovirus Disease |
Jazz Pharmaceuticals |
2010-11 | PHASE2 |
| NCT01143181 | COMPLETED | Double-stranded DNA Virus |
Jazz Pharmaceuticals |
2010-12 | PHASE3 |
| NCT00942305 | COMPLETED | Cytomegalovirus Infection |
Jazz Pharmaceuticals |
2009-10 | PHASE2 |
| NCT05391724 | Completed | Hepatic Impairment |
Chimerix |
2011-02 | Phase 1 |
| NCT00793598 | COMPLETED | Viruria |
Jazz Pharmaceuticals |
2009-11 | PHASE1; PHASE2 |
| NCT00780182 | Completed | Healthy |
Chimerix|National Institutes of Health (NIH) |
2008-10 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-07-22)
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>).