Drugs / Brincidofovir
Brincidofovir
also known as
BCV · CMX001 · SyB V-1901 · Hdp-cidofovir · HDP-Cidofovir Conjugate · Hexadecyloxypropyl cidofovir · Tembexa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | TEMBEXA | — | 2021-06-04 | fda.gov ↗ |
Trials 17 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04542252 | Nov → Dec 2020 | — | SymBio Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05391724 | Feb → Sep 2011 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT00780182 | Oct → Dec 2008 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06761677 | Jun 2025 → Oct 2027 | lymphoma | SymBio Pharmaceuticals | Suspended | No outcome recorded |
| Phase 1/2 | NCT00793598 | Nov 2009 → Oct 2010 | — | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT07511049 | Jun 2026 → Dec 2029 expected | progressive multifocal leukoencephalopathy | National Institute of Neurological Disorders and Stroke (NINDS) | Recruiting | No outcome recorded |
| Phase 2 | NCT05511779 | Oct 2022 → Apr 2023 | polyomavirus infectious disease | SymBio Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04706923 | Aug 2021 → Sep 2026 expected | adenoviridae infectious disease, cytomegalovirus infection | SymBio Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT03532035 | Dec 2018 → May 2019 | adenoviridae infectious disease | Jazz Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT03339401 | Dec 2017 → May 2019 | adenoviridae infectious disease | Jazz Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02271347 | Oct 2014 → Jan 2015 | Ebola hemorrhagic fever | Jazz Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT04268966 | Oct 2014 → Nov 2015 | Ebola hemorrhagic fever | Jazz Pharmaceuticals | Withdrawn | No outcome recorded |
| Phase 2 | NCT00942305 | Oct 2009 → Jan 2012 | cytomegalovirus infection | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07387367 | Mar 2026 → Jan 2028 expected | adenoviridae infectious disease | SymBio Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT02087306 | Mar 2014 → Jun 2016 | adenoviridae infectious disease | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01143181 | Dec 2010 → Dec 2012 | virus associated tumor | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT02596997 | — | adenoviridae infectious disease | Jazz Pharmaceuticals | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01610765 Comparator | Jan 2016 → Jun 2017 | herpes simplex infectious disease | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01241344 Comparator | Nov 2010 → Jun 2013 | adenoviridae infectious disease | Jazz Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02439970 Comparator | Sep 2015 → Jan 2016 | cytomegalovirus infection | Jazz Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT02439957 Comparator | Sep 2015 → May 2016 | cytomegalovirus infection, disease related to solid organ transplantation | Jazz Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT01769170 Comparator | Aug 2013 → Dec 2015 | cytomegalovirus infection | Jazz Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Brincidofovir | “This is a Phase IIa, open-label, multiple ascending dose confirmation, multicenter study to evaluate the safety and tolerability of intravenous Brincidofovir (BCV, SyB V-1901)...” NCT04706923 ↗ |
| Known as | BCV | “The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly...” NCT04706923 ↗6“This was a Phase 3 open-label, non-randomized, multicenter study of oral brincidofovir (BCV) administered twice weekly for the treatment of adenovirus (AdV) infection detected...” NCT02087306 ↗ “This was a multicenter, open-label study of oral brincidofovir (BCV) treatment of serious disease or conditions caused by double-stranded DNA (dsDNA) virus(es).” NCT01143181 ↗ “efficacy and safety of Brincidofovir (SyB V-1901, BCV) in patients with relapsed or refractory Extranodal Natural Killer/T-cell Lymphoma (ENKL).” NCT06761677 ↗ “Brincidofovir (BCV) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.” NCT03339401 ↗ “Brincidofovir (BCV) is an antiviral drug approved to treat smallpox.” NCT07511049 ↗ “Brincidofovir (BCV)” NCT03532035 ↗ |
| Known as | CMX001 | “A Safety and Dose-Determining Study of CMX001 In Infants With Neonatal Herpes Simplex Virus (HSV) Infection Involving the Central Nervous System (CNS Disease)” NCT01610765 ↗4“A Phase 3, Open-Label, Multicenter Study of the Safety and Efficacy of Brincidofovir (CMX001) in the Treatment of Early Versus Late Adenovirus Infection” NCT02087306 ↗ |
| Known as | Hdp-cidofovir | ChEMBL registry synonym — accepted as the source's own label CHEMBL203321 ↗ |
| Known as | HDP-Cidofovir Conjugate | “CMX001 (HDP-Cidofovir Conjugate) Delivered as a Tablet Formulation vs a Solution Formulation” NCT00780182 ↗ |
| Known as | Hexadecyloxypropyl cidofovir | ChEMBL registry synonym — accepted as the source's own label CHEMBL203321 ↗ |
| Known as | SyB V-1901 | “The purpose of this study is to determine the safety and tolerability of intravenous (IV) brincidofovir (BCV; SyB V-1901) 0.2 mg/kg, 0.3 mg/kg or 0.4 mg/kg dosed twice weekly...” NCT04706923 ↗2“efficacy and safety of Brincidofovir (SyB V-1901, BCV) in patients with relapsed or refractory Extranodal Natural Killer/T-cell Lymphoma (ENKL).” NCT06761677 ↗ |
| Known as | Tembexa | ChEMBL registry synonym — accepted as the source's own label CHEMBL203321 ↗ |
| Modality | Other / unclassified | “Brincidofovir (BCV) is an orally bioavailable lipid conjugate of cidofovir (CDV)” PMID 27851688 ↗ Dec 2016 |
| Route | Oral | “oral brincidofovir (BCV)” NCT00793598 ↗ |