CDEK
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brincidofovir

Trade name: Tembexa

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Jun 4, 2021

Brincidofovir, sold under the brand name Tembexa, is an antiviral drug used to treat smallpox. Brincidofovir is a prodrug of cidofovir. Conjugated to a lipid, the compound is designed to release cidofovir intracellularly, allowing for higher intracellular and lower plasma concentrations of cidofovir, effectively increasing its activity against dsDNA viruses, as well as oral bioavailability. — Wikipedia

Clinical trial activity

21 trials · 7 clinical orgs · 2 marketing orgs

Phase 1
7
Phase 2
15
Phase 3
5
Phase 4
0

Earliest trial started Oct 1, 2008 (NCT00780182)

Timeline

2000s

  1. Jan 1, 2008

    Chimerix — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2009

    Chimerix — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Chimerix — Earliest Phase 3 Sponsor(trial)

  2. Jun 5, 2018

    Orphan Drug Designation

2020s

  1. Jun 4, 2021

    Emergent BioSolutions — Earliest FDA Approval

  2. Jun 4, 2021

    Chimerix — Marketing Organization

  3. Jun 4, 2021

    Emergent BioSolutions — Marketing Organization

  4. Jun 4, 2021

    Emergent BioSolutions — NDA Secondary Org

  5. Jun 4, 2021

    Emergent BioSolutions — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackJun 4, 2021

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCCCCCCCCCCCOCCCOP(=O)(O)CO[C@H](CO)Cn1ccc(N)nc1=O
Mol. weight
561.7 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • brincidofovir
  • brincidofovir
  • brincidofovir
  • brincidofovir
  • brincidofovir
  • cidofovir hexadecyloxypropyl ester
  • cmx001
  • cmx001
  • cmx001
  • cmx001
  • cmx 001
  • cmx-001
  • hdp-cdv
  • hexadecyloxypropyl cidofovir
  • hexadecyloxypropyl cidofovir

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06761677Phase 1/Phase 2 (Phase 2)Jan 7, 2025SymBio Pharmaceuticals
NCT05935917Phase 1May 30, 2023Emergent BioSolutions
NCT05511779Phase 2Oct 14, 2022SymBio Pharmaceuticals
NCT04706923Phase 2Aug 16, 2021SymBio Pharmaceuticals
NCT04542252Phase 1Nov 9, 2020SymBio Pharmaceuticals
NCT03532035Phase 2Aug 30, 2018Chimerix
NCT03339401Phase 2Dec 22, 2017Chimerix
NCT01610765Phase 1/Phase 2 (Phase 2)Jan 1, 2016University of Alabama, Birmingham
NCT02596997N/ANov 3, 2015Chimerix
NCT02439970Phase 3Sep 1, 2015Chimerix
NCT02439957Phase 3Sep 1, 2015Chimerix
NCT04268966Phase 2Oct 31, 2014Chimerix, Food and Drug Administration
NCT02271347Phase 2Oct 1, 2014Chimerix
NCT02087306Phase 3Mar 1, 2014Chimerix
NCT01769170Phase 3Aug 1, 2013Chimerix
NCT05391724Phase 1Feb 28, 2011Chimerix
NCT01143181Phase 2/Phase 3 (Phase 3)Dec 1, 2010Chimerix
NCT01241344Phase 2Nov 1, 2010Chimerix
NCT00942305Phase 2Oct 1, 2009Chimerix
NCT00793598Phase 1/Phase 2 (Phase 2)Nov 1, 2008Chimerix
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (7)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ChimerixFor profit151542008
SymBio PharmaceuticalsFor profit4422020
AAIPharmaFor profit1012008
Emergent BioSolutionsFor profit1112023
Food and Drug AdministrationGovernment1012014
National Institutes of Health (NIH)Government1012008
University of Alabama, BirminghamAcademic/Hospital1112016
7 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
ChimerixFor profitMKTGJun 4, 2021
Emergent BioSolutionsFor profitMKTGJun 4, 2021
Emergent BioSolutionsFor profitNDA2Jun 4, 2021
Emergent BioSolutionsFor profitNDAJun 4, 2021