Brincidofovir is under clinical development by Emergent BioSolutions and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Brincidofovir’s likelihood of approval (LoA) and phase transition for Adenoviridae Infections took place on 28 Oct 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Brincidofovir Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Brincidofovir overview

Brincidofovir (Tembexa) is an alkoxyalkyl ester prodrug containing the synthetic, acyclic nucleoside monophosphate analog cidofovir, with antiviral activity. It is formulated as film coated tablets and suspension for oral route of administration. Tembexa is indicated for the treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates.

Brincidofovir (BCV, CMX-001) is under development for the prevention and treatment of smallpox, brain tumors, adenovirus (AdV) infections, BK virus infection after renal transplantation and refractory or relapsed diffuse large B-cell lymphoma and Epstein-Barr virus (EBV) positive lymphoma. The drug candidate is administered orally and intravenously. It is a prodrug of cidofovir. It is based on lipid-antiviral-conjugate technology. The drug candidate was also under development for progressive multifocal leukoencephalopathy, monkeypox, human herpesvirus 6 (HHV-6), Ebola virus disease, adenovirus (AdV) infections, polyomavirus infections (BK virus) and other DNA virus-induced diseases.

Emergent BioSolutions overview

Emergent BioSolutions (Emergent) is a life sciences company that provides specialized products to address medical needs and public health threats (PHTs). Its solutions help address PHTs including chemical, biological, radiological, nuclear and explosives (CBRNE), emerging infectious diseases, travel health, emerging health crises, and acute/emergency care. It offers vaccines, therapeutics, drug-device combination products, and contract development and manufacturing services. Emergent’s pipeline candidates target dengue and other influenza infections. It also offers specialized products to governments and commercial customers. The company distributes its products in the US and Canada through its commercial sales forces and third-party distributors. Emergent is headquartered in Rockville, Maryland, the US.

Quick View Brincidofovir LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Brincidofovir
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.