O-304 is under clinical development by Betagenon and currently in the Phase I and 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 O-304’s likelihood of approval (LoA) and phase transition for Peripheral Arterial Disease (PAD)/ Peripheral Vascular Disease (PVD) took place on 25 Aug 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 O-304 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

O-304 overview

O-304 is under development for the treatment of non-alcoholic fatty liver disease, obesity, heart failure with preserved ejection fraction (HFpEF) (NAFLD)/non-alcoholic steatohepatitis (NASH), peripheral vascular disease, type 2 diabetes and diabetic kidney disease. The drug candidate is administered orally and is formulated as suspension for type 2 diabetes. The drug candidate acts by targeting adenosine monophosphate activated protein kinase (AMPK) and proprotein convertase subtilisin/kexin type 9. It was also under development for sarcopenia and cancer.

Betagenon overview

Betagenon is a biotechnology company. It is engaged in the development of AMP-activated protein kinase (AMPK) activator compounds to treat chronic energy balance disorders diseases in metabolically challenged elderly and obese individuals. The company develops O304, an AMPK activator compound that exhibits favorable pre-clinical pharmacology and toxicology profiles. Its O304 uses purified human recombinant enzymes to suppress the dephosphorylation of p-T172 AMPK trimer by both PP2C and PP1 protein phosphatases and improves peripheral microvascular perfusion. The company operates through its laboratory facilities in Umea, Sweden. Betagenon is headquartered in Umea, Vasterbotten, Sweden.

Quick View O-304 LOA Data

Report Segments
  • Innovator
Drug Name
  • O-304
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Gastrointestinal
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

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.