Insulin aspart is under clinical development by Biocon and currently in the Pre-Registration 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 Insulin aspart’s likelihood of approval (LoA) and phase transition for Type 2 Diabetes took place on 10 Aug 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Insulin aspart overview

Insulin aspart recombinant (Kixelle/Kirsty) is a rapid-acting human insulin analog acts as antidiabetic agent. It is produced by employing recombinant DNA technology on Pichia pastoris. It is formulated as solution for subcutaneous, intravenous route of administration. Kixelle is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Biosimilar of insulin aspart is under development for the treatment of type 2 diabetes. It is administered through subcutaneous  and intravenous route. It is a rapid acting drug candidate. It works by stabilizing the insulin that is disturbed during the disease. It was under development for the treatment of type 1 diabetes.

Biocon overview

Biocon is a biopharmaceutical company that focuses on the research and development of therapies for the treatment of chronic conditions such as cancer, diabetes and autoimmune diseases. It offers a range of active pharmaceutical ingredients (APIs), branded formulations, complex biologics and biosimilars including monoclonal antibodies (MAbs), rh-Insulin and insulin analogs. The company also provides services including contract manufacturing, drug licensing, research, development and manufacturing of small and large molecules for biotechnology and pharmaceutical companies across the world. It has a manufacturing facility and R&D center at BioXcell, Malaysia. It operates overseas offices in the UK, Ireland, the US, Switzerland, Dubai, and Malaysia. Biocon is headquartered in Bangalore, Karnataka, India.

Quick View Insulin aspart LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Insulin aspart
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Metabolic Disorders
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.