Insulin human is under clinical development by Generex Biotechnology and currently in the Phase III 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 human’s likelihood of approval (LoA) and phase transition for Type 1 Diabetes (Juvenile Diabetes) took place on 15 Aug 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 15 Aug 2022 decreased Insulin human’s LoA and PTSR for Type 2 Diabetes.

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

Insulin human overview

Insulin human (Oral Recosulin) is a recombinant insulin. It is formulated as spray for oral route administration. Oral Recosulin is indicated for the treatment of type 1 and type 2 diabetes.

Insulin human (Oral Recosulin) is under development for the treatment of type I and type II diabetes. It is formulated as solution spray for oral route of administration. It is developed based on RapidMist, buccal drug delivery technology. 

Generex Biotechnology overview

Generex Biotechnology (Generex) carries out the research, development and commercialization of drug delivery systems and technologies. It developed a proprietary platform technology to deliver drugs into the human body through the oral cavity. The company’s proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using proprietary RapidMist device. Generex through its subsidiary, Antigen Express, has expanded its focus to include immunomedicines incorporating proprietary vaccine formulations for the treatment of infectious, malignant, allergic and autoimmune diseases. Generex is headquartered in Miramar, Florida, the US.

Quick View Insulin human LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Insulin human
Administration Pathway
  • Buccal
  • Oral
Therapeutic Areas
  • Metabolic Disorders
Key Developers
Highest Development Stage
  • Withdrawn (Marketed)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.