DM-199 is under clinical development by DiaMedica Therapeutics 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 DM-199’s likelihood of approval (LoA) and phase transition for Chronic Kidney Disease (Chronic Renal Failure) took place on 28 Apr 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.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their DM-199 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

DM-199 overview

DM-199 is under development for the treatment of diabetic nephropathy (diabetic kidney disease), other metabolic diseases, chronic kidney diseases in patients with type-1 diabetes and vascular dementia, IgA nephropathy. The drug candidate is administered through subcutaneous and intravenous route. DM-199 is a recombinant human tissue kallikrein-1 protein known as rhKLK-1.

The drug candidate was also under development for Alzheimer's disease, acute ischemic stroke, rheumatoid arthritis, type 2 diabetes, type 1 diabetes, acute kidney injury and Alport syndrome.

DiaMedica Therapeutics overview

DiaMedica Therapeutics (DiaMedica), formerly DiaMedica, is a biopharmaceutical company. It develops innovative medicines for the treatment neurological and kidney diseases. Its lead product candidate DM-199, is a human recombinant protein that treats diabetes type 1 and type 2, and associated complications including diabetic kidney disease and alport syndrome; and DM300 for treating acute pancreatitis. DiaMedica’s DM199 is also used for the treatment of diabetic nephropathy and post-insult treatment from acute ischemic stroke (AIS). The company discovers and develops novel therapies for kidney dysfunction and metabolic disorders. The company also provides clinical trial services. DiaMedica is headquartered in Minneapolis, Minnesota, the US.

Quick View DM-199 LOA Data

Report Segments
  • Innovator
Drug Name
  • DM-199
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Genetic Disorders
  • Genito Urinary System And Sex Hormones
  • Immunology
  • Metabolic Disorders
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.