RZ-358 is under clinical development by Rezolute 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 RZ-358’s likelihood of approval (LoA) and phase transition for Hyperinsulinemia took place on 09 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

In addition, the same event on 09 Jun 2022 increased RZ-358’s LoA and PTSR for Hypoglycemia.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their RZ-358 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

RZ-358 overview

RZ-358 (XOMA-358) is under development for the treatment of hyperinsulinemic hypoglycemia post gastric bypass surgery, and hypoglycemia associated with congenital hyperinsulinism. The drug candidate is a fully human monoclonal antibody which is administered through intravenous route as a solution. It is a fully human negative allosteric selective insulin receptor modulator (SIRMs) antibody derived from the XMet platform. It was also under development for the treatment of insulinomas.

Rezolute overview

Rezolute formerly, AntriaBio Inc, is a clinical-stage biopharmaceutical company that carries out the development of innovative drug therapies for the treatment of metabolic diseases related to chronic glucose imbalance. Its pipeline product portfolio includes RZ358 which is an intravenous monoclonal antibody. RZ358 is used for the treatment of conditions characterized by excessive insulin levels and is developing to treat hyperinsulinism and low blood sugar characteristic of diseases such as congenital hyperinsulinism. The company also offers RZ402 which is a potent plasma kallikrein inhibitor used for the treatment of diabetic macular edema (DME). Rezolute is headquartered in Redwood City, California, the US.

Quick View RZ-358 LOA Data

Report Segments
  • Innovator
Drug Name
  • RZ-358
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Metabolic Disorders
  • Oncology
Key Developers
  • Sponsor Company: Rezolute
  • Originator: XOMA
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.