RZ-358 is a Monoclonal Antibody owned by Rezolute, and is involved in 7 clinical trials, of which 5 were completed, 1 is ongoing, and 1 is planned.

RZ-358 is an antagonist (deactivator) of the insulin receptor. Inhibition of the insulin receptor mitigates the insulin-induced hypoglycemia by inhibiting the downstream signaling of insulin.

The revenue for RZ-358 is expected to reach a total of $1.3bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the RZ-358 NPV Report.

RZ-358 was originated by XOMA and is currently owned by Rezolute. XOMA is the other company associated in development or marketing of RZ-358.

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.

The operating loss of the company was US$22.4 million in FY2021, compared to an operating loss of US$20.5 million in FY2020. The net loss of the company was US$20.9 million in FY2021, compared to a net loss of US$20.3 million in FY2020.

Quick View – RZ-358

Report Segments
  • Innovator
Drug Name
  • RZ-358
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Metabolic Disorders
  • Oncology
Key Companies
Highest Development Stage
  • Phase II

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.