SureNano Science (CSE: SURE | OTCQB: SURNF) is pushing its lead weight loss and diabetes candidate GEP-44 into a critical new phase, announcing the launch of a comprehensive FDA IND-enabling Good Laboratory Practice toxicology and pharmacology study program — while simultaneously entering discussions to acquire an ibogaine formulation IP portfolio targeting mental health and addiction treatment.
The GEP-44 Program
SureNano’s subsidiary GlucaPharm is moving forward with a multi-species, GLP-compliant preclinical study package designed to satisfy FDA requirements ahead of a Phase I clinical trial. The company plans to conduct the program in collaboration with LabCorp, a globally recognized CRO with deep preclinical development expertise, subject to finalizing definitive collaboration agreements and securing related funding.
The study program will span rodents, non-rodent species, and primates, generating the safety and pharmacology data the FDA requires before human trials can begin. Specifically, the studies will establish the maximum tolerated dose, identify potential biomarkers for toxicity monitoring, assess whether toxic effects are reversible, and define the safety margin necessary to support first-in-human dosing. That dataset will directly feed SureNano’s Clinical Trial Notification submission in Australia — a jurisdiction the company has deliberately chosen for its efficient regulatory framework and accelerated path to first-in-human studies.
Chief Scientific Officer Nihar Pandey, PhD, underscored the significance of the move. “Initiating these FDA IND-enabling studies is a major milestone for SureNano Science and GlucaPharm, moving us firmly towards the final, rigorous evaluation in various clinical phases before entering the clinic,” Pandey said. “Partnering with a globally renowned CRO like LabCorp will ensure our studies meet the highest regulatory standards.”
Why GEP-44 Matters
GEP-44 is a novel, patented peptide originally developed by researchers at Syracuse University, and it targets the same receptor pathways that have made GLP-1 agonists like Ozempic, Wegovy, Mounjaro, and Retatrutide among the most commercially significant drug classes in recent pharmaceutical history. SureNano is positioning GEP-44 as a next-generation entry in that space — targeting comparable or superior efficacy with improved patient tolerability and delivery potential across Type II Diabetes and obesity indications.
The commercial stakes here are hard to overstate. The GLP-1 market has exploded into one of the fastest-growing therapeutic categories globally, and even incremental clinical differentiation — better tolerability, improved delivery, or a cleaner side effect profile — can translate into enormous commercial opportunity in a market already generating tens of billions in annual revenue.
The Ibogaine Angle
Beyond GEP-44, SureNano is also entering discussions to acquire an ibogaine formulation IP portfolio targeting mental health and addiction treatment. While still in early-stage discussions, the move signals that SureNano is actively building out a pipeline that extends beyond metabolic disease — tapping into another high-growth, high-need therapeutic area that has attracted significant scientific and investor interest in recent years.
What to Watch
For investors tracking SURE and SURNF, the near-term focus falls on two fronts: the finalization of the LabCorp collaboration agreement and funding, and the progression of ibogaine IP acquisition discussions. Further out, the completion of GLP toxicology studies and the subsequent CTN submission in Australia will mark the next major clinical milestone on the path toward a Phase I trial.
For more investor relations information on SureNano Science please visit www.surenano.com/investors .
The post SureNano Science Launches FDA-Track Toxicology Program for GEP-44, Eyes Ibogaine IP Acquisition appeared first on PRISM MarketView.