Disseminated on behalf of SureNano Science Ltd. (CSE: SURE) (OTCQB: SURNF) and may include a paid advertisement.
- SureNano Science initiated an FDA-aligned IND-enabling GLP toxicology and pharmacology program for lead candidate GEP-44, a multi-receptor peptide targeting obesity and type 2 diabetes, positioned within the growing GLP-1 therapeutic market as a minnow among giants.
- The studies will assess safety, dosing thresholds, and pharmacological effects across multiple species, GEP-44 preclinical results position it head-to-head with leaders such as Ozempic, Mounjaro, Wegovy.
- The program is expected to support a Phase I clinical trial in Australia, subject to regulatory submission and study outcomes.
- The company is also exploring acquisition or licensing of Ibogaine-related intellectual property for potential mental health and addiction treatments.
- SureNano’s transition toward a pharmaceutical-focused model follows its acquisition of GlucaPharm, now operating in the rapidly expanding GLP market expected to hit $200 billion in sales by 2030.
SureNano Science (CSE: SURE) (OTCQB: SURNF), a Canadian life sciences company, has begun a key phase of preclinical development for its lead drug candidate GEP-44, a multi-receptor peptide targeting obesity and type 2 diabetes. The company is initiating a Good Laboratory Practice (“GLP”) toxicology and pharmacology program aligned with U.S. Food and Drug Administration (“FDA”) requirements, intended to support an Investigational New Drug (“IND”) application and represents a necessary step before first-in-human clinical trials. Against a backdrop of a rapidly expanding GLP market, SureNano is positioning itself as an agile entrant in the next-generation GLP-1 landscape having developed a patented high-performing second-generation incretin-based therapy after securing licensing rights to the GEP-44 compound developed by Syracuse University.
The GLP economic opportunity is substantial with the global GLP-1 receptor agonist market projections range from $100 billion to J.P. Morgan estimates of the broader incretin market to reach $200 billion by 2030, with ~25 million by 2030 patients using GLP-1 therapies in the United States alone. SureNano is participating in one of the fastest-growing and most commercially significant therapeutic markets in modern healthcare, with the GEP-44 contender that performs with higher tolerability and a friendly administration method, including greater weight loss, enhanced glucose control and an absence of the gastrointestinal side effects than first-generation therapies.
The studies are expected to be conducted in collaboration with Labcorp, a contract research organization (“CRO”) specializing in preclinical development services to support clinical development, subject to final agreements and funding (https://ibn.fm/xo3MQ).
According to the company, the GLP-compliant program will evaluate safety, toxicology, and pharmacology across multiple species, including rodents, non-rodents, and primates. The objective is to determine the maximum tolerated dose, identify biomarkers for monitoring toxicity, assess whether adverse effects are reversible, and establish safety margins for initial human testing.
Following completion of the studies, SureNano plans to submit a Clinical Trial Notification in Australia, where it intends to begin Phase I trials. The company cited Australia’s regulatory framework and clinical research infrastructure as factors supporting an accelerated pathway to first-in-human studies.
Dr. Nihar Pandey, Chief Scientific Officer at SureNano, said the program marks a transition toward clinical-stage evaluation. “Initiating these U.S. Food and Drug Administration 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,” said Dr. Pandey. “Partnering with a globally renowned CRO like LabCorp will ensure our studies meet the highest regulatory standards. This package is vital to de-risk our lead candidate and is designed to support our strategy of launching a Phase I clinical trial in Australia.”
GEP-44, the company’s lead asset, is being developed through subsidiary GlucaPharm, which SureNano acquired earlier in 2026. The peptide was originally developed at Syracuse University and is designed as a multi-receptor agonist targeting pathways involved in glucose regulation and appetite control, designed as a triple agonist targeting GLP-1 and peptide YY (“PYY”) receptors (“Y1” and “Y2”), combining glucose regulation, appetite suppression, and improved tolerability within a single molecule.
It is positioned within the same therapeutic category as widely prescribed GLP-1 drugs, including Ozempic, Wegovy, and Mounjaro. Those drugs have reshaped treatment approaches for obesity and type 2 diabetes and contributed to rapid growth in the GLP-1 market, which industry estimates place at tens of billions of dollars annually, with continued expansion expected.
SureNano said its candidate is designed to address some of the limitations associated with current therapies, including gastrointestinal side effects and the need for injectable delivery. The company is also exploring alternative delivery methods, including oral, sublingual, and nasal formats, which could affect patient adherence if successfully developed.
At this stage, GEP-44 remains in preclinical development, and its efficacy and safety in humans have not yet been established. The IND-enabling program is intended to generate the data required for regulators to evaluate whether human trials can proceed.
In parallel with its metabolic disease program, SureNano said it has begun discussions to acquire or license intellectual property related to Ibogaine formulations. Ibogaine is a naturally occurring psychoactive compound that has been studied for potential use in treating addiction and certain mental health conditions.
The company said it is in early-stage discussions with academic institutions and research groups regarding synthesis, formulation, and delivery technologies for Ibogaine and related compounds. No agreements have been finalized, and management noted that there is no assurance that any transaction will be completed.
Interest in Ibogaine has increased in recent years alongside broader research into psychedelic-assisted therapies. Recent regulatory developments in the United States, including IND clearance for Ibogaine-related studies, have opened the possibility of controlled clinical trials, although the field remains at an early stage.
SureNano’s approach reflects a broader shift in its business model. The company began with a focus on nanotechnology and formulation science, including the development of its SureNano(TM) emulsifier, a plant-derived compound used to improve stability and bioavailability in various applications.
Following the acquisition of GlucaPharm, the company has moved toward a pharmaceutical development strategy centered on therapeutic candidates with potential applications in large and growing healthcare markets. Obesity and type 2 diabetes remain among the most significant global health challenges, with prevalence rates rising and healthcare systems facing increasing costs associated with long-term management.
For more information, visit the company’s website at www.SureNano.com.
NOTE TO INVESTORS: The latest news and updates relating to SURNF are available in the company’s newsroom at https://ibn.fm/SURNF
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