In the field of metabolic disease treatment, the development of peptide drugs has always been a focus of research. Among them, NA-931, as a novel peptide drug, has shown remarkable potential in addressing obesity, diabetes and other metabolic disorders. This article will delve into the mechanism, clinical performance, product characteristics ofNA-931, and its alignment with the latest FDA guidelines, to provide a comprehensive understanding of this promising peptide.
NA-931, also known as bioglutide, is a groundbreaking quadruple receptor agonist that targets four key hormone receptors: glucagon-like peptide-1 receptor (GLP-1R), glucose-dependent insulinotropic polypeptide receptor (GIPR), glucagon receptor (GCGR), and insulin-like growth factor-1 receptor (IGF-1R) . This unique multi-target design is based on in-depth insights into receptor structures and signal transduction pathways, allowing NA-931 to bind to these receptors specifically and mimic the functions of natural ligands, thereby activating downstream signaling cascades . For ordinary users, this means NA-931 can regulate multiple metabolic processes in the body simultaneously, rather than relying on a single pathway, which brings more comprehensive therapeutic effects.
A key advantage of NA-931 lies in its ability to achieve “weight loss without muscle loss”, a feature that addresses a major concern in current metabolic disease treatment. The IGF-1R targeted by NA-931 plays a crucial role in energy metabolism and body composition regulation . While other weight-loss drugs often lead to concurrent muscle loss, NA-931’s activation of IGF-1R helps preserve muscle mass during weight reduction, which is vital for maintaining basal metabolic rate and overall physical function. This characteristic makes NA-931 particularly suitable for obese or overweight patients who need to improve body composition while losing weight.
Clinical trials have further verified the efficacy and safety of NA-931. At the 2025 European Association for the Study of Diabetes (EASD) Annual Meeting, phase II clinical data of NA-931 were released . The 13-week randomized, double-blind, placebo-controlled trial involved 125 obese (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) adult patients with at least one weight-related comorbid condition. Results showed that NA-931 exhibited dose-dependent weight reduction effects. At the daily dose of 150 mg, patients achieved a maximum mean weight loss of 14.8% by week 13, which was 13.2% higher than the placebo group . More impressively, up to 72% of patients treated with NA-931 lost ≥ 12% of their body weight, compared to only 2% in the placebo group . These data fully demonstrate the strong weight-loss efficacy of NA-931.
In terms of safety, NA-931 has shown good tolerability. Treatment-emergent adverse events (TEAEs) were mainly mild and non-significant. Gastrointestinal reactions such as mild nausea and vomiting were common but had similar incidence rates between the treatment and placebo groups . Diarrhea was reported in 8.1% of NA-931 recipients, slightly higher than the 3.2% in the placebo group, but still within the acceptable range . Notably, no muscle loss was observed in the NA-931 group, which is consistent with its mechanism of action . These safety results lay a solid foundation for the further development and clinical application of NA-931.
From the perspective of product attributes, NA-931 has practical advantages that meet clinical needs. As an oral peptide drug, it offers a convenient alternative to the subcutaneous injections commonly used for GLP-1-based treatments , significantly improving patient compliance. In terms of product quality, NA-931 supplied by professional manufacturers typically has a purity (HPLC) of ≥ 98.0%, with single impurities ≤ 2.0%, acetate content ranging from 5.0% to 12.0%, and water content (Karl Fischer) ≤ 10.0%, ensuring high peptide content (≥ 80.0%) . The product is delivered in low-temperature vacuum packaging, with precise dosing down to the milligram level as required , guaranteeing stability and accuracy during storage and use.
The development and application of NA-931 also strictly adhere to the latest FDA guidelines. In November 2024, the FDA updated the labels of all GLP-1 receptor agonists, adding a warning about pulmonary aspiration during general anesthesia or deep sedation . The warning notes that there have been rare post-marketing reports of pulmonary aspiration in patients taking GLP-1 receptor agonists who underwent elective surgery or procedures requiring general anesthesia or deep sedation, even if they adhered to preoperative fasting recommendations . As a peptide drug targeting GLP-1R,NA-931fully complies with this guideline. In clinical practice, it is emphasized that patients taking NA-931 must inform healthcare providers before any planned surgery or procedure, and physicians should counsel patients about the risk of delayed gastric emptying leading to anesthesia-related complications . This adherence to FDA safety requirements ensures that NA-931 is used safely and standardizedly.
Additionally, the FDA’s January 2025 draft guideline for weight-loss drug development focuses on novel approaches such as improving administration convenience and ensuring safety . NA-931’s oral administration route and proven safety profile are highly consistent with these regulatory trends, making it a competitive candidate in the field of metabolic disease treatment.
Preguntas y respuestas comunes
Q: How is NA-931 different from other weight-loss peptides I’ve heard of?
A: The biggest difference is that NA-931 is the world’s first quadruple receptor agonist targeting GLP-1R, GIPR, GCGR, and IGF-1R . Most existing weight-loss peptides only target 1 or 2 receptors. Its unique targeting of IGF-1R allows it to achieve “weight loss without muscle loss”, which is rarely seen in other products. Moreover, NA-931 is taken orally, avoiding the pain and inconvenience of injections.
Q: Is NA-931 safe? Are there any important precautions I need to know?
A: Phase II clinical trials show that NA-931’s adverse reactions are mainly mild, such as occasional nausea or diarrhea, and no serious safety issues have been found . However, following FDA guidelines , if you are taking NA-931 and need surgery or procedures requiring anesthesia, you must tell your doctor in advance. This is because NA-931 may slow gastric emptying, increasing the risk of food or liquid entering the lungs during anesthesia.
Q: What is the purity of NA-931, and how is it packaged to ensure quality?
A: Reputable suppliers provide NA-931 with a purity of at least 98.0%, and the peptide content is not less than 80.0% . To maintain its stability, NA-931 is packaged in vacuum-sealed containers and requires low-temperature storage. The packaging can be customized to precise milligram doses according to needs, ensuring accuracy when used.
