NANJING, China – Triastek, a pioneer in 3D printed pharmaceutical technology, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for T25 (Octreotide Acetate Tablet), a 3D printed oral peptide product. T25 is a modified-release somatostatin analog developed under the 505(b)(2) regulatory pathway, indicated for maintenance treatment in adult patients with acromegaly who have responded to and tolerated treatment with somatostatin analogues. The product uses Triastek’s proprietary 3D Microstructure for Oral Macromolecules (3DμS^®-OM) delivery system and represents the company’s first oral peptide candidate to enter clinical development, marking a significant step toward addressing the long-standing challenges of oral peptide delivery.

Acromegaly is a rare disorder caused by excessive secretion of growth hormone. For patients who fail to achieve biochemical control after surgery or are not candidates for surgical intervention, somatostatin receptor ligands (SRLs) represent the mainstay of medical therapy. SRLs are typically administered as monthly injections, which may cause local adverse reactions and add to the psychological burden for some patients.^[1] The development of oral octreotide formulations offers the potential for a more convenient treatment option for these patients. According to Global Growth Insights, the global octreotide market was valued at approximately $2.34 billion in 2024 and is projected to reach $4.17 billion by 2035.^[2]

However, the oral delivery of peptide drugs represents a major challenge due to multiple technical hurdles. Peptide molecules are susceptible to enzymatic degradation and acidic conditions in the gastrointestinal tract, while the intestinal epithelial barrier and mucus layer further restrict effective absorption. Compounded by significant inter-individual variability, these factors have made the development of oral peptide therapeutics a long-standing challenge in the pharmaceutical industry.

Process and Structure Synergy: Advancing Oral Peptide Delivery

T25 is manufactured using Triastek’s proprietary MED&SSE (Melt Extrusion Deposition plus Semi-Solid Extrusion) process, in which the MED process prints the outer shell while the SSE process prints the drug-loaded core. The low printing temperature of SSE is particularly well-suited for the manufacturing of peptide and macromolecule-based drug products, helping to preserve the stability of these active ingredients during production and effectively avoiding the activity loss typically associated with high temperatures in conventional processes.

Building on this process, T25 is enabled by Triastek’s proprietary 3D Microstructure for Oral Macromolecules (3DμS^®-OM) delivery system. At the structural design level, the dual-chamber design protects the peptide from gastric degradation, enabling precise delivery to the intended absorption site in the gastrointestinal tract. Meanwhile, optimization of the formulation architecture allows for tailored control of drug release, thereby enhancing the bioavailability of oral peptide therapeutics.

Dr. Feihuang Deng, Vice President of Technology at Triastek, commented: “T25 is Triastek’s first oral peptide product to enter clinical development, and this FDA IND clearance marks an important step forward—moving 3D printed pharmaceutical technology from concept validation to clinical translation in oral peptide delivery, while also demonstrating the power of combining our MED&SSE process with the 3DμS^®-OM delivery system. This technological approach holds promise for tackling the long-standing challenges of oral peptide delivery. We look forward to advancing T25 through clinical development and applying this delivery system to more peptide therapeutics, ultimately bringing patients a new oral treatment option.”

References：

[1] Remba-Shapiro, I., & Nachtigall, L. B. (2024). Treatment of acromegaly with oral octreotide. Best Practice & Research Clinical Endocrinology & Metabolism, 38(4), 101888.

[2] Global Growth Insights. (2024). Octreotide Market Size, Share & Industry Analysis, 2025–2035. Retrieved from https://www.globalgrowthinsights.com/market-reports/octreotide-market-100386

About Triastek：

Global leader in 3D printing pharmaceuticals, Pioneer of new digital pharmaceutical processes.

Founded in July 2015, Triastek is dedicated to the mission of "revolutionizing the pharmaceutical industry, unlocking the next generation of medicine and benefitting patients worldwide." We have created the Melt Extrusion Deposition (MED^®) 3D printing pharmaceutical process, transforming the delivery, development, and production of medicines through digital product development and continuous manufacturing. Leveraging our proprietary 3D printing pharmaceutical technology, we design and develop transformative medicines for patients. Through collaboration with global pharmaceutical companies, we tackle challenging formulation problems, accelerating the development of new drug products and improving the quality of pharmaceuticals. Our vision is to become the world's most influential intelligent pharmaceutical enterprise.