FDA Status

Stramsen Biotech is pleased to announce significant progress in our drug development pipeline, marking a crucial milestone in our mission to revolutionize wound care treatment. We anticipate submitting our Pre-Investigational New Drug (Pre-IND) meeting request to the Food and Drug Administration (FDA) for our promising drug candidate, SBX1977, by July 15, 2025. This strategic move will pave the way for valuable feedback and guidance from regulatory authorities, ensuring our development process aligns with FDA requirements.

Following this critical step, we expect to file the official Investigational New Drug (IND) application with the FDA by the end of September 2025. This timeline demonstrates our commitment to advancing SBX1977 through the regulatory process efficiently while maintaining the highest standards of safety and efficacy. The IND filing will enable us to initiate clinical trials, bringing us one step closer to introducing this innovative treatment to patients in need.

SBX1977 represents a breakthrough in wound care medicine, leveraging the power of natural plant-based compounds to address a significant unmet medical need. This innovative therapy is designed to treat both chronic and acute wounds, with a particular focus on challenging diabetic ulcers. By harnessing the healing properties of carefully selected botanical ingredients, SBX1977 offers a unique approach to wound management that may provide superior outcomes compared to existing treatments.

The potential impact of SBX1977 extends beyond individual patient care, addressing broader healthcare challenges:

Improved healing rates for chronic wounds, potentially reducing healthcare costs and patient suffering
A natural alternative to synthetic pharmaceuticals, aligning with the growing demand for plant-based medical solutions
Enhanced treatment options for diabetic patients, a rapidly growing demographic with specific wound care needs
Potential applications in various medical settings, from hospitals to outpatient clinics, expanding market opportunities

As we progress through these crucial regulatory milestones, Stramsen Biotech remains committed to advancing SBX1977 and addressing the critical need for effective wound care solutions. Our team's expertise, combined with the promising potential of SBX1977, positions us to make a significant impact in the biotech industry and, most importantly, in the lives of patients struggling with chronic and acute wounds.