STRAMSEN BIOTECH, INC
FDA Status
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We are thrilled to share pivotal updates from Stramsen Biotech Inc. On April 21, 2026, we received positive and encouraging written feedback from the FDA following our second pre-Investigational New Drug (pre-IND) submission for SBX-1977, our groundbreaking topical botanical gel designed to revolutionize wound healing and closure.
The U.S. Food and Drug Administration's positive response is a testament to our strategic development of SBX-1977. Their feedback affirms that our Chemistry, Manufacturing, and Controls (CMC), along with our nonclinical data packages, are robust and sufficient to support our upcoming IND submission. As we advance towards Phase 1 clinical trials, the FDA's guidance across CMC, nonclinical, and clinical domains—particularly regarding our proposed Phase 1 design—positions SBX-1977 for impactful first-in-human studies.
Our immediate focus is on the formal submission of a comprehensive IND package, followed by a rigorous regulatory review, to initiate Phase 1 clinical trials.
SBX-1977, a topical gel sourced from botanicals, is being developed to significantly enhance wound healing and closure. This plant-based medicine, with a rich history of human use overseas, has proven efficacy in treating various wounds, including diabetic ulcers and other acute and chronic wounds.
The FDA's insights included recommendations to fine-tune our clinical trial design, focusing on study population definitions, endpoint considerations, and safety assessments. They underscored the necessity of a complete IND submission to support the transition to first-in-human use. Stramsen Biotech is committed to integrating these recommendations into our development strategy and accelerating IND-enabling activities in preparation for submission.
Forward-Looking Statements: This announcement contains forward-looking statements regarding the development of SBX-1977, including our plans for IND submission and the initiation of clinical trials. These statements are subject to risks and uncertainties, such as regulatory review outcomes and the ability to adhere to development timelines. Actual outcomes may differ materially from those anticipated.
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