Krafted Therapeutics Inc. develops proprietary botanical drugs and licenses our intellectual property to enable broader innovation in botanical therapeutics. We are dedicated to building the future of regulated botanical medicine by bridging the gap between unregulated nutraceuticals and traditional synthetic pharmaceuticals.

At the heart of our operations is our patent-pending Assay-Guided Stoichiometric Blending manufacturing platform. Because botanical raw materials suffer from extreme natural variability, they typically lack the batch-to-batch consistency required for FDA approval. 

Our lead investigational candidate, Primustatin™, is a highly standardized botanical drug substance derived from Monascus purpureus-fermented Oryza sativa (Red Yeast Rice). Advanced through the FDA’s 505(b)(2) regulatory pathway, Primustatin™ is engineered to provide an ultra-low, highly tolerable dose of monacolin K enhanced by the synergistic benefits of the natural botanical matrix. It is specifically intended for the early, conservative management of borderline-elevated LDL-C, and as a safe, effective therapeutic alternative for patients suffering from statin intolerance and statin-associated muscle symptoms (SAMS).

In addition to advancing our internal clinical pipeline, Krafted Therapeutics strategically licenses our manufacturing intellectual property to external partners. Our assay-guided blending platform is broadly applicable to other complex botanical matrices—such as cannabinoids, artemisinin, and curcumin—enabling the wider life sciences and dietary supplement industries to overcome natural variability, meet strict regulatory standards, and deliver safe, reliable botanical products to patients globally.

Krafted Therapeutics Inc.

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