Building the Future of Regulated Botanical Medicine.
Our Development Model
Krafted Therapeutics develops investigational botanical drug programs within established FDA regulatory pathways. Our strategy integrates pharmaceutical-grade manufacturing, intellectual property protection, and structured clinical development from inception.
We prioritize regulatory alignment, disciplined capital deployment, and risk isolation at the operating company level. Each program is designed with a defined regulatory pathway, defensible intellectual property, and a clear milestone-driven development plan.
Our objective is not incremental supplementation, it is the advancement of regulated botanical therapeutics within modern preventive medicine.
Lead Program: Primustatin™
Primustatin™ is an investigational botanical drug candidate being developed under the FDA Botanical Drug Development framework utilizing a 505(b)(2) regulatory strategy.
The program is intended for adults with borderline-elevated LDL-C seeking earlier, conservative LDL management within guideline-directed care.
• Accelerated botanical IND-to-NDA platform demo
• Patent protection initiated
• Investigational status - pending