Takoda Health, Inc

Medicine for the Real World, turning a single prescription into a complete drug system stabilizing the most complex diabetes patients that every other treatment leaves behind.

Takoda Health is building the first non-generic drug system for Type 2 diabetes. TKD-001 is a single prescription that activates three things simultaneously: a proprietary metformin SmartPack formulation with a staged gated dosing algorithm, the Padura software platform embedded in the prescription through FDA's Prescription Drug Use-Related Software pathway, and protocolized clinical support that monitors the patient and never stops. No separate enrollment. No patient opt-in. It is the drug.

We target the 20% of Type 2 diabetes patients who drive 80% of costs — persistently poorly controlled patients on 5 to 8 medications simultaneously, cycling in and out of hospitals because the infrastructure that makes drugs work in clinical trials vanishes the moment they go home. VA program data shows 1.5% HbA1c improvement under structured conditions, double any real-world result. The gap is not pharmacological. It is the absence of support at discharge.

TKD-001 is prescribed and billed like any branded pharmaceutical through Part D pharmacy benefits. Orange Book listing and a triad patent architecture create 15 years of exclusivity through 2046. A competitor must independently build and receive FDA clearance for the entire integrated system — a 5-year barrier that cannot be shortcut. Service model competitors earn $3 to $5 per member per month with no regulatory protection. Takoda targets $300 to $400 per member per month — half the GLP-1 price, 100 times service revenue.

The leadership team brings 80 plus years of combined experience in pharmaceutical development, clinical operations, regulatory strategy, and enterprise management. John Maki, CEO, is the architect of a VA clinical trial protocol demonstrating 1.5% HbA1c improvement under structured conditions. Travis Maki, COO, leads technology and operational integration across TKD-001. Sam Fairchild, President, CSO and CFO and Board Chair, leads corporate strategy and capital deployment.

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Takoda Health, Inc

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