Medicine for the Real World

The first non-generic
drug system for
Type 2 diabetes.

Prescribed like a drug. Billed like a drug. Protected like a drug. TKD-001 closes the gap between what medications achieve in clinical trials and what they deliver in the real world.

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The Scale of the Problem
60–75%
of T2D patients discontinue therapy within one year
20% → 80%
of patients drive 80% of total diabetes costs
$730B
projected annual T2D spending by 2035
$8,400
per patient per year in structurally invisible failed-prescription cost
The Problem

The drugs work.
The system around them does not.

Type 2 diabetes consumes 25% of every U.S. healthcare dollar. Yet the majority of patients discontinue therapy within a year. Not because the drug failed. Because the infrastructure that made it work in trials simply disappeared at discharge.

The Patient
20% of patients drive 80% of cost.
Persistently poorly controlled patients take 5 to 8 medications simultaneously. Each drug carries its own failure rate, and those failures compound. By 2035, cost per patient reaches $60,000 to $80,000 annually.
The Cost
$8,400 per patient, per year. Invisible.
No drug budget captures a prescription that technically filled but clinically failed. This cost is structurally invisible in every healthcare system today, creating a gap no existing solution addresses.
The Evidence
Infrastructure vanishes at discharge.
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 infrastructure at discharge.
"The problem is not the molecule. It is the absence of support when the patient goes home."
Our Approach

One prescription.
Everything the patient needs.

TKD-001 is a non-generic drug system. A single prescriber order activates medication management, software support, and protocolized care simultaneously. No separate enrollment. No opt-in. It is the drug.

01
Metformin SmartPack
95% of T2D patients already qualify.
A proprietary metformin formulation with smart packaging and a staged gated dosing algorithm that stabilizes patients across their entire polypharmacy stack, addressing the three root causes of treatment failure: unstabilized, underdosed, unsupported.
02
Padura Software — PDURS
Embedded in the prescription. No opt-in.
FDA's Prescription Drug Use-Related Software pathway allows software to be co-labeled with the drug itself. State-action logic monitors the patient and triggers protocolized responses automatically, billed through pharmacy benefits and Orange Book eligible.
03
Protocolized Support
Never stops. Never disappears.
Medication review specialists and care navigators manage the full polypharmacy stack and close the hospital-to-home transition window that drives 30% of avoidable rehospitalizations. The support that makes trials work, made permanent.
One prescription activates all three. It is the drug. It is the infrastructure. It never stops working.
Competitive Position

We operate on drug rails.
No competitor does.

TKD-001 is prescribed, dispensed, and billed like any branded pharmaceutical, protected by FDA Orange Book listing and a triad patent architecture no competitor can replicate without independently completing a five-year development program.

Pharmacy Billing
The prescription is the revenue event.
Billed through Part D pharmacy benefits like every branded drug. No annual payer contract, no employer negotiation, no renegotiation cycle. Service competitors renegotiate every 12 months. Takoda does not.
Orange Book Protection
15 years of exclusivity through 2046.
A competitor must independently build, validate, and receive FDA clearance for the entire integrated system. A five-year barrier that cannot be shortcut regardless of capital deployed.
The Pricing Difference
100x more revenue than services.
GLP-1 therapies charge $600 to $800 per member per month. Service competitors earn $3 to $5. Takoda targets $300 to $400, half the GLP-1 price, with 15 years of patent exclusivity.
Not a digital health company. A pharma company serving patients that existing products cannot reach, at half the price of the category leaders.
The Market

25% of every healthcare dollar.
We target the most expensive 20%.

32M
Diagnosed T2D patients by 2035
$730B
Annual T2D spending by 2035
6.4M
High-cost patients driving $584B

Our target patient is unserved by any pharmaceutical product designed for their complexity. The model: cut their cost by 25%, capture half as revenue through the pharmacy benefit. At $300 to $400 per member per month through pharmacy benefits, that represents $6 billion annually at 1.2 million patients, and $12 billion at 2.4 million.

Phase 3 study sites convert to paying customers at NDA approval, meaning commercial launch begins with revenue already in place. Target systems include Mayo Clinic, Geisinger, Robert Wood Johnson Barnabas Health, and Kaiser. The VA system, with 120 sites and 9.1 million veterans, represents a major scaling channel.

The Team

The people who have done this before.

80 years of combined experience in pharmaceutical development, clinical operations, regulatory strategy, and enterprise management.

John Maki
John Maki
Chief Executive Officer
40 years spanning clinical development, pharmaceutical strategy, and healthcare system management. Architect of a VA clinical trial protocol demonstrating 1.5% HbA1c improvement, double any real-world result. Board member at BioNJ, 3DMatrix, and Vicus Therapeutics.
Travis Maki
Travis Maki
Chief Operating Officer
Leads operational execution and technology integration across TKD-001. Responsible for the infrastructure connecting SmartPack logistics, Padura software, and clinical workflow deployment across regulatory, clinical, and technology workstreams.
Sam Fairchild
Sam Fairchild
President, CSO & CFO | Board Chair
Chairs the Board while leading corporate strategy, financial planning, and capital deployment. Drives positioning across regulatory, clinical, and technology workstreams toward a strategic acquisition or IPO outcome.
Key Hires in Process
Chief Medical & Development Officer  ·  CMC Manufacturing Expert  ·  Clinical Operations Leader  ·  Regulated Software Expert  ·  B12 Study Principal Investigator  ·  Clinical Advisory Board Members
Regulatory Pathway

The PDURS pathway: established,
navigable, and strategically timed.

What PDURS Is
FDA's Prescription Drug Use-Related Software guidance, finalized in 2023, enables software to be co-labeled with a drug as part of the approved prescription. The software is not a standalone device. It is part of the drug product, billed through pharmacy benefits, Orange Book listed, and protected by the same patent architecture as the drug itself.
Why Takoda's Application Is Clean
TKD-001's software is state-action logic. It monitors defined patient states and triggers protocolized responses. This is the lowest-complexity PDURS tier: no diagnostic output, no treatment decision, no software as a medical device classification required. FDA has provided clear guidance on this category.
The Development Timeline
The FDA Type C meeting confirms the development pathway before the majority of capital is deployed. IND submission follows FDA guidance. The B12 enablement study runs as the framework trial under PDURS. Estimated timeline from Type C meeting to NDA: under five years.
2023
Year FDA finalized PDURS guidance, establishing the co-labeling framework that makes TKD-001 possible.
5 years
Minimum time any competitor must independently spend to replicate the integrated system from scratch.
Type C
The FDA meeting class that confirms the development pathway. Takoda's first gate, and the primary de-risking event for the program.
Get in Touch

We welcome conversations
with aligned partners.

Takoda Health is actively engaging strategic partners, healthcare systems, and investors who understand that infrastructure is what makes medicine work in the real world.

Email
info@takoda.health
Website
www.takoda.health
Entity
Takoda Health, Inc.
Delaware C Corporation
Primary Contact
Sam Fairchild
President, CSO & CFO | Board Chair