Clinical Evidence as the Foundation: Why Ayamed Chose the More Difficult — and More Valuable — Path of a Regulated Prescription Phytomedicine

The global natural-products landscape is growing rapidly, but very few products are able to generate real clinical evidence capable of transforming patient outcomes. This is the fundamental divide between dietary supplements and prescription phytomedicines, and the reason Ayamed chose the regulated pharmaceutical route.

While supplements occupy retail shelves without needing to prove therapeutic effect, clinical evidence is mandatory for any regulated botanical drug. And it is precisely this path — more rigorous, more demanding, and far more scientifically grounded — that defines Ayamed’s mission.

Why Supplements Cannot Generate Real Clinical Evidence

In Brazil, the United States, and Europe, dietary supplements are not required to demonstrate clinical evidence, therapeutic effect, or pharmacological consistency. They do not undergo:

• standardized extract validation;

• phytochemical reproducibility;

• toxicology studies;

• PK/PD studies;

• stability studies;

• regulated manufacturing controls;

• or clinical protocols aligned with hospital systems.

This regulatory model prevents supplements from generating high-quality clinical evidence, and therefore limits their use in medical practice, public health systems, and scientifically validated treatments.

For Ayamed — focused on conditions like treatment-resistant depression and substance use disorders — the absence of required clinical evidence makes the supplement path insufficient.

Prescription Phytomedicine: The Only Path That Delivers Clinical Evidence, Credibility, and Access

A prescription phytomedicine is a regulated medicine, subjected to the same standards applied to synthetic pharmaceuticals. This means clinical evidence is central to every stage of development.

A regulated botanical medicine requires:

• full phytochemical standardization;

• validated preclinical studies generating reproducible clinical evidence;

• acute, sub-chronic, and genotoxic toxicology;

• pharmacokinetic and pharmacodynamic models (PK/PD);

• stability and purity dossiers;

• seed-to-lab traceability;

• regulatory alignment with ANVISA, FDA, and ICH.

And this leads to:

✔ Higher medical credibility

Physicians prescribe treatments backed by clinical evidence, not supplements.

✔ Greater patient safety

Toxicology and PK/PD generate real safety-based clinical evidence.

✔ Greater access to hospitals and public systems

Only medicines supported by clinical evidence can be incorporated into:

• hospital protocols,

• public health programs,

• insurance coverage,

• clinical guidelines.

✔ Regulatory strength and IP protection

Scientific and regulatory clinical evidence becomes part of the intellectual asset.

Why Ayamed’s Strategy Depends on Clinical Evidence

Ayamed was founded with the premise of developing a prescription phytomedicine that delivers measurable therapeutic outcomes through robust clinical evidence.

This requires:

• comprehensive preclinical programs;

• definition of NOAEL;

• high-resolution PK/PD mapping;

• phytocomplex standardization;

• reproducible fractionation of active compounds;

• green biotechnology capable of guaranteeing stability and phytochemical consistency;

• strict toxicology capable of generating high-quality clinical evidence.

This approach increases scientific rigor but reduces technical risk — and positions Ayamed for meaningful long-term value creation.

Green Biotechnology as a Driver of Real Clinical Evidence

Green biotechnology is essential to transform natural raw materials into a reproducible medicine that can produce real clinical evidence.

Ayamed uses green biotechnology to:

• cultivate its botanical matrix in controlled regenerative agroforestry systems;

• ensure zero contamination and genetic preservation;

• standardize phytoactive fractions;

• stabilize the phytocomplex to enable reproducible clinical evidence;

• maintain batch-to-batch consistency;

• guarantee ethical, sustainable sourcing with Indigenous benefit-sharing.

Clinical evidence depends on stability and replicability — and green biotechnology is what makes that possible.

Why the Harder Path Generates More Value

Choosing the regulated route — the one centered on clinical evidence — creates a dramatically more valuable and defensible business.

It also:

• creates real barriers to entry;

• avoids commodity competition;

• generates publishable scientific data and clinical evidence;

• attracts prescribing physicians;

• builds credibility with patients and consumers;

• unlocks institutional access;

• supports superior valuation;

• enables global licensing;

• complies with environmental, social, and modern regulatory standards.

The route of clinical evidence is the route of real impact.

Ayamed’s Vision: Clinical Evidence as the Basis for Transforming Mental Health

Supplements have their place.But only a medicine capable of generating clinical evidence can change therapeutic guidelines and reach the populations that need it most.

Ayamed chose the most demanding path — the path of clinical evidence, biotechnology, pharmacology, Indigenous partnership, environmental ethics, and rigorous drug development.

This is how a botanical medicine capable of transforming mental health is built.

About Ayamed

Ayamed develops prescription botanical medicines backed by clinical evidence, green biotechnology, sustainable cultivation, and ethical collaboration with Indigenous communities.

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