TFA EVIDENCE LIBRARY

Science and intellectual property

Published Antcin A research, preliminary study data, and patents across four jurisdictions—with public-source links.

PEER-REVIEWED · PATENT RECORDS

Evidence boundaries

Preclinical research does not establish clinical benefit, and patents do not imply drug approval. Each item states its limits.

6peer-reviewed publications

Model and preclinical evidence, not clinical efficacy.

2preliminary datasets

A 14-day female-rat screen and a 15-dog exploratory observation.

4patent jurisdictions

Cultivation and porous-carrier protection, not drug approval.

HOW TO READ THE EVIDENCE

Start with the molecule, model and conclusion

Each summary follows the original publication and does not replace it.

Keep molecules distinct

Antcin A, Antcin K and Antrocin are different compounds. Findings for one cannot be applied to another.

Label every model

General cell models, Caco-2 absorption models, animal studies, and human evidence represent different levels; each publication is labeled accordingly.

Stay within the paper

Mechanistic signals are not described as clinical benefit, and exploratory findings are not described as approved uses.

DEVELOPMENT EVIDENCE MAP

One TFA-01 evidence path

Each of six milestones states what is supportable and where the evidence boundary remains.

Molecule, mechanism & rights

Published foundation / program validation underway

Published studies support GR/GRα-related signaling for Antcin A in defined models. TFA-01 test-article, batch and indication bridging remains underway.

Next milestoneComplete candidate test-article and batch definition and strengthen program-level pharmacology relevant to canine osteoarthritis.BoundaryAvailable studies do not establish direct biochemical binding between Antcin A and GR, canine or human clinical efficacy, program-specific pharmacokinetic parameters, or drug approval.View progress details

CMC & controlled supply

Source foundation in place / specifications and batch bridging underway

Research across dozens of strains and content profiles is being connected to controlled cultivation, source selection, purification, analytics and formulation development.

Next milestoneComplete physicochemical validation of the nano-enabled clear aqueous formulation, then advance formal specifications, batch consistency and process scale-up.BoundaryFormal specifications, COAs, batch consistency, commercial scale-up and GMP validation are not complete. The nano-enabled clear aqueous formulation remains under physicochemical validation and is not a final dosage form.View progress details

Safety & toxicology

14-day preliminary toxicology report available / formal work underway

A 14-day preliminary toxicology study in female rats is complete and a report is available to inform later study design. Target-animal safety, toxicology and residue work continues.

Next milestoneComplete subsequent formal regulatory toxicology reports and establish a program-specific safety range for the purified candidate drug substance and final product.BoundaryThe preliminary screen was not GLP regulatory toxicology or a long-term safety study. It does not establish canine safety, long-term safety, or the safety of purified Antcin A or a final product.View progress details

Canine OA clinical development

Exploratory observation completed / formal study to be established

The Shanghai Pet GCP Clinical Trial Team completed a two-week exploratory observation in 15 dogs. It can inform later protocol design but does not establish efficacy.

Next milestoneComplete a standardized canine osteoarthritis study with a full protocol, prespecified endpoints and a statistical analysis plan.BoundaryThe exploratory observation lacks the full protocol, prespecified endpoints and statistical analysis needed for confirmatory conclusions. It does not establish clinical efficacy or safety, equivalence to dexamethasone, or superiority over dexamethasone.View progress details

Regulatory & commercialization

Taiwan advancing / U.S. CVM planning

Taiwan veterinary-drug data integration continues while the U.S. CVM path is being planned. Partnership and licensing evaluation will follow the maturity of the evidence.

Next milestoneObtain clear regulatory feedback on study design, process specifications and remaining data gaps, then form an executable submission plan.BoundaryRegulatory acceptance, application acceptance, drug approval, launch timing and commercial outcomes have not been established.View progress details

CORE PUBLISHED LITERATURE