From Ancient Wisdom to Modern Medicine: Curanex Advances Botanical Drug for FDA Review

JERICHO, NY – February 25, 2026 – Curanex Pharmaceuticals Inc. (Nasdaq: CURX) today announced a significant step in its mission to bring a botanical-based treatment for ulcerative colitis to Western markets. The development-stage company confirmed the completion of a pilot-scale batch of its lead drug candidate, Phyto-N, manufactured under the U.S. Food and Drug Administration's strict Good Manufacturing Practice (GMP) standards.

This achievement marks a critical manufacturing milestone for Curanex, which went public in August 2025. The company is now positioned to initiate advanced preclinical studies required for its planned Investigational New Drug (IND) application, which it targets for submission in the fourth quarter of 2026. The move signals a pivotal moment in the journey of Phyto-N, a drug rooted in decades of traditional use, as it navigates the rigorous pathway of modern pharmaceutical validation.

A Bridge Between Tradition and Regulation

Phyto-N is not a typical drug candidate synthesized in a lab. It is a botanical extract from a single plant with a 30-year history of human use in China, where it has been administered to thousands of patients for various inflammatory conditions, reportedly with favorable tolerability. This background places Curanex at the intersection of traditional medicine and contemporary regulatory science—a challenging but potentially rewarding position.

The FDA, while open to botanical drugs, maintains the same stringent requirements for safety and efficacy as for any other new medicine. The agency's "Guidance for Industry: Botanical Drug Products" lays out a framework that acknowledges the unique nature of plant-based therapies. The primary hurdle for any botanical drug developer is proving consistency. Unlike a single-molecule synthetic drug, a botanical extract is a complex mixture of compounds whose composition can be influenced by everything from plant genetics and growing conditions to harvesting and processing methods.

This is where the challenge of Chemistry, Manufacturing, and Controls (CMC) becomes paramount. Curanex's announcement that it has successfully produced a GMP-compliant pilot batch directly addresses this core regulatory concern. By establishing reproducible manufacturing processes and developing robust quality control methods for its raw materials and final drug substance, the company is building the data-driven foundation the FDA demands. This milestone demonstrates that Curanex can, at least at a pilot scale, create a consistent product batch after batch—a non-negotiable prerequisite for any clinical trial or eventual market approval. While few botanical drugs, such as Veregen and Fulyzaq, have successfully navigated this path, their approval proves it is achievable with meticulous science and manufacturing discipline.

The High Stakes of Manufacturing

For a development-stage biotech company like Curanex, the successful GMP pilot batch is a significant de-risking event. It provides tangible evidence to investors and regulators that the company is moving beyond theoretical science and can execute the complex logistics of drug production. The newly manufactured GMP-compliant material is earmarked for crucial IND-enabling studies, including Good Laboratory Practice (GLP) toxicology and pharmacokinetic analyses in animals. These studies will provide the formal safety data the FDA requires before allowing a new drug to be tested in humans.

Curanex’s Chief Executive Officer, Mr. Jun Liu, commented on the achievement in a press release, stating, “Completion of a GMP-compliant pilot-scale batch marks a key milestone in the advancement of our Phyto-N program. High-quality and reproducible preclinical data, supported by robust manufacturing standards, are an essential factor for successful regulatory submissions.”

This sentiment was echoed by the company's Chief Operating Officer, Dr. Liqin Xie. “With the data from the GMP material now available, we are positioned to advance our GLP toxicology and pharmacokinetic studies as we work toward our targeted IND submission in the fourth quarter of 2026,” Dr. Xie added, also noting the company's intent to pursue subsequent clinical development in Australia, subject to regulatory approvals.

The availability of this material now unlocks the next phase of development. Exploratory non-GLP safety studies in rats and dogs had previously shown no treatment-related toxicological findings, providing early confidence. The formal GLP studies will now build on that data package with the rigor required for regulatory review.

Addressing a Significant Unmet Need in Ulcerative Colitis

Curanex has chosen ulcerative colitis (UC) as the initial target for Phyto-N, a decision that places it in a large and competitive, yet underserved, market. Ulcerative colitis is a chronic inflammatory bowel disease (IBD) that causes inflammation and ulcers in the lining of the large intestine, affecting approximately 5 million people globally. The condition can be debilitating, with symptoms including persistent diarrhea, abdominal pain, and rectal bleeding, significantly impacting a patient's quality of life.

The global market for UC therapies was valued at over $11 billion in 2026 and continues to grow. Current treatments range from first-line aminosalicylates (5-ASAs) for milder cases to powerful biologics (like TNF inhibitors and IL-23 inhibitors) and small molecule JAK inhibitors for moderate-to-severe disease. While these advanced therapies have transformed care for many, significant unmet needs remain. Clinical response rates can be as low as 30-60%, and many patients either do not respond or lose response over time. Furthermore, these treatments often suppress the immune system, carrying risks of serious infections and other side effects that can limit their long-term use.

This is the landscape into which Curanex hopes to introduce Phyto-N. The company highlights the drug's anti-inflammatory properties, which it says act via multiple targets and mechanisms—a characteristic common to many multi-component botanical therapies. If Phyto-N can demonstrate a strong safety profile, drawing on its long history of human use, while proving efficacy in rigorous clinical trials, it could offer a compelling alternative for patients who have failed existing therapies or are concerned about the side effects of conventional immunosuppressants.

With its IND submission targeted for late 2026, Curanex is methodically advancing its lead program. The company has validated Phyto-N's effects in animal models of several inflammatory diseases, including atopic dermatitis and diabetes, but its primary focus remains on bringing a new option to those suffering from moderate to severe ulcerative colitis. This manufacturing success represents a crucial and concrete step forward on that long and demanding path.