U.S. Congress introduces bill to boost botanical drug development

On August 27, 2026, U.S. Congress introduced the "ADVANCING BOTANICAL DRUG DEVELOPMENT ACT OF 2026," a bill that would grant 12 years of post-approval market exclusivity to encourage investment in the development of FDA-regulated botanical drugs. The move is aimed at fostering innovation in a drug category that is often overlooked.

Rep. Lauren Boebert, the sponsor, and Rep. Derrick Van Orden, the co-sponsor, have championed the legislation. Boebert emphasized the significance of botanical drugs, stating, "Because they contain many natural compounds, they can work on multiple targets at once, which may help with complex chronic and age-related conditions such as Alzheimer's, Parkinson's, and others."

The bill seeks to expand treatment options for complex chronic and age-related diseases while maintaining existing FDA safety and efficacy standards. Boebert further explained, "The legislation would address barriers to late-stage development of botanical medicines by providing a defined period of regulatory exclusivity for qualifying products, thereby creating the certainty needed to support rigorous development of promising multi-constituent therapies."

Saad Harti, the founder and CEO of Legacy Healthcare, expressed enthusiasm about the proposed legislation. "Botanical drugs can indeed act on multiple biological targets at once, offering potential to unlock treatments for many unmet medical needs," he said. "A clear and appropriate period of post-approval market exclusivity will strengthen the ability to attract investment in this emerging drug category, which is much favored by patients."

Legacy Healthcare's lead candidate, Cinainu, is the first botanical drug authorized to enter Phase 3 by both the U.S. Food and Drug Administration and the Japanese health authorities (PMDA). In a Phase 2/3 study for alopecia areata (AA), Cinainu demonstrated efficacy, long-term effects, and no autoimmune-related side effects. The company is currently raising funds to conduct the FDA and PMDA-authorized Phase 3 program. If approved, Cinainu will be the first treatment for children, adolescents, and adults with both severe and moderate AA.

Harti added, "Cinainu is supported by intellectual-property protection extending through 2043, ensuring the company's ability to capitalize on the drug’s potential."

The proposed bill is available for review, and Rep. Boebert's press release is also accessible online. Legacy Healthcare's Cinainu is a significant step forward in the treatment of autoimmune diseases, and the company is hopeful that the legislation will provide the necessary support to bring innovative botanical drugs to market.