The “ADVANCING BOTANICAL DRUG DEVELOPMENT ACT OF 2026,” introduced on Aug 27, 2026, would provide 12-year post-approval market exclusivity to encourage investment in FDA-regulated botanical drugs innovation
EPALINGES, Switzerland, Sept. 3, 2026 /PRNewswire/ — Legacy Healthcare welcomes the introduction in U.S. Congress of the “ADVANCING BOTANICAL DRUG DEVELOPMENT ACT OF 2026” by Rep. Lauren Boebert (Sponsor) and Rep. Derrick Van Orden (Co-sponsor). To encourage investment in this important and overlooked drug category,
the proposed bill intends to provide FDA-regulated botanical drugs with a 12-years market exclusivity period post-approval.
Rep. Boebert made the following statements on botanical drugs’ importance to patients, public health and the bill.
- “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 (…)”
- “The bill seeks to expand treatment options for complex chronic and age-related diseases while maintaining existing FDA safety and efficacy requirements.”
- “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 so promising multi-constituent therapies can reach patients.”
“Botanical drugs can indeed act on multiple biological targets at once, offering potential to unlock treatments for many unmet medical needs” said Saad Harti, founder and CEO of Legacy Healthcare. “A clear and appropriate period of post-approval market exclusivity will strengthen the ability to attract investment in this emerging drug category – much favored by patients.”
Legacy Healthcare’s lead candidate – Cinainu – is the first botanical drug for an autoimmune disease authorized to enter Phase 3 by the U.S. Food and Drug Administration and Japanese health authorities (PMDA). In a Phase 2/3 study in alopecia areata (AA), Cinainu demonstrated efficacy, long-term effect and no autoimmune related side-effects, a first. The company is now raising financing 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. Cinainu is supported by intellectual-property protection extending through 2043.
The proposed bill is available here. Rep. Boebert’s press release is available here.
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SOURCE Legacy Healthcare
