What natural-product-derived active ingredients are used in Alzheimer's or other dementia treatments approved by FDA or EMA?

Checked on December 3, 2025
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Executive summary

Only a small handful of FDA- or EMA‑approved dementia drugs trace back to natural products: galantamine — originally isolated from plants and now the active moiety in recently approved ZUNVEYL (benzgalantamine) — is the clearest example [1] [2]. Most high‑profile recent disease‑modifying approvals (lecanemab/Leqembi) are monoclonal antibodies unrelated to natural‑product scaffolds [3] [4]. Available sources do not mention other FDA‑ or EMA‑approved Alzheimer’s or dementia medicines that are directly derived from natural products beyond galantamine [5] [1].

1. What counts as a “natural‑product‑derived” drug — and which approved dementia drugs qualify?

“Natural‑product‑derived” usually means the active ingredient was either isolated from a plant, fungus, marine organism or directly modified from such a compound. Sources identify galantamine — and a chemically modified derivative now marketed as ZUNVEYL (benzgalantamine) — as the modern, approved cholinesterase inhibitor that traces to plant sources; galantamine itself has long history and was FDA‑approved prior to this reformulation [1] [2]. Reviews of FDA‑approved Alzheimer’s drugs list the symptomatic agents (donepezil, rivastigmine, galantamine) and newer symptomatic or adjunctive drugs, but only galantamine is explicitly tied to a natural product in the provided reporting [5] [1]. Available sources do not mention other approved dementia drugs that are explicitly natural‑product derivatives [5] [6].

2. Galantamine / ZUNVEYL — the clear natural‑product lineage

Galantamine was the original natural‑product linked therapy commonly used in Alzheimer’s care; reporting shows the new branded approval ZUNVEYL (benzgalantamine) is a chemically‑modified version of the cholinesterase inhibitor galantamine and received FDA approval for mild‑to‑moderate Alzheimer’s disease [2] [1]. Company announcements emphasize galantamine’s long clinical track record and biological rationale (acetylcholinesterase inhibition and additional receptor effects) as the basis for ZUNVEYL’s development [1]. This is the single concrete example in the supplied material where an approved product’s active moiety is derived from a plant natural product [1].

3. Disease‑modifying biologics — not natural products

High‑visibility, recently approved disease‑modifying drugs such as lecanemab (Leqembi / LEQEMBI) are monoclonal antibodies targeting amyloid‑beta protofibrils and plaques; these are manufactured biologics, not small molecules derived from natural products [3] [4]. Press releases and regulator statements about lecanemab describe trial endpoints, dosing and regulatory status without indicating any natural‑product origin [3] [4]. Therefore, the latest wave of regulatory approvals in 2023–2025 is dominated by biologics and synthetic small molecules rather than plant‑derived actives [3] [4].

4. Symptomatic agents beyond galantamine — synthetic or repurposed drugs

Guidelines and primers listing FDA‑approved symptomatic drugs for Alzheimer’s enumerate donepezil, rivastigmine, memantine and others; those accounts treat galantamine as the one with plant origins while the rest are synthetic molecules or repurposed agents [5]. Company and industry reporting about new symptom‑relief approvals (e.g., brexpiprazole for agitation) likewise do not link those actives to natural products in the sources provided [5] [7]. Available sources do not mention any other approved dementia therapies being direct natural‑product derivatives [5] [7].

5. Research interest in natural products — lots of preclinical promise, few approved drugs

Review literature notes growing interest in natural products as multi‑target agents in Alzheimer’s research and many preclinical and early clinical studies of plant, fungal and dietary bioactives [6]. That literature frames natural compounds as promising for mechanisms like anti‑inflammatory or anti‑amyloid effects but does not identify additional FDA/EMA‑approved dementia drugs originating from these sources [6]. In short: active basic science activity exists, but regulatory approvals from the agencies cited are dominated by non‑natural biologics and synthetic small molecules [6] [3].

6. What the sources don’t say — limits and next steps for reporters and researchers

The assembled sources document galantamine/ZUNVEYL as the principal natural‑product lineage among approved dementia drugs and note many investigational natural compounds in research [1] [6]. They do not provide a comprehensive, agency‑level table of every historic approval and chemical origin, so claims beyond the cited examples would be unsupported by these documents (available sources do not mention a broader list) [5] [1]. For definitive, exhaustive confirmation researchers should cross‑check Drugs@FDA and EMA product monographs for origin details — those agency registries are referenced but not exhaustively quoted in the available reporting [8] [9].

Sources cited: company press releases and FDA/clinical summaries for Leqembi and ZUNVEYL, treatment primers and a 2025 review of natural products in Alzheimer’s research [4] [3] [2] [5] [1] [6] [8] [9].

Want to dive deeper?
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