What clinical trials or peer‑reviewed studies exist on GaraHerb's ingredients and long‑term safety?

1. Name collision: garadacimab (drug) versus GaraHerb (supplement), and why it matters

Confusion starts with similar names: multiple peer‑reviewed articles and regulatory documents describe garadacimab, a fully human anti‑activated factor XII monoclonal antibody developed for hereditary angioedema, with Phase 2 dose‑finding and Phase 3 VANGUARD trials plus open‑label extension data on long‑term safety and efficacy ^{[1] [3] [5]}; by contrast, the consumer product GaraHerb is marketed as a natural male‑enhancement supplement and its coverage in the dataset is limited to reviews and promotional pages that explicitly state there are no independent clinical trials of the proprietary GaraHerb formula itself ^{[4] [6]}.

2. What the clinical literature says about garadacimab’s clinical trials and long‑term safety

Peer‑reviewed Phase 2 and Phase 3 programs for garadacimab have been published or summarized: a global Phase 2 study reported up to ~129 weeks of monthly subcutaneous administration with data on efficacy, health‑related quality of life, and safety in adults with hereditary angioedema, supporting durable protection and a favorable safety profile ^[1]. The VANGUARD Phase 3 program and its open‑label extension have similarly reported long‑term safety and efficacy, with regulatory documentation (FDA labeling material for ANDEMBRY) summarizing exposure across randomized and open‑label studies and noting tolerability findings across 164 patients in pivotal studies ^{[3] [5]}. Those publications and regulatory documents also disclose investigator ties and industry funding, information important for interpreting reported safety conclusions ^{[2] [3]}.

3. What the reporting shows about GaraHerb’s evidence base and ingredient‑level research

Independent reporting and product reviews converge on the same central point: there are no independent clinical trials of the GaraHerb proprietary formula available in the provided sources, and the company’s marketing claims are not a substitute for randomized, peer‑reviewed trials of the finished product ^[4]. Several ingredient names appear in product listings (niacin, zinc oxide, L‑citrulline, L‑carnitine, Pinus pinaster bark extract, Mucuna pruriens, maca, grape skin extract, saffron) according to vendor text included in consumer pages, but the dataset does not contain peer‑reviewed trials that test that exact combination or report long‑term safety for GaraHerb as sold ^{[7] [4]}. Reviews note that the evidence for many individual botanical or amino‑acid ingredients is mixed—some animal and small human studies suggest biological activity for isolated ingredients, while larger, controlled trials and safety follow‑up are often lacking or inconsistent ^[4].

4. Bottom line, limits of the record, and what responsible consumers or clinicians should do next

Based on the sources provided, garadacimab/ANDEMBRY has a substantial, peer‑reviewed clinical trial footprint with Phase 2 and Phase 3 long‑term safety and efficacy data for hereditary angioedema and regulatory documentation summarizing trial exposure, whereas GaraHerb the supplement lacks independent clinical trials of its formula and relies on mixed ingredient‑level literature and marketing claims ^{[1] [3] [5] [4]}. The present reporting does not allow a definitive assessment of long‑term safety for GaraHerb’s proprietary mix because no randomized, peer‑reviewed trials of the finished product were provided; for anyone seeking more certainty, the next steps are systematic searches for randomized trials of each active ingredient and requests to the manufacturer for clinical data or third‑party testing—none of which are present in the supplied sources ^{[4] [7]}.