Overview
Ginkgo biloba extract contains a group of terpene lactones (notably, ginkgolides and diterpenes) and ginkgo flavone glycosides (notably, ginkgetin, bilobetin, and sciadopitysin) that have antioxidant and vasoactive properties. Most of the studies that investigate the effect of ginkgo biloba use the standardized extract of Ginkgo biloba (EGb) 761 (EGb761), which was developed by a German pharmaceutical company in 1964. EGb761 contains 6% terpene lactones and 24% flavonoid glycosides. Flavonoids include quercetin, rutin, kaempferol, and isorhamnetin. Lactones include ginkgolide A, ginkgolide B, ginkgolide C, bilobalide, and ginkgotoxin, a lactone that is structurally related to pyridoxine. Ginkgo biloba is an herbal plant that is now cultivated worldwide. It is originally native to China, and ginkgo biloba extract has been used in traditional Chinese medicine for centuries. After its nootropic properties were discovered, ginkgo biloba has gained attention as a therapeutic ingredient for memory and concentration enhancement in cognitive impairment and neurogenerative diseases, such as dementia. Ginkgo biloba was investigated in preliminary studies for a variety of therapeutic purposes such as improving cardiovascular health, sexual dysfunction, psychiatric disorders, skin disorders, and glaucoma. Ginkgo biloba is found in a number of homeopathic and over-the-counter herbal products and dietary supplements, but it has no approved therapeutic indications by regulatory bodies, such as the FDA, EMA, and Health Canada. Ginkgo folium, the leaf extract of Ginkgo biloba, is considered an anti-dementia drug by the World Health Organization.
Indication
Ginkgo biloba does not currently have any approved therapeutic indications, and there is insufficient evidence to support its unapproved use. It is available in over-the-counter herbal products mostly for oral use, to improve memory and cognitive problems.
Associated Conditions
- Cognitive Dysfunctions
- Cognitive Functioning
- Depression
Research Report
Ginkgo biloba (DB01381): A Comprehensive Pharmacological and Clinical Review
Executive Summary
Ginkgo biloba (DrugBank ID: DB01381; CAS Number: 90045-36-6) is a phytopharmaceutical agent with a unique standing in both traditional and modern medicine. Derived from one of the world's oldest living tree species, its leaf extract has been investigated for a wide range of therapeutic applications, primarily centered on cognitive and circulatory disorders. The extract's pharmacological activity is attributed to a complex mixture of bioactive compounds, principally flavonoid glycosides and terpene lactones, which confer a multifaceted mechanism of action. These mechanisms include potent antioxidant effects, vasodilation and improvement of blood rheology, modulation of key neurotransmitter systems, and antagonism of Platelet-Activating Factor (PAF).
This comprehensive review synthesizes the current body of scientific evidence on Ginkgo biloba, critically examining its botanical origins, pharmacology, clinical efficacy, safety profile, and regulatory status. A central theme emerging from the analysis is the significant discrepancy between the highly standardized, pharmaceutical-grade extract used in credible clinical research (EGb 761) and the often-adulterated, unregulated products sold as dietary supplements, which complicates the translation of research findings into clinical practice.
The clinical evidence for Ginkgo biloba is marked by a significant paradox. While a large body of evidence from systematic reviews and meta-analyses suggests that the standardized extract EGb 761 at a dose of 240 mg/day may offer modest symptomatic benefit in stabilizing or slowing the decline in cognition and function in patients with established dementia or mild cognitive impairment, the most definitive large-scale trial to date—the Ginkgo Evaluation of Memory (GEM) Study—found it to be unequivocally ineffective for the primary prevention of dementia in older adults.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/11/26 | Phase 4 | Recruiting | Wanbangde Pharmaceutical Group Co., LTD | ||
2024/07/10 | Phase 4 | Not yet recruiting | Beijing Tiantan Hospital | ||
2023/11/20 | Not Applicable | Not yet recruiting | Yi Yang | ||
2023/11/09 | Not Applicable | Not yet recruiting | |||
2023/05/12 | Phase 4 | Not yet recruiting | Shanghai 10th People's Hospital | ||
2022/12/23 | Phase 2 | Recruiting | Shanghai Yueyang Integrated Medicine Hospital | ||
2022/10/24 | Not Applicable | Completed | |||
2022/09/08 | Phase 2 | Recruiting | Shanghai Yueyang Integrated Medicine Hospital | ||
2022/02/28 | Not Applicable | Completed | |||
2020/08/27 | Phase 4 | UNKNOWN | Wanbangde Pharmaceutical Group Co., LTD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Deseret Biologicals, Inc. | 43742-2178 | ORAL | 6 [hp_X] in 1 mL | 4/22/2025 | |
Deseret Biologicals, Inc. | 43742-2145 | ORAL | 3 [hp_X] in 1 mL | 5/27/2025 | |
Maplewood Company | 51987-0002 | ORAL | 6 [hp_X] in 1 mL | 4/8/2025 | |
Deseret Biologicals, Inc. | 43742-2266 | ORAL | 3 [hp_X] in 1 mL | 5/6/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Cellula-T oral powder jar | 43995 | Hong Sp & Hs | Medicine | A | 4/13/1993 |
Lifetime Brain Q | 297835 | Medicine | A | 12/20/2017 | |
Spring Leaf Ginkgo Biloba 2000mg | 110297 | Medicine | A | 9/28/2004 | |
Heart Health Advance Spray | 297100 | Medicine | A | 12/2/2017 | |
Healthy Care Ginkgo Biloba 2000 Capsules | 178194 | Medicine | A | 12/7/2010 | |
WYLD MAN | 264894 | Medicine | A | 11/30/2015 | |
Stress Forte | 373634 | RN Labs Pty Ltd | Medicine | A | 8/27/2021 |
Swisse Men's Multivitamins | 351919 | Medicine | A | 12/18/2020 | |
Memory Ginkgo Biloba 2000mg | 338574 | Medicine | A | 6/29/2020 | |
EHT Brain Formula | 405416 | Medicine | A | 2/27/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
GINKGO | kootenay born botanicals | 02232059 | Liquid - Oral | 1 X | 5/15/1998 |
ADAPTAGEN | bio active canada ltd. | 02233546 | Liquid - Oral | 3 X | 5/26/1998 |
GINKGO GOMP | terra botanica products ltd. | 02233332 | Liquid - Oral | 1 X | 5/25/1998 |
DIATHESIS IV | bio active canada ltd. | 02233601 | Liquid - Oral | 6 X | 5/26/1998 |
DIATHESIS I | bio active canada ltd. | 02233598 | Liquid - Oral | 6 X | 5/26/1998 |
MEDIPLEX 640 - LIQ | mediherb inc. | 02116901 | Liquid - Oral | 10 X / ML | 12/19/1996 |
GINKGO-BOSAN B37-LIQ | professional health products | 02157691 | Liquid - Oral | 1 D / ML | 12/31/1996 |
DIATHESIS V-I | bio active canada ltd. | 02234231 | Liquid - Oral | 6 X | 5/26/1998 |
MYRRHPLEX | bio active canada ltd. | 02233655 | Liquid - Oral | 1 X | 5/26/1998 |
DIATHESIS V-2 | bio active canada ltd. | 02234230 | Liquid - Oral | 6 X | 5/26/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
GINKGO ARKOPHARMA cápsulas duras | Arkopharma Laboratorios S.A.U. | 74474 | CÁPSULA DURA | Sin Receta | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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