Benfotiamine

Overview

Benfotiamine has been investigated for the treatment and prevention of Diabetic Nephropathy and Diabetes Mellitus, Type 2.

Indication

No indication information available.

Associated Conditions

Thiamine Deficiency

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)	2024/01/25	NCT06223360	Phase 2	Recruiting	Alzheimer's Disease Cooperative Study (ADCS)
Benfotiamine in Alzheimer's Disease: A Pilot Study	2014/11/17	NCT02292238	Phase 2	Completed	Burke Medical Research Institute
Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)	2013/06/04	NCT01868191	Phase 3	UNKNOWN	Diabetes Schwerpunktpraxis
Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers	2008/11/05	NCT00785460	Phase 3	Completed	Ruhr University of Bochum
High Dose Vitamin B1 to Reduce Abusive Alcohol Use	2008/05/19	NCT00680121	Phase 4	Completed	University of Kansas
Benfotiamine in Diabetic Nephropathy	2007/11/29	NCT00565318	Phase 4	Completed	University Medical Center Groningen
Chronic Treatment With Benfotiamine Restores Endothelial Function in People With Type 2 Diabetes Mellitus	2007/03/13	NCT00446810	Phase 4	UNKNOWN	Ruhr University of Bochum
Effects of Benfotiamine and AGE on Endothelial Function in People With Diabetes	2007/02/19	NCT00437008	Phase 4	Completed	Ruhr University of Bochum
Effects of Vitamin B1 in Type 1 Diabetic Patients	2005/07/04	NCT00117026	Phase 1	Completed	University Hospital, Aker

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
MELGAMA 300 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Aaa-Pharma Gmbh	90406	COMPRIMIDO RECUBIERTO CON PELÍCULA	Sin Receta	Not 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.

Related News

Benfotiamine Enters Phase 2 Trial as Novel Alzheimer's Treatment

8 months ago

• A Phase 2A-2B clinical trial, Benfoteam, is underway to evaluate benfotiamine, a thiamine precursor, for slowing Alzheimer's progression in patients with mild cognitive impairment or mild dementia. • The trial, involving 406 participants across 50 sites, aims to determine the optimal safe dose of benfotiamine and its impact on global function and cognition over 18 months. • Benfotiamine targets thiamine deficiency, hypothesized to alter glucose metabolism in brain cells, potentially addressing the root cause of Alzheimer's disease, unlike current treatments focused on amyloid plaques. • Previous pilot studies showed promising results, with benfotiamine increasing blood thiamine levels and reducing cognitive decline, warranting further investigation into its efficacy.

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