Last reviewed · How we verify
Betivina (BENFOTIAMINE)
Betivina (generic name: BENFOTIAMINE) is a benfotiamine drug. It is currently in Phase 3 development.
Benfotiamine works by increasing the levels of thiamine pyrophosphate in cells, which is essential for glucose metabolism and nerve function.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BENFOTIAMINE |
|---|---|
| Drug class | benfotiamine |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | Phase 3 |
Mechanism of action
Think of benfotiamine like a key that unlocks the proper functioning of cells. It helps cells use glucose, a type of sugar, for energy. This is especially important for nerve cells, which rely heavily on glucose for proper function.
Approved indications
Common side effects
- Fall
- Anxiety
- Pain
- Cold Symptoms
- Dizziness
- Bruise
- NAUSEA
- Depression
- Heart Arrhythmia
- ACNE
- RASH ERYTHEMATOUS
- URTICARIA
Key clinical trials
- A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam) (PHASE2)
- Glycine and Magnesium+Thiamine for the Treatment of Primary Ciliary Dyskinesia (NA)
- GLYLO Supplement Pilot Trial on Glycation and Aging in Postmenopausal Women (NA)
- Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain (PHASE2)
- Benfotiamine in Alzheimer's Disease: A Pilot Study (PHASE2)
- Milgamma® and Milgamma® Compositum Step-therapy in Patients With Acute Non-specific Low Back Pain Receiving Modern NSAID
- Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG (NA)
- Reactive Oxygen Species in the Pathogenesis of Diabetic Complications (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Betivina CI brief — competitive landscape report
- Betivina updates RSS · CI watch RSS
Frequently asked questions about Betivina
What is Betivina?
How does Betivina work?
What is the generic name of Betivina?
What drug class is Betivina in?
What development phase is Betivina in?
What are the side effects of Betivina?
Related
- Drug class: All benfotiamine drugs
- Therapeutic area: All drugs in Metabolic
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing