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Béfizal
Béfizal is a SGLT2 inhibitor Small molecule drug developed by Hôpital Necker-Enfants Malades. It is currently in Phase 2 development for Type 2 diabetes.
Béfizal is a small molecule that targets the SGLT2 receptor.
Béfizal is a medication being studied for the treatment of Leber Hereditary Optic Neuropathy. It is being investigated in a clinical trial (NCT04561466) to assess its safety and efficacy in this condition.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Béfizal |
|---|---|
| Sponsor | Hôpital Necker-Enfants Malades |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 2 |
Mechanism of action
By inhibiting SGLT2, Béfizal reduces glucose reabsorption in the kidneys, leading to decreased blood glucose levels. This mechanism is particularly useful in the treatment of type 2 diabetes.
Approved indications
- Type 2 diabetes
Common side effects
- Increased risk of genital yeast infections
Key clinical trials
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:
- Béfizal CI brief — competitive landscape report
- Béfizal updates RSS · CI watch RSS
- Hôpital Necker-Enfants Malades portfolio CI
Frequently asked questions about Béfizal
What is Béfizal?
How does Béfizal work?
What is Béfizal used for?
Who makes Béfizal?
What drug class is Béfizal in?
What development phase is Béfizal in?
What are the side effects of Béfizal?
What does Béfizal target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: Hôpital Necker-Enfants Malades — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing