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Biguanide (BG)
Biguanide (BG) is a Biguanide Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development for Type 2 diabetes mellitus.
Biguanides reduce hepatic glucose production and improve insulin sensitivity by activating AMP-activated protein kinase (AMPK) and inhibiting mitochondrial complex I.
Biguanides reduce hepatic glucose production and improve insulin sensitivity by activating AMP-activated protein kinase (AMPK) and inhibiting mitochondrial complex I. Used for Type 2 diabetes mellitus.
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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). -
Big-pharma sponsor
+3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Biguanide (BG) |
|---|---|
| Sponsor | Eli Lilly and Company |
| Drug class | Biguanide |
| Target | AMPK, mitochondrial complex I |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Biguanides are a class of antidiabetic agents that work primarily by decreasing gluconeogenesis in the liver and improving peripheral glucose uptake and utilization. They activate AMPK, a key metabolic regulator, and inhibit mitochondrial respiratory chain complex I, leading to reduced ATP production and suppression of hepatic glucose output. This mechanism makes them effective for lowering blood glucose without stimulating insulin secretion.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Lactic acidosis (rare, serious)
- Vitamin B12 deficiency
- Metallic taste
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:
- Biguanide (BG) CI brief — competitive landscape report
- Biguanide (BG) updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Biguanide (BG)
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Related
- Drug class: All Biguanide drugs
- Target: All drugs targeting AMPK, mitochondrial complex I
- Manufacturer: Eli Lilly and Company — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing