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Biguanides
Biguanides is a Small molecule drug developed by Canadian Network for Observational Drug Effect Studies, CNODES. It is currently in Phase 2 development. Also known as: oral hypoglycemic agent, phenformin, metformin, buformin.
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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 | Biguanides |
|---|---|
| Also known as | oral hypoglycemic agent, phenformin, metformin, buformin |
| Sponsor | Canadian Network for Observational Drug Effect Studies, CNODES |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants (PHASE1)
- Metformin Hydrochloride in Preventing Oral Cancer in Patients With an Oral Premalignant Lesion (PHASE2)
- Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib (PHASE1)
- Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2)
- Metformin for People With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function (PHASE2)
- Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) (PHASE2)
- Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients (PHASE4)
- PMPR and Chlorhexidine on Periodontal Disease and Vascular Function (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:
- Biguanides CI brief — competitive landscape report
- Biguanides updates RSS · CI watch RSS
- Canadian Network for Observational Drug Effect Studies, CNODES portfolio CI
Frequently asked questions about Biguanides
What is Biguanides?
Who makes Biguanides?
Is Biguanides also known as anything else?
What development phase is Biguanides in?
Related
- Manufacturer: Canadian Network for Observational Drug Effect Studies, CNODES — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: oral hypoglycemic agent, phenformin, metformin, buformin