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Metformin immediate release
Metformin immediate release is a Biguanide Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 3 development for Type 2 diabetes mellitus, Prediabetes (prevention of progression to type 2 diabetes).
Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK) and inhibiting mitochondrial complex I.
Metformin immediate release is a small molecule used to treat conditions such as Type 2 Diabetes Mellitus and Gestational Diabetes Mellitus. It is typically administered orally in a fixed dose combination with other medications, such as saxagliptin, for the treatment of these conditions.
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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
Janssen Research & Development, LLC 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 | Metformin immediate release |
|---|---|
| Sponsor | Janssen Research & Development, LLC |
| Drug class | Biguanide |
| Target | AMP-activated protein kinase (AMPK); mitochondrial complex I |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Metformin is a biguanide that primarily works by decreasing gluconeogenesis in the liver and improving peripheral glucose uptake and utilization. It activates AMPK, a key metabolic regulator, and may also enhance insulin signaling in muscle and adipose tissue. The drug does not stimulate insulin secretion, making it weight-neutral and useful across a broad range of glucose levels.
Approved indications
- Type 2 diabetes mellitus
- Prediabetes (prevention of progression to type 2 diabetes)
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Metallic taste
- Vitamin B12 deficiency
- Lactic acidosis (rare)
Key clinical trials
- A Study to Investigate the Effects of Multiple Doses of Rezatapopt on the Pharmacokinetics of Metformin, Rosuvastatin, Repaglinide, and Midazolam in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation. (PHASE1)
- Mitochondrial Redox Modulation in Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Trial Comparing Imeglimin vs. Metformin Monotherapy (PHASE4)
- DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes (PHASE4)
- Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets (PHASE1)
- PK and Relative Bioavailability of Novel Liquid Metformin vs Tablets (PHASE1)
- Short-Term Glycemic Effects of Liquid Metformin vs Standard Tablets (PHASE1)
- Tolerability Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets (PHASE1)
- Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury (PHASE4)
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:
- Metformin immediate release CI brief — competitive landscape report
- Metformin immediate release updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Metformin immediate release
What is Metformin immediate release?
How does Metformin immediate release work?
What is Metformin immediate release used for?
Who makes Metformin immediate release?
What drug class is Metformin immediate release in?
What development phase is Metformin immediate release in?
What are the side effects of Metformin immediate release?
What does Metformin immediate release target?
Related
- Drug class: All Biguanide drugs
- Target: All drugs targeting AMP-activated protein kinase (AMPK); mitochondrial complex I
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Indication: Drugs for Prediabetes (prevention of progression to type 2 diabetes)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing