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Metformin - Rescue
Metformin - Rescue is a Biguanide Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Type 2 diabetes mellitus. Also known as: Metformin, Glucophage, Glucophage XR, Glumetza.
Metformin reduces hepatic glucose production and improves insulin sensitivity to lower blood glucose levels in type 2 diabetes.
Metformin is a small molecule used to treat conditions such as type 2 diabetes and atherosclerosis, as indicated by studies on ClinicalTrials.gov. It is a medication that has been studied in combination with saxagliptin and as a monotherapy in clinical trials.
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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
Merck Sharp & Dohme 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 - Rescue |
|---|---|
| Also known as | Metformin, Glucophage, Glucophage XR, Glumetza, Fortamet |
| Sponsor | Merck Sharp & Dohme 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 insulin sensitivity. It may also have modest effects on glucose absorption in the intestine. The drug does not stimulate insulin secretion, making it useful across a range of glycemic states.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Metallic taste
- Vitamin B12 deficiency
- Lactic acidosis (rare)
Key clinical trials
- Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059) (PHASE3)
- Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes (PHASE4)
- Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083) (PHASE3)
- A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289) (PHASE3)
- Semaglutide Anti-Atherosclerotic Mechanisms of Action Study in Type 2 Diabetes Patients (NA)
- Pregnancy Outcomes: Effects of Metformin Study (POEM Study) (PHASE3)
- Efficacy and Safety of Liraglutide in Combination With Metformin Compared to Metformin Alone, in Children and Adolescents With Type 2 Diabetes (PHASE3)
- Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus (PHASE3)
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 - Rescue CI brief — competitive landscape report
- Metformin - Rescue updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Metformin - Rescue
What is Metformin - Rescue?
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What is Metformin - Rescue used for?
Who makes Metformin - Rescue?
Is Metformin - Rescue also known as anything else?
What drug class is Metformin - Rescue in?
What development phase is Metformin - Rescue in?
What are the side effects of Metformin - Rescue?
What does Metformin - Rescue target?
Related
- Drug class: All Biguanide drugs
- Target: All drugs targeting AMP-activated protein kinase (AMPK); mitochondrial complex I
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Also known as: Metformin, Glucophage, Glucophage XR, Glumetza, Fortamet
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing