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Metformin (Active Rescue)
Metformin (Active Rescue) is a Biguanide Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Type 2 diabetes mellitus.
Metformin reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK).
Metformin is a small molecule used to treat conditions such as Type 2 Diabetes Mellitus and Atherosclerosis. It is typically administered in combination with other medications, such as Saxagliptin, and is available in a 500 mg dosage.
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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
AstraZeneca 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 (Active Rescue) |
|---|---|
| Sponsor | AstraZeneca |
| Drug class | Biguanide |
| Target | AMPK (AMP-activated protein kinase) |
| 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, which enhances insulin sensitivity and reduces blood glucose levels without stimulating insulin secretion. The 'Active Rescue' designation likely refers to a formulation or combination strategy, though the core mechanism remains glucose homeostasis improvement.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal discomfort)
- Metallic taste
- Lactic acidosis (rare)
- Vitamin B12 deficiency
Key clinical trials
- Semaglutide Anti-Atherosclerotic Mechanisms of Action Study in Type 2 Diabetes Patients (NA)
- Randomized, Double-blind, Active-controlled, Study of Rivoglitazone in Type 2 Diabetes Mellitus (PHASE3)
- Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002) (PHASE3)
- Evaluate the Efficacy and Safety of Saxagliptin in Combination With Metformin IR Compared to Saxagliptin Monotherapy and to Metformin IR Monotherapy in Drug Naive Chinese Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control (PHASE3)
- Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin as Monotherapy in Pediatric Patients With Type 2 Diabetes (PHASE3)
- A Phase 3 Study of BMS-477118 in Combination With Metformin in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise (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 (Active Rescue) CI brief — competitive landscape report
- Metformin (Active Rescue) updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about Metformin (Active Rescue)
What is Metformin (Active Rescue)?
How does Metformin (Active Rescue) work?
What is Metformin (Active Rescue) used for?
Who makes Metformin (Active Rescue)?
What drug class is Metformin (Active Rescue) in?
What development phase is Metformin (Active Rescue) in?
What are the side effects of Metformin (Active Rescue)?
What does Metformin (Active Rescue) target?
Related
- Drug class: All Biguanide drugs
- Target: All drugs targeting AMPK (AMP-activated protein kinase)
- Manufacturer: AstraZeneca — 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