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Metformin Immediate-Release Tablet
Metformin Immediate-Release Tablet is a Small molecule drug developed by Aspargo Labs, Inc. It is currently in Phase 1 development.
Metformin Immediate-Release Tablet is a small molecule used to treat conditions such as Type 2 Diabetes Mellitus. It is a medication that has been studied in clinical trials for its efficacy and bioequivalence in comparison to other formulations.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 Tablet |
|---|---|
| Sponsor | Aspargo Labs, Inc |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
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 Tablet CI brief — competitive landscape report
- Metformin Immediate-Release Tablet updates RSS · CI watch RSS
- Aspargo Labs, Inc portfolio CI
Frequently asked questions about Metformin Immediate-Release Tablet
What is Metformin Immediate-Release Tablet?
Who makes Metformin Immediate-Release Tablet?
What development phase is Metformin Immediate-Release Tablet in?
Related
- Manufacturer: Aspargo Labs, Inc — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing