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Open-label Glimepiride
Open-label Glimepiride is a Sulfonylurea Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Type 2 diabetes mellitus. Also known as: Amaryl®, Glimy.
Glimepiride stimulates insulin secretion from pancreatic beta cells by binding to sulfonylurea receptors on the cell membrane.
Glimepiride stimulates insulin secretion from pancreatic beta cells by binding to sulfonylurea receptors on the cell membrane. Used for Type 2 diabetes mellitus.
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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 | Open-label Glimepiride |
|---|---|
| Also known as | Amaryl®, Glimy |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Sulfonylurea |
| Target | Sulfonylurea receptor (SUR1) / ATP-sensitive potassium channel |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Glimepiride is a meglitinide-class sulfonylurea that closes ATP-sensitive potassium channels in pancreatic beta cells, leading to cell depolarization and calcium influx, which triggers insulin release. This mechanism helps lower blood glucose levels in patients with type 2 diabetes by increasing endogenous insulin secretion.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Weight gain
- Dizziness
- Headache
- Nausea
Key clinical trials
- Evaluate the Efficacy and Safety of Empagliflozin or Glimepiride Combination Therapy in Type 2 Diabetes Mellitus Patients (PHASE4)
- Efficacy and Safety Study of MP-513 in Combination With Sulfonylurea in Patients With Type 2 Diabetes (PHASE3)
- A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria (PHASE4)
- Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263) (PHASE4)
- Interaction of Bexagliflozin With Metformin, Glimepiride and Sitagliptin (PHASE1)
- Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D) (PHASE4)
- COMPOUND (INN): HOE490O - GLIMEPIRIDE / METFORMIN HCl (Amaryl® M)0 (Glimepiride/Metformin Hydrochloride Immediate Release Combination Tablet) in Fed Conditions in Healthy Male and/or Female Subjects. (PHASE1)
- Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan (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:
- Open-label Glimepiride CI brief — competitive landscape report
- Open-label Glimepiride updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Open-label Glimepiride
What is Open-label Glimepiride?
How does Open-label Glimepiride work?
What is Open-label Glimepiride used for?
Who makes Open-label Glimepiride?
Is Open-label Glimepiride also known as anything else?
What drug class is Open-label Glimepiride in?
What development phase is Open-label Glimepiride in?
What are the side effects of Open-label Glimepiride?
What does Open-label Glimepiride target?
Related
- Drug class: All Sulfonylurea drugs
- Target: All drugs targeting Sulfonylurea receptor (SUR1) / ATP-sensitive potassium channel
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Also known as: Amaryl®, Glimy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing