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Standard glycemia control
Standard glycemia control is a SGLT2 inhibitor Small molecule drug developed by National Heart, Lung, and Blood Institute (NHLBI). It is currently in Phase 3 development for Type 2 diabetes, Heart failure.
This drug works by lowering blood sugar levels through the regulation of glucose metabolism.
Standard glycemia control involves dietary modification and medications, as well as therapeutic education, to manage conditions such as Type 1 and Type 2 Diabetes Mellitus, Gestational Diabetes, and Diabetic Kidney Disease. The interventions used in standard glycemia control are primarily small molecule medications, which are a type of pharmacological treatment.
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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).
| 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 | Standard glycemia control |
|---|---|
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
It achieves this by enhancing the body's natural insulin response and improving insulin sensitivity, thereby reducing glucose levels in the blood. This is particularly beneficial for individuals with type 2 diabetes, allowing for better glucose control and reduced risk of complications.
Approved indications
- Type 2 diabetes
- Heart failure
Common side effects
- Increased risk of genital yeast infections
- Increased risk of urinary tract infections
- Dehydration
- Nausea
- Vomiting
Key clinical trials
- Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D) (PHASE4)
- Effect of Ambient Temperature on Blood Glucose and Insulin Absorption in Adults With Type 1 Diabetes (NA)
- Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT) (PHASE4)
- Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes (PHASE2)
- Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome (NA)
- Impact of Clinical Nursing Guideline on Outcomes of Children With Diabetic Ketoacidosis. (NA)
- COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (NA)
- Role of Combination Therapy of Glucose Insulin Potassium Infusion (GIK), Intravenous Hydrocortisone and Oral Sevelamer in Treatment of Acute Aluminum Phosphide Poisoned Cases Admitted to Intensive Care Unit (ICU) at Sohag University Hospitals. (NA)
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:
- Standard glycemia control CI brief — competitive landscape report
- Standard glycemia control updates RSS · CI watch RSS
- National Heart, Lung, and Blood Institute (NHLBI) portfolio CI
Frequently asked questions about Standard glycemia control
What is Standard glycemia control?
How does Standard glycemia control work?
What is Standard glycemia control used for?
Who makes Standard glycemia control?
What drug class is Standard glycemia control in?
What development phase is Standard glycemia control in?
What are the side effects of Standard glycemia control?
What does Standard glycemia control target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: National Heart, Lung, and Blood Institute (NHLBI) — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
- Indication: Drugs for Heart failure
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing