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Basal insulin only
Basal insulin only is a Insulin (basal/long-acting) Small molecule drug developed by Mount Sinai Hospital, Canada. It is currently in Phase 3 development for Type 1 diabetes mellitus, Type 2 diabetes mellitus. Also known as: Basal insulin glargine.
Basal insulin provides a steady, long-acting background level of insulin to regulate fasting blood glucose and suppress hepatic glucose production.
Basal insulin is used to treat conditions such as Type 1 Diabetes, Type 2 Diabetes, and Pregnancy in Diabetic, and it works by acting as an insulin receptor agonist. It is administered through various methods, including insulin pump therapy, and has been studied in clinical trials for its effectiveness in managing glucose levels.
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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 | Basal insulin only |
|---|---|
| Also known as | Basal insulin glargine |
| Sponsor | Mount Sinai Hospital, Canada |
| Drug class | Insulin (basal/long-acting) |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Basal insulin mimics the body's natural basal insulin secretion by binding to insulin receptors on target tissues, facilitating glucose uptake and storage while suppressing gluconeogenesis. This long-acting formulation is designed to maintain stable insulin levels throughout the day and night, forming the foundation of insulin therapy in type 1 and type 2 diabetes management.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Weight gain
- Injection site reactions
- Lipodystrophy
Key clinical trials
- Oral Anti Diabetic Agents in the Hospital (PHASE4)
- A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus (PHASE4)
- A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) (PHASE1)
- DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes (PHASE4)
- Regulatory Post Marketing Surveillance (rPMS) Study of Xultophy® (Insulin Degludec/Liraglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
- A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar (PHASE2, PHASE3)
- Physical Activity and Insulin Sensitivity Dynamics (NA)
- IRAPs (Secreted Insulin Regulated AminoPeptidase): a New Insulin Sensitivity Biomarker (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:
- Basal insulin only CI brief — competitive landscape report
- Basal insulin only updates RSS · CI watch RSS
- Mount Sinai Hospital, Canada portfolio CI
Frequently asked questions about Basal insulin only
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Related
- Drug class: All Insulin (basal/long-acting) drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: Mount Sinai Hospital, Canada — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 1 diabetes mellitus
- Indication: Drugs for Type 2 diabetes mellitus
- Also known as: Basal insulin glargine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing