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Insulin / Diluent
Insulin / Diluent is a Insulin Small molecule drug developed by University Health Network, Toronto. It is currently in Phase 3 development for Type 1 diabetes mellitus, Type 2 diabetes mellitus (when oral agents are insufficient).
Insulin replaces or supplements the body's natural insulin to regulate blood glucose by promoting glucose uptake into cells and storage as glycogen.
Insulin is a protein that acts as an agonist to the insulin receptor, a protein modality. It is used to treat various conditions, including Major Depressive Disorder, Cystic Fibrosis, and Multiple Sclerosis, among others.
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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 | Insulin / Diluent |
|---|---|
| Sponsor | University Health Network, Toronto |
| Drug class | Insulin |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Insulin is a peptide hormone that binds to insulin receptors on cell surfaces, facilitating glucose transport into muscle, fat, and liver cells. This lowers blood glucose levels and promotes anabolic metabolism. The diluent is a sterile solution used to reconstitute or dilute insulin formulations for injection.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus (when oral agents are insufficient)
Common side effects
- Hypoglycemia
- Weight gain
- Injection site reactions
- Lipodystrophy
Key clinical trials
- Exenatide for Smoking Cessation and Prevention of Weight Gain (PHASE2)
- SNIFF - Combo INI+EMPA Trial (PHASE2)
- SNIFF - 3-Week Aptar CPS Device (PHASE2)
- The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients (PHASE2, PHASE3)
- Efficacy and Safety Between Different Dilution of Insulin (NA)
- Dose-Dependent Effect of Intranasal Insulin in Humans Using Functional Magnetic Resonance Imaging (fMRI) (PHASE1)
- Brain Insulin Resistance in Mood Disorders (PHASE1, PHASE2)
- A Study of Infusion Site Pain After Infusion of Excipients in Participants With Type 1 Diabetes Mellitus (PHASE1)
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:
- Insulin / Diluent CI brief — competitive landscape report
- Insulin / Diluent updates RSS · CI watch RSS
- University Health Network, Toronto portfolio CI
Frequently asked questions about Insulin / Diluent
What is Insulin / Diluent?
How does Insulin / Diluent work?
What is Insulin / Diluent used for?
Who makes Insulin / Diluent?
What drug class is Insulin / Diluent in?
What development phase is Insulin / Diluent in?
What are the side effects of Insulin / Diluent?
What does Insulin / Diluent target?
Related
- Drug class: All Insulin drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: University Health Network, Toronto — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 1 diabetes mellitus
- Indication: Drugs for Type 2 diabetes mellitus (when oral agents are insufficient)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing