Last reviewed · How we verify
Diluent / Insulin
Diluent / Insulin is a Insulin diluent / Excipient 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.
A diluent formulation designed to facilitate the preparation and administration of insulin by reducing concentration or adjusting osmolality.
A diluent formulation designed to facilitate the preparation and administration of insulin by reducing concentration or adjusting osmolality. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
-
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 | Diluent / Insulin |
|---|---|
| Sponsor | University Health Network, Toronto |
| Drug class | Insulin diluent / Excipient |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Diluents for insulin are sterile solutions used to dilute concentrated insulin preparations to achieve desired dosing concentrations or to improve stability and administration characteristics. This formulation from University Health Network appears to be a specialized diluent vehicle for insulin delivery, potentially optimizing bioavailability or patient convenience in Phase 3 development.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Injection site reactions
- Allergic reactions
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:
- Diluent / Insulin CI brief — competitive landscape report
- Diluent / Insulin updates RSS · CI watch RSS
- University Health Network, Toronto portfolio CI
Frequently asked questions about Diluent / Insulin
What is Diluent / Insulin?
How does Diluent / Insulin work?
What is Diluent / Insulin used for?
Who makes Diluent / Insulin?
What drug class is Diluent / Insulin in?
What development phase is Diluent / Insulin in?
What are the side effects of Diluent / Insulin?
Related
- Drug class: All Insulin diluent / Excipient drugs
- 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
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing