Last reviewed · How we verify
Intranasal insulin
Intranasal insulin is a Insulin preparation Small molecule drug developed by University Health Network, Toronto. It is currently in Phase 3 development for Type 2 diabetes mellitus, Type 1 diabetes mellitus. Also known as: Insulin, HUMULIN R U-500, Insulin injection，H10890001,Jiangsu Wanbang Biochemical Medicine Group Co., Ltd, Novolin R.
Intranasal insulin delivers insulin directly to the nasal mucosa for systemic absorption, bypassing first-pass hepatic metabolism to improve glycemic control.
Intranasal insulin is being studied as a potential treatment for type 1 diabetes, specifically for hypoglycemia unawareness, through a clinical trial using the SipNose intranasal device. The study involves administering regular insulin (Humulin-R) via the intranasal route to middle-aged patients with type 1 diabetes.
-
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 | Intranasal insulin |
|---|---|
| Also known as | Insulin, HUMULIN R U-500, Insulin injection，H10890001,Jiangsu Wanbang Biochemical Medicine Group Co., Ltd, Novolin R, Actrapid |
| Sponsor | University Health Network, Toronto |
| Drug class | Insulin preparation |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Insulin administered intranasally is absorbed through the highly vascularized nasal epithelium, allowing it to enter systemic circulation while avoiding degradation in the gastrointestinal tract and first-pass hepatic metabolism. This route of administration may provide more physiologic insulin kinetics and potentially improve postprandial glucose control compared to subcutaneous injection. The nasal mucosa's large surface area and rich blood supply facilitate rapid absorption of the peptide hormone.
Approved indications
- Type 2 diabetes mellitus
- Type 1 diabetes mellitus
Common side effects
- Nasal irritation or congestion
- Hypoglycemia
- Headache
- Rhinitis
Key clinical trials
- Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants (PHASE1)
- Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury (PHASE1)
- The Importance of Insulin Action in the Brain for the Immune System During Physical Activity-Overweight (NA)
- Long-Term Effects of Walnut Consumption on Brain Function (NA)
- Relative Contribution of Brain Insulin Action for Postprandial Metabolism (NA)
- Intranasal Insulin in Parkinson's Disease (PHASE2)
- Intranasal Platelet-Rich Plasma With or Without Topical Insulin for Post-Inflammatory Anosmia (NA)
- Impact of Intranasal Insulin on Sympathetic Activity and Cerebral Vasodilation (EARLY_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:
- Intranasal insulin CI brief — competitive landscape report
- Intranasal insulin updates RSS · CI watch RSS
- University Health Network, Toronto portfolio CI
Frequently asked questions about Intranasal insulin
What is Intranasal insulin?
How does Intranasal insulin work?
What is Intranasal insulin used for?
Who makes Intranasal insulin?
Is Intranasal insulin also known as anything else?
What drug class is Intranasal insulin in?
What development phase is Intranasal insulin in?
What are the side effects of Intranasal insulin?
What does Intranasal insulin target?
Related
- Drug class: All Insulin preparation drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: University Health Network, Toronto — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Indication: Drugs for Type 1 diabetes mellitus
- Also known as: Insulin, HUMULIN R U-500, Insulin injection，H10890001,Jiangsu Wanbang Biochemical Medicine Group Co., Ltd, Novolin R, Actrapid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing