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Insulin VIAject™ (75%)
Insulin VIAject™ (75%) is a Rapid-acting insulin Small molecule drug developed by Biodel. It is currently in Phase 3 development for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
Insulin VIAject is a rapid-acting insulin formulation designed to be absorbed faster than standard insulin injections, allowing for quicker onset of action and better postprandial glucose control.
Insulin VIAject is a rapid-acting insulin formulation designed to be absorbed faster than standard insulin injections, allowing for quicker onset of action and better postprandial glucose control. Used for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
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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 VIAject™ (75%) |
|---|---|
| Sponsor | Biodel |
| Drug class | Rapid-acting insulin |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
VIAject uses Biodel's proprietary formulation technology to accelerate insulin absorption from subcutaneous injection sites, achieving faster peak serum levels compared to conventional insulin. This faster pharmacokinetic profile aims to more closely mimic the body's natural insulin secretion pattern in response to meals, potentially improving glycemic control and reducing hypoglycemic episodes.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Injection site reactions
- Weight gain
Key clinical trials
- MiniMed™ 670G System China Study for Type I Diabetic (NA)
- BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500 Post-Meal Glucose Control in Patients With Severe Insulin Resistance (PHASE1, PHASE2)
- Effect of Treatment With Insulin VIAjectTM Compared to Regular Human Insulin and Insulin Lispro on Mealtime Blood Vessel Stress in Patients With Type 2 Diabetes Mellitus. (PHASE3)
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 VIAject™ (75%) CI brief — competitive landscape report
- Insulin VIAject™ (75%) updates RSS · CI watch RSS
- Biodel portfolio CI
Frequently asked questions about Insulin VIAject™ (75%)
What is Insulin VIAject™ (75%)?
How does Insulin VIAject™ (75%) work?
What is Insulin VIAject™ (75%) used for?
Who makes Insulin VIAject™ (75%)?
What drug class is Insulin VIAject™ (75%) in?
What development phase is Insulin VIAject™ (75%) in?
What are the side effects of Insulin VIAject™ (75%)?
What does Insulin VIAject™ (75%) target?
Related
- Drug class: All Rapid-acting insulin drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: Biodel — 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