Last reviewed · How we verify
FlexPen NovoLog®
FlexPen NovoLog® is a Rapid-acting insulin analog Small molecule drug developed by Mylan Inc.. It is currently in Phase 3 development for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
NovoLog is a rapid-acting insulin analog that binds to insulin receptors to facilitate glucose uptake and utilization in cells.
FlexPen NovoLog is a medication used to treat diabetes, specifically Type 1 and Type 2 diabetes mellitus. It works as an insulin receptor agonist, binding to the insulin receptor to stimulate insulin activity.
-
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 | FlexPen NovoLog® |
|---|---|
| Sponsor | Mylan Inc. |
| Drug class | Rapid-acting insulin analog |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
NovoLog (insulin aspart) is a recombinant human insulin analog with a rapid onset of action, typically beginning to work within 10-20 minutes of injection. It mimics the body's natural insulin response to meals by binding to insulin receptors on muscle and fat cells, promoting glucose uptake and storage while inhibiting hepatic glucose production. This rapid action makes it suitable for mealtime insulin therapy in diabetes management.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Injection site reactions
- Weight gain
- Lipodystrophy
Key clinical trials
- Mylan Insulin Aspart Study (PHASE3)
- Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients (PHASE3)
- A Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus (T2DM)
- Efficacy, Safety and Preference Study of a Insulin Pen PDS290 vs. a Novo Nordisk Marketed Insulin Pen in Diabetics (PHASE3)
- Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes (PHASE4)
- Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes (PHASE4)
- Switch From Premixed Human Insulin to Biphasic Insulin Aspart in the Netherlands
- Comparison of Biphasic Insulin Aspart 30 Individually Adjusted by the Subject and the Trial Physician, Both Combined With Metformin in Subjects With Type 2 Diabetes (PHASE4)
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:
- FlexPen NovoLog® CI brief — competitive landscape report
- FlexPen NovoLog® updates RSS · CI watch RSS
- Mylan Inc. portfolio CI
Frequently asked questions about FlexPen NovoLog®
What is FlexPen NovoLog®?
How does FlexPen NovoLog® work?
What is FlexPen NovoLog® used for?
Who makes FlexPen NovoLog®?
What drug class is FlexPen NovoLog® in?
What development phase is FlexPen NovoLog® in?
What are the side effects of FlexPen NovoLog®?
What does FlexPen NovoLog® target?
Related
- Drug class: All Rapid-acting insulin analog drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: Mylan Inc. — 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