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Humalog Mix 50
Humalog Mix 50 is a Insulin combination therapy Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development for Type 1 diabetes mellitus, Type 2 diabetes mellitus.
Humalog Mix 50 is a combination insulin therapy that provides both rapid-acting and intermediate-acting insulin to control blood glucose levels in diabetes.
Humalog Mix 50 is a type of insulin used to treat conditions such as hyperglycemia, type 1 diabetes, and type 2 diabetes mellitus. It is a mixture of regular insulin and lispro insulin, which are both forms of human insulin analogs.
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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). -
Big-pharma sponsor
+3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | Humalog Mix 50 |
|---|---|
| Sponsor | Eli Lilly and Company |
| Drug class | Insulin combination therapy |
| Target | Insulin receptor |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Humalog Mix 50 contains 50% insulin lispro (rapid-acting) and 50% insulin lispro protamine suspension (intermediate-acting). The rapid-acting component begins working within 15 minutes to address postprandial glucose spikes, while the intermediate-acting component provides basal insulin coverage over several hours. Together, they mimic the body's natural biphasic insulin secretion pattern.
Approved indications
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Common side effects
- Hypoglycemia
- Injection site reactions
- Weight gain
- Lipodystrophy
Key clinical trials
- Impact on Birth Weight of Two Therapeutic Strategies (Insulin Therapy From the Beginning of Pregnancy vs. Insulin Therapy Initiated According to Fetal Growth Evaluated by Ultrasonography Measurements) in Pregnant Women With Monogenic Diabetes (NA)
- Testing a Conversion Factor for a More Rapidly Acting Insulin in an Automated Insulin Delivery System Among Adolescents With T1D (NA)
- Study to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity Between NKF-INS(L), US-Humalog®, and EU-Humalog® (PHASE1)
- Oral Anti Diabetic Agents in the Hospital (PHASE4)
- Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes (NA)
- DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes (PHASE4)
- Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes (PHASE1)
- The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal. (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:
- Humalog Mix 50 CI brief — competitive landscape report
- Humalog Mix 50 updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Humalog Mix 50
What is Humalog Mix 50?
How does Humalog Mix 50 work?
What is Humalog Mix 50 used for?
Who makes Humalog Mix 50?
What drug class is Humalog Mix 50 in?
What development phase is Humalog Mix 50 in?
What are the side effects of Humalog Mix 50?
What does Humalog Mix 50 target?
Related
- Drug class: All Insulin combination therapy drugs
- Target: All drugs targeting Insulin receptor
- Manufacturer: Eli Lilly and Company — 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