MYXREDLIN (insulin human)
MYXREDLIN is a short-acting human insulin preparation. It is indicated to improve glycemic control in both adult and pediatric patients diagnosed with diabetes mellitus. As a short-acting insulin, it serves as a therapeutic intervention to manage blood sugar levels in this patient population.
How MYXREDLIN Works
MYXREDLIN regulates glucose metabolism by facilitating the uptake of glucose into peripheral tissues, particularly skeletal muscle and fat. It further reduces blood glucose levels by inhibiting the production of glucose within the liver. Beyond glucose regulation, the drug inhibits lipolysis and proteolysis while enhancing protein synthesis.
Details
- Status
- Prescription
- First Approved
- 2019-06-20
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
MYXREDLIN Approval History
What MYXREDLIN Treats
1 indicationsMYXREDLIN is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
MYXREDLIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in MYXREDLIN's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MYXREDLIN treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06558422 | AAAU9702 P30DK063608, K12DK133995 | Ph 1 | not yet recruiting | Human Models of Selective Insulin Resistance: Pancreatic Clamp |
| NCT05724134 | AAAU3014 3P30DK063608 | Ph 1 | completed | Pancreatic Clamp in NAFLD |
| NCT06939959 | 579/DME/KMC | Ph 4 | recruiting | Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease. |
| NCT06126354 | AAAU7680 3P30DK063608 | Ph 1 | withdrawn | Dexamethasone/Pancreatic Clamp P&F |
| NCT02028078 PILOT_EGP | PILOT_EGP | Ph 2 | completed | Pilot Study Investigating the Feasibility of Determining the Endogenous Glucose Production During a Hypoglycaemia |
| NCT01269606 | ANA-3877 U1111-1117-1353, JapicCTI-111383 | Ph 1 | completed | Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MYXREDLIN FDA Label Details
Indications & Usage
FDA Label (PDF)MYXREDLIN is indicated for the treatment of Diabetes.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.