LYUMJEV (insulin lispro-aabc)
LYUMJEV (insulin lispro-aabc) is a rapid-acting human insulin analog. It is indicated to improve glycemic control in both adult and pediatric patients with diabetes mellitus. The medication serves as a therapeutic intervention for managing blood sugar levels in patients across these age groups.
How LYUMJEV Works
LYUMJEV regulates glucose metabolism by binding to specific insulin receptors. This binding action lowers blood glucose levels by stimulating peripheral glucose uptake in skeletal muscle and fat and inhibiting the production of glucose in the liver. Furthermore, the drug inhibits lipolysis and proteolysis while enhancing protein synthesis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-06-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LYUMJEV Approval History
What LYUMJEV Treats
1 indicationsLYUMJEV is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
LYUMJEV 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 LYUMJEV's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LYUMJEV treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LYUMJEV
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
111 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07293715 PRISM-T1D | STUDY 20252532 | Ph 4 | recruiting | Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D) |
| NCT07548996 | 2026-SR-107 | Ph 2, Ph 3 | recruiting | Open-Label Study of Dimethyl Fumarate in Adults With Type 1 Diabetes |
| NCT06111586 FABULINUS | DRI17476 U1111-1275-9618, 2022-500531-36 | Ph 2 | recruiting | FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS) |
| NCT06699810 | STUDY00008366 2024P008641 | Ph 4 | active not recruiting | Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity |
| NCT07494084 | R01HL177106 R01HL177106 | Ph 4 | not yet recruiting | Sleep Loss and Circadian Misalignment - Mechanisms of Insulin Resistance |
| NCT03527537 GAP | PRO00030802 | Ph 4 | active not recruiting | Gestational Diabetes and Pharmacotherapy (GAP) |
| NCT02176681 | 5706 2013-004737-33 | Ph 4 | completed | A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM |
| NCT06762314 | Tanta 145 | Ph 2 | recruiting | Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes |
| NCT05692739 | 22/211-EC_M | Ph 4 | completed | Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye |
| NCT02220920 results posted | TA-7284-11 | Ph 4 | completed | Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus |
| NCT02622113 results posted | TA-7284-13 | Ph 4 | completed | Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus |
| NCT06445946 DECIDE | 2024H0193 | Ph 4 | recruiting | DECIDE: A Comparative Effectiveness Trial of Metformin Versus Insulin for the Treatment of Gestational Diabetes |
| NCT02081599 results posted | 3000-A15 | Ph 4 | completed | Efficacy and Safety Study of Teneligliptin (MP-513) in Combination With Insulin in Patients With Type 2 Diabetes |
| NCT07259564 | GenSci073-202 | Ph 2 | not yet recruiting | A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD) |
| NCT04029480 results posted | 8835-059 PHRR190913-002184, 2022-501085-21-00 | Ph 3 | completed | Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059) |
| NCT03857321 results posted | IRB00055429 | Ph 2 | completed | Study of Nasal Insulin to Fight Forgetfulness - Device Study |
| NCT06370715 | 18269 I8B-MC-ITTA | Ph 4 | completed | A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India |
| NCT04533646 results posted | STUDY20060197 | Ph 4 | completed | Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes |
| NCT02054429 | INSULIN | Ph 1 | completed | Intensive Insulin Therapy With Tight Glycemic Control to Improve Outcomes After Endovascular Therapy for Acute Ischemic Stroke |
| NCT03241706 | 2016-7982 | Ph 1 | active not recruiting | Liver Glycogen and Hypoglycemia in Humans |
| NCT03899402 | STUDY00002775 1987 | Ph 2, Ph 3 | active not recruiting | Triple Therapy in T1DM |
| NCT06781775 | 231576 | Ph 4 | recruiting | GDM: Insulin with or Without Metformin? |
| NCT06601101 | 77229224.8.0000.5404 Topical Insulin | Ph 3 | recruiting | Effects of Topical Insulin on Corneal Epithelium Healing After Corneal Crosslinking in Patients With Keratoconus |
| NCT03029702 MATCh-GDM results posted | PRO16100499 K23HD092893 | Ph 4 | completed | Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus |
| NCT02847091 | 1941-MA-3054 | Ph 4 | completed | Study of Ipragliflozin in Patients With Type 2 Diabetes Mellitus Receiving Insulin Therapy |
| NCT06017362 | 22/457-EC_M | Ph 4 | recruiting | Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors |
| NCT04635774 PODS | STUDY00146489 | Ph 1, Ph 2 | withdrawn | Post Operative Delirium Study |
| NCT05441631 | RC 1.6.2020 | Ph 1 | completed | Can Intensive Insulin Therapy Improve Outcomes of COVID-19 Patients |
| NCT04599075 results posted | H00021746 | Ph 4 | completed | Intravenous Insulin vs Subcutaneous Insulin Infusion in Intrapartum Management of Type 1 Diabetes Mellitus |
| NCT04687878 | IR.SBMU.PHNS.REC.1398.094 | Ph 2 | completed | The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients |
| NCT03429543 results posted | 1218-0091 2016-000669-21 | Ph 3 | completed | Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM |
| NCT05321251 | Pro00107280 | Ph 2, Ph 3 | withdrawn | Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy. |
| NCT02518945 results posted | 1969 | Ph 3 | completed | Dapagliflozin As Additional Treatment To Liraglutide And Insulin In Patients With Type 1 Diabetes |
| NCT03665207 TGC-fast | S61145 2018-000756-17 | Ph 3 | active not recruiting | Tight Versus Liberal Blood Glucose Control in Adult Critically Ill Patients |
| NCT02988401 results posted | IRB00095554 | Ph 1, Ph 2 | completed | Intranasal Insulin for Improving Cognitive Function in Multiple Sclerosis |
| NCT05752929 CAPADOCIA1 | HUCSR20161 | Ph 4 | completed | Comparison of 2 Hyperglycemia-correction Scales in Hospitalized Patients |
| NCT05479214 | reda-metformin | Ph 4 | completed | Effect of Adding Metformin to Insulin in Uncontrolled Diabetic Patients During the 3rd Trimester of Pregnancy |
| NCT05161741 RISE | GTZ-DM-004-21 | Ph 4 | completed | Research on Human Insulin rDNA Safety and Efficacy in Patients With Type 2 Diabetes Mellitus |
| NCT01719640 | MSC-MC-DM | Ph 1, Ph 2 | completed | MSC and MC in Type 2 Diabetes Mellitus |
| NCT02574156 CHyCS | SDC | Ph 3 | terminated | Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial |
| NCT04079881 results posted | 201909013 | Ph 1, Ph 2 | terminated | Glucagon Response to Prandial Insulin Administration in Persons With Type 1 Diabetes |
| NCT01760447 results posted | 0431A-289 2012-004035-23, 2011-002529-23 | Ph 3 | completed | A Pooled Analysis of the Safety and Efficacy of MK-0431A and MK-0431A XR in Pediatric Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin Therapy (Alone or in Combination With Insulin) (MK-0431A-170/MK-0431A-289) |
| NCT03998709 | 19-003325 R01DK078646 | Ph 4 | withdrawn | Effect of Fasting Free Fatty Acids and Fasting Glucose on 1st and 2nd Phase Insulin Secretion |
| NCT01565941 HALF-PINT results posted | IRB-P00002310 U01HL107681 | Ph 3 | completed | Heart And Lung Failure - Pediatric INsulin Titration Trial |
| NCT05461365 | 01007 | Ph 3 | completed | Intranasal Insulin for COVID-19-related Smell Loss |
| NCT04385589 | 3241 | Ph 4 | completed | Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure |
| NCT01860911 | 12-005173 | Ph 1 | completed | Plasma Triglyceride Extraction by The Muscle |
| NCT02407899 | NCRCMD LADA SAX 2015 | Ph 4 | completed | Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes |
| NCT04542213 Covid19DPP4i | CEI-22-2020 | Ph 3 | completed | Dipeptidyl Peptidase-4 Inhibitor (DPP4i) for the Control of Hyperglycemia in Patients With COVID-19 |
| NCT02432976 ExeQOL | 09/503 | Ph 2, Ph 3 | completed | Impact of Perioperative Exenatide Infusion on Quality of Life in Cardiac Surgery Patients |
Showing 50 of 111 trials
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.
LYUMJEV FDA Label Details
Indications & Usage
FDA Label (PDF)LYUMJEV 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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment