Drugs / Insulin Lispro-aabc
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | LYUMJEV | — | 2021-08-13 – 2022-10-14 | fda.gov ↗ |
| Approved | US (FDA) | LYUMJEV | — | 2020-06-15 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 41 trial | ||||||
| Phase 4 | NCT06370715 | Apr 2024 → Sep 2025 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT07090824 Comparator | Oct 2025 → May 2026 | type 1 diabetes mellitus | Stanford University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-08-16 | Eli Lilly and Company | Regulatory FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved an expanded label for Eli Lilly and Company's (NYSE: LLY) rapid-acting insulin, Lyumjev® (insulin lispro-aabc injection) 100 units/mL indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. |
| 2020-06-15 | Eli Lilly and Company | Regulatory FDA approves Lyumjev™ (insulin lispro-aabc injection), Lilly's new rapid-acting insulin lilly.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-08-16 | Eli Lilly and Company | FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps lilly.com ↗ |
| 2020-06-15 | Eli Lilly and Company | FDA approves Lyumjev™ (insulin lispro-aabc injection), Lilly's new rapid-acting insulin lilly.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin lispro-aabc | “Commercially available U-100 Lyumjev (insulin lispro-aabc) administered unmodified as comparator.” NCT07090824 ↗ |
| Known as | Lyumjev | “Commercially available U-100 Lyumjev (insulin lispro-aabc) administered unmodified as comparator.” NCT07090824 ↗ |
| Modality | Protein / enzyme biologic | “insulin lispro-aabc” NCT06370715 ↗ |
| Route | Subcutaneous | “Administered subcutaneously” NCT06370715 ↗ |