Drugs / Lyumjev
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 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT05262387 | Feb 2022 → Mar 2023 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06854861 | Apr → Nov 2025 | type 1 diabetes mellitus | St. Olavs Hospital | Suspended | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT06021158 Background | Dec 2023 → Dec 2024 | type 1 diabetes mellitus | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | No outcome recorded |
| Phase 2/3 | NCT06046417 Background | Nov 2023 → Apr 2025 | type 1 diabetes mellitus | McGill University Health Centre/Research Institute of the McGill University Health Centre | Unknown | 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 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lyumjev | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06046417 ↗ |
| Known as | ultrarapid lispro insulin | “We developed a novel automated insulin delivery (AID) system using ultrarapid lispro insulin (Lyumjev®), replacing carbohydrate counting with qualitative meal-size estimation...” PMID 42267693 ↗ Jun 2026 |
| Route | Subcutaneous | “Administered SC.” NCT05262387 ↗ |