Insulin Efsitora Alfa
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 111 trials | ||||||
| Phase 1 | NCT06362265 | Oct 2024 → Jan 2026 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06169982 | Dec 2023 → Jul 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05914688 | Jun 2023 → Jan 2024 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05596747 | Nov 2022 → Oct 2023 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05615532 | Nov 2022 → Jun 2023 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04957914 | Jul 2021 → Oct 2022 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04768842 | Mar → Sep 2021 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04276428 | Feb → Nov 2020 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03603704 | Aug 2018 → May 2019 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03367377 | Jan → Oct 2018 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02942914 | Dec 2016 → Oct 2017 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 23 trials · 2 met primary | ||||||
| Phase 2 | NCT04450407 | Jul 2020 → Oct 2021 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT04450394 | Jul 2020 → Oct 2021 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 2 | NCT03736785 | Nov 2018 → Feb 2020 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 35 trials · 5 met primary | ||||||
| Phase 3 | NCT05662332 | Jan 2023 → Jul 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05463744 | Aug 2022 → May 2024 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05462756 | Aug 2022 → Feb 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05362058 | Jun 2022 → Apr 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 3 | NCT05275400 | Mar 2022 → May 2024 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-09-24 | Eli Lilly and Company | Regulatory U.S. Food and Drug Administration (FDA) approves Lilly's Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin injection treatment for adults living with type 2 diabetes lilly.com ↗
Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) approval of Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin, indicated along with diet and exercise to control high blood sugar in adults with type 2 diabetes. |
| 2025-06-22 | Eli Lilly and Company | Results Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials lilly.com ↗
In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. |
| 2024-09-10 | Eli Lilly and Company | Results Once-weekly dose of insulin efsitora alfa delivers A1C reduction consistent with the most advanced daily insulin in people with type 2 diabetes lilly.com ↗
For the efficacy estimand1,2, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95% respectively3 at 52 weeks. |
| 2024-09-10 | Eli Lilly and Company | Results With once-a-week dosing, insulin efsitora alfa delivers similar A1C reduction compared to daily insulin in adults with type 1 diabetes lilly.com ↗
In the trial, efsitora met the primary endpoint of non-inferior A1C reduction at week 26. |
| 2024-09-05 | Eli Lilly and Company | Results In a first-of-its-kind fixed dose study, once weekly insulin efsitora alfa leads to A1C reduction similar to daily insulin lilly.com ↗ |
| 2024-05-16 | Eli Lilly and Company | Results With Once-a-Week Dosing, Insulin Efsitora Alfa Delivers A1C Reduction and Safety Profile Consistent with Daily Insulin lilly.com ↗
In the treat-to-target clinical trials, efsitora showed non-inferior A1C reduction compared to the most commonly used daily basal insulins globally. |
All press releases naming this drug 6 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | insulin efsitora alfa | “This analysis aimed to assess the safety and tolerability of insulin efsitora alfa (efsitora, basal insulin Fc, LY3209590) and characterize the pharmacokinetic and...” PMID 39928225 ↗ Feb 20257“Basal insulin Fc (BIF, insulin efsitora alfa), designed for once-weekly administration, is a fusion protein combining a novel single-chain insulin variant with a human...” PMID 36758572 ↗ Feb 2023 “Basal insulin Fc (BIF) (insulin efsitora alfa; LY3209590), a fusion protein combining a novel single-chain insulin variant with a human IgG Fc domain” PMID 36944059 ↗ May 2023 |
| Known as | BIF | “Basal insulin Fc (BIF, insulin efsitora alfa), designed for once-weekly administration, is a fusion protein combining a novel single-chain insulin variant with a human...” PMID 36758572 ↗ Feb 20231“Basal insulin Fc (BIF) (insulin efsitora alfa; LY3209590), a fusion protein combining a novel single-chain insulin variant with a human IgG Fc domain” PMID 36944059 ↗ May 2023 |
| Known as | efsitora | “This analysis aimed to assess the safety and tolerability of insulin efsitora alfa (efsitora, basal insulin Fc, LY3209590) and characterize the pharmacokinetic and...” PMID 39928225 ↗ Feb 20254“Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin...” NCT05462756 ↗ “Plain Language Summary: Insulin efsitora alfa (efsitora) is an innovative once-weekly basal insulin treatment evaluated in the Phase 3 QWINT clinical trials.” PMID 41591636 ↗ Jan 2026 “The phase 3 QWINT-2 study demonstrated that once-weekly insulin efsitora alfa (efsitora) was noninferior to once-daily insulin degludec” PMID 42177728 ↗ May 2026 “Insulin efsitora alfa (efsitora) is a once-weekly basal insulin.” PMID 39270686 ↗ Sep 2024 |
| Known as | insulin efsitora | “Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW) along with 100 U/mL insulin...” NCT05462756 ↗1“Participants received 500 units per milliliter (U/mL) Insulin Efsitora Alfa (insulin efsitora) administered subcutaneously (SC) once weekly (QW).” NCT05275400 ↗ |
| Known as | LY3209590 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05615532 ↗ |
| Modality | Protein / enzyme biologic | “is a fusion protein combining a novel single-chain insulin variant with a human immunoglobulin G (IgG) Fc domain.” PMID 36758572 ↗ Feb 2023 |
| Route | Subcutaneous | “LY3209590 administered subcutaneously (SC).” NCT02942914 ↗ |