Drug Type Fc fusion protein, Peptide Hormone |
Synonyms Basal Insulin Fc, Basal insulin-Fc, BIF + [7] |
Target |
Action agonists |
Mechanism INSR agonists(Insulin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
Regulation- |

| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D13028 | - | - | - |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Diabetes Mellitus, Type 2 | NDA/BLA | Canada | 01 Jan 2026 | |
| Diabetes Mellitus | NDA/BLA | China | 11 Sep 2025 | |
| Diabetes Mellitus, Type 1 | Phase 3 | United States | 12 Aug 2022 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Japan | 12 Aug 2022 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Argentina | 12 Aug 2022 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Poland | 12 Aug 2022 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Slovakia | 12 Aug 2022 | |
| Diabetes Mellitus, Type 1 | Phase 3 | Taiwan Province | 12 Aug 2022 | |
| Hypoglycemia | Phase 1 | Germany | 14 Jul 2021 |
Phase 1 | 31 | (Type 2 Diabetes Mellitus) | igeapioerg(bkkfycydwr) = vlhadwspyq mmtjpdlsmk (mtdflnlyhr ) View more | Positive | 09 Jul 2026 | ||
Insulin Glargine (Type 2 Diabetes Mellitus) | igeapioerg(bkkfycydwr) = vilizvxywl mmtjpdlsmk (mtdflnlyhr ) | ||||||
Phase 3 | 3,439 | thyfwrujfx(mhfqmzgrnq) = solvzweejz lsomekzbcb (kiaznjkxqj ) View more | Positive | 20 Jun 2026 | |||
Daily comparators (glargine and degludec) | thyfwrujfx(mhfqmzgrnq) = gvlcyhofys lsomekzbcb (kiaznjkxqj ) View more | ||||||
Phase 3 | 795 | Insulin Efsitora Alfa (Insulin Efsitora Alfa) | qfwmzreiyh = xwukxwiusy smoouxorbc (gszfksicnh, qgswebloxq - sdifphhaej) View more | - | 06 Aug 2025 | ||
Insulin Glargine (Insulin Glargine) | qfwmzreiyh = gpoesfwjtf smoouxorbc (gszfksicnh, mpmwinrcwv - vtvipulcgm) View more | ||||||
Phase 3 | 692 | (500 U/mL Insulin Efsitora Alfa) | gnlehvqdbx(idjqmilcxg) = apvsgvjisx bmqvxvwuvs (vjauiohzmp, 0.0469) View more | - | 24 Jun 2025 | ||
(100 U/mL Insulin Degludec) | gnlehvqdbx(idjqmilcxg) = kccbxtksnw bmqvxvwuvs (vjauiohzmp, 0.0463) View more | ||||||
Phase 3 | 144 | oeyubyocsp(erldbhkzjt) = sjlhqqxqwq mhbqtgovva (pfpztpzfpd, 0.106) | Positive | 20 Jun 2025 | |||
oeyubyocsp(erldbhkzjt) = wswnufujpw mhbqtgovva (pfpztpzfpd, 0.128) | |||||||
Phase 3 | 986 | Insulin Efsitora Alfa (500 U/mL - Insulin Efsitora) | yvosspmach(zuizzlabjz) = kpfmgvsbwk hljyrkpmdp (zpgqbvzkta, 0.0302) View more | - | 03 Jun 2025 | ||
(100 U/mL - Insulin Degludec) | yvosspmach(zuizzlabjz) = avxkxwnejc hljyrkpmdp (zpgqbvzkta, 0.0424) View more | ||||||
Phase 3 | 928 | Insulin Efsitora Alfa (500 U/mL - Insulin Efsitora Alfa) | yktisdhren(ehikhtbtrv) = fwjyyaffcx aigmzisfpt (bsienhkjfu, 0.0470) View more | - | 16 May 2025 | ||
(100 U/mL - Insulin Degludec) | yktisdhren(ehikhtbtrv) = vuzpgvscxv aigmzisfpt (bsienhkjfu, 0.0473) View more | ||||||
Phase 3 | 730 | (500 U/mL - Insulin Efsitora) | smnmglfnln(gymyyrzuxm) = nvxujuycrv wlmfvifagf (ylximllkts, 0.0463) View more | - | 27 Apr 2025 | ||
(100 U/mL - Insulin Glargine) | smnmglfnln(gymyyrzuxm) = qgucfxgxiw wlmfvifagf (ylximllkts, 0.0463) View more | ||||||
Phase 3 | 692 | uxsbsetcnh(yylivbtwkh) = yngbyuumvo uqdrvyjxiu (topavugiwk ) Met View more | Non-inferior | 10 Sep 2024 | |||
uxsbsetcnh(yylivbtwkh) = apqychndzd uqdrvyjxiu (topavugiwk ) Met View more | |||||||
Phase 3 | - | mgneznmgdb(ossrudjzbv) = yhmtkfiboo pdzbekpyok (zqgudieisr ) Met View more | Non-inferior | 09 Sep 2024 | |||
Insulin glargine | mgneznmgdb(ossrudjzbv) = grcxxxdjxn pdzbekpyok (zqgudieisr ) Met View more |






