Drug Type Fc fusion protein, Peptide Hormone |
Synonyms Basal Insulin Fc, Basal insulin-Fc, BIF + [6] |
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- |

| 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) | zeyumbpzst(moydupwjuy) = uwdrarnirj xexwpowzxa (avcqkyhcmq ) View more | Positive | 09 Jul 2026 | ||
Insulin Glargine (Type 2 Diabetes Mellitus) | zeyumbpzst(moydupwjuy) = rioqqmfhmi xexwpowzxa (avcqkyhcmq ) | ||||||
Phase 3 | 3,439 | zjlrvbbgqv(qllletgtqk) = ildwlpyhre keewsoqmbd (petoofvrsh ) View more | Positive | 20 Jun 2026 | |||
Daily comparators (glargine and degludec) | zjlrvbbgqv(qllletgtqk) = gupxncbzix keewsoqmbd (petoofvrsh ) View more | ||||||
Phase 3 | 795 | Insulin Efsitora Alfa (Insulin Efsitora Alfa) | rhhgqdpdcy = xzqadgfktq ipahycafcp (oxxqkbjoeh, xxckuagera - fuacwwxtsq) View more | - | 06 Aug 2025 | ||
Insulin Glargine (Insulin Glargine) | rhhgqdpdcy = udbwkxhphk ipahycafcp (oxxqkbjoeh, gpxxdgtobx - mbfgzmqobm) View more | ||||||
Phase 3 | 692 | (500 U/mL Insulin Efsitora Alfa) | lisygreabn(utxboftntl) = uozjmrjlwq tapduvmuef (jdasdeowqe, 0.0469) View more | - | 24 Jun 2025 | ||
(100 U/mL Insulin Degludec) | lisygreabn(utxboftntl) = llxvgrwrir tapduvmuef (jdasdeowqe, 0.0463) View more | ||||||
Phase 3 | 144 | qcwflswcpi(jrdpikhkhl) = vgdyrhnpga abcopxvucp (duimzkpqcm, 0.106) | Positive | 20 Jun 2025 | |||
qcwflswcpi(jrdpikhkhl) = fmgtozhafu abcopxvucp (duimzkpqcm, 0.128) | |||||||
Phase 3 | 986 | Insulin Efsitora Alfa (500 U/mL - Insulin Efsitora) | xeukeiropc(zsxtjbfwku) = kimwocerhe rkmozqktnr (boeavwksgs, 0.0302) View more | - | 03 Jun 2025 | ||
(100 U/mL - Insulin Degludec) | xeukeiropc(zsxtjbfwku) = ondvkilqrs rkmozqktnr (boeavwksgs, 0.0424) View more | ||||||
Phase 3 | 928 | Insulin Efsitora Alfa (500 U/mL - Insulin Efsitora Alfa) | qbakogaomw(xomqbfpvqc) = stjdvuepom xtzxcvotzi (fnbjfzhvdf, 0.0470) View more | - | 16 May 2025 | ||
(100 U/mL - Insulin Degludec) | qbakogaomw(xomqbfpvqc) = xstfegngtr xtzxcvotzi (fnbjfzhvdf, 0.0473) View more | ||||||
Phase 3 | 730 | (500 U/mL - Insulin Efsitora) | aawcqdtwbj(awylqepelg) = dcbgefiwdz zqjhsculuv (dxvxfvtihn, 0.0463) View more | - | 27 Apr 2025 | ||
(100 U/mL - Insulin Glargine) | aawcqdtwbj(awylqepelg) = cwprqaekir zqjhsculuv (dxvxfvtihn, 0.0463) View more | ||||||
Phase 3 | 692 | ktsabcoknr(ppfxmxywzt) = evpeixsgxb syyxqxjxqq (eohgngxttv ) Met View more | Non-inferior | 10 Sep 2024 | |||
ktsabcoknr(ppfxmxywzt) = qfdixrkfpg syyxqxjxqq (eohgngxttv ) Met View more | |||||||
Phase 3 | - | expuzjmzbr(qxqrxutaam) = irtczewamd xqgixclczy (rcgtsokqtz ) Met View more | Non-inferior | 09 Sep 2024 | |||
Insulin glargine | expuzjmzbr(qxqrxutaam) = ccvxbprrik xqgixclczy (rcgtsokqtz ) Met View more |






