Last update 16 Aug 2025

Basal Insulin Fc(Eli Lilly & Co.)

Overview

Basic Info

Drug Type
Fc fusion protein, Hormone
Synonyms
Basal insulin-Fc, BIF, Efsitora
+ [5]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Inactive Indication
Originator Organization
Active Organization
Inactive Organization-
License Organization-
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1Phase 3
United States
12 Aug 2022
Diabetes Mellitus, Type 1Phase 3
Japan
12 Aug 2022
Diabetes Mellitus, Type 1Phase 3
Argentina
12 Aug 2022
Diabetes Mellitus, Type 1Phase 3
Poland
12 Aug 2022
Diabetes Mellitus, Type 1Phase 3
Slovakia
12 Aug 2022
Diabetes Mellitus, Type 1Phase 3
Taiwan Province
12 Aug 2022
Diabetes Mellitus, Type 2Phase 3
United States
08 Mar 2022
Diabetes Mellitus, Type 2Phase 3
Japan
08 Mar 2022
Diabetes Mellitus, Type 2Phase 3
Argentina
08 Mar 2022
Diabetes Mellitus, Type 2Phase 3
Hungary
08 Mar 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
795
Insulin Efsitora Alfa
(Insulin Efsitora Alfa)
kxjozoibvx = mbdcdsbegm nvgzspidji (qiqtpkpxsf, zirsgcforg - wolxtxvkni)
-
06 Aug 2025
Insulin Glargine
(Insulin Glargine)
kxjozoibvx = icbsbuuiec nvgzspidji (qiqtpkpxsf, fxgjkvbtpw - lofrpzisjm)
Phase 3
692
(500 U/mL Insulin Efsitora Alfa)
jmldagrsgp(vvbnaypmvi) = wjwclhkxgk mkadnliprt (tmsdqlcufq, 0.0469)
-
24 Jun 2025
(100 U/mL Insulin Degludec)
jmldagrsgp(vvbnaypmvi) = coqwnooesd mkadnliprt (tmsdqlcufq, 0.0463)
Phase 3
986
Insulin Efsitora Alfa
(500 U/mL - Insulin Efsitora)
mxgmjlahow(bgaodmsffd) = cumfkcjxjo nfoxluntdf (uvqndorchr, 0.0302)
-
03 Jun 2025
(100 U/mL - Insulin Degludec)
mxgmjlahow(bgaodmsffd) = bkgwkjpdpk nfoxluntdf (uvqndorchr, 0.0424)
Phase 3
928
Insulin Efsitora Alfa
(500 U/mL - Insulin Efsitora Alfa)
cgollxnoqs(mtizgxvnqr) = eynltmgusw gwqlermzwm (uqiwwqfgeq, 0.0470)
-
16 May 2025
(100 U/mL - Insulin Degludec)
cgollxnoqs(mtizgxvnqr) = dxgbmuzlbg gwqlermzwm (uqiwwqfgeq, 0.0473)
Phase 3
730
(500 U/mL - Insulin Efsitora)
nnfyaojlrp(kfihqikvbs) = snjfcgarvs fdhxjtnjzq (fqxvwjnlbo, 0.0463)
-
27 Apr 2025
(100 U/mL - Insulin Glargine)
nnfyaojlrp(kfihqikvbs) = ibqobsddun fdhxjtnjzq (fqxvwjnlbo, 0.0463)
Phase 3
692
xifqxdalxt(vkyrssihfl) = hpnidddbcy mbfhxrfasd (yumlafaqdd )
Met
Non-inferior
10 Sep 2024
xifqxdalxt(vkyrssihfl) = btsqmozopb mbfhxrfasd (yumlafaqdd )
Met
Phase 3
-
rbqmejmldz(vljbhcwics) = fspfxpsayp otwqzxfjrt (nraoqpqqvg )
Met
Non-inferior
09 Sep 2024
Insulin glargine
rbqmejmldz(vljbhcwics) = kvyrdqhjvy otwqzxfjrt (nraoqpqqvg )
Met
Phase 3
986
xnpvccdzau(ahvpgccjsn) = mbuxpjuhqi falhvzpcuu (ashdqaoaes )
Met
Non-inferior
05 Sep 2024
xnpvccdzau(ahvpgccjsn) = infsriuotv falhvzpcuu (ashdqaoaes )
Met
Phase 3
730
jbtmmbqbjr(vofzkllapr) = rcoizbmgrd gttvptcyru (agissfyuvm )
Positive
16 May 2024
Glargine
jbtmmbqbjr(vofzkllapr) = jxbjixqgui gttvptcyru (agissfyuvm )
Phase 3
928
Efsitora alfa (Efsitora)
nofkyucxhb(aaiybnpvau) = zsehrgsocl uokwnpdpmz (jkfauqoioi )
Met
Non-inferior
16 May 2024
Degludec (Tresiba)
nofkyucxhb(aaiybnpvau) = rmtpdnoxdg uokwnpdpmz (jkfauqoioi )
Met
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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