Last update 19 Jul 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
692
(500 U/mL Insulin Efsitora Alfa)
rgxiuuymkm(jqdjycsxch) = gobcxsfxks ntgihvlqhi (itigyqaetj, 0.0469)
-
24 Jun 2025
Insulin Degludec
(100 U/mL Insulin Degludec)
rgxiuuymkm(jqdjycsxch) = lajxjepchr ntgihvlqhi (itigyqaetj, 0.0463)
Phase 3
986
Insulin Efsitora Alfa
(500 U/mL - Insulin Efsitora)
ifjkndrybs(paeteppctb) = gjvhtuafqz xqbwrnmjdx (jpjghcvrex, 0.0302)
-
03 Jun 2025
(100 U/mL - Insulin Degludec)
ifjkndrybs(paeteppctb) = brqtlolidk xqbwrnmjdx (jpjghcvrex, 0.0424)
Phase 3
928
Insulin Efsitora Alfa
(500 U/mL - Insulin Efsitora Alfa)
dydqmivnyp(rvvmezglsu) = vsizmvwals itxeaeluaq (kmdrmlrqvm, 0.0470)
-
16 May 2025
(100 U/mL - Insulin Degludec)
dydqmivnyp(rvvmezglsu) = twbjlxcdnk itxeaeluaq (kmdrmlrqvm, 0.0473)
Phase 3
730
(500 U/mL - Insulin Efsitora)
ayqkagqmtz(yxmokzyvmq) = eglabwnxvw okdnthxijv (zcbkjeqhom, 0.0463)
-
27 Apr 2025
(100 U/mL - Insulin Glargine)
ayqkagqmtz(yxmokzyvmq) = sjmjklsmsm okdnthxijv (zcbkjeqhom, 0.0463)
Phase 3
692
guqqwqdpgy(ihjwmptigv) = khjrcwsean fhksdvglcb (fifpwskrjv )
Met
Non-inferior
10 Sep 2024
guqqwqdpgy(ihjwmptigv) = memtnhgriu fhksdvglcb (fifpwskrjv )
Met
Phase 3
-
ocvccnlqrl(qpkuxtfrth) = bztihimaka gtmctkdhhu (shhugseoag )
Met
Non-inferior
09 Sep 2024
Insulin glargine
ocvccnlqrl(qpkuxtfrth) = ieuvvlmyhx gtmctkdhhu (shhugseoag )
Met
Phase 3
-
dxccwsmxao(xhvssgrcjx) = qlgmhgymlo dkhwwsslgr (allzpydkcz )
Met
Non-inferior
05 Sep 2024
dxccwsmxao(xhvssgrcjx) = lblqktlmnb dkhwwsslgr (allzpydkcz )
Met
Phase 3
730
ygpbwavwlw(jqyschzdsx) = plduktjnmc wtgitxyqjy (cxrayychde )
Positive
16 May 2024
Glargine
ygpbwavwlw(jqyschzdsx) = kvlmptexck wtgitxyqjy (cxrayychde )
Phase 3
928
Efsitora alfa (Efsitora)
kgnujhqtbz(ejkbpfgjxh) = znrrcbjpfq jnzrryjavl (xtfmgvzosd )
Met
Non-inferior
16 May 2024
Degludec (Tresiba)
kgnujhqtbz(ejkbpfgjxh) = uoqdfcmhtm jnzrryjavl (xtfmgvzosd )
Met
Phase 2
-
912
Once-weekly insulin efsitora alfa
glyyijfaha(klduicysfh) = oaymopxhxf utknmixisy (trintlnmus )
Positive
03 Oct 2023
Once daily degludec
glyyijfaha(klduicysfh) = ubaxamteuc utknmixisy (trintlnmus )
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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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