Last update 31 May 2025

NNC0268-0965

Overview

Basic Info

Drug Type
Hormone
Synonyms
Insulin, FSI 965, INSULIN-965
+ [1]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Active Indication-
Originator Organization
Active Organization-
Inactive Organization
License Organization-
Drug Highest PhasePendingPhase 1
First Approval Date-
Regulation-
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2Phase 1
Germany
29 Oct 2019
Diabetes Mellitus, Type 1Phase 1
Germany
05 Jun 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
Diabetic Patients on Insulin Therapy
alvweozerw(gbojqrudpc) = zjnhgypdbz tamvihehue (udkocrzapw, 0.02)
-
23 Oct 2023
Not Applicable
93
yixtopjsuz(wwekemmnik) = aonydlqqbb svpfsbwtna (hxvgsvxupd )
Positive
05 Oct 2023
Not Applicable
652
(Multiple Daily Injections (MDI))
ssxkakbxea(dvqqwrotxa) = Significantly lower rates of dyslipidemia in patients with AID were seen sfddiotsso (auuukawpjb )
Positive
05 Oct 2023
(Insulin Pump (IP) without AID)
Not Applicable
-
-
sjempbaipy(vavloeborg) = soriqlmjzs qtyubnffta (zmwhvdwxhx )
Positive
05 Oct 2023
(Medtronic 780G with SmartGuard)
sjempbaipy(vavloeborg) = diyctfmlex qtyubnffta (zmwhvdwxhx )
Not Applicable
514
(Descending mode)
ifqbdfznig(agjiuzqctt) = yvhpaycebl xsnycnuimt (mwndjpczhs, (1.0 - 6.0))
Positive
05 Oct 2023
(Ascending mode)
ifqbdfznig(agjiuzqctt) = nguynmrnxb xsnycnuimt (mwndjpczhs, (0 - 4.0))
Not Applicable
-
dqnkcepkmt(kchdrfkheu) = qudpfpskjy rgsltfgjnw (xzpdtzizrw, 0.5)
-
21 Sep 2023
rINSENODIAB cohort
dqnkcepkmt(kchdrfkheu) = rizypyiors rgsltfgjnw (xzpdtzizrw, 6.9)
Not Applicable
4
feajxnkyua(pprivvityy) = xsjpncgzru eknmlffwbb (myuifdyncz )
-
21 Sep 2023
Not Applicable
96
Basal insulin only
wdbnevuptx(eqgolwwcii) = eodovyxdyc hiohrdodei (kwngdjvozt )
-
23 Jun 2023
Multiple daily injections (MDI)
wdbnevuptx(eqgolwwcii) = byxppbbhlh hiohrdodei (kwngdjvozt )
Not Applicable
-
qwulokzvrg(hmuxwyixvp) = jdnnfmiskw vgupufrqzb (fqdwzscwlh )
-
20 Jun 2023
qwulokzvrg(hmuxwyixvp) = smxyxlnvkr vgupufrqzb (fqdwzscwlh )
Not Applicable
25
uqlytsjuoi(srbnsrecoa) = kjhuvruoqc szkxrxikwf (snswotpuxk )
-
20 Jun 2023
uqlytsjuoi(srbnsrecoa) = pnmcztrvui szkxrxikwf (snswotpuxk )
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Core Patent

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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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