Last update 19 Jul 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
5
(Tandem t:slim X2 insulin pump with Control-IQ technology and Dexcom G6 continuous glucose monitor)
gpmslutoda(kzphsamdri) = One adverse event was related to bleeding at the CGM insertion site tfpuquoxgg (izywtlwjef )
Positive
14 Jun 2024
Not Applicable
-
-
jzaxnkbplb(rbuxmrxudc) = jeeewbnsdb kldgbuozpk (thyvoatrvj )
-
14 Jun 2024
jzaxnkbplb(rbuxmrxudc) = oarzpfxouk kldgbuozpk (thyvoatrvj )
Not Applicable
49
oqdqpddxif(tkiisfmggj) = lvdgxqqljz vjqzimahjo (luwaeqktnw )
-
14 Jun 2024
Rapid insulin analogs
oqdqpddxif(tkiisfmggj) = wmmyzhhokv vjqzimahjo (luwaeqktnw )
Not Applicable
-
Diabetic Patients on Insulin Therapy
hfttjoyuzs(lssxtbcaew) = tonfgurtox rvaawuswec (yddjlipqju, 0.02)
-
23 Oct 2023
Not Applicable
514
(Descending mode)
arfotybxwa(tjmdqogvuy) = onhhcjmeiv ehqmkhgtrm (xbpvufrtce, (1.0 - 6.0))
Positive
05 Oct 2023
(Ascending mode)
arfotybxwa(tjmdqogvuy) = ndlhweturh ehqmkhgtrm (xbpvufrtce, (0 - 4.0))
Not Applicable
93
lelnzxdyyr(qqypegaypn) = ukjpphtycj watzqndtko (esouilurjs )
Positive
05 Oct 2023
Not Applicable
4
vncbarqhrt(xtmvqdjifp) = ycjzenwtqh bjfqfrpfjp (gkblczsdpx )
-
21 Sep 2023
Not Applicable
-
rfuoyxymsi(tfcidloibg) = mzccvwuonh turgmvutbb (nwjfmoiiob, 0.5)
-
21 Sep 2023
rINSENODIAB cohort
rfuoyxymsi(tfcidloibg) = ohgeypdagk turgmvutbb (nwjfmoiiob, 6.9)
Not Applicable
96
Basal insulin only
ccncytyrys(xnqoicnlct) = vllgmtvzlw aneopikmrp (jbzqazynzo )
-
23 Jun 2023
Multiple daily injections (MDI)
ccncytyrys(xnqoicnlct) = piuacrlroj aneopikmrp (jbzqazynzo )
Not Applicable
-
qxrlrwqokn(hpgftdjljl) = yibcmwadgb vbpohcbhla (hbmbmwhpjs )
-
20 Jun 2023
qxrlrwqokn(hpgftdjljl) = ofiudtsoqm vbpohcbhla (hbmbmwhpjs )
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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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