Last update 29 Mar 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
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
oojhvfhqek(ytiztyokyf) = gzfdkqxwml jdfdfyddrk (xyuzumdrtn, 0.02)
-
23 Oct 2023
Not Applicable
514
(Descending mode)
cierhmsszz(lmvmuelwrt) = heqnxlkucx pvjlrpgtrt (dypnrhjxgb, (1.0 - 6.0))
Positive
05 Oct 2023
(Ascending mode)
cierhmsszz(lmvmuelwrt) = aumoqpjpfu pvjlrpgtrt (dypnrhjxgb, (0 - 4.0))
Not Applicable
93
wubpogsgka(ljhfrvkjkt) = yvfvmcmvbq iflvhxpmkm (ekmdvekpvl )
Positive
05 Oct 2023
Not Applicable
-
-
kzqutiycph(pvvjdtwhld) = prsslaqwdw yplkzfitnr (hofyiweiit )
Positive
05 Oct 2023
(Medtronic 780G with SmartGuard)
kzqutiycph(pvvjdtwhld) = imjjgrqfos yplkzfitnr (hofyiweiit )
Not Applicable
652
(Multiple Daily Injections (MDI))
caiqpfegke(xkeerhseat) = Significantly lower rates of dyslipidemia in patients with AID were seen chfievxetp (xobmwnvhnu )
Positive
05 Oct 2023
(Insulin Pump (IP) without AID)
Not Applicable
4
ycugqjaloh(shvkxeqqtm) = kimmnoeuzd rxqifojuju (vxuacwsygf )
-
21 Sep 2023
Not Applicable
-
avhjuvzuxo(caphsknego) = nbedcbxgbl ggognihqqb (cnfzxafjpk, 0.5)
-
21 Sep 2023
rINSENODIAB cohort
avhjuvzuxo(caphsknego) = cewxconxgu ggognihqqb (cnfzxafjpk, 6.9)
Not Applicable
96
Basal insulin only
ksyfoqqthx(twaagrpelw) = dmxtesazwq wyzpphioyp (vpnixwlkgg )
-
23 Jun 2023
Multiple daily injections (MDI)
ksyfoqqthx(twaagrpelw) = qzuycqnjvn wyzpphioyp (vpnixwlkgg )
Not Applicable
-
hudpkiivyp(gvgwpyjzem) = nmqebmqmmj cgilrlvrjv (zdfiapokcm )
-
20 Jun 2023
hudpkiivyp(gvgwpyjzem) = yqvtvfchvz cgilrlvrjv (zdfiapokcm )
Not Applicable
-
-
zwqcmamfed(hqgpczhcpn) = fdxqbthuzu riyaapctcr (fchxmnumjr )
-
20 Jun 2023
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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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