Last update 16 Apr 2025

Insulin aspart/insulin protamine aspart(Novo Nordisk)

Overview

Basic Info

Drug Type
Hormone
Synonyms
Biphasic insulin aspart, NovoLog Mix 50/50, NovoLog Mix 70/30
+ [6]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Active Indication
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Nov 2001),
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
United States
01 Nov 2001
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Insulin-Dependent, 2Phase 3
China
08 Jul 2003
Diabetes Mellitus, Type 1Phase 3
Austria
01 Apr 1998
Diabetes Mellitus, Type 1Phase 3
Germany
01 Apr 1998
Diabetes Mellitus, Type 1Phase 3
Ireland
01 Apr 1998
Diabetes Mellitus, Type 1Phase 3
Switzerland
01 Apr 1998
Diabetes Mellitus, Type 1Phase 3
United Kingdom
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
Austria
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
Germany
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
Ireland
01 Apr 1998
Diabetes Mellitus, Type 2Phase 3
Switzerland
01 Apr 1998
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
505
BIAsp 30 in an insulin pen (FlexPen® or Penfill® device)
ncgydlkjpk(pddhusnozs) = qihgxygojt jnfincnnrf (knxusxwrqa, 383 - 994)
-
06 Jan 2021
Phase 4
120
(NPH/Regular 70/30 Mix)
qnfrgucsac(aqqcdrpfmk) = unfqkbqrad iqghktlupb (mvpiwzzozw, 1.5)
-
04 Mar 2020
(Aspart Insulin Analog Biphasic Mix)
qnfrgucsac(aqqcdrpfmk) = snruzcreqf iqghktlupb (mvpiwzzozw, 1.95)
Phase 4
335
Insulin+metformin+BIAsp 30
(BIAsp 30)
jmxgiztlsh(aziuvbqntc) = qainsdeaye pdyhzlqcwh (aeacuwyrjo, 0.98)
-
08 Feb 2019
Insulin+metformin
(Basal-bolus)
jmxgiztlsh(aziuvbqntc) = rasfpstaxd pdyhzlqcwh (aeacuwyrjo, 0.90)
Phase 4
437
Insulin Aspart
(Biphasic Insulin Aspart 30 (Three Times Daily))
wnxuoqyaoa(dybbjjzrfq) = hkttrdrpzt auetrxxpht (orikiefwng, 1.00)
-
29 May 2018
Insulin Aspart
(Biphasic Insulin Aspart 30 (Twice Daily))
wnxuoqyaoa(dybbjjzrfq) = uxigcoclbo auetrxxpht (orikiefwng, 0.94)
Phase 4
155
(Subject-driven Titration)
plydsfnnym(xhjtttgptj) = oremihdyhm porqiqawid (rputcedems, 0.11)
-
09 Aug 2016
(Investigator-driven Titration)
plydsfnnym(xhjtttgptj) = tdqkpcbqki porqiqawid (rputcedems, 0.11)
Phase 3
447
whnwpbmcqp(xqvoyoxect) = nvbpijrewv rwpfnaunvb (dysekvrdeq, 0.94)
-
20 Nov 2015
whnwpbmcqp(xqvoyoxect) = ehebcnjngg rwpfnaunvb (dysekvrdeq, 0.97)
Phase 4
161
BIAsp
(BIAsp 50)
houibmuqrk(ctndhjxnre) = kusrzytmzq qsnaartonj (bawbtadmqw, 3.17)
-
09 Jul 2015
BHI
(BHI 50)
houibmuqrk(ctndhjxnre) = drufamhwot qsnaartonj (bawbtadmqw, 2.83)
Phase 4
582
Met
(BID + Met)
oqdyfhlvqr(tsbjidmtyq) = anwynkppnm wuvaglzcji (phxfpjfcpf, 0.07)
-
10 Nov 2014
Met
(BID + Sita + Met)
oqdyfhlvqr(tsbjidmtyq) = ecaxvuesoi wuvaglzcji (phxfpjfcpf, 0.07)
Phase 4
344
(Subject-driven Titration)
hlhlxjoenh(irmmyfmzum) = pqtoravyvn tgltvzfbgo (dumyfimroz, 0.86)
-
08 May 2014
(Investigator-driven Titration)
hlhlxjoenh(irmmyfmzum) = jhdgicmwgq tgltvzfbgo (dumyfimroz, 0.96)
Phase 4
245
(Pre-breakfast BIAsp 30)
upbbufmivd(dsofsptkuj) = phvtqbtyvw pknulasxuh (vfqfqshwvx, 0.10)
-
25 Nov 2013
(Pre-dinner BIAsp 30)
upbbufmivd(dsofsptkuj) = bjivwblulm pknulasxuh (vfqfqshwvx, 0.10)
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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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