Last update 24 Jun 2025

Insulin aspart/insulin protamine aspart(Novo Nordisk)

Overview

Basic Info

Drug Type
Hormone
Synonyms
BIAsp30, Biphasic insulin aspart, NovoLog Mix 50/50
+ [7]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Active Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (01 Aug 2000),
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
European Union
01 Aug 2000
Diabetes Mellitus
Iceland
01 Aug 2000
Diabetes Mellitus
Liechtenstein
01 Aug 2000
Diabetes Mellitus
Norway
01 Aug 2000
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
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
Diabetes Mellitus, Type 2Phase 3
United Kingdom
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)
zrnarazvsb(wmfqcuthfh) = kmjrcsgrcj fysnxjeenw (bxacqrcslw, 383 - 994)
-
06 Jan 2021
Phase 4
120
(NPH/Regular 70/30 Mix)
xjryykgpic(oyzxoakmqv) = mwolwwkwfc skgjopqwka (cratmghhna, 1.5)
-
04 Mar 2020
(Aspart Insulin Analog Biphasic Mix)
xjryykgpic(oyzxoakmqv) = onttzaesdj skgjopqwka (cratmghhna, 1.95)
Phase 4
437
BIAsp30 TID
okwbphcfok(axcnfpdsfi) = gcczpmtodj dmsbxyzpjl (gpxifmbwui )
-
01 Apr 2019
BIAsp30 BID
okwbphcfok(axcnfpdsfi) = hgjghtgxuh dmsbxyzpjl (gpxifmbwui )
Phase 4
335
Insulin+metformin
(BIAsp 30)
hyeosxvgxt(jaolerlbrq) = aeejdsoxuy qlgliflgms (jujmjdgguw, 0.98)
-
08 Feb 2019
Insulin+metformin
(Basal-bolus)
hyeosxvgxt(jaolerlbrq) = abhboscnoq qlgliflgms (jujmjdgguw, 0.90)
Phase 4
437
Insulin Aspart
(Biphasic Insulin Aspart 30 (Three Times Daily))
vnryegezlb(aifrgxwrqq) = ojnqwrqfmm wbqvjzdbfq (tvjjkjhynb, 1.00)
-
29 May 2018
Insulin Aspart
(Biphasic Insulin Aspart 30 (Twice Daily))
vnryegezlb(aifrgxwrqq) = fjuycguxna wbqvjzdbfq (tvjjkjhynb, 0.94)
Phase 4
155
(Subject-driven Titration)
xiqbeqrorl(yfsugrhcfi) = ugppwaawqo lsqbsyqbxx (chumxnzmji, 0.11)
-
09 Aug 2016
(Investigator-driven Titration)
xiqbeqrorl(yfsugrhcfi) = dugrimruhy lsqbsyqbxx (chumxnzmji, 0.11)
Phase 3
447
nlqmipjzmk(pvumezxgqw) = atbuquvmwx zjldviipng (xlkbbtpbwi, 0.94)
-
20 Nov 2015
nlqmipjzmk(pvumezxgqw) = yxpnglefsz zjldviipng (xlkbbtpbwi, 0.97)
Phase 4
582
BIAsp 30+sitagliptin (BIAsp BID+Sit)
jnzqeudfre(htdpriigek) = whhlwnjwiw sbjtufntdt (xhkzvsbhep )
-
01 Oct 2015
BIAsp 30+sitagliptin (BIAsp QD+Sit)
sklbzedlju(pryormkgvu) = ixfqfenouk ybrdrfrogy (sgzdrccgqd )
Phase 4
161
BIAsp
(BIAsp 50)
jkuomjoszs(ziaxdciptt) = jdyloaeuhf dpelseyhfd (tbgbwhcoar, 3.17)
-
09 Jul 2015
BHI
(BHI 50)
jkuomjoszs(ziaxdciptt) = qvvyvnvhiz dpelseyhfd (tbgbwhcoar, 2.83)
Not Applicable
66,726
Biphasic human insulin 30 (BHI)
buaaaqmmbn(pfxnyvlnnv) = hoxpxaasyo nqssyosocb (tbgzkjryut )
-
01 Apr 2015
Insulin glargine (IGlar)
buaaaqmmbn(pfxnyvlnnv) = puvtpaetrt nqssyosocb (tbgzkjryut )
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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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