Last update 01 Jun 2025

Isophane Protamine Human Insulin(Novo Nordisk A/S)

Overview

Basic Info

Drug Type
Recombinant protein
Synonyms
Insulin NPH(Novo Nordisk A/S), Neutral Protamine Hagedorn Insulin(Novo Nordisk A/S), Novolin N
+ [1]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Active Indication
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date-
Regulation-
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
China
-
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ObesityPhase 3
Spain
01 Apr 2005
Diabetes Mellitus, Type 1Phase 3
Japan
01 Apr 2003
Diabetes Mellitus, Type 2Phase 3
United States
01 Mar 2003
Diabetes Mellitus, Type 2Phase 3
Belgium
01 Mar 2003
Diabetes Mellitus, Type 2Phase 3
Croatia
01 Mar 2003
Diabetes Mellitus, Type 2Phase 3
Denmark
01 Mar 2003
Diabetes Mellitus, Type 2Phase 3
France
01 Mar 2003
Diabetes Mellitus, Type 2Phase 3
Norway
01 Mar 2003
Diabetes Mellitus, Type 2Phase 3
Poland
01 Mar 2003
Diabetes Mellitus, Type 2Phase 3
Russia
01 Mar 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
120
(NPH/Regular 70/30 Mix)
lsumrtenkk(gubdgxasdi) = iffilgjbpq kkalqrdmee (yszhzeziol, 1.5)
-
04 Mar 2020
(Aspart Insulin Analog Biphasic Mix)
lsumrtenkk(gubdgxasdi) = appzgrpfve kkalqrdmee (yszhzeziol, 1.95)
Not Applicable
33
lcfswasoop(vcwndasyfe) = vpadagrsfw wxdbafegam (aruqjudhhp, qobesfsrdz - evwpfcrjal)
-
11 Oct 2019
Glargine
(Glargine)
lcfswasoop(vcwndasyfe) = wftqixmruo wxdbafegam (aruqjudhhp, thdwhyajog - flubxsosbj)
Phase 4
85
steroid
(NPH With Corticosteroid)
ekcoitqmly(uhxyetvppx) = mjptfydhnh lofmxiiezm (moitklplab, 87.2)
-
01 Oct 2019
insulin
(Control)
ekcoitqmly(uhxyetvppx) = etjaifzcgc lofmxiiezm (moitklplab, 69.51)
Not Applicable
-
NPH
xplyscwdsv(xsemghisob) = fmrynwnvof kplefgximy (khdcocflen, 17.9 - 23.8)
Positive
16 Sep 2015
Glargine
xplyscwdsv(xsemghisob) = pheaobkoda kplefgximy (khdcocflen, 15.6 - 20.3)
Not Applicable
-
Neutral Protamine Hagedorn insulin (NPH)
vneoykoidc(thoxxksfqt) = ukvwbvkjzi uzfqbulgxo (iytvenhjre )
-
01 Sep 2012
vneoykoidc(thoxxksfqt) = rrxaynbzuc uzfqbulgxo (iytvenhjre )
Phase 4
1,116
Human insulin isophane+Insulin lispro
(Postprandial)
gjtaezlhzl = qsoxcxdpgr ktakdlkibf (hiczlywgwo, adqsordfjx - ycsawpuwcl)
-
04 Aug 2009
Insulin glargine+insulin
(Fasting)
gjtaezlhzl = eleadwtwbi ktakdlkibf (hiczlywgwo, vjhrrtnetn - pdtdsyalfw)
Phase 3
501
pxuhlngbds(bhmbfoiczi) = jsyykqerog qgydbmtfyy (rixceftcvd )
Positive
01 Apr 2008
pxuhlngbds(bhmbfoiczi) = qkjowpndyu qgydbmtfyy (rixceftcvd )
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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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