Delving into the Latest Updates on Insulin human biosimilar(Wockhardt Ltd.) with Synapse

Overview

Basic Info

Drug Type

Biosimilar, Hormone

Synonyms

Wosulin, Wosulin Pen, Wosulin Pen Royale

+ [1]

Target

INSR

Mechanism

INSR agonists(Insulin receptor agonists)

Therapeutic Areas

Immune System DiseasesEndocrinology and Metabolic Disease

Active Indication

Diabetes Mellitus, Type 1

Inactive Indication-

Originator Organization

Wockhardt Ltd.

Active Organization

Wockhardt Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

IN (01 Oct 2003),

Diabetes Mellitus, Type 1

Regulation-

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A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO TREATMENT, TWO-PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST FOR BIOEQUIVALENCE BETWEEN WOCKHARDTâ??S WOSULINÂ® 30/70 (100 IU/mL) {BIPHASIC ISOPHANE INSULIN INJECTION/ 70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (r-DNA ORIGIN)} AND HUMULINÂ® 70/30 (100 U/mL) {70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (rDNA origin)} IN HEALTHY SUBJECTS. - Clamp Study

Start Date10 May 2021

Sponsor / Collaborator

Wockhardt Bio AG

CTRI/2021/04/032915 / RecruitingNot Applicable

A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO TREATMENT, TWO-SEQUENCE, TWO PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST FOR BIOEQUIVALENCE BETWEEN WOCKHARDTâ??S WOSULINÂ® N (100 IU/mL) {ISOPHANE INSULIN HUMAN, SUSPENSION, r-DNA ORIGIN} AND HUMULINÂ® N (100 U/mL) {HUMAN INSULIN (r-DNA ORIGIN) ISOPHANE SUSPENSION}, IN HEALTHY SUBJECTS. - Clamp Study

Start Date19 Apr 2021

Sponsor / Collaborator

Wockhardt Bio AG

CTRI/2011/10/002042 / CompletedPhase 3

An Open Label, Randomized, comparison of the Immunogenicity and Safety of Wockhardts Human Insulin Basal Bolus Regimen {Intensified Conventional Insulin Therapy with Soluble Insulin and Isophane Insulin (Wosulin R, Wosulin N and Wosulin 70/30)} with the Novo Nordisk?s yeast based Human Insulin Basal Bolus Regimens, marketed in United States (Novolin® R, Novolin® N and Novolin® 70/30) in Type 1 Diabetics.

Start Date18 Jul 2011

Sponsor / Collaborator

Wockhardt Ltd.

100 Clinical Results associated with Insulin human biosimilar(Wockhardt Ltd.)

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100 Translational Medicine associated with Insulin human biosimilar(Wockhardt Ltd.)

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100 Patents (Medical) associated with Insulin human biosimilar(Wockhardt Ltd.)

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100 Deals associated with Insulin human biosimilar(Wockhardt Ltd.)

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