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Last update 08 May 2025
Insulin human biosimilar(Wockhardt Ltd.)
Last update 08 May 2025
Overview
Basic Info
Drug Type Biosimilar, Hormone |
Synonyms Wosulin, Wosulin Pen, Wosulin Pen Royale + [1] |
Target |
Action agonists |
Mechanism INSR agonists(Insulin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date India (01 Oct 2003), |
Regulation- |
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Related
10
Clinical Trials associated with Insulin human biosimilar(Wockhardt Ltd.)CTRI/2021/05/033411
A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO TREATMENT, TWO-PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST FOR BIOEQUIVALENCE BETWEEN WOCKHARDTâ??S WOSULIN® 30/70 (100 IU/mL) {BIPHASIC ISOPHANE INSULIN INJECTION/ 70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (r-DNA ORIGIN)} AND HUMULIN® 70/30 (100 U/mL) {70% HUMAN INSULIN ISOPHANE SUSPENSION AND 30% HUMAN INSULIN INJECTION (rDNA origin)} IN HEALTHY SUBJECTS. - Clamp Study
CTRI/2021/04/032915
A RANDOMIZED, SINGLE CENTER, DOUBLE BLIND, TWO TREATMENT, TWO-SEQUENCE, TWO PERIOD, CROSSOVER GLUCOSE CLAMP STUDY TO TEST FOR BIOEQUIVALENCE BETWEEN WOCKHARDTâ??S WOSULIN® N (100 IU/mL) {ISOPHANE INSULIN HUMAN, SUSPENSION, r-DNA ORIGIN} AND HUMULIN® N (100 U/mL) {HUMAN INSULIN (r-DNA ORIGIN) ISOPHANE SUSPENSION}, IN HEALTHY SUBJECTS. - Clamp Study
CTRI/2015/05/005801
A double-blind, randomized, single dose, two-period, two-way crossover bioequivalence study between two Recombinant DNA human soluble Insulin Formulations - Wockhardtâ??s rDNA human regular Insulin Injection (Wosulin R) 100 IU/mL with Actrapid® HM Penfill® (Regular, Human Insulin injection [rDNA origin] IP) 100 IU/mL, 3.0 mL of Imported by: Novo Nordisk India Private Limited and Manufactured by: Novo Nordisk Producao Farmaceutica do Brasil Ltda. Brazil 39404004, INDIA in healthy, adult, male subjects under fasting condition. - PK PD Trial
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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R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Diabetes Mellitus, Type 1 | India | 01 Oct 2003 |
Developing
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Diabetes Mellitus, Type 1 | Preclinical | United States | 01 Mar 2011 |
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