Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
Details : Merilog (insulin aspart) is rapid acting human insulin, which is indicated to improve glycemic control in adults and children with diabetes mellitus.
Product Name : Merilog
Product Type : Hormone
Upfront Cash : Inapplicable
February 14, 2025
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA CHMP Recommends Grant of Marketing Authorization of Insulin Aspart Biosimilars
Details : Truvelog Mix 30 is approved and available as a 100 U/ml suspension for injection. The active substance of Truvelog Mix 30 is insulin aspart, an intermediate- or long-acting insulin which is combined with fast-acting insulin and used in diabetes.
Product Name : Truvelog Mix 30
Product Type : Hormone
Upfront Cash : Inapplicable
February 24, 2022
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
At278 Insulin Shows Superiority in Phase I Trial for Type 2 Diabetes
Details : AT278 is an ultra-concentrated, ultra-rapid acting, novel formulation of insulin that accelerates the absorption of insulin post injection. It is being evaluated for the treatment of type 2 diabetics.
Product Name : AT278
Product Type : Hormone
Upfront Cash : Inapplicable
May 20, 2024
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Preclinical
Sponsor : Meitheal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Meitheal Announces Exclusive Commercial Licensing Agreement for Insulin Biosimilars in the U.S.
Details : Under the terms of the agreement, Meitheal, through its parent company, will receive exclusive rights to commercialize biosimilar versions of insulin aspart, insulin lispro, and insulin glargine in the U.S. upon approval by the FDA.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Undisclosed
September 21, 2023
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Preclinical
Sponsor : Meitheal Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Biogenomics
Deal Size : Undisclosed
Deal Type : Partnership
USV, Biogenomics Launch Biosimilar Insulin Aspart INSUQUICK
Details : Under the partnership, USV and Biogenomics launched Insuquick, India's first biosimilar insulin aspart, a rapid-acting analogue of insulin, for the treatment of diabetes.
Product Name : Insuquick
Product Type : Hormone
Upfront Cash : Undisclosed
September 11, 2023
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Biogenomics
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AT278, is an ultra-concentrated novel formulation of insulin, that has been designed to significantly accelerate insulin absorption post injection to enable more effective and convenient management of blood glucose levels in people with high daily insuli...
Product Name : AT278
Product Type : Hormone
Upfront Cash : Inapplicable
December 04, 2022
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Data from Phase I clinical trial of AT278 (Ultra-Concentrated Rapid Acting Insulin Aspart), showed that it exhibited an accelerated PK and PD profile when compared to NovoRapid®, a gold standard prandial insulin treatment, despite a 5-fold increase in c...
Product Name : AT278
Product Type : Hormone
Upfront Cash : Inapplicable
May 18, 2022
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : PK/PD profile for AT278 was accelerated compared with NovoRapid. Following dosing, AT278 showed faster onset of insulin exposure compared with NovoRapid, demonstrated by an earlier onset of appearance, also showed rapid onset of glucose-lowering effect c...
Product Name : AT278
Product Type : Hormone
Upfront Cash : Inapplicable
April 28, 2022
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
Sponsor : Viatris
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above, has been approved as a 100 units/ml solution for injection in vial and pre-filled pen presentations.
Product Name : Kixelle
Product Type : Hormone
Upfront Cash : Inapplicable
December 02, 2021
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : Viatris
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Study Phase : Undisclosed
Sponsor : Lannett Company, Inc.
Deal Size : Undisclosed
Deal Type : Collaboration
Lannett Expands Strategic Relationship To Include Biosimilar Fast-Acting Insulin
Details : The biosimilar insulin aspart is currently in development and Lannett will help manage the remaining clinical and regulatory steps specific for a U.S. Food and Drug Administration (FDA) approval to market the product.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Undisclosed
September 02, 2021
Lead Product(s) : Insulin aspart
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Sponsor : Lannett Company, Inc.
Deal Size : Undisclosed
Deal Type : Collaboration
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