Pramlintide

Overview

Pramlintide is a relatively new adjunct treatment for diabetes (both type 1 and 2), developed by Amylin Pharmaceuticals. It is derived from amylin, a hormone that is released into the bloodstream, in a similar pattern as insulin, after a meal. Like insulin, amylin is deficient in individuals with diabetes.

Indication

用于1型和2型糖尿病的辅助治疗。

Associated Conditions

Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Tailoring Obesity Treatment Trial	2024/10/01	NCT06619015	Phase 2	Suspended	Esbjerg Hospital - University Hospital of Southern Denmark
A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes	2023/09/21	NCT06046417	Phase 2	Recruiting	McGill University Health Centre/Research Institute of the McGill University Health Centre
A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes	2022/01/20	NCT05199714	Not Applicable	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre
Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study	2020/02/05	NCT04252612	Early Phase 1	Withdrawn	H. Lee Moffitt Cancer Center and Research Institute
Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes	2020/01/28	NCT04243629	Not Applicable	Recruiting	McGill University
Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas	2019/11/15	NCT04163874	Not Applicable	Completed	McGill University
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D	2019/08/30	NCT04074317	Phase 2	Completed	Xeris Pharmaceuticals
A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus	2019/04/16	NCT03916640	Phase 1	Completed	Adocia
Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease	2018/06/19	NCT03560960	Early Phase 1	Active, not recruiting	Boston University
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus	2018/04/30	NCT03512236	Phase 1	Completed	Adocia

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
SymlinPen	AstraZeneca Pharmaceuticals LP	0310-6627	SUBCUTANEOUS	1000 ug in 1 mL	12/18/2019
SymlinPen	AstraZeneca Pharmaceuticals LP	0310-6615	SUBCUTANEOUS	1000 ug in 1 mL	12/18/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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