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Last Updated: January 17, 2025

CLINICAL TRIALS PROFILE FOR PRAMLINTIDE ACETATE


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All Clinical Trials for Pramlintide Acetate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00042458 ↗ Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control Completed AstraZeneca Phase 3 2002-04-01 This is a randomized, triple-blind, placebo-controlled, multicenter study to investigate the safety of pramlintide treatment using pramlintide dose-titration coupled with insulin adjustments in subjects with type 1 diabetes who are actively trying to improve their glycemic control.
NCT00042471 ↗ Evaluation of the Bioavailability of Pramlintide Completed AstraZeneca Phase 2 2002-06-01 This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.
NCT00042601 ↗ Evaluation of the Effect of Pramlintide on Satiety and Food Intake Completed AstraZeneca Phase 2 2002-07-01 This is a single center, randomized, blinded, placebo-controlled, two-period, cross-over study to evaluate the effect of pramlintide on satiety and food intake in normal-weight and obese non-diabetic subjects and in insulin-treated subjects with type 1 and type 2 diabetes.
NCT00044707 ↗ Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide Completed AstraZeneca Phase 2 2002-08-01 This is a randomized, single-blind, placebo-controlled, crossover study to examine the effect of pramlintide on the pharmacokinetics of an orally administered medication
NCT00107107 ↗ Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus Completed AstraZeneca Phase 3 2002-11-01 This is a multicenter, open-label extension study designed to examine the long-term safety of pramlintide treatment in subjects with type 1 diabetes who have successfully completed treatment in the parent study 137-150.
NCT00108004 ↗ Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus Completed AstraZeneca Phase 3 2003-04-01 This open-label, multicenter study is designed to investigate the clinical utility and safety of pramlintide treatment in subjects with type 1 and type 2 diabetes who are failing to achieve the desired level of glycemic control using insulin therapy.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pramlintide Acetate

Condition Name

Condition Name for Pramlintide Acetate
Intervention Trials
Type 1 Diabetes Mellitus 6
Diabetes Mellitus, Type 1 5
Obesity 5
Type 2 Diabetes Mellitus 3
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Condition MeSH

Condition MeSH for Pramlintide Acetate
Intervention Trials
Diabetes Mellitus, Type 1 13
Diabetes Mellitus 13
Diabetes Mellitus, Type 2 7
Body Weight 4
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Clinical Trial Locations for Pramlintide Acetate

Trials by Country

Trials by Country for Pramlintide Acetate
Location Trials
United States 208
Canada 2
Australia 1
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Trials by US State

Trials by US State for Pramlintide Acetate
Location Trials
Texas 12
Florida 12
Oregon 11
California 11
New York 8
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Clinical Trial Progress for Pramlintide Acetate

Clinical Trial Phase

Clinical Trial Phase for Pramlintide Acetate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 3
Phase 2 9
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Clinical Trial Status

Clinical Trial Status for Pramlintide Acetate
Clinical Trial Phase Trials
Completed 18
Not yet recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Pramlintide Acetate

Sponsor Name

Sponsor Name for Pramlintide Acetate
Sponsor Trials
AstraZeneca 16
Amylin Pharmaceuticals, LLC. 3
Juvenile Diabetes Research Foundation 3
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Sponsor Type

Sponsor Type for Pramlintide Acetate
Sponsor Trials
Industry 19
Other 11
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Pramlintide Acetate: Clinical Trials, Market Analysis, and Projections

Introduction

Pramlintide acetate, marketed under the brand name Symlin, is an anti-diabetic medication used in the treatment of diabetes, particularly for patients who are treated with insulin. Here, we will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Completed Trials

Pramlintide acetate has been involved in numerous clinical trials over the years. As of recent updates, several trials are either ongoing or have been completed:

  • Phase 1 and Phase 4 Trials: There are ongoing Phase 1 trials focusing on the combination of pramlintide with insulin, as well as Phase 4 trials evaluating the efficacy of pre-meal pramlintide and post-meal insulin therapy[4].
  • Discontinued Trials: Notably, the development of a combination therapy involving pramlintide and metreleptin for obesity was discontinued due to a commercial reassessment of the program. This decision was made despite the therapy being in Phase 2 development[3].

Future Trials

  • IND Submission: An Investigational New Drug (IND) submission for pramlintide acetate is expected in 2025 by Pep2Tango Therapeutics Inc, indicating potential new avenues for the drug[4].

Mechanism and Indications

Mechanism of Action

Pramlintide acetate works as a calcitonin receptor agonist, mimicking the natural hormone amylin. Amylin is involved in glucose regulation by slowing gastric emptying, reducing postprandial glucagon secretion, and promoting satiety[4].

Active Indications

  • Type 1 and Type 2 Diabetes: Pramlintide acetate is approved for use in patients with type 1 and type 2 diabetes who are treated with insulin. It helps to improve glycemic control by reducing postprandial glucose spikes[2].

Market Analysis

Global Market Size and Growth

  • Current Market Size: The global Symlin (pramlintide) market was valued at a significant amount in 2022, although the exact figure is not specified in the available sources[2].
  • Projected Growth: The market is anticipated to grow at a notable Compound Annual Growth Rate (CAGR) from 2023 to 2029. This growth is driven by increasing demand for effective diabetes management therapies[2].

Regional Market Analysis

  • North America: The North American market for Symlin is expected to increase significantly from 2023 to 2029, driven by the high prevalence of diabetes and the need for advanced therapeutic options[2].
  • Asia-Pacific: This region is also projected to see substantial growth, reflecting the expanding healthcare infrastructure and increasing awareness of diabetes management[2].

Key Players

  • AstraZeneca: Among the key global companies involved in the Symlin market, AstraZeneca is a prominent player. The top three vendors in the market accounted for a significant portion of the revenue in 2022[2].

Market Segmentation

The Symlin market is segmented based on type and application:

  • Type: The market is segmented by the type of pramlintide formulation, which includes injectable forms.
  • Application: The primary application is in the treatment of type 1 and type 2 diabetes, with a focus on patients using insulin therapy[5].

Impact of External Factors

COVID-19 and Geopolitical Events

The COVID-19 pandemic and geopolitical events like the Russia-Ukraine War have been considered in market size estimations and forecasts. These factors have influenced the supply chain, demand, and overall market dynamics[2].

Technological Trends and New Developments

  • Combination Therapies: Although the pramlintide/metreleptin combination for obesity was discontinued, there is ongoing research into other combination therapies that could enhance the efficacy of pramlintide in various indications[3].
  • New Formulations: Continuous research is aimed at improving the delivery and efficacy of pramlintide, which could lead to new formulations or administration methods in the future.

Key Takeaways

  • Clinical Trials: Ongoing and future clinical trials are focused on optimizing the use of pramlintide acetate in diabetes management and exploring new indications.
  • Market Growth: The global Symlin market is projected to grow significantly over the next few years, driven by increasing demand and advancements in diabetes care.
  • Regional Markets: North America and Asia-Pacific are expected to be key regions driving this growth.
  • Key Players: Companies like AstraZeneca play a crucial role in the market, contributing significantly to revenue and innovation.

FAQs

What is pramlintide acetate used for?

Pramlintide acetate, marketed as Symlin, is used in the treatment of type 1 and type 2 diabetes to improve glycemic control in patients treated with insulin.

What is the mechanism of action of pramlintide acetate?

Pramlintide acetate works as a calcitonin receptor agonist, mimicking the natural hormone amylin to slow gastric emptying, reduce postprandial glucagon secretion, and promote satiety.

What is the current market size of the Symlin (pramlintide) market?

The exact current market size is not specified, but it is valued at a significant amount and is expected to grow substantially from 2023 to 2029.

Which regions are expected to drive the growth of the Symlin market?

North America and the Asia-Pacific region are anticipated to be key drivers of the market growth due to the high prevalence of diabetes and the need for advanced therapeutic options.

Why was the pramlintide/metreleptin combination therapy for obesity discontinued?

The development of the pramlintide/metreleptin combination therapy for obesity was discontinued due to a commercial reassessment of the program, taking into account evolving dynamics within the obesity therapeutic area.

Sources

  1. Amylin Pharmaceuticals, Inc. - Drug pipelines, Patents, Clinical trials - Synapse.
  2. Symlin (pramlintide) Market: Size, Share, Growth, Analysis - OpenPR.
  3. Amylin and Takeda Discontinue Development of Pramlintide/Metreleptin - PR Newswire.
  4. Pramlintide Acetate - Drug Targets, Indications, Patents - Synapse.
  5. Market Analysis Reports of Pramlintide - chemBlink.

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