PeptideTrace
ApprovedAmylin Analogue

Pramlintide

Symlin

A

Evidence Grade A — Regulatory approved. 442 published studies. 59 registered clinical trials.

59 trials442 studiesUSEUCA

Licensed Indications

  • Diabetes Mellitus (Adjunct to Mealtime Insulin)

User Experience Reports

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Overview

Pramlintide (sold as Symlin) is an injectable medication that replaces amylin — a hormone your pancreas normally releases alongside insulin after every meal. In people with diabetes (especially type 1), amylin production is reduced or absent. Pramlintide fills this gap by slowing digestion, reducing appetite, and preventing inappropriate blood sugar spikes after eating. It is the only approved amylin-based treatment.

Research Activity

442studies
Human 350
Animal 28
In-vitro 23
Reviews 172

442 published studies: 350 human, 28 animal, 23 in-vitro, 172 reviews

Regulatory Status

US
Not approved by FDA(FDA)
EU
Not authorised by EMA(EMA)
CA
Not approved by Health Canada(Health Canada)

Legal Status

USNot applicable (not approved)
EUNot applicable (not authorised)
CANot applicable (not approved)

Summary

Pramlintide is marketed as Symlin (approved March 2005) and remains the only approved amylin-based treatment. It is used alongside mealtime insulin in both type 1 and type 2 diabetes. Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2–0.6%) and approximately 2.3 kg of weight loss — less dramatic than GLP-1 treatments but meaningful as an add-on therapy.

Symlin carries a boxed warning for severe hypoglycaemia, particularly when combined with insulin, and requires careful dose adjustment. Practical uptake has been limited by the need for separate injections at each meal alongside existing insulin injections. Despite its modest clinical impact, pramlintide remains the only medication that addresses the amylin deficiency in diabetes, filling a distinct biological role that GLP-1 treatments do not cover.

Mechanism of Action

Every time your pancreas releases insulin after a meal, it also releases a companion hormone called amylin. In people with diabetes, amylin production is reduced or absent (especially in type 1 diabetes). Pramlintide replaces this missing hormone. It slows stomach emptying so food is absorbed more gradually, tells the brain you are full to reduce overeating, and suppresses the inappropriate release of glucagon (a hormone that raises blood sugar) after meals. These three effects work alongside insulin to smooth out the blood sugar spikes that follow eating.

Research Summary

Clinical trials showed modest blood sugar improvements (HbA1c reductions of 0.2-0.6%) and approximately 2.3 kg of weight loss when added to insulin therapy. These results are less dramatic than GLP-1 medications, and the requirement for additional injections at every meal — on top of existing insulin injections — has been a major practical barrier. Symlin carries a boxed warning for severe hypoglycaemia when combined with insulin, requiring careful dose adjustment. Despite its limited commercial success, the amylin pathway is now experiencing a resurgence of interest. Cagrilintide, a next-generation long-acting amylin analogue from Novo Nordisk, is being studied in combination with semaglutide (as CagriSema) — a combination that could potentially validate the amylin approach in a way pramlintide's inconvenient dosing never could.

Clinical Trials

NCT07506369N/ARecruiting

Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans

University Hospital, Gentofte, CopenhagenEndpoint: Food intakeCompletion: 2028-10-01
NCT07340775N/ANot Yet Recruiting

Hypersensitivity to Amylin in Post-Traumatic Headache

Danish Headache CenterEndpoint: Incidence of migraine-like headacheCompletion: 2028-12-01
NCT07340788N/ANot Yet Recruiting

Amylin-Induced Migraine Attacks Without Aura

Danish Headache CenterEndpoint: Incidence of migraine attacks without auraCompletion: 2028-10-30
NCT06422325N/ACompleted

Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide

Oregon Health and Science UniversityEndpoint: Incremental Area Under the Curve of Postprandial Glucose Following the First MealCompletion: 2025-01-28
NCT06186063N/AUnknown

The Role of Amylin in Bone Metabolism

Filip Krag KnopEndpoint: Relative changes in the plasma levels of C-terminal telopeptide of type I collagen (CTX-1)Completion: 2024-08-01
View all 59 trials on ClinicalTrials.gov →

Regulatory Timeline

2005
Regulatory

FDA ORIG 1

2007
Regulatory

FDA SUPPL 6

2008
Regulatory

FDA SUPPL 10

2012
Regulatory

FDA SUPPL 20

2014
Regulatory

FDA SUPPL 7

2014
Regulatory

FDA SUPPL 16

2015
Regulatory

FDA SUPPL 23

2015
Regulatory

FDA SUPPL 25

2015
Regulatory

FDA SUPPL 24

2017
Regulatory

FDA SUPPL 26

2019
Regulatory

FDA SUPPL 28

Related Compounds

Exenatide

Approved
GLP-1 Receptor Agonist

Exenatide was the first GLP-1 receptor agonist approved anywhere, reaching the market as Byetta in April 2005. The once-weekly formulation Bydureon followed in 2012. Clinical trials showed blood sugar reductions (HbA1c) of 1.6–1.9% and modest weight loss of 2–4 kg. The EXSCEL cardiovascular outcomes trial, involving over 14,700 patients, showed a trend toward cardiovascular benefit but narrowly missed statistical significance. While exenatide was groundbreaking as the first in its class, it has been largely overtaken by newer GLP-1 treatments that offer greater efficacy, less frequent dosing, and proven cardiovascular benefits. It remains available and in clinical use, particularly in combination products.

Lixisenatide

Approved
GLP-1 Receptor Agonist

Lixisenatide was marketed as Adlyxin in the US (approved July 2016), though it has since been discontinued in the US market. The ELIXA cardiovascular trial, involving over 6,000 patients, was the first cardiovascular outcomes trial for any GLP-1 medication to report results. It showed a neutral cardiovascular profile — neither harmful nor beneficial — meeting safety requirements but not demonstrating the heart benefits later shown by semaglutide and liraglutide. Lixisenatide found its primary clinical role in combination with basal insulin, marketed as Soliqua (lixisenatide plus insulin glargine). This combination addresses both fasting blood sugar (via insulin) and post-meal spikes (via lixisenatide) in a single daily injection. As a standalone treatment, it has been largely superseded by more potent GLP-1 medications.

Octreotide

Approved
Somatostatin Analogue

Octreotide is marketed as Sandostatin (approved 1988), Sandostatin LAR monthly depot (approved 1998), and Mycapssa oral capsules (approved June 2020 — the first oral somatostatin analogue). It is used for acromegaly, carcinoid syndrome, VIPomas, and gastroenteropancreatic neuroendocrine tumours (GEP-NETs). The PROMID trial demonstrated that octreotide LAR significantly delayed tumour progression in patients with neuroendocrine tumours of the midgut, establishing somatostatin analogues as a standard treatment for these cancers. The approval of Mycapssa as an oral formulation was a significant advance for patients who had been receiving monthly injections for years. Octreotide has been on the market for over 35 years and has one of the longest safety track records of any peptide medication.