Pramlintide

Also known as: Symlin

Approved, discontinued

Last verified: October 30, 2026

At a glance

FDA approval Approved, discontinued 1 application
Randomized controlled trials 64 of 451 publications on PubMed
Registered clinical trials 64 5 active
Adverse event reports 3,069 628 classified as serious
  • Pramlintide was approved by the FDA (Symlin, March 16, 2005), but the products are no longer marketed.
  • PubMed lists 451 publications mentioning it, including 64 randomized controlled trials and 28 animal-only studies.
  • ClinicalTrials.gov lists 64 registered studies testing it (5 active).
  • FDA's adverse event system (FAERS) holds 3,069 reports mentioning it; 628 classified as serious. Reports do not prove causation.

Research topics

  • Islet Amyloid Polypeptide 107
  • Hypoglycemic Agents 88
  • Insulin 54
  • Diabetes Mellitus, Type 1 49
  • Diabetes Mellitus, Type 2 38
  • Blood Glucose 37
  • Obesity 20
  • Amylin Receptor Agonists 16
  • Amyloid 14
  • Weight Loss 14

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

Application Product Status First approval Sponsor
NDA021332 SYMLIN Approved, discontinued March 16, 2005 ASTRAZENECA AB

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 451
  • Human (MeSH) 357
  • Animal only 28
  • Clinical trials 77
  • Randomized controlled trials 64
  • Systematic reviews & meta-analyses 5
  • Case reports 4
  • Retracted 1

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
64
Active
5
With posted results
15

Conditions studied

  • Type 1 Diabetes 16
  • Type 1 Diabetes Mellitus 12
  • Obesity 10
  • Diabetes Mellitus, Type 1 10
  • Type 2 Diabetes Mellitus 5
  • Overweight 4
  • Peptide Hormones 3
  • Type 2 Diabetes 3
  • Headache Disorders 2
  • Brain Diseases 2
  • Nervous System Diseases 2
  • Central Nervous System Diseases 2
Study Status Phase Start
Postprandial Regulation of Bone Perfusion in Healthy Individuals
NCT07679516 University of Copenhagen
Not yet recruiting N/A July 19, 2026
Pancreatic Polypeptide as a Modulator of Amylin- Induced Satiety in Healthy Humans
NCT07506369 University Hospital, Gentofte, Copenhagen
Recruiting N/A Apr 2026
Amylin-Induced Migraine Attacks Without Aura
NCT07340788 Danish Headache Center
Not yet recruiting N/A Feb 2026
Hypersensitivity to Amylin in Post-Traumatic Headache
NCT07340775 Danish Headache Center
Not yet recruiting N/A Feb 2026
Multi-Center Development of a Novel Diagnostic Test for Alzheimer's Disease
NCT03560960 Boston University
Active, not recruiting Early phase 1 February 4, 2020
Tailoring Obesity Treatment Trial
NCT06619015 Esbjerg Hospital - University Hospital of Southern Denmark
Withdrawn Phase 2, Phase 3 April 1, 2025
Two Way Crossover Closed Loop Study Insulin vs Insulin and Pramlintide
NCT06422325 Oregon Health and Science University Results posted
Completed N/A July 12, 2024
The Role of Amylin in Bone Metabolism
NCT06186063 Filip Krag Knop
Unknown status N/A February 12, 2024
A Fully Automated Lyumjev and Pramlintide Delivery System for Adults With Type 1 Diabetes
NCT06046417 McGill University Health Centre/Research Institute of the McGill University Health Centre
Unknown status Phase 2, Phase 3 November 30, 2023
A Fully-closed Loop, Pramlintide and Insulin, Artificial Pancreas Clinical Trial for Adults With Type 1 Diabetes
NCT05199714 McGill University Health Centre/Research Institute of the McGill University Health Centre
Completed N/A February 21, 2022
Show 40 more studies
Study Status Phase Start
Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes
NCT04243629 McGill University
Unknown status N/A November 12, 2021
Safety and Efficacy of BC LisPram
NCT04972175 Michael Tsoukas
Unknown status Phase 1 July 28, 2021
Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas
NCT04163874 McGill University
Completed N/A February 14, 2020
Biological Outcomes of Pramlintide in Resectable Cutaneous Squamous Cell Carcinoma: A Pilot Study
NCT04252612 H. Lee Moffitt Cancer Center and Research Institute
Withdrawn Early phase 1 January 30, 2020
Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D
NCT04074317 Xeris Pharmaceuticals Results posted
Completed Phase 2 August 22, 2019
A Trial to Assess Safety and Efficacy of ADO09 Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus
NCT03981627 Adocia
Completed Phase 1, Phase 2 June 6, 2019
Pramlintide and Fiasp Closed-Loop With a Simple Meal Announcement
NCT03993366 McGill University
Completed N/A March 1, 2019
Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting
NCT03800875 McGill University
Completed Phase 2 February 8, 2019
A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
NCT03916640 Adocia
Completed Phase 1 January 4, 2019
Amylin and CGRP Head to Head Provocation in Migraine Without Aura Patients
NCT03598075 Danish Headache Center
Completed N/A July 1, 2018
Glucagon Counterregulation in Type 1 Diabetes
NCT03547427 University of Virginia
Terminated N/A May 20, 2018
A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus
NCT03512236 Adocia
Completed Phase 1 April 25, 2018
Effect of Basal-Bolus Closed-Loop Co-Administration of Insulin and Pramlintide on Improving the Glycemic Control in Type 1 Diabetes
NCT02814123 McGill University
Completed Phase 2 January 13, 2017
Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus
NCT02500979 AstraZeneca Results posted
Completed Phase 1 August 17, 2015
Phase 2 Study of Adaptive Insulin Meal Supervisor (AIMS) in Adults With Type 1 Diabetes Mellitus
NCT01839370 University of Virginia
Completed N/A Jul 2013
Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM
NCT01708044 AstraZeneca
Completed Phase 1 Nov 2012
Pramlintide Combined With Model Predictive Control Algorithm
NCT01434862 University of Virginia
Terminated N/A Feb 2011
A Study To Examine The Efficacy And Safety Of Pramlintide+Metreleptin In Obese Subjects
NCT01235741 AstraZeneca Results posted
Terminated Phase 2 Jan 2011
Closed Loop System With Pramlintide Versus Exenatide
NCT01269008 Albert Einstein College of Medicine
Completed Phase 1 Dec 2010
Efficacy Study of High Dose Symlin to Treat Type 2 Diabetes Mellitus
NCT01137695 Cheryl Rosenfeld, DO
Unknown status Phase 3 May 2010
Pramlintide (Symlin) for the Treatment of Hypoglycemia Following Gastric Bypass Surgery
NCT01841359 Joslin Diabetes Center Results posted
Completed Phase 4 February 2, 2010
Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus
NCT01165944 University of Colorado, Denver
Withdrawn Phase 1, Phase 2 Aug 2009
Use of Exenatide and Pramlintide to Decrease Post-prandial Hyperglycemia
NCT01269047 Albert Einstein College of Medicine Results posted
Completed Phase 4 Aug 2009
Safety Study of Using Symlin Alongside Insulin in a Multiple Injection Port
NCT00790699 Texas Diabetes & Endocrinology, P.A. Results posted
Terminated N/A Aug 2009
The Effect of Byetta and Symlin on Post-meal Meal Blood Sugar Levels in Children With Type 2 Diabetes
NCT00950677 Baylor College of Medicine
Completed Phase 4 Jul 2009
Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM
NCT00732147 University of Maryland, Baltimore
Withdrawn N/A Apr 2009
Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin
NCT00819234 AstraZeneca Results posted
Completed Phase 2 Nov 2008
Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects
NCT00673387 AstraZeneca Results posted
Completed Phase 2 Apr 2008
Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia
NCT00690235 University of Texas Southwestern Medical Center Results posted
Completed Phase 4 Nov 2007
The Effect of Pramlintide on Meal Time Insulin Bolus
NCT00460304 Diabetes Care Center
Completed N/A Sep 2007
Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes
NCT00505882 University of Texas Southwestern Medical Center
Withdrawn Phase 4 Jul 2007
A Pilot Study of Continuous Subcutaneous Pramlintide Infusion Therapy in Patients With Type 1 Diabetes
NCT00502138 University Diabetes & Endocrine Consultants
Completed Phase 4 Jul 2007
A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes
NCT00467649 AstraZeneca Results posted
Completed Phase 4 May 2007
Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus
NCT00442767 Montefiore Medical Center Results posted
Completed Phase 4 Feb 2007
Pramlintide in Adolescents With Type 1 Diabetes
NCT00842075 University of Colorado, Denver Results posted
Completed N/A Dec 2006
A Study to Examine the Safety, Tolerability, and Body Weight Effect of Pramlintide Alone and in Combination With Oral Antiobesity Agents in Overweight and Obese Subjects
NCT00402077 AstraZeneca
Completed Phase 2 Nov 2006
A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects
NCT00392925 AstraZeneca Results posted
Completed Phase 2 Oct 2006
A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus
NCT00313183 AstraZeneca
Completed Phase 2 Apr 2006
A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide
NCT00691158 Oregon Health and Science University
Unknown status N/A Jan 2006
Continuous Subcutaneous Infusion of Pramlintide and Insulin
NCT00291772 Baylor College of Medicine
Completed Phase 4 Jan 2006

All 64 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
3,069
Serious
628
With death outcome
40

Most reported reactions

  • Blood glucose increased 952
  • Nausea 676
  • Blood glucose decreased 365
  • Weight decreased 332
  • Injection site pain 259
  • Decreased appetite 231
  • Drug ineffective 222
  • Fatigue 164
  • Vomiting 139
  • Medication error 136
  • Dizziness 135
  • Diarrhoea 134

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

FDA prescribing information

Official US prescribing information. Dosing sections are intentionally not shown.

Boxed warning SymlinPen · December 18, 2019
Original FDA text (English) WARNING: SEVERE HYPOGLYCEMIA SYMLIN use with insulin increases the risk of severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia occurs, it is seen within 3 hours following a SYMLIN injection. Serious injuries may occur if severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities. Appropriate patient selection, careful patient instruction, and insulin dose reduction are critical elements for reducing this risk. WARNING: SEVERE HYPOGLYCEMIA See full prescribing information for complete boxed warning. • SYMLIN use with insulin has been associated with an increased risk of severe hypoglycemia, particularly in patients with type 1 diabetes. • Hypoglycemia risk may be reduced by appropriate patient selection, careful patient instruction, and insulin dose reduction (5.1 , 5.2) .
  • SymlinPen HUMAN PRESCRIPTION DRUG AstraZeneca Pharmaceuticals LP December 18, 2019

Source: DailyMed / openFDA

Change history

No changes since monitoring began on October 30, 2026.