Symlin

(Pramlintide acetate)

ApprovedSmall molecule

Pramlintide is used to help people with diabetes (both type 1 and type 2) better control their blood sugar levels by slowing down how quickly food moves through the stomach and reducing the amount of sugar the body produces.[2] Symlin is currently approved and in use across 2 indications[4].[1]

Symlin is one of 66 small molecule programs targeting Type 1 Diabetes. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Type 1 DiabetesActive, not recruiting

Type 2 DiabetesActive, not recruiting

Type 1 DiabetesPreclinical

Active, not recruiting

Type 2 DiabetesApproved

Active, not recruiting

Competition

Competitive Landscape

171 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Symlin

AstraZeneca

Approved

2 2

NOVOLIN R

Novo Nordisk

Preclinical

5 3

Cysteine Hydrochloride

Novartis

Preclinical

1 4

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 5

Aurlumyn

BBTG International Inc.

Preclinical

1 6

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

1 7

Inderal

WWyeth-Lederle Vaccines

Preclinical

1 8

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

1 9

SGLT-2 Inhibitor

SSheffield Teaching Hospitals NHS Foundation Trust

Preclinical

2 10

Routine Treatment

GSK

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Type 1 Diabetes3 trials

An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes

Completed· AstraZeneca logo

AstraZeneca··NCT00229658·1,297 enrolled

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

Completed·MMcGill University·N/A·NCT04163874·36 enrolled

Co-administration of Pramlintide and Insulin Via an Automated Dual-hormone Artificial Pancreas System in Adults With Type 1 Diabetes

Unknown status·MMcGill University·N/A·NCT04243629·26 enrolled

Type 1 Diabetes Mellitus3 trials

Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02500979·34 enrolled

Study of the Long-Term Safety of Pramlintide in Subjects With Type 1 Diabetes Mellitus

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00107107·190 enrolled

A Study to Evaluate Symlin in Adolescent Subjects With Type 1 Diabetes Mellitus

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00313183·12 enrolled

Body Weight3 trials

A Study to Examine the Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00112021·400 enrolled

A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00189514·210 enrolled

Extension Study of Protocol DFA102 to Examine the Long-Term Safety, Tolerability, and Effect on Body Weight of Pramlintide Administered in Combination With Metreleptin

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00819234·274 enrolled

Overweight3 trials

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

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00402077·258 enrolled

Study to Examine Safety, Tolerability, and Effect on Body Weight of Metreleptin Administered in Conjunction With Pramlintide in Obese and Overweight Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00673387·636 enrolled

A Study to Evaluate the Effect on Body Weight of Leptin Administered in Conjunction With Pramlintide in Overweight and Obese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00392925·177 enrolled

Type 2 Diabetes2 trials

A Study Evaluating the Efficacy and Safety of Adding Symlin® to Lantus® (Insulin Glargine) in Subjects With Type 2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00240253·200 enrolled

A Study to Characterize Regimens of Basal Insulin Intensified With Either Symlin® or Rapid Acting Insulin in Patients With Type 2 Diabetes

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00467649·112 enrolled

7 more indications

AML2 trials

Evaluation of the Effect of Pramlintide on Satiety and Food Intake

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00042601·51 enrolled

Evaluation of the Bioavailability of Pramlintide

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00042471·75 enrolled

T1DM1 trial

Effect of Different Fixed Pramlintide:Insulin Dose Ratios on Postprandial Glucose in T1DM

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01708044·32 enrolled

Type 2 Diabetes Mellitus1 trial

Clinical Utility and Safety of Pramlintide in Subjects With Type 1 and Type 2 Diabetes Mellitus

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00108004·400 enrolled

MPR1 trial

Evaluation of Dose-titration of Pramlintide During Initiation of Therapy in Patients Trying to Improve Glucose Control

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00042458·296 enrolled

Obese1 trial

Exploratory Study to Evaluate Various Pharmacodynamic Effects of Subcutaneously Infused or Injected Pramlintide in Obese Subjects

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00444561·184 enrolled

Medication1 trial

Evaluation of an Orally Administered Medication When Taken in Conjunction With Pramlintide

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00044707·24 enrolled

T2DM1 trial

Effects of Pramlintide on Endogenous Production of Very-low-density-lipoprotein (VLDL)-Triglyceride and Glucose in the Post Prandial State in T2DM

Withdrawn·UUniversity of Maryland, Baltimore·N/A·NCT00732147

Regulatory

FDA Approval Timeline[5]

Sep 25, 2007

SYMLIN

NDA NDA021332

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Pramlintide acetate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Symlin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Pramlintide acetate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Pramlintide acetate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021332). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Amylin Receptor AMY2; CALCR/RAMP2 Agonist; Amylin Receptor AMY3; CALCR/RAMP3 Agonist; Amylin Receptor AMY1, CALCR/RAMP1 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Symlin

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Type 1 Diabetes3 trials

Type 1 Diabetes Mellitus3 trials

Body Weight3 trials

Overweight3 trials

Type 2 Diabetes2 trials

AML2 trials

T1DM1 trial

Type 2 Diabetes Mellitus1 trial

MPR1 trial

Obese1 trial

Medication1 trial

T2DM1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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