Pramlintide (Symlin)
AstraZeneca
What it is
An FDA-approved injectable amylin analogue used alongside mealtime insulin, with modest glucose and weight benefits and a boxed warning for severe hypoglycemia. The current FDA database lists all Symlin products discontinued; remaining pharmacy stock is unverified.
Editorial review: .
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Glycemic benefit: Editorial estimate: labelled T1D trials show modest HbA1c improvement alongside mealtime insulin.[1]
- Important harms and treatment burden
- Safety: Editorial estimate: boxed warning for severe hypoglycemia with insulin; contraindicated with hypoglycemia unawareness or gastroparesis.[1]
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Read the full discussion and original sources for follow-up duration and study limitations.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 45 × 25 + 35 × 25 + 40 × 15 + 85 × 20 + 0 × 15 = 4300; divide by total weight 100. Unrounded weighted result: 43.
Editorial estimate: labelled T1D trials show modest HbA1c improvement alongside mealtime insulin.[1]
Editorial estimate: boxed warning for severe hypoglycemia with insulin; contraindicated with hypoglycemia unawareness or gastroparesis.[1]
Editorial estimate: modest weight benefit, without established T1D cardiovascular or kidney outcome protection.[1]
Editorial estimate: a T1D adjunct approved in the US in 2005, supported by randomized studies and long-standing labeling.[1]
Editorial estimate: FDA lists all Symlin products discontinued. Routine new-start supply is not established; remaining local stock is not verified.[2]
These ratings concern add-on treatment alongside insulin in T1D. Maturity reflects the T1D evidence, and safety receives substantial editorial weight because risks differ by drug and population. For example, SGLT2 inhibitors can cause ketoacidosis even without markedly high glucose; this is not exclusive to T1D. Access reflects the stated indication and region, including whether a separate obesity indication applies.
The full picture
Pramlintide is an injectable analogue of amylin, a hormone normally released with insulin. Its US label covers selected people with type 1 or type 2 diabetes using mealtime insulin who have not reached desired glucose control. It reduces post-meal glucose excursions and can modestly reduce HbA1c and weight.1
Why safety and burden matter
The label carries a boxed warning for severe hypoglycemia when used with insulin, particularly in T1D. It requires careful selection, clinician-directed insulin changes and frequent glucose monitoring. Hypoglycemia unawareness and confirmed gastroparesis are contraindications. Pramlintide and insulin are separate injections and must not be mixed. Nausea and extra mealtime injections add burden.1
Current availability
The FDA drug database, updated 15 September 2026, lists the vial and both pen presentations as discontinued. DailyMed retains label information and lists January 2027 marketing-end dates; those administrative records do not establish pharmacy stock. This historical record therefore does not present Symlin as routinely obtainable. Discontinued marketing alone does not establish withdrawal of approval for safety or effectiveness.2
Standalone Symlin is distinct from investigational insulin–pramlintide closed-loop delivery and coformulations. Scores are editorial evidence comparisons.
Sources
- [1]SYMLIN prescribing information and product listing · Regulatory decision
DailyMed. SYMLIN prescribing information.
- [2]Drugs@FDA Symlin NDA021332: all three products discontinued · Regulatory decision — API dataset last updated 15 September 2026. DailyMed lists a later marketing-end date; neither proves local remaining stock.
FDA. Drugs@FDA, NDA021332.