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type1.science

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: . What was checked and what remains uncertain.

Source dates appear in the references where available; this record has no dated citation metadata.

Trial status, labels and access can change between reviews.

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Discontinued productsRegulator-approvedadjunctamylinhistorical

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 record-specific review limits for gaps in evidence, source access or availability checks.
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.

Glycemic benefit45

Editorial estimate: labelled T1D trials show modest HbA1c improvement alongside mealtime insulin.[1]

Safety35

Editorial estimate: boxed warning for severe hypoglycemia with insulin; contraindicated with hypoglycemia unawareness or gastroparesis.[1]

Wider metabolic benefit40

Editorial estimate: modest weight benefit, without established T1D cardiovascular or kidney outcome protection.[1]

Maturity85

Editorial estimate: a T1D adjunct approved in the US in 2005, supported by randomized studies and long-standing labeling.[1]

Access & cost0

Editorial estimate: FDA lists all Symlin products discontinued. Routine new-start supply is not established; remaining local stock is not verified.[2]

These are scored as add-ons to insulin in Type 1 diabetes, never on their Type 2 diabetes evidence — a drug with a large Type 2 trial base but only small Type 1 studies scores low on maturity. Safety carries heavy weight here because the best-known adjunct risk, diabetic ketoacidosis at normal glucose levels, is potentially fatal and specific to Type 1. Most of this class is used off-label; that is reflected in access, not hidden.

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.

References

  1. DailyMed. SYMLIN prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4aea30ff-eb0d-45c1-b114-3127966328ff ↩ ↩2

  2. FDA. Drugs@FDA, NDA021332. https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA021332&limit=1 ↩

Sources

  1. [1]SYMLIN prescribing information and product listing · regulatory
  2. [2]Drugs@FDA Symlin NDA021332: all three products discontinued · regulatory — API dataset last updated 15 September 2026. DailyMed lists a later marketing-end date; neither proves local remaining stock.