Pramlintide

Status

No approved product. FDA-approved as Symlin (NDA 021332); Drugs@FDA lists the product as discontinued (retrieved 25 October 2026), and the FDA shortage listing dates the US SymlinPen discontinuation to 27 October 2025. Its label described use as an adjunct to mealtime insulin in patients with type 1 or type 2 diabetes who have failed to achieve adequate glucose control. It carries a boxed warning for severe hypoglycaemia occurring within three hours of injection, particularly in type 1 diabetes.

What it is

An approved amylin analogue used with insulin at mealtimes.

What published research measured

A synthetic analogue of amylin, the hormone co-secreted with insulin by pancreatic beta cells, which slows gastric emptying and suppresses inappropriate post-meal glucagon. Randomized trials in type 1 and insulin-treated type 2 diabetes established modest reductions in HbA1c and in post-meal glucose excursions, with small accompanying weight reduction. The dominant safety finding is that pramlintide given alongside insulin substantially increases the risk of severe hypoglycaemia, which is why its approved use requires insulin dose reduction and close monitoring. Nausea is common and is the usual reason for discontinuation.

Source

FDA labeling for Symlin (pramlintide acetate), including the boxed warning for severe hypoglycaemia

Sources

• Half-life source for Pramlintide
• Symlin (pramlintide acetate) injection label (revised DailyMed SPL, last revised 2015; US pens discontinued October 2025)