Hormones & metabolism Amylin analog
Pramlintide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Pramlintide is a synthetic analog of amylin, the hormone the pancreas releases alongside insulin, and it is not a GLP-1 drug. Injected before meals, it slows gastric emptying, suppresses glucagon, and increases fullness, and it is approved as an add-on to mealtime insulin for adults with type 1 or type 2 diabetes. Approved in 2005 and still marketed as Symlin, it carries a boxed warning for severe insulin-induced hypoglycemia.
At a glance
- FDA status
- FDA-approved peptide, sold as Symlin, used alongside insulin at mealtimes
- What it is
- Synthetic version of amylin, a hormone the pancreas releases with insulin, and not a GLP-1 drug
- How it's taken
- Injected before meals to blunt after-meal blood sugar spikes and reduce appetite
- Evidence strength
- FDA approved
Summary
Pramlintide is an FDA-approved amylin analog used with mealtime insulin. Learn how it lowers after-meal glucose and how it differs from GLP-1 drugs.
What is pramlintide?
Pramlintide is a synthetic analog of amylin, a hormone that the pancreas releases together with insulin after meals. It is not a GLP-1 drug, which sets it apart from most of the injectable diabetes peptides.
Natural human amylin tends to clump together and is difficult to formulate as a medicine, so pramlintide was designed with three amino acid substitutions that keep it soluble and stable while preserving its activity. It is made by AstraZeneca and sold as Symlin (SymlinPen), given as a subcutaneous injection before meals.
How does it work?
Pramlintide lowers after-meal blood sugar by replacing amylin, the hormone that normally works alongside insulin to control how fast glucose enters the blood. It acts in three ways:
- It slows stomach emptying so glucose is absorbed more gradually.
- It suppresses the release of glucagon after meals, something insulin alone does not fully control.
- It acts on the brain to increase fullness and reduce food intake.
Because insulin handles glucose entering the cells while amylin controls the rate and timing of glucose appearing in the blood, pramlintide is used as an add-on to mealtime insulin rather than a replacement for it. It typically produces small reductions in A1c along with modest weight loss.
Is it FDA-approved?
Editor’s note
Status: FDA-approved peptide, sold as Symlin, used alongside insulin at mealtimes
Category: FDA-approved · Primary body area: Hormones & metabolism
Yes. Pramlintide was approved in 2005 and remains on the market as Symlin. It is approved as an add-on to mealtime insulin for adults with type 1 or type 2 diabetes who use insulin but have not reached their blood sugar goals.
What is pramlintide prescribed for?
Pramlintide is prescribed alongside mealtime insulin for adults with type 1 or type 2 diabetes who are already using insulin but still have high after-meal blood sugar. It is added to insulin, not used on its own. It is contraindicated in people who have trouble sensing low blood sugar (hypoglycemia unawareness) or who have gastroparesis, a condition of very slow stomach emptying.
What are the side effects?
According to the prescribing information, the most common side effects are:
- Nausea
- Vomiting
- Decreased appetite
- Headache
- Low blood sugar
The most serious risk is severe low blood sugar. Pramlintide carries a boxed warning that, when added to insulin, it can cause severe insulin-induced hypoglycemia, usually within three hours of injection. Because of this, insulin doses are reduced when starting pramlintide, and it is used carefully in people at high risk of low blood sugar.
Sources: FDA prescribing information for Symlin (pramlintide acetate). This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
amylin (PDF)
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