Key facts
- Pramlintide is a synthetic 37-amino-acid analogue of human amylin, sold as Symlin (pramlintide acetate) and approved by the US FDA in 2005.[1][2]
- The FDA classes it as an amylin analogue, not a GLP-1 drug.[4]
- It peaks in the blood about 20 minutes after a dose and has a half-life of about 48 minutes, so it is injected before each major meal.[1]
- It carries a boxed warning for severe hypoglycaemia with insulin, and the label calls for mealtime insulin to be cut by 50% when starting.[1]
- FDA records (Orange Book and Drugs@FDA) list all three Symlin products as discontinued.[3][2]
What Is Pramlintide?
Pramlintide is a synthetic 37-amino-acid analogue of the hormone amylin, approved by the US FDA on 16 March 2005 as an add-on to mealtime insulin in type 1 and type 2 diabetes.[1][2]
| Feature | Pramlintide |
|---|---|
| Brand name | Symlin; pen-injectors sold as SymlinPen 60 and SymlinPen 120[1] |
| Active ingredient | Pramlintide acetate[1] |
| Drug class (FDA) | Amylin analogue; mechanism listed as amylin agonist[4] |
| Application holder | AstraZeneca AB, NDA 021332[2] |
| First US approval | 16 March 2005[2] |
| Labelled use | Add-on for type 1 or type 2 diabetes on mealtime insulin; not weight management[1] |
| Route and timing | Subcutaneous injection immediately before each major meal[1] |
| Peak time (Tmax) | About 19 to 21 minutes[1] |
| Half-life | About 48 minutes[1] |
| Bioavailability | About 30% to 40% after a subcutaneous dose[1] |
| US marketing status | Discontinued (all three products)[3][2] |
Pramlintide differs from human amylin at three positions, where proline replaces alanine (25), serine (28) and serine (29).[1] Human amylin itself clumps into amyloid fibrils, which is why drugs use modified analogues.[6] For the hormone it copies, see what is amylin.
Pramlintide Brand Name and Drug Class
The brand name for pramlintide is Symlin, and the FDA places it in the amylin analogue class, with amylin agonism as its mechanism.[1][4]
- Symlin is the product name on the FDA label; the pens are called SymlinPen 60 and SymlinPen 120.[1]
- Pramlintide acetate is the salt in the product, a white, water-soluble powder with a molecular weight of 3949.4.[1]
- Amylin analogue is its FDA established pharmacologic class. The FDA lists its mechanism as amylin agonist.[4]
- It is not a GLP-1 receptor agonist. It acts on amylin receptors, which are the calcitonin receptor paired with RAMP1, RAMP2 or RAMP3.[4][7]
- The application is held by AstraZeneca AB under NDA 021332.[2]
Pramlintide Mechanism of Action
Pramlintide works like amylin after a meal in three ways: it slows gastric emptying, suppresses the rise in glucagon, and reduces food intake through the brain, cutting buffet calorie intake by about 21% to 23% in label studies.[1]
- Replaces a missing hormone. Amylin is stored and released with insulin by pancreatic beta cells, and people with type 1 and type 2 diabetes release less of both after food.[1][9]
- Slows gastric emptying. Food leaves the stomach more slowly, without changing total nutrient absorption.[1]
- Lowers glucagon after meals. Less glucagon means less glucose released by the liver, an effect insulin alone does not normalise.[1]
- Reduces appetite. A single dose 1 hour before an unlimited buffet cut calorie intake by about 21% (30 mcg, type 1) and 23% (120 mcg, type 2) against placebo, without shortening the meal.[1]
- Acts on amylin receptors. Amylin works largely through brain areas outside the blood-brain barrier.[8][7]
Pramlintide Peak Time and Half-Life
Pramlintide reaches peak blood levels about 19 to 21 minutes after a subcutaneous dose and has a half-life of about 48 minutes in healthy people.[1]
| Dose | Peak time (Tmax) | Half-life |
|---|---|---|
| 30 mcg | 21 min | 55 min |
| 60 mcg | 20 min | 49 min |
| 90 mcg | 19 min | 51 min |
| 120 mcg | 21 min | 48 min |
- Absolute bioavailability after a subcutaneous dose is about 30% to 40%, and exposure rises in line with the dose.[1]
- About 40% of the drug circulates unbound; it does not bind much to albumin or red blood cells.[1]
- The main metabolite, des-Lys1 pramlintide (2-37 pramlintide), is active in lab tests. Exposure stays steady with repeat dosing, so it does not build up.[1]
- Injection into the arm gave 20% to 36% higher exposure, with more variability, than the abdomen or thigh.[1]
- This short half-life is why pramlintide is given at every main meal, while newer analogues are built for once-weekly dosing.[10]
Pramlintide Dosing in the Label
The label lists a starting dose of 15 mcg before major meals in type 1 diabetes, titrated to 30 or 60 mcg, and 60 mcg in type 2 diabetes, increased to 120 mcg, with mealtime insulin cut by 50% at the start.[1]
| Type 1 diabetes | Type 2 diabetes | |
|---|---|---|
| Starting dose | 15 mcg before major meals | 60 mcg before major meals |
| Titration in the label | 15 mcg steps to 30 or 60 mcg | Increase to 120 mcg |
| If nausea persists | Reduce to 30 mcg; consider stopping if 30 mcg is not tolerated | Reduce from 120 mcg to 60 mcg |
| Step condition | No clinically significant nausea for at least 3 days | No clinically significant nausea for at least 3 days |
| Mealtime insulin at start | Reduced by 50% | Reduced by 50% |
- The label defines a major meal as at least 250 kcal or at least 30 g of carbohydrate.[1]
- Symlin and insulin must be given as separate injections and never mixed.[1]
- Pen strengths: SymlinPen 60 holds 1.5 mL at 1000 mcg/mL and delivers 15, 30, 45 or 60 mcg doses; SymlinPen 120 holds 2.7 mL at 1000 mcg/mL and delivers 60 or 120 mcg doses.[1]
- The label lists 120 mcg as the maximum recommended dose in type 2 diabetes.[1]
Side Effects and the Hypoglycaemia Warning
Nausea is the most common side effect of pramlintide, reported in 48% of people with type 1 diabetes (placebo 17%) and 28% with type 2 diabetes (placebo 12%) in pooled label trials.[1]
| Adverse reaction | Type 1: Symlin 30 or 60 mcg (n = 716) | Type 1: placebo (n = 538) | Type 2: Symlin 120 mcg (n = 292) | Type 2: placebo (n = 284) |
|---|---|---|---|---|
| Nausea | 48% | 17% | 28% | 12% |
| Anorexia | 17% | 2% | 9% | 2% |
| Vomiting | 11% | 7% | 8% | 4% |
| Headache | Not listed | Not listed | 13% | 7% |
| Fatigue | 7% | 4% | 7% | 4% |
| Dizziness | 5% | 4% | 6% | 4% |
Nausea is highest at the start of treatment and fades with time in most people, and gradual titration reduces it.[1] The label carries a boxed warning: used with insulin, pramlintide raises the risk of severe hypoglycaemia, mainly in type 1 diabetes, and when it happens it occurs within 3 hours of an injection. Patient selection, careful instruction and the insulin dose cut are described as critical to lowering that risk.[1] It is contraindicated in people with hypoglycaemia unawareness or confirmed gastroparesis.[1]
Does Pramlintide Cause Weight Loss?
Pramlintide caused modest weight loss in its diabetes trials, -1.4 kg at 52 weeks on 120 mcg twice daily against +0.7 kg on placebo in type 2 diabetes, but it is not approved for weight management.[12][1]
- Type 2 diabetes, 52 weeks (n = 656): HbA1c fell 0.62 points on 120 mcg twice daily, with weight -1.4 kg vs +0.7 kg on placebo.[12]
- Type 1 diabetes, 52 weeks (n = 480): 30 or 60 mcg four times daily lowered HbA1c by 0.67 points at week 13 against 0.16 on placebo, with average weight loss rather than gain.[11]
- Type 1 diabetes, 52 weeks (n = 651): 60 mcg three or four times daily lowered weight by 0.4 kg against a 0.8 kg gain on placebo.[13]
- Obesity without diabetes, 12 months (n = 411 randomised): at higher research doses (120 mcg three times daily or 360 mcg twice daily) with lifestyle support, placebo-corrected weight loss was 5.6% and 6.8% at month 12.[14]
The obesity study used doses above the label range and was never turned into an approved weight indication.[14][1] The newer amylin drugs below were designed for that purpose.
Is Symlin Discontinued?
Yes, according to FDA records: the Orange Book and Drugs@FDA list all three Symlin products, the original 600 mcg/mL presentation and both SymlinPen strengths, with a marketing status of Discontinued.[3][2]
- The FDA NDC directory and the DailyMed listing record a marketing end date of 31 January 2027 for both SymlinPen packages (NDC 0310-6615-02 and 0310-6627-02).[4][5]
- The current DailyMed listing is version 18, published 20 August 2024, and carries the prescribing information last revised in December 2019.[5][1]
- The FDA approved the two SymlinPen strengths on 25 September 2007, after the original 2005 approval.[2]
Pramlintide vs Newer Amylin Drugs
Pramlintide has a half-life of about 48 minutes, against 159 to 195 hours for cagrilintide and 310 to 366 hours for eloralintide, which is why the newer drugs are given once a week.[1][15][16]
Novo Nordisk built cagrilintide on the pramlintide backbone and added a fatty acid to make it last long enough for weekly dosing.[10] Lilly’s eloralintide also carries a fatty acid, which binds albumin and extends its half-life.[16] Neither is approved. Read what is cagrilintide, what is eloralintide, and the full analogue comparison in what is amylin.
Frequently Asked Questions
What is pramlintide?
Pramlintide is a synthetic analogue of the hormone amylin, sold as Symlin. The FDA approved it in 2005 as an add-on to mealtime insulin in type 1 and type 2 diabetes.
What is the brand name for pramlintide?
Symlin. The active ingredient is pramlintide acetate, and the pen-injectors are called SymlinPen 60 and SymlinPen 120.
Is pramlintide a GLP-1?
No. The FDA classes pramlintide as an amylin analogue. It acts on amylin receptors, not the GLP-1 receptor.
What class of drug is pramlintide?
It is an amylin analogue, and the FDA lists its mechanism as amylin agonist. It is used alongside mealtime insulin.
Is Symlin discontinued?
FDA records list all three Symlin products as discontinued in the Orange Book and Drugs@FDA. The NDC directory gives a marketing end date of 31 January 2027 for both SymlinPen packages.
Does pramlintide cause weight loss?
Modestly. In a 52-week type 2 diabetes trial, weight changed by -1.4 kg on 120 mcg twice daily vs +0.7 kg on placebo. It is not approved for weight management.
Sources
- FDA. SYMLIN (pramlintide acetate) prescribing information, revised 12/2019
- FDA. Drugs@FDA, NDA 021332 (Symlin): products, marketing status and approval history
- FDA. Orange Book product details for NDA 021332 (Symlin), and Orange Book data files dated October 2026
- FDA National Drug Code Directory via openFDA: SymlinPen (pramlintide acetate), pharmacologic class and marketing dates
- NLM DailyMed. SymlinPen (pramlintide acetate) injection, AstraZeneca Pharmaceuticals LP, SPL version 18, published 20 Aug 2024
- Wang H, et al. Rational design of non-amyloidogenic amylin analogues. Biochemistry 2014;53:5876-5884
- Hay DL, et al. Update on the pharmacology of calcitonin/CGRP family receptors (IUPHAR Review 25). British Journal of Pharmacology 2018;175:3-17
- Hay DL, et al. Amylin: pharmacology, physiology, and clinical potential. Pharmacological Reviews 2015;67:564-600. DOI 10.1124/pr.115.010629
- Lebovitz HE. Adjunct therapy for type 1 diabetes mellitus. Nature Reviews Endocrinology 2010;6:326-334
- Kruse T, et al. Development of cagrilintide, a long-acting amylin analogue. J Med Chem 2021;64:11183-11194. DOI 10.1021/acs.jmedchem.1c00565
- Whitehouse F, et al. Pramlintide as an adjunct to insulin in type 1 diabetes, 52-week trial. Diabetes Care 2002;25:724-730. DOI 10.2337/diacare.25.4.724
- Hollander PA, et al. Pramlintide as an adjunct to insulin in type 2 diabetes, 1-year trial. Diabetes Care 2003;26:784-790. DOI 10.2337/diacare.26.3.784
- Ratner RE, et al. Pramlintide in type 1 diabetes, 1-year trial. Diabetic Medicine 2004;21:1204-1212. DOI 10.1111/j.1464-5491.2004.01319.x
- Smith SR, et al. 12-month pramlintide treatment with lifestyle intervention in obesity. Diabetes Care 2008;31:1816-1823. DOI 10.2337/dc08-0029
- Enebo LB, et al. Cagrilintide with semaglutide 2.4 mg, phase 1b. The Lancet 2021;397:1736-1748. DOI 10.1016/S0140-6736(21)00845-X
- Briere DA, et al. Discovery and first-in-human study of eloralintide. Molecular Metabolism 2025;102:102271. DOI 10.1016/j.molmet.2025.102271
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