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Metabolic

Pramlintide

Also known as Symlin · SymlinPen · Pramlintide acetate · Tripro-amylin · AC137 · AC-0137

Approved, no longer marketedAHuman trial evidenceWhat this means

Pramlintide is a synthetic 37-amino-acid analog of human amylin, FDA-approved in 2005 as Symlin for adjunctive use with mealtime insulin in type 1 and type 2 diabetes; Drugs@FDA now lists all Symlin products as discontinued.

US status
Approved, no longer marketed
Evidence
Grade A
Half-life
Approximately 48 minutes in healthy individuals; elimination half-life 48-55 minutes across single subcutaneous doses in the label's PK table 1.
Class
Amylin analog
Studied in: Metabolic & insulin research · Class: Amylin analogues
More
Log a sample
Dosing referenceCycle-length evidence
Unbranded reference vial illustrating Pramlintide; not an actual product
Research reference, not advice. Label quotes, not a recommendation. Amiravo sells nothing; some links are referrals.Read the full notice

Key takeaways

  • Pramlintide is a synthetic amylin analog approved as Symlin for use with mealtime insulin in type 1 and type 2 diabetes; all Symlin products are now listed as discontinued 1,2.
  • The label's boxed warning states that use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, usually within 3 hours of injection 1.
  • Placebo-subtracted HbA1c reductions in the label trials were about 0.25-0.34% at 6 months 1.
  • Nausea was the most common adverse reaction (48% versus 17% placebo in type 1 diabetes) and tended to decrease over time 1.
  • Contraindications include hypoglycemia unawareness and confirmed gastroparesis 1.

Development stage

Where Pramlintide sits between laboratory work and regulatory approval.

  1. Preclinical
  2. Phase 1
  3. Phase 2
  4. Phase 3
  5. Approved (current)

Stage comes from the regulatory record and ClinicalTrials.gov studies naming the compound (for compounds approved nowhere, only completed trials or trials with posted results count) (checked 2026-10-24). A registered trial is not a result.

Mechanism of action

Pramlintide is an analog of human amylin, which is co-located with insulin in beta-cell secretory granules and co-secreted in response to food intake 1.

Actions

  • In human studies, pramlintide slowed gastric emptying, reduced the postprandial rise in plasma glucagon and modulated satiety, decreasing caloric intake 1.
  • In nonclinical studies amylin suppresses glucagon secretion and regulates food intake through centrally mediated modulation of appetite 1.
  • Controlled hypoglycemic-challenge studies showed no change in the counter-regulatory hormonal response to insulin-induced hypoglycemia 1.

Pharmacokinetics

Absolute bioavailability after subcutaneous injection is about 30-40%; the main metabolite, des-Lys1 pramlintide, is active in vitro 1.

Molecular structure

PubChem CID 70691388 ↗
2D chemical structure of Pramlintide

2D depiction generated from the PubChem record. Depictions are schematic and do not show salt form, counter-ions or conformation.

Formula
C171H267N51O53S2
Molecular weight
3949.4 g/mol
CAS
151126-32-8
InChIKey
TZIRZGBAFTZREM-MKAGXXMWSA-N

Research overview

Human research

Randomized placebo-controlled trials of 26 to 52 weeks in people with type 1 diabetes and insulin-treated type 2 diabetes support the labeled indication 1,3. A 12-month dose-ranging study in adults with obesity without diabetes reported body-weight changes, outside the labeled indication 4.

Animal research

The label summarizes nonclinical findings that amylin slows gastric emptying, suppresses glucagon secretion and regulates food intake through central appetite pathways 1.

In-vitro research

The primary metabolite, des-Lys1 pramlintide (2-37 pramlintide), is biologically active in vitro 1.

Key studies

  1. Whitehouse et al., Diabetes Care (2002)
    52-week double-blind, placebo-controlled, multicenter trial plus 1-year open-label extension
    Model: Humans (480 people with type 1 diabetes)

    HbA1c fell 0.67% versus 0.16% by week 13 with a sustained placebo-corrected difference at week 52; nausea and anorexia were most common and diminished over time 3.

  2. Symlin prescribing information, Section 14.1 (three type 1 diabetes trials) (2019)
    Three 26- to 52-week randomized, double-blind, placebo-controlled trials
    Model: Humans (people with type 1 diabetes)

    Placebo-subtracted HbA1c change at 6 months of -0.34%, -0.32% and -0.25% 1.

  3. Symlin prescribing information, Section 14.2 (two type 2 diabetes trials) (2019)
    26-week and 52-week randomized, double-blind, placebo-controlled trials
    Model: Humans (people with type 2 diabetes on insulin, HbA1c above 8%)

    Placebo-subtracted HbA1c change at 6 months of -0.34% and -0.30% 1.

  4. Smith et al., Diabetes Care (2008)
    4-month double-blind, placebo-controlled dose-ranging trial plus 8-month single-blind extension
    Model: Humans (411 adults with obesity, with lifestyle intervention)

    Body-weight change at 4 months ranged from -3.8 to -6.1 kg versus -2.8 kg with placebo; nausea 9-29% versus 2% 4.

Dosing as stated on the FDA label

Quoted from the prescribing information for reference. Prescribing decisions belong to a licensed clinician; this is not a recommendation or instruction for use.

Full dosing reference, study durations and vial arithmetic →
  • Type 2 diabetes using mealtime insulin: reduce mealtime insulin (including premixed) by 50%, then start at 60 micrograms subcutaneously immediately before each major meal; increase to 120 micrograms when no clinically significant nausea has occurred for at least 3 days; reduce to 60 micrograms if significant nausea persists 1.
  • Type 1 diabetes: reduce mealtime insulin by 50%, then start at 15 micrograms before each major meal; increase to the next increment (30, 45 or 60 micrograms) when no clinically significant nausea has occurred for at least 3 days; decrease to 30 micrograms if nausea persists at 45 or 60 micrograms 1.
  • A major meal is defined in the label as at least 250 kcal or at least 30 g of carbohydrate. Administration instructions are in the label and are not reproduced here 1.

Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

Label warnings

  • Boxed warning: use with insulin increases the risk of severe hypoglycemia, particularly in type 1 diabetes, usually within 3 hours of injection 1. 1
  • Contraindications: serious hypersensitivity to Symlin or its components, hypoglycemia unawareness, and confirmed gastroparesis 1. 1
  • The label states patients should not be considered for therapy with poor adherence to insulin or glucose monitoring, HbA1c above 9%, recurrent severe hypoglycemia in the past 6 months, gastroparesis, use of drugs that stimulate GI motility, or in pediatric patients 1. 1
  • Pens must never be shared, and Symlin must never be mixed with insulin 1. 1
  • Slowed gastric emptying may delay absorption of oral medications; the label gives timing guidance for drugs whose rapid onset matters 1. 1
  • Nausea
    48% versus 17% (type 1); 28% versus 12% (type 2)
    Pooled placebo-controlled trials (type 1 n=716 vs 538; type 2 n=292 vs 284) 1 · Higher at treatment start and decreased with time in most patients
  • Anorexia
    17% versus 2% (type 1); 9% versus 2% (type 2)
    Same pools 1 · Not graded in table
  • Vomiting
    11% versus 7% (type 1); 8% versus 4% (type 2)
    Same pools 1 · Not graded in table
  • Headache
    13% versus 7%
    Type 2 diabetes pool 1 · Not graded in table
  • Inflicted injury
    14% versus 10%
    Type 1 diabetes pool 1 · Abrasions, bruises, burns, fractures and similar
  • Patient-ascertained severe hypoglycemia, months 0-3
    16.8% versus 10.8% (type 1, no insulin reduction); 8.2% versus 2.1% (type 2)
    Six-month placebo-controlled trials 1 · Requiring assistance of another person or medical intervention

Emerging safety signals

  • Postmarketing reports include injection site reactions and pancreatitis 1. 1 (2019)

What is not known: Safety and effectiveness in pediatric patients have not been established, and use has not been studied in hepatic impairment or end-stage renal disease 1. Effects on body weight in people without diabetes are outside the labeled indication 1,4.

Background viewing

We haven't found a clinician video focused on Pramlintide yet. Meanwhile, this widely watched talk covers the science of aging in general. It does not discuss Pramlintide.

David Sinclair, PhD (Harvard Medical School) on the biology of aging
The Diary Of A CEO · 6.9M views · 2026

These creators are not affiliated with Amiravo and do not endorse Amiravo or any product linked on this site. Nothing here is medical advice. Video views counted on YouTube as of Oct 24, 2026.

Regulatory status

Status
FDA-approved (initial U.S. approval 2005) as Symlin under NDA 021332; as of 2026-10-24 Drugs@FDA lists all Symlin products as discontinued 1,2.
United States (FDA)
FDA-approved (initial U.S. approval 2005) as Symlin, NDA 021332; Drugs@FDA lists all three Symlin products as discontinued as of 2026-10-24 1,2.
Sport (WADA)
Amylin analogs, including pramlintide, were not mentioned on the WADA 2026 Prohibited List page reviewed 5.

Status varies by country and changes over time. How we describe regulatory status.

Quality and testing notes

A certificate of analysis for pramlintide material would be expected to show HPLC purity, identity by mass spectrometry against the label's molecular weight of 3949.4 (free base), confirmation of the C-terminal amide, acetate and net peptide content, and endotoxin level [1, 6].

How purity testing works · Reading a certificate of analysis

Check a Pramlintide certificate of analysis against its expected mass (3,949.4 Da)

Storage and handling

The label directs refrigerated storage (2-8°C) protected from light for unopened pens, not frozen; after first use, pens may be refrigerated or kept up to 30°C and used within 30 days [1].

Frequently asked questions

What is pramlintide?
A synthetic analog of human amylin with three proline substitutions 1.
What was it approved for?
As adjunctive treatment for people with type 1 or type 2 diabetes using mealtime insulin who have not reached glucose goals despite optimal insulin therapy 1.
Is Symlin still marketed in the U.S.?
Drugs@FDA lists all Symlin products as discontinued as of 2026-10-24 2.
What is the main safety concern?
Severe hypoglycemia when used with insulin, particularly in type 1 diabetes; the label carries a boxed warning 1.
How does it act?
It slows gastric emptying, reduces the postprandial glucagon rise and modulates satiety 1.
How long does it last?
The label gives a half-life of approximately 48 minutes in healthy individuals 1.
Was it studied in obesity?
A 12-month dose-ranging study in adults with obesity reported body-weight changes, but obesity is not a labeled indication 4.

Latest indexed research

No new studies were filed in the last sweep.

Search all studies on Pramlintide (PubMed, Europe PMC, ClinicalTrials.gov)

Listed by publication type from the index record. Inclusion is not an endorsement; open the source to read the findings.

Revision history

Meaningful changes to this entry, with dates and sources. Last reviewed Oct 24, 2026. Typo and layout fixes are not listed.

  • New section· entryOct 24, 2026

    New research reference added: Pramlintide.

Last reviewed October 24, 2026 by the Amiravo editorial team.

Read our editorial policy · Report an error on this page

Need the math?

Laboratory arithmetic with every formula shown.

For research use only. Not for human or veterinary use. Not a drug, food, or dietary supplement. This page is educational and is not medical advice.

Unbranded reference vial illustrating Pramlintide; not an actual product

Unbranded reference image. Amiravo does not produce, supply or sell this compound.

Specifications

Molecular formula
C171H267N51O53S2
Molecular weight
3,949.4 g/mol
CAS number
151126-32-8
PubChem CID
70691388
FDA UNII
D3FM8FA78T
ChEMBL
CHEMBL2103758
Sequence
Lys-Cys-Asn-Thr-Ala-Thr-Cys-Ala-Thr-Gln-Arg-Leu-Ala-Asn-Phe-Leu-Val-His-Ser-Ser-Asn-Asn-Phe-Gly-Pro-Ile-Leu-Pro-Pro-Thr-Asn-Val-Gly-Ser-Asn-Thr-Tyr-NH2
Type
Single compound

Identifiers from PubChem. Verify against the supplier’s documentation for your lot.

Research stats

How much has been published, not how good it is.

PubMed records
445
Indexed as human research
352
Animal-only research
28
Randomized controlled trials
64
Registered trials
64
Trials with posted results
15
FDA adverse-event reports (FAERS)
84
NIH-funded projects naming it
128
2006: 252007: 232008: 242009: 202010: 162011: 122012: 72013: 162014: 262015: 172016: 162017: 222018: 242019: 122020: 182021: 252022: 142023: 92024: 222025: 152026: 1520062026
PubMed records per year (current year is partial).

Counts from title/abstract searches of PubMed, ClinicalTrials.gov, openFDA and NIH RePORTER, checked 2026-10-24. Names shared with other substances can inflate counts. FAERS reports are spontaneous and do not establish cause. Funding shows interest, not evidence. Method

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