Skip to content

Metabolic & endocrine

Pramlintide

A synthetic amylin analogue approved as an add-on in insulin-treated diabetes.

L5Practice-changingApproved — narrow indicationApprovedHigh confidenceLast reviewed 2026-08-23
SC injection

Also known as: Symlin, pramlintide acetate

Evidence passport

Last reviewed 2026-08-23

Evidence level
L5Practice-changing
Confidence
High confidence
Human efficacy
80/100
Human safety
78/100
Regulatory status
Approved — narrow indication
Development
Approved
Routes
SC injection
Evidence base
Includes human data
Furthest stage
Approved
Source curation
Sources fully curated
Clinical maturity
Approved adjunct medicine with long post-marketing history

Overview

Human evidence80/100
Preclinical evidence75/100
Human safety evidence78/100

Clinical maturity: Approved adjunct medicine with long post-marketing history

Routes & formulations

Studied / approved routes

SC injection

The approved product is a mealtime subcutaneous injection taken alongside insulin under its label.

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

  6. Approved

Approved

What it is

A synthetic analogue of amylin, the hormone co-secreted with insulin that slows gastric emptying and suppresses post-meal glucagon.

What people claim

  • Improves post-meal glucose control as an insulin adjunct
  • Modest weight effects in studied populations

What the evidence actually says

Controlled trials supported its adjunctive approval. Its modern relevance is partly historical: amylin biology validated here is the same pathway now being exploited by next-generation obesity candidates such as cagrilintide.

Human evidence

  • Randomised controlled trials in insulin-treated type 1 and type 2 diabetes supporting approval.

Preclinical evidence

  • Amylin pharmacology and metabolic models.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • Amylin-receptor activation slows gastric emptying, suppresses postprandial glucagon and increases satiety.

Safety and unknowns

  • The label carries a serious hypoglycaemia warning when combined with insulin without dose adjustment.
  • Nausea is common, particularly at initiation.

Cancer relevance

No concern identified

No established human cancer signal within approved use.

Regulatory status

FDA-approved (Symlin) as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin and have not achieved adequate control. Approval is specific to that adjunctive role.

Evidence grade

L5Practice-changingHigh confidence

Replicated large randomised trials, pivotal Phase 3 programmes, or a major regulatory decision.

What would change our rating?

  • Not applicable at this evidence tier.

References and sources

Sources fully curated

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

No recorded changes yet. Baseline position set on 2026-08-23.