Insulin

Classification

Peptide hormone (glucose-lowering medicine)

Approval status

Approved medicine

Research status

Approved essential peptide hormone medicines for diabetes. Formulation-specific.

Molecular formula

Insufficient reliable evidence identified.

Molecular weight

Insufficient reliable evidence identified.

Sequence

Two-chain peptide hormone; licensed products are characterised biologics.

Primary biological target

Insulin receptor (INSR)

Half-life

Formulation-dependent (rapid analogues minutes–hours; basal analogues many hours)

Routes investigated

Subcutaneous, Intravenous, Inhaled (specific products)

Human evidence level

A — Approved clinical use / strong human evidence

A life-saving prescription medicine for diabetes. Unlabelled research vials sold as ‘insulin’ are extremely dangerous.

Human insulin or analogues produced recombinantly.

Established (labelled / textbook receptor pharmacology)

Insulin binds the insulin receptor, triggering PI3K–AKT and MAPK signalling that promotes glucose uptake (notably via GLUT4 in muscle and adipose tissue) and metabolic storage. This is established physiology and labelled pharmacology.

Hypoglycaemia can be fatal within minutes if mis-dosed.

• Diabetes mellitus

  A · Approved clinical use / strong human evidence

  Approved replacement/pharmacotherapy across type 1 and insulin-requiring type 2 diabetes.^[1]

Investigational findings are not proven clinical benefits unless an authority has labelled that indication.

Overall human evidence grade: A · Approved clinical use / strong human evidence

Among the most studied peptide medicines — for licensed products.

Animal, cell and in-vitro findings are listed separately from human effects.

N/A relative to human use.

This section does not provide personalised medical dosing. Values are those reported in papers or protocols. Animal mg/kg doses are not converted to human doses.

Doses reported in human studies

Insufficient reliable evidence identified.

Preclinical / animal study dosing

Insufficient reliable evidence identified.

Taken from regulator product information. This is not mixed with research-chemical schedules.

• TGA · Australia

  ARTG-registered insulin products

  Indication: Diabetes mellitus as labelled

  Regimen: Individualised, glucose-monitored units. Never copy research-chemical ‘insulin-like’ peptides.

  Australian Product Information — insulin

• FDA · United States

  Multiple insulin NDAs/BLAs

  Indication: Diabetes as labelled per product

  Regimen: See each USPI.

  FDA insulin labels

PK is entirely formulation-specific (aspart, glargine, degludec, regular, NPH, inhaled).

Hypoglycaemia is the principal harm. Weight gain, injection-site lipodystrophy.

Serious events. Severe hypoglycaemia, hypokalaemia with IV insulin.

Interactions. Many drugs alter insulin requirement.

Unknowns. Absence of a published harm signal is not evidence of safety.

Contraindications. Never use non-pharmacy insulin. Medical emergency if hypoglycaemia occurs.

Australia — TGA

Registered prescription (and some pharmacist-supply) insulins — product-specific.

United States — FDA

Approved.

European Union — EMA

Authorised.

1. [1] Pharmacologic Approaches to Glycemic Treatment — Standards of Care in Diabetes

   American Diabetes Association Professional Practice Committee Pharmacologic Approaches to Glycemic Treatment — Standards of Care in Diabetes Diabetes Care. 2024.

   Open source