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Insulin (human)

Peptide hormone (insulin)

Status

Approved

Recombinant human insulin has been FDA-approved since 1982 (Humulin) and centrally authorized in the EU since 2002 (for example Actrapid); in the US some Humulin R presentations are sold over the counter while others need a prescription.

Evidence

Strong

Insulin is essential therapy in type 1 diabetes, and large randomized trials such as the DCCT show that intensive insulin therapy prevents diabetic complications.

In sport

WADAProhibited (WADA)

Insulin is the pancreatic hormone that lowers blood glucose. Recombinant human insulin, two peptide chains linked by disulfide bonds, has been approved since 1982 to treat type 1 and type 2 diabetes and is the template for the modified insulin analogs used today.

Structure

51 residues
A chain
  1. aC7Disulfide to B-chain Cys7 (A7-B7)
  2. bC20Disulfide to B-chain Cys19 (A20-B19)
B chain
  1. aC7Disulfide to A-chain Cys7 (B7-A7)
  2. bC19Disulfide to A-chain Cys20 (B19-A20)

Point at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.

Sequence as text
A chain: H-G-I-V-E-Q-C-C-T-S-I-C-S-L-Y-Q-L-E-N-Y-C-N-OH
B chain: H-F-V-N-Q-H-L-C-G-S-H-L-V-E-A-L-Y-L-V-C-G-E-R-G-F-F-Y-T-P-K-T-OH

What it is used for

  • Glycemic control in type 1 diabetes (approved)
  • Glycemic control in type 2 diabetes (approved)

How it works

Insulin's main job is to regulate glucose metabolism. It lowers blood glucose by driving glucose uptake into tissues, especially skeletal muscle and fat, and by switching off glucose production in the liver. It also blocks the breakdown of fat (lipolysis) and protein and promotes protein and glycogen synthesis.

How strong the evidence is

StrongSeveral large randomised controlled trials in people.

The Diabetes Control and Complications Trial (NEJM 1993) randomized 1,441 people with type 1 diabetes to intensive or conventional insulin therapy for a mean 6.5 years. Intensive therapy cut the risk of developing retinopathy by 76% and slowed its progression by 54%, and also reduced kidney and nerve complications, at the cost of more severe hypoglycemia. Insulin analogs, developed from the human sequence, change absorption speed and duration rather than the underlying action.

Risks and side effects

  • Hypoglycemia, which can be severe or fatal, including from dosing or product mix-ups
  • Hypokalemia (low potassium), especially with intravenous use
  • Injection-site lipodystrophy and localized cutaneous amyloidosis; rotate sites
  • Fluid retention and heart failure when combined with thiazolidinediones (PPAR-gamma agonists)
  • Hypersensitivity reactions, including rare generalized allergy

Label dosing

Label (Humulin R): dose is individualized to metabolic needs and glucose monitoring, injected subcutaneously about 30 minutes before a meal and usually combined with an intermediate- or long-acting insulin.

Summarised from the official prescribing information. Not a recommendation: dosing is decided with a prescriber.

Regulatory status

RegionYearApproved for
USFDA1982Glycemic control in adults and children with diabetes mellitus
EUEMA2002Treatment of diabetes mellitus

Status by country

JurisdictionStatusSource
USUnited StatesAuthorised medicineSource 4
EUEuropean UnionAuthorised medicineSource 5
UKUnited KingdomAuthorised medicineSource 9
AUAustraliaAuthorised medicineSource 10
CACanadaAuthorised medicineSource 11
Whether a medicine containing it is authorised, checked in each regulator’s records on Oct 1, 2026.

Status of every peptide by country

Trials of Insulin (human) to watch

  1. Phase 2Recruiting

    INHALE-1st(opens the source in a new tab)

    INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes

    Primary completion expected March 2027100 participantsSponsor: Mannkind CorporationNCT07224321

  2. Phase 3Not yet recruiting

    Oral insulin ORMD-0801 in T2D(opens the source in a new tab)

    A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus.

    Primary completion expected Apr 25, 2027300 participantsSponsor: Oramed, Ltd.NCT06731075

All trials to watch

Timeline

  1. 2027

    1. Oral insulin ORMD-0801 in T2D
    2. INHALE-1st

  2. 2026

    1. ApprovalFDA approves Onswik (efsitora), a second once-weekly basal insulin for type 2 diabetes

  3. 2002

    1. Approved, EU (EMA)Treatment of diabetes mellitus

  4. 1982

    1. Approved, US (FDA)Glycemic control in adults and children with diabetes mellitus

Sources

  1. 01Insulin (P01308, INS_HUMAN)(opens the source in a new tab) UniProt
  2. 02Insulin human (D03230): sequence and structure entry(opens the source in a new tab) KEGG DRUG
  3. 03Humulin R (insulin human) injection: prescribing information(opens the source in a new tab) DailyMed, U.S. National Library of Medicine, 2026
  4. 04Drugs@FDA: Humulin R (BLA 018780) approval history and marketing status(opens the source in a new tab) U.S. Food and Drug Administration, 2026
  5. 05Actrapid: EPAR (European public assessment report)(opens the source in a new tab) European Medicines Agency, 2026
  6. 06The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus (DCCT)(opens the source in a new tab) New England Journal of Medicine, 1993
  7. 07Insulin analogues(opens the source in a new tab) New England Journal of Medicine, 2005
  8. 08World Anti-Doping Code International Standard: Prohibited List 2026(opens the source in a new tab) World Anti-Doping Agency, 2025
  9. 09Humulin S (Soluble) 100 IU/ml solution for injection in vial: Summary of Product Characteristics(opens the source in a new tab) electronic medicines compendium (emc), 2026
  10. 10ACTRAPID human insulin (rys) 100IU/mL injection multidose vial (169625)(opens the source in a new tab) Therapeutic Goods Administration
  11. 11Drug Product Database: Novolin ge Toronto (DIN 02024233)(opens the source in a new tab) Health Canada, 2026
  1. In clinical trialsAmycretinUnimolecular GLP-1 and amylin receptor agonistNo single sequence68 WADA banned
  2. Not approvedAOD-9604Modified growth hormone fragment (research peptide)16 WADA banned
  3. In clinical trialsCagrilintideLong-acting amylin analog (amylin and calcitonin receptor agonist)37 WADA banned
  4. ApprovedDulaglutideGLP-1 receptor agonist (Fc fusion protein)31
  5. ApprovedExenatideGLP-1 receptor agonist39

Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.