Somatropin (hGH 191AA)

Classification

Recombinant GH (prescription medicine)

Approval status

Approved medicine

Research status

Approved recombinant growth hormone for specific deficiency and other labelled paediatric/adult indications.

Molecular formula

Recombinant 191-amino-acid human GH (product-specific)

Molecular weight

~22 kDa

Sequence

Identical primary sequence to pituitary 22-kDa GH in somatropin products (confirm PI).

Primary biological target

Growth hormone receptor (GHR)

Half-life

Hours after subcutaneous injection; IGF-1 pharmacodynamics last longer (see each PI)

Routes investigated

Subcutaneous, Intramuscular (older)

Human evidence level

A — Approved clinical use / strong human evidence

A prescription protein hormone for documented GH deficiency and other labelled indications. Grey-market ‘HGH 191AA’ vials are illicit in ordinary wellness commerce. Not sold.

Recombinant human growth hormone.

Established (labelled / textbook receptor pharmacology)

Somatropin binds the growth-hormone receptor, activating JAK-STAT signalling and increasing IGF-1 production. Labelled uses are indication-specific (GH deficiency and other registered conditions), not anti-ageing or athletic enhancement.

Anabolic/metabolic hormone — specialist endocrinology only.

• Growth-hormone deficiency

  A · Approved clinical use / strong human evidence

  Approved replacement therapy in documented GH deficiency, product-specific.^[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

Extensive for registered products.

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

Classic GH biology.

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.

• FDA · United States

  Multiple somatropin brands (e.g. Genotropin, Norditropin, Humatrope)

  Indication: Paediatric and adult GH deficiency and other labelled indications — brand-specific

  Regimen: Weight- or IGF-1–guided subcutaneous dosing in the PI. Athletic ‘cycles’ are not labelled regimens.

  FDA Prescribing Information — somatropin products

• TGA · Australia

  ARTG-registered somatropin

  Indication: As per Australian PI

  Regimen: Specialist endocrinology dosing only.

  TGA Product Information

Half-life

Product-specific; subcutaneous daily or long-acting depot products differ

Long-acting GH products have separate PIs.

Oedema, arthralgia, carpal-tunnel symptoms, glucose intolerance, injection-site reactions.

Serious events. Contraindicated in active malignancy in many labels; intracranial hypertension and slipped capital femoral epiphysis discussed in paediatric PI.

Pregnancy / lactation. See PI.

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

Contraindications. Active malignancy; as per Product Information.

Australia — TGA

Registered prescription medicine, indication-specific.

United States — FDA

Approved, brand-specific.

European Union — EMA

Authorised, brand-specific.

1. [1] Somatropin prescribing information (representative class labelling)

   FDA / TGA product information Somatropin prescribing information (representative class labelling)

   Open source