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somatropin

Phase 3
Novo Nordisk A/S (NVO)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

2

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Growth Hormone Disorder

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Drug Information

Target Indication

Growth Hormone Disorder

Clinical Trial

NCT00102817

Last updated: 12/7/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA4/24/2006

Valtropin

Paediatric poulation Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with growth failure due to an inadequate secretion of normal endogenous growth hormone. Treatment of short stature in children with Turner syndrome, confirmed by chromosome analysis. Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency. Adult patients Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- or adult-onset aetiology. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated growth hormone deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. The cut-off point of the dynamic test should be strict.

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EMA4/12/2006

Omnitrope

Infants, children and adolescents Growth disturbance due to insufficient secretion of growth hormone (GH). Growth disturbance associated with Turner syndrome. Growth disturbance associated with chronic renal insufficiency. Growth disturbance (current height standard-deviation score (SDS) < -2.5 and parental adjusted SDS < -1) in short children / adolescents born small for gestational age (SGA), with a birth weight and / or length below -2 standard deviations (SDs), who failed to show catch-up growth (height velocity (HV) SDS < 0 during the last year) by four years of age or later. Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing. Adults Replacement therapy in adults with pronounced growth hormone deficiency. Patients with severe growth hormone deficiency in adulthood are defined as patients with known hypothalamic pituitary pathology and at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo a single dynamic test in order to diagnose or exclude a growth hormone deficiency. In patients with childhood-onset isolated GH deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests should be recommended, except for those having low insulin-like-growth-factor-I (IGF-I) concentrations (SDS < -2) who may be considered for one test. The cut-off point of the dynamic test should be strict.

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Drug Science
Mechanism of action & safety profile
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