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Lonapegsomatropin - Ascendis Pharma

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Drug Profile

Lonapegsomatropin - Ascendis Pharma

Alternative Names: ACP 001; ACP 011; Lonapegsomatropin-tcgd; SKYTROFA; TransCon growth hormone; TransCon hGH; TransCon PEG growth hormone; TransCon PEG hGH; TransCon PEG somatropin

Latest Information Update: 26 Nov 2025

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At a glance

  • Originator Ascendis Pharma
  • Developer Ascendis Pharma; Specialised Therapeutics Asia; VISEN Pharmaceuticals
  • Class Growth hormones; Hormonal replacements; Polyethylene glycols; Recombinant proteins
  • Mechanism of Action Human growth hormone replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Somatotropin deficiency
  • New Molecular Entity No

Highest Development Phases

  • Marketed Somatotropin deficiency
  • Phase III Growth disorders
  • Phase II Achondroplasia; Turner's syndrome

Most Recent Events

  • 13 Nov 2025 Phase-III clinical trials in Growth disorders (In adolescents, In children) (SC)
  • 28 Oct 2025 Ascendis Pharma plans a phase III trial for Turner Syndrome and Short stature (in Children, In adolescents) in November 2025 (SC, Injection) (NCT07221851)
  • 28 Jul 2025 Launched for Somatotropin deficiency (In the elderly, In adults) in USA (SC)

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