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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: 16 Feb 2026

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At a glance

  • Originator Ascendis Pharma
  • Developer Ascendis Pharma; Specialised Therapeutics Asia; Teijin; 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

  • 12 Feb 2026 Preregistration for Somatotropin deficiency (In children, Treatment-naive) in Japan (SC)
  • 26 Jan 2026 Registered for Somatotropin deficiency (In adolescents, In children) in China (SC)
  • 10 Jan 2026 Ascendis Pharma anticipates Biologic License Application (BLA) approval from NMPA in China in the first quarter of 2026

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