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Inclisiran - Alnylam Pharmaceuticals/Novartis

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Drug Profile

Inclisiran - Alnylam Pharmaceuticals/Novartis

Alternative Names: ALN-60212; ALN-PCSsc; KJX-839; Leqvio; PCSK9si

Latest Information Update: 07 Feb 2024

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At a glance

  • Originator Alnylam Pharmaceuticals
  • Developer Novartis
  • Class Amides; Amino sugars; Antihyperlipidaemics; Cardiovascular therapies; Drug conjugates; Small interfering RNA; Vascular disorder therapies
  • Mechanism of Action PCSK9 protein expression inhibitors; RNA interference
  • Orphan Drug Status

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

    Yes - Hypercholesterolaemia
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hypercholesterolaemia
  • Registered Hyperlipidaemia
  • Phase III Cardiovascular disorders; Coronary artery disease

Most Recent Events

  • 07 Feb 2024 Novartis intends to submit first regulatory application for Hypercholesterolaemia (primary prevention of cardiovascular events) in or after 2027 (Novartis pipeline, February 2024)
  • 08 Jan 2024 Novartis intends to submit first regulatory application for Hypercholesterolaemia (In children, In infants, In adolescents) by or in 2027 (Novartis pipeline, February 2027)
  • 25 Sep 2023 Registered for Hypercholesterolaemia in Japan (SC)
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