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Acetylcysteine lysinate - Laboratoires SMB

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Drug Profile

Acetylcysteine lysinate - Laboratoires SMB

Alternative Names: L-Lysine-N-acetyl-L-cysteinate; N-acetylcysteine lysinate; Nacystelyn

Latest Information Update: 09 Sep 2025

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At a glance

  • Originator Galephar; Laboratoires SMB
  • Class Antiacnes; Expectorants; Reducing agents; Small molecules; Sulfur amino acids
  • Mechanism of Action Antioxidants
  • Orphan Drug Status

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

    Yes - Cystic fibrosis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Acne vulgaris; Chronic obstructive pulmonary disease; Sleep apnoea syndrome
  • Discontinued Cystic fibrosis

Most Recent Events

  • 11 Jul 2024 Phase-II clinical trials in Sleep apnoea syndrome in Belgium (Inhalation) (CTIS2023-508445-40-00)
  • 11 Jul 2024 Phase-II clinical trials in Sleep apnoea syndrome in France (Inhalation) (CTIS2023-508445-40-00)
  • 01 Sep 2022 LABORATOIRES SMB completes a phase II trial in Acne vulgaris (In adolescents, In adults, Combination therapy) in Bulgaria (PO) (EudraCT2020-005270-10)

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