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Seralutinib - Gossamer Bio

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Drug Profile

Seralutinib - Gossamer Bio

Alternative Names: GB-002; PK-10571

Latest Information Update: 19 Jun 2025

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At a glance

  • Originator YM BioSciences
  • Developer Gossamer Bio
  • Class Amides; Pyrazines; Pyridines; Small molecules
  • Mechanism of Action Macrophage colony stimulating factor inhibitors; Platelet-derived growth factor alpha receptor antagonists; Platelet-derived growth factor beta receptor antagonists; Proto-oncogene protein c-kit inhibitors
  • Orphan Drug Status

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

    Yes - Pulmonary arterial hypertension
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Pulmonary arterial hypertension

Most Recent Events

  • 16 Jun 2025 Gossamer Bio completes enrolment in the phase III PROSERA trial in Pulmonary arterial hypertension (Treatment-experienced) in the US, Argentina, Australia, Austria, Belgium, Brazil, Chile, Czech Republic, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Latvia, Lithuania, Mexico, the Netherlands, Poland, Portugal, Puerto Rico, Romania, Serbia, Singapore, South Korea, Spain and the UK (Inhalation) (NCT05934526; EudraCT2023-503614-80-00)
  • 13 Mar 2025 Gossamer and Chiesi plans the global phase III SERANATA registrational trial in Pulmonary Hypertension in the second half of 2025
  • 31 Jan 2025 Seralutinib - Gossamer Bio receives Orphan Drug status for Pulmonary arterial hypertension in Japan

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