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Sitokiren - Shanghai Pharmaceuticals Holding

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Drug Profile

Sitokiren - Shanghai Pharmaceuticals Holding

Alternative Names: I-001; I001-A; I001-B; MT-2765; Sitokiren malate - Shanghai Pharmaceuticals Holding; SPH-3127

Latest Information Update: 31 Dec 2025

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At a glance

  • Originator Shanghai Pharmaceuticals Holding; Tanabe Pharma Corporation
  • Developer Shanghai Pharmaceuticals Holding
  • Class Amides; Anti-inflammatories; Antihypertensives; Carbamates; Cyclopropanes; Morpholines; Pyrazoles; Pyridines; Small molecules
  • Mechanism of Action Renin inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Essential hypertension
  • Phase II Diabetic nephropathies; Ulcerative colitis

Most Recent Events

  • 31 Dec 2025 Launched for Essential hypertension in China (PO), in December 2025 (Shanghai Pharmaceuticals Holding pipeline, December 2025)
  • 09 Dec 2025 Registered for Essential hypertension in China (PO) - First global approval
  • 09 Dec 2025 Pharmacodynamics data from a preclinical trials in Hypertension released by Shanghai Pharmaceutical Holding

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