R&D Towards better quality of life, GNT Pharma

Overview

Road Map and Status for Pharmaceutical Development
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Road Map and Status for Pharmaceutical Development
  • 01 Discovering new drug candidates

    Discovery of the NMDA receptor blocking action of aspirin.

    Discovery of the NMDA receptor blocking and antioxidant actions of sulfasalazine (a drug used to treat enteritis and arthritis).

    Generation of GNT’s ligand- and structure-based new chemical entity (NCE) library to support the multi-targeting treatment of neurological diseases.

    Development of nelonemdaz (2nd generation NMDA blocker + antioxidant) as a NCE drug candidate for acute ischemic stroke

    Development of crisdesalazine (microsomal prostaglandin E-1 synthase inhibitor + antioxidant) as a NCE drug candidate for disease-modifying treatment of degenerative brain diseases.

    Development of flusalazine (microsomal prostaglandin E-1 synthase inhibitor + antioxidant) as a NCE drug candidate for inflammatory diseases, COPD, or asthma.

  • 02 Non-clinical research

    Examination of drug candidate safety and efficacy in animal models of targeted diseases.

    Research on ADME (absorption-distribution-metabolism-elimination) and toxicities for clinical entry.

    Determination of clinical dosage based on pharmacokinetic and pharmacodynamic studies.

    Development of drug substance (API) and clinical formulation (DP).

    Identification of biomarkers to aid clinical studies of safety and efficacy.

  • 03 Clinical Research-Approval-Post-marketing Surveillance (PMS)

    Successful execution of clinical studies in accordance with the Korea Good Clinical Practice (KGCP) for Drugs (Ministry of Food and Drug Safety) and the KGCP for Veterinary Drugs (Animal and Plant Quarantine Agency).

    1. Phase III clinical study of nelonemdaz in acute ischemic stroke patients undergoing surgical thrombectomy within 12 hours of ischemia onset (RODIN)
    2. Phase III clinical study of nelonemdaz in acute ischemic stroke patients undergoing medical thrombolytic therapy within 8 hours of ischemia onset (ENIS III)
    3. Phase II clinical study of nelonemdaz as a brain protective agent in patients resuscitated after cardiac arrest (AWAKE)
    4. Phase 1b clinical study of crisdesalazine in Korea
    5. IND preparation and Phase I clinical testing of flusalazine in Korea
    6. PMS on GedaCure Chewable Tab, approved and marketed in Korea for the treatment of canine cognitive dysfunction syndrome
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Pipeline Pre-clinical study Phase I
clinical study
Phase II
clinical study
Phase III
clinical study
Post-marketing surveillance (PMS)
GedaCure Chewable Tab.
Approval as a new drug for CCDS from the Animal and Plant Quarantine Agency (2021.02.)
Nelonemdaz
Ongoing phase III clinical study for stroke (ENIS III)
Ongoing phase III clinical study for stroke (RODIN)
Ongoing phase II clinical study for cardiac arrest (Korea)
Crisdesalazine
Ongoing phase 1b clinical study
Flusalazine
Ongoing Phase 1, IND Preparation