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GYRE THERAPEUTICS, INC. (GYRE)

Gyre Therapeutics, Inc. is a pharmaceutical company dedicated to discovering, advancing, and bringing to market small-molecule drugs that target inflammation and fibrosis in various organs. The company's key anti-fibrotic medication, ETUARY (Pirfenidone), has received approval for treating idiopathic pulmonary fibrosis. Beyond this, ETUARY is also undergoing late-stage (Phase 3) clinical trials for several other conditions, including dermatomyositis and interstitial lung disease linked to systemic sclerosis, pneumoconiosis, and diabetic kidney disease. The company's pipeline further includes F351 (Hydronidone), a compound structurally related to ETUARY. F351 is currently in Phase 3 studies for chronic hepatitis B-induced liver fibrosis and is in Phase 1 trials for liver fibrosis associated with nonalcoholic associated steatohepatitis (NASH). Other programs in development feature F573, which is progressing through Phase 2 studies for acute and acute-on-chronic liver failure. Additionally, two early-stage candidates, F528 and F230, are in preclinical development, focusing on chronic obstructive pulmonary disease (COPD) and pulmonary arterial hypertension (PAH), respectively. Established in 2002, Gyre Therapeutics, Inc. is based in San Diego, California, and operates as a subsidiary of GNI USA, Inc.

Sector: Pharmaceutical Preparations

Industry: Biotechnology

Gyre Therapeutics, Inc. logo

Gyre Therapeutics, Inc.

NASDAQ:GYREHealthcare
-28.94%$4.55
AH$4.60+0.99%vs close
Mkt Cap$507.93M
Float16.76M
O/S111.51M
Vol
$ Vol
RVOL
Inst Own7.8%
SI11.5%
Earnings
Dilution
Gyre Therapeutics, Inc. logoNASDAQ:GYRE$4.55-28.94%
Phase Distribution
37 lead-sponsored trials·1 active·27 completed
Phase 15
Phase 1/23
Phase 218
Phase 2/31
Phase 36
Not applicable4
(13 more as collaborator)
Status Overview
Recruiting1
Completed27
Stopped8
Expanded access1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Completed

    A Phase 3 Study of Amifampridine Phosphate in Patients With Lambert Eaton Myasthenic Syndrome (LEMS)

    Amifampridine Phosphate, Placebo

    Lambert Eaton Myasthenic Syndrome

    Enrollment
    38
    Start
    Jun 2011
    Primary Completion
    Jul 2016
    Completion
    Jul 2016
    NCT01377922
  • Phase 3
    Completed

    Amifampridine Phosphate for the Treatment of Congenital Myasthenic Syndromes

    amifampridine phosphate, Placebo

    Myasthenic Syndromes, Congenital

    Enrollment
    20
    Start
    Jan 2016
    Primary Completion
    Aug 2019
    Completion
    Oct 2019
    NCT02562066
  • Phase 3
    Completed

    Phase 3 Study to Evaluate Efficacy of Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS)

    Amifampridine Phosphate, Placebo Oral Tablet

    Lambert-Eaton Myasthenic Syndrome

    Enrollment
    26
    Start
    Nov 2016
    Primary Completion
    Oct 2017
    Completion
    Oct 2017
    NCT02970162
  • Phase 3
    Completed

    Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MG

    Amifampridine Phosphate, Placebo Oral Tablet

    Myasthenia Gravis, Generalized

    Enrollment
    93
    Start
    Apr 2018
    Primary Completion
    Jan 2020
    Completion
    Mar 2020
    NCT03304054
  • Phase 3
    Terminated

    Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)

    Amifampridine Phosphate

    Myasthenia Gravis, MuSK, AChR Myasthenia Gravis

    Enrollment
    63
    Start
    Jun 2018
    Primary Completion
    Aug 2022
    Completion
    Aug 2022
    NCT03579966
  • Phase 3
    Terminated

    Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B

    MarzAA

    Hemophilia A With Inhibitor, Hemophilia B With Inhibitor

    Enrollment
    18
    Start
    May 2021
    Primary Completion
    Nov 2021
    Completion
    Dec 2021
    NCT04489537
  • Phase 2/3
    Completed

    Vigabatrin for the Treatment of Cocaine Dependency

    Vigabatrin, Matching Placebo

    Cocaine Addiction, Cocaine Dependence

    Enrollment
    207
    Start
    Jan 2011
    Primary Completion
    Oct 2012
    Completion
    Dec 2012
    NCT01281202
  • Phase 2
    Completed

    A Safety and Efficacy Study of Ispronicline (TC-1734-112) in Subjects With Age Associated Memory Impairment (AAMI)

    ispronicline (nicotinic acetylcholine receptor agonist)

    Age-Related Memory Disorders

    Enrollment
    174
    Start
    Jan 2005
    Primary Completion
    -
    Completion
    Oct 2005
    NCT00109564
  • Phase 2
    Completed

    Flexible Dose Titration Add-on Study to Treat Major Depressive Disorder

    Mecamylamine

    Major Depressive Disorder

    Enrollment
    450
    Start
    Feb 2005
    Primary Completion
    -
    Completion
    Aug 2006
    NCT00593879
  • Phase 2
    Completed

    Vigabatrin for Treatment of Cocaine Dependence

    vigabatrin, placebo

    Cocaine Dependence

    Enrollment
    186
    Start
    Jan 2008
    Primary Completion
    May 2009
    Completion
    Oct 2012
    NCT00611130
  • Phase 2
    Completed

    TC-5214 as add-on the Treatment of Major Depressive Disorder

    TC-5214 + citalopram, Placebo + citalopram

    Major Depressive Disorder, Depression

    Enrollment
    574
    Start
    Jun 2008
    Primary Completion
    May 2009
    Completion
    Jul 2009
    NCT00692445
  • Phase 2
    Terminated

    Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence

    CPP-109 vigabatrin, Matching Placebo

    Methamphetamine Dependence

    Enrollment
    55
    Start
    Jul 2008
    Primary Completion
    Jun 2009
    Completion
    Nov 2009
    NCT00730522
  • Phase 2
    Completed

    TC-5619 as Augmentation Therapy to Improve Cognition in Outpatients With Cognitive Dysfunction in Schizophrenia

    TC-5619, Placebo

    Cognitive Dysfunction, Schizophrenia

    Enrollment
    184
    Start
    Oct 2009
    Primary Completion
    Nov 2010
    Completion
    Dec 2010
    NCT01003379
  • Phase 2
    Completed

    Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)

    TC-5619-238, Placebo

    ADHD

    Enrollment
    134
    Start
    May 2010
    Primary Completion
    Feb 2011
    Completion
    Feb 2011
    NCT01124708
  • Phase 2
    Completed

    Proof-of-Principle Study of TC-6499 in the Treatment of Constipation Predominant Irritable Bowel Syndrome (IBS)

    TC-6499, Placebo

    Irritable Bowel Syndrome

    Enrollment
    24
    Start
    May 2010
    Primary Completion
    Oct 2010
    Completion
    Oct 2010
    NCT01149200
  • Phase 2
    Completed

    Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus

    TC-6987, Placebo

    Type 2 Diabetes Mellitus

    Enrollment
    440
    Start
    Jan 2011
    Primary Completion
    Jan 2012
    Completion
    Jan 2012
    NCT01293669
  • Phase 2
    Completed

    TC-6987 for the Treatment of Mild to Moderate Asthma

    TC-6987, Placebo

    Asthma

    Enrollment
    203
    Start
    Feb 2011
    Primary Completion
    Jan 2012
    Completion
    Jan 2012
    NCT01296087
  • Phase 2
    Completed

    Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)

    Donepezil, AZD3480

    Alzheimer's Disease

    Enrollment
    386
    Start
    Oct 2011
    Primary Completion
    May 2014
    Completion
    May 2014
    NCT01466088
  • Phase 2
    Completed

    Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)

    TC-5619-238 5mg, TC-5619-238 25mg

    Attention Deficit Hyperactivity Disorder

    Enrollment
    250
    Start
    Nov 2011
    Primary Completion
    Jul 2012
    Completion
    Jul 2012
    NCT01472991
  • Phase 2
    Completed

    Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia

    TC-5619, Placebo

    Schizophrenia, Negative Symptoms +1

    Enrollment
    603
    Start
    Dec 2011
    Primary Completion
    Nov 2013
    Completion
    Nov 2013
    NCT01488929
  • Phase 2
    Completed

    Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder

    dexmecamylamine, Placebo

    Overactive Bladder

    Enrollment
    1,635
    Start
    May 2013
    Primary Completion
    Jun 2014
    Completion
    Jun 2014
    NCT01868516
  • Phase 2
    Completed

    Study of Coagulation Factor VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia A and B

    Coagulation Factor VIIa variant

    Hemophilia A With Inhibitor, Hemophilia B With Inhibitor

    Enrollment
    11
    Start
    Dec 2017
    Primary Completion
    Mar 2019
    Completion
    Apr 2019
    NCT03407651
  • Phase 2
    Completed

    Controlled Trial to Evaluate Amifampridine Phosphate in Spinal Muscular Atrophy Type 3 Patients

    Amifampridine Phosphate, Placebo Oral Tablet

    Muscular Atrophy, Spinal

    Enrollment
    13
    Start
    Jan 2019
    Primary Completion
    Jul 2020
    Completion
    Jul 2020
    NCT03781479
  • Phase 2
    Terminated

    Long Term Safety of Amifampridine Phosphate in Spinal Muscular Atrophy 3

    Amifampridine Phosphate 10 MG Oral Tablet

    Spinal Muscular Atrophy Type 3

    Enrollment
    13
    Start
    Mar 2019
    Primary Completion
    Sep 2021
    Completion
    Sep 2021
    NCT03819660
  • Phase 2
    Completed

    Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B

    Coagulation Factor IX variant, Coagulation Factor IX variant

    Hemophilia B

    Enrollment
    6
    Start
    Jun 2019
    Primary Completion
    Feb 2020
    Completion
    Apr 2020
    NCT03995784

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