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  • ||||||||||  hydronidone (F351) / Gyre Therapeutics, pirfenidone / Generic mfg.
    Review, Journal:  TGF-? inhibitors: the future for prevention and treatment of liver fibrosis? (Pubmed Central) -  Jul 14, 2025   
    In clinical trials, drugs such as Pirfenidone and Hydronidone have demonstrated potential for fibrosis reversal in patients with chronic hepatitis. Although TGF-?-targeted therapy has made breakthroughs in basic research and clinical translation, future studies need to focus on multi-target drug design, personalized treatment regimens, and novel delivery systems to accelerate the transition from preclinical research to clinical application, providing innovative therapeutic strategies for liver fibrosis and related liver diseases.
  • ||||||||||  hydronidone (F351) / Catalyst Biosci
    Review, Journal:  Mechanism-guided drug development and treatment for liver fibrosis: a clinical perspective. (Pubmed Central) -  Jun 10, 2025   
    Moreover, multi-pathway guided combination therapy or traditional Chinese medicine demonstrate significant advantages in combating liver fibrosis. Finally, new technologies and approaches affecting the clinical development of anti-hepatic fibrosis drugs were discussed.
  • ||||||||||  entecavir / Generic mfg., hydronidone (F351) / Catalyst Biosci
    P3 data, Journal:  Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial. (Pubmed Central) -  May 19, 2025   
    Our Phase 2 trial of hydronidone for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis showed that adding hydronidone to entecavir resulted in significant reversal of liver fibrosis...The primary endpoint of the trial is to demonstrate the efficacy of fibrosis reversal, defined as a decrease in the Ishak stage score of liver fibrosis by ?1 after 52 weeks of treatment, compared to baseline. The results of this trial are expected to further support the antifibrotic indication for this novel drug.
  • ||||||||||  Review, Journal:  Advances in Development of Drug Treatment for Hemophilia with Inhibitors. (Pubmed Central) -  Dec 19, 2024   
    All of these agents are administered subcutaneously, with some offering the convenience of less frequent dosing (e.g., weekly or monthly). These potential drug candidates may provide significant benefits for the prophylaxis or treatment of bleeding disorders in patients with hemophilia and inhibitors.
  • ||||||||||  hydronidone (F351) / Catalyst Biosci
    Trial completion date, Trial primary completion date:  Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial. (clinicaltrials.gov) -  Aug 9, 2024   
    P3,  N=248, Recruiting, 
    These potential drug candidates may provide significant benefits for the prophylaxis or treatment of bleeding disorders in patients with hemophilia and inhibitors. Trial completion date: Jun 2024 --> Jan 2025 | Trial primary completion date: Mar 2024 --> Oct 2024
  • ||||||||||  hydronidone (F351) / Catalyst Biosci
    Enrollment open:  Hydronidone Capsules in Long-term Treatment in Patients With Chronic Viral Hepatitis B Liver Fibrosis (clinicaltrials.gov) -  Jan 17, 2024   
    P3,  N=248, Recruiting, 
    No statistically significant difference in treatment response between MarzAA and intravenous SoC was identified, indicating the potential of MarzAA for treatment of episodic bleeding events with a favorable subcutaneous administration route. Not yet recruiting --> Recruiting
  • ||||||||||  AZD1466 / AstraZeneca, Catalyst Biosci, anatabine (RCP-006) / Rock Creek Pharma
    Preclinical, Journal:  Nicotine-mediated effects in neuronal and mouse models of synucleinopathy. (Pubmed Central) -  Sep 18, 2023   
    Moreover, when investigating the role of nicotinic acetylcholine receptor (nAChR) signaling in nicotine's neuroprotective effects in iPSC-derived dopaminergic neurons, we observed that while ?4-specific antagonists reduced the nicotine-induced calcium response, ?4 agonists (e.g., AZD1446 and anatabine) mediated similar neuroprotective responses against ?-Syn PFF-provoked neurodegeneration. Our results show that nicotine attenuates ?-Syn-provoked neuropathology in vivo and in a humanized neuronal model of synucleinopathy and that activation of ?4?2 nicotinic receptors might mediate these neuroprotective effects.
  • ||||||||||  TC-2429 / Catalyst Biosciences
    Journal:  Short- and Long-Term Effects of Cocaine on Enteric Neuronal Functions. (Pubmed Central) -  Feb 26, 2023   
    Key results obtained are that cocaine (1) exhibits a stimulating, non-neuronal effect on gastric antrum motility, (2) acutely (but not chronically) diminishes responses of primary cultured enteric neurons to nicotinic and serotonergic stimulation and (3) reversibly attenuates neuronal-mediated intestinal mucosal secretion. It can be concluded that cocaine, among its central effects, also alters enteric neuronal functions, providing potential explanations for the coexistence of cocaine abuse and gastrointestinal complaints.
  • ||||||||||  marzeptacog alfa (CB 813d) / Catalyst Biosci
    P3 data, PK/PD data, Journal:  Phase-3 Dose Selection of Marzeptacog Alfa (Activated) Informed by Population Pharmacokinetic Modeling: A Novel Hemostatic Drug. (Pubmed Central) -  Oct 4, 2022   
    According to the Phase-3 protocol, if a second dose was required after three hours due to lack of efficacy, 90% of the population was observed to be above target six hours after the initial dose. The model-informed drug development approach integrated information from several trials and guided dose selection in the pivotal Phase-3 clinical trial for episodic treatment of an acute bleeding event in individuals with HA or HB with inhibitors, without the execution of a Phase-2 trial for that indication.
  • ||||||||||  hydronidone (F351) / Catalyst Biosci
    Trial completion, Enrollment change:  A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis (clinicaltrials.gov) -  Jun 23, 2022   
    P2,  N=168, Completed, 
    The model-informed drug development approach integrated information from several trials and guided dose selection in the pivotal Phase-3 clinical trial for episodic treatment of an acute bleeding event in individuals with HA or HB with inhibitors, without the execution of a Phase-2 trial for that indication. Unknown status --> Completed | N=240 --> 168
  • ||||||||||  ispronicline (AZD3480) / AstraZeneca
    Journal:  Nicotine-like discriminative and aversive effects of two α4β2-selective nicotine agonists, ispronicline and metanicotine. (Pubmed Central) -  Feb 15, 2022   
    Both ispronicline and metanicotine as well as nicotine were avoided in the drug + food vs. food choice situation. The receptor-selective nature of ispronicline and metanicotine was hereby confirmed in a behavioral assay, as were earlier reports that the discriminative stimulus effects of relatively small doses of nicotine are likely mediated by activity at the α4β2* nicotine receptor.
  • ||||||||||  arecoline / Cogent
    Journal:  Nicotinic aspects of the discriminative stimulus effects of arecoline. (Pubmed Central) -  Feb 15, 2022   
    These data indicate a selective α4β2* nicotine receptor component to the behavioral effects of arecoline. Although the nicotinic aspects of arecoline's behavior effects could suggest that abuse of arecoline-containing material (e.g. betel nut chewing) is mediated through nicotinic rather than muscarinic actions, further research, specifically on the reinforcing effects of arecoline, is necessary before this conclusion can be supported.
  • ||||||||||  marzeptacog alfa (CB 813d) / GC Biopharma
    Trial termination:  Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Inherited Bleeding Disorders (clinicaltrials.gov) -  Dec 21, 2021   
    P1/2,  N=19, Terminated, 
    Although the nicotinic aspects of arecoline's behavior effects could suggest that abuse of arecoline-containing material (e.g. betel nut chewing) is mediated through nicotinic rather than muscarinic actions, further research, specifically on the reinforcing effects of arecoline, is necessary before this conclusion can be supported. Recruiting --> Terminated; Company decision (not a safety issue)
  • ||||||||||  marzeptacog alfa (CB 813d) / GC Biopharma
    Enrollment change, Trial completion date, Trial termination:  Study of Coagulation Factor VIIa Marzeptacog Alfa (Activated) in Subjects With Hemophilia A or B (clinicaltrials.gov) -  Dec 17, 2021   
    P3,  N=18, Terminated, 
    Recruiting --> Terminated; Company decision (not a safety issue) N=60 --> 18 | Trial completion date: Mar 2022 --> Dec 2021 | Recruiting --> Terminated; Sponsor decision (not a safety decision)
  • ||||||||||  dalcinonacog alfa (CB2679d) / ISU Abxis, Catalyst Biosci, CB 2679-GT / Catalyst Biosci
    Journal:  Gene Therapy For Hemophilia B Using CB 2679d-GT: A Novel Factor IX Variant With Higher Potency Than Factor IX Padua. (Pubmed Central) -  Dec 16, 2021   
    FIX expression was sustained for at least 20 weeks with both CB 2679d-GT and R338L-Padua while immunogenicity was not significantly increased. This is a novel gene therapy study demonstrating the superiority of CB 2679d-GT highlighting its potential to obtain higher FIX activity levels and superior hemostatic efficacy following AAV directed gene therapy in hemophilia B patients than what is currently achievable with the R338L-Padua variant.
  • ||||||||||  dalcinonacog alfa (CB2679d) / ISU Abxis, Catalyst Biosci
    Clinical, Journal:  Efficacy and safety of subcutaneous prophylaxis with dalcinonacog alfa in adults with haemophilia B. (Pubmed Central) -  Sep 26, 2021   
    Taken together, these data provide robust nonclinical evidence that a single dose of SQ MarzAA may be successful in treat ing episodic bleeding when administered after bleeding has started. Subcutaneous dalcinonacog alfa is effective in raising FIX levels into the mild haemophilia range, comparable to intravenous extended half-life FIX clotting factors.
  • ||||||||||  marzeptacog alfa (CB 813d) / Catalyst Biosciences
    [VIRTUAL] Subcutaneous Marzeptacog Alfa (Activated) is Effective Treatment of Bleeding in FVII Deficient Rats (Room 3) -  Jun 9, 2021 - Abstract #ISTH2021ISTH_1067;    
    Methods : Sprague Dawley rats were treated with intravenous (IV) vehicle or warfarin 0.3 mg/kg to induce FVIID...Rats were placed under isoflurane anesthesia for the TVT procedure...Conclusions : SQ MarzAA successfully treated induced bleeding in FVIID rats. These results provide robust nonclinical evidence that SQ MarzAA has the potential for prophylaxis or on-demand treatment of bleeding in patients with FVIID.
  • ||||||||||  marzeptacog alfa (CB 813d) / Catalyst Biosciences
    [VIRTUAL] Dose Selection of Marzeptacog Alfa (Activated) in Children with Hemophilia: A Population Pharmacokinetic Exposure Matching Strategy (Room 3) -  Jun 9, 2021 - Abstract #ISTH2021ISTH_817;    
    Results : The relationship between MarzAA CL and BW was found to be non-linear with higher CL/kg at lower BW (Figure 1), with most of the non-linear trend below 14 kg, corresponding to the median BW in children of 2 years of age as described in The National Health and Nutrition Examination Survey (NHANES) database.Across all age groups using a single 60 μg/kg dose, the lower bound of the 95% PI of AUC0-24h in pediatrics was only slightly lower compared to that of adults, and a similar pattern was observed for Cmax (Figure 2), indicating comparable exposure across pediatric age groups compared to adults. Conclusions : The simulations support selecting a SQ dose of 60 μg/kg MarzAA in a clinical trial with pediatric subjects with HA/HB with inhibitors.
  • ||||||||||  dalcinonacog alfa (CB2679d) / ISU Abxis, Catalyst Biosci
    [VIRTUAL] Mitigation of Injection Site Reactions after Subcutaneous Administration of Dalcinonacog Alfa (DalcA) in Hemophilia B Using Preclinical Models (Room 3) -  Jun 9, 2021 - Abstract #ISTH2021ISTH_812;    
    A biomarker signature predictive of minipig ISR was generated from the cross comparison of cutaneous proteomes of minipig and ex vivo human skin models. Conclusions : This approach of integrating ex vivo and in vitro studies with a defined biomarker signature coupled with a drug product stability profile facilitated identification of an improved formulation buffer expected to lower the risk of clinical ISR with SQ DalcA injection without impacting DalcA product quality.
  • ||||||||||  hydronidone (F351) / Catalyst Biosci
    Trial completion, Trial completion date:  Study on Pharmacokinetics of Hydronidone (clinicaltrials.gov) -  Mar 24, 2021   
    P1,  N=48, Completed, 
    Based on the results, a Phase 2b trial to assess the safety and efficacy of 28 daily SQ doses of DalcA was performed. Enrolling by invitation --> Completed | Trial completion date: May 2020 --> Mar 2021
  • ||||||||||  hydronidone (F351) / Catalyst Biosci
    Trial completion, Trial completion date, Trial primary completion date:  Study on PK of Hydronidone in Patients and Special Population (clinicaltrials.gov) -  Mar 24, 2021   
    P1,  N=8, Completed, 
    Enrolling by invitation --> Completed | Trial completion date: May 2020 --> Mar 2021 Recruiting --> Completed | Trial completion date: Jun 2020 --> Jan 2021 | Trial primary completion date: Mar 2020 --> Oct 2020