Ztalmy (ganaxolone oral) / Marinus 
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 6 Diseases   3 Trials   3 Trials   392 News 


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  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Journal:  Ganaxolone: A New Treatment for CDKL5 Deficiency Disorder. (Pubmed Central) -  Nov 26, 2022   
    Ganaxolone was generally well-tolerated in the OLE with safety findings consistent with the double-blind phase. No abstract available
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Journal:  Ganaxolone versus phenobarbital for neonatal seizure management. (Pubmed Central) -  Nov 19, 2022   
    Ganaxolone provided better seizure control than phenobarbital in this perinatal asphyxia model and was neuroprotective for the newborn brain, affording a new therapeutic opportunity for treatment of neonatal seizures. ANN NEUROL 2022;92:1066-1079.
  • ||||||||||  progesterone / Generic mfg.
    Review, Journal:  Many or too many progesterone membrane receptors? Clinical implications. (Pubmed Central) -  Nov 18, 2022   
    CT1812 (Elayta™) is also being tested for the treatment of Alzheimer's disease (AD) in Phase 2 clinical trials, targeting the P4 receptor membrane component 1 (PGRMC1)/S2R complex. In this Review, we highlight emerging knowledge on the mechanisms of nongenomically initiated actions of P4 and its derivatives.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus, Dojolvi (triheptanoin) / Ultragenyx
    Journal:  Updates on the diagnostic evaluation, genotype-phenotype correlation, and treatments of genetic epilepsies. (Pubmed Central) -  Nov 4, 2022   
    There has been interest in using the neurosteroid ganaxolone for various genetic epilepsy syndromes, with clear efficacy in certain trials. Triheptanoin for epilepsy secondary to glucose transporter 1 ( GLUT1 ) deficiency syndrome is not clearly effective but further studies will be needed.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Trial completion date, Trial initiation date, Trial primary completion date:  Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old (clinicaltrials.gov) -  Oct 31, 2022   
    P3,  N=20, Not yet recruiting, 
    Triheptanoin for epilepsy secondary to glucose transporter 1 ( GLUT1 ) deficiency syndrome is not clearly effective but further studies will be needed. Trial completion date: Oct 2023 --> Dec 2024 | Initiation date: Apr 2022 --> May 2023 | Trial primary completion date: Oct 2023 --> Dec 2024
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Trial completion, Trial completion date:  Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B) (clinicaltrials.gov) -  Oct 31, 2022   
    P2,  N=24, Completed, 
    Trial completion date: Oct 2023 --> Dec 2024 | Initiation date: Apr 2022 --> May 2023 | Trial primary completion date: Oct 2023 --> Dec 2024 Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Aug 2022
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Journal:  Ganaxolone. (Pubmed Central) -  Oct 25, 2022   
    Active, not recruiting --> Completed | Trial completion date: Dec 2021 --> Aug 2022 No abstract available
  • ||||||||||  Zulresso (brexanolone) / Sage Therapeutics, Ztalmy (ganaxolone oral) / Marinus, zuranolone (SAGE-217) / Sage Therapeutics, Shionogi, Biogen
    Journal:  Neuroactive steroids - new possibilities in the treatment of postpartum depression. (Pubmed Central) -  Oct 16, 2022   
    In the case of severe depression, the patient is switched to pharmacological treatment, with sertraline being the most commonly used for this diagnosis...In addition to the registered brexanolone, another steroidal drug, zuranolone, is available in the third phase of the clinical trial...Another synthetic analogue of neuroactive allopregnanolone, known as ganaxolone, did not show a significant reduction in depressive symptoms in the second phase of the clinical trial compared to placebo. Nevertheless, it has great therapeutic potential in the treatment of various types of epilepsy.
  • ||||||||||  Differential network activity of benzodiazepines and neuroactive steroids observed with cortical EEG in rat. (SDCC Halls B-H) -  Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_4742;    
    Increased θ-band power was observed clinically with zuranolone (Antonoudiou 2022), whereas reduced θ-band power was reported in humans with lorazepam (Gilles 2002)...All compounds increased β-band power. The differential effects on θ-band power in rat EEG recordings between NAS GABAAR PAMs and the other GABAergic compounds tested may reflect the differential modulation of GABAAR subpopulations, since only the NAS GABAAR PAMs in this study modulate both γ and δ subunit-containing GABAARs.
  • ||||||||||  Journal:  Current and future pharmacotherapy options for drug-resistant epilepsy. (Pubmed Central) -  Sep 30, 2022   
    For specific epilepsy syndromes, XEN 496 is under Phase III development for potassium voltage-gated channel subfamily Q member 2 developmental and epileptic encephalopathy (KCNQ2-DEE), carisbamate is under Phase III development for LGS and Ganaxolone under Phase III development for TSC. Finally, in preclinical models several molecular targets including inhibition of glycolysis, neuroinflammation and sodium channel inhibition have been identified in animal models although further data in animal and later human studies are needed.
  • ||||||||||  Diacomit (stiripentol) / Biocodex, Meiji Seika, Ztalmy (ganaxolone oral) / Marinus
    Review, Journal:  Adjuvant Treatment for Protocadherin 19 (PCDH19) Syndrome. (Pubmed Central) -  Aug 26, 2022   
    A ketogenic diet has been studied to treat several refractory epilepsies, including PCDH19; it has promising results as effective adjuvant therapy in the resolution of status epilepticus, suggesting it could be used as part of the treatment in early childhood. Stiripentol was given as adjuvant therapy in a patient with PCDH19 epilepsy resulting in the most extended period of seizure-free episodes, but more studies must be performed to assess its efficacy.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Review, Journal:  Epilepsy and cognitive impairment in childhood and adolescence: A Mini review. (Pubmed Central) -  Jul 9, 2022   
    In addition to conventional antiseizure medications (ASMs), ketogenic diet, hormone therapy and epilepsy surgery play an important role especially in cases of drug resistance. This review aims to provide a comprehensive overview of the mainfactors influencing cognition in children and adolescents with epilepsy and the main therapeutic options available for the epilepsies associated with intellectual disability.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Review, Journal:  Ganaxolone: First Approval. (Pubmed Central) -  Jun 23, 2022   
    Oral ganaxolone is also currently undergoing phase III evaluation in the treatment of tuberous sclerosis complex-related epilepsy, while an intravenous formulation of ganaxolone is being evaluated in refractory status epilepticus. This article summarizes the milestones in the development of ganaxolone leading to this first approval for seizures associated with CDD.
  • ||||||||||  Review, Journal:  GABAkines - Advances in the discovery, development, and commercialization of positive allosteric modulators of GABA receptors. (Pubmed Central) -  May 19, 2022   
    Traditional GABAkines like diazepam have safety and tolerability concerns that include sedation, motor-impairment, respiratory depression, tolerance and dependence...The compounds that are presently being developed and commercialized include several neuroactive steroids (an allopregnanolone formulation (brexanolone), an allopregnanolone prodrug (LYT-300), Sage-324, zuranolone, and ganaxolone), the α2/3-preferring GABAkine, KRM-II-81, and the α2/3/5-preferring GABAkine PF-06372865 (darigabat)...Medicinal chemistry efforts are also ongoing to identify novel and improved GABAkines. The data document gaps in our understanding of the molecular pharmacology of GABAkines that drive differential pharmacological profiles, but emphasize advancements in the ability to successfully utilize GABA receptor potentiation for therapeutic gain in neurology and psychiatry.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Journal:  Examining Neurosteroid-Analogue Therapy in the Preterm Neonate For Promoting Hippocampal Neurodevelopment. (Pubmed Central) -  May 7, 2022   
    We found that of the three doses, only the highest dose of ganaxolone (2.5 mg/kg) impaired key indicators of physical health and wellbeing over extended periods of time. Whilst it may be too early to see improvements in markers of neurodevelopment, further long-term study utilising the lower doses are warranted to assess functional outcomes at ages when preterm birth associated behavioural disorders are observed.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    P2/3 data, Clinical Trial,Phase III, Journal:  Epilepsy: Expert opinion on emerging drugs in phase 2/3 clinical trials. (Pubmed Central) -  Apr 6, 2022   
    Novel mechanisms of action involve cholesterol degradation, mitochondrial pathways, anti-inflammation and neuro-regeneration. Earlier identification of genetic conditions through genetic testing will allow for earlier use of disease specific and disease-modifying therapies.
  • ||||||||||  KRM-81 / RespireRx, Ztalmy (ganaxolone oral) / Marinus
    Review, Journal:  The imidazodiazepine, KRM-II-81: An example of a newly emerging generation of GABAkines for neurological and psychiatric disorders. (Pubmed Central) -  Mar 9, 2022   
    These GABAkines and non-steroid compounds (GRX-917, a TSPO binding site ligand), darigabat (CVL-865), an α2/3/5-preferring GABAkine, SAN711, an α3-preferring GABAkine, and the α2/3-preferring GABAkine, KRM-II-81, bring new therapeutic promise to this highly utilized medicinal target in neurology and psychiatry...KRM-II-81 also produces anxiolytic- and antidepressant-like effects in rodent models. Other key features of the pharmacology of this compound are its low sedation rate, lack of tolerance development, and the ability to prevent the development of seizure sensitization.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Aggregated Safety and Tolerability Experience from the Ganaxolone Development Program (Poster Hall) -  Mar 6, 2022 - Abstract #AAN2022AAN_2727;    
    Ganaxolone was generally well tolerated with somnolence reported as the most common adverse event. The experience with the investigational use of ganaxolone in studies conducted to date suggests an acceptable tolerability and safety profile.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Clinical, Journal:  Ganaxolone treatment for epilepsy patients: from pharmacology to place in therapy. (Pubmed Central) -  Feb 1, 2022   
    The availability of oral and intravenous formulations allows reaching adult and pediatric patients in acute and chronic care settings. Further evidence will complement the understanding of the potentialities of GNX and possibly lead to indications for use in clinical practice.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Aggregated Safety and Tolerability Experience from the Ganaxolone Development Program () -  Dec 12, 2021 - Abstract #AES2021AES_1139;    
    Larger studies may further elucidate the potential of ganaxolone as a treatment for seizures associated with LGS. The experience with the investigational use of ganaxolone in studies conducted to date suggests an acceptable tolerability and safety profile.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Effect of Ganaxolone on Quality of Life in Children with the CDKL5 Deficiency Disorder () -  Dec 12, 2021 - Abstract #AES2021AES_959;    
    Along with a reduction in frequency of major motor seizures, children who received ganaxolone had higher QOL scores than children in the placebo group when controlling for potential confounding factors although the estimates lacked precision. Future analysis of the Marigold data will investigate the reasons for improved QOL following administration of ganaxolone.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Investigational Ganaxolone in the Treatment of Refractory Seizure Disorders (W474b) -  Dec 12, 2021 - Abstract #AES2021AES_369;    
    Due to seizure cluster fluctuation in PCDH19-CE, novel epilepsy clinical trial designs may be needed for future studies. OVERVIEW:Visitors to this Scientific Exhibit will learn about Marinus' current findings of ganaxolone in the treatment of rare acute and chronic seizure disorders, the Marinus research pipeline, and Marinus' goals in treating refractory seizures. Exhibitor: Marinus Pharmaceuticals, Inc.
  • ||||||||||  Ztalmy (ganaxolone oral) / Marinus
    Review, Journal:  Expanding the Treatment Landscape for Lennox-Gastaut Syndrome: Current and Future Strategies. (Pubmed Central) -  Nov 24, 2021   
    Other treatments in clinical development include fenfluramine in late phase III, perampanel, soticlestat-OV953/TAK-953, carisbamate and ganaxolone...Because LGS is not a single entity, tailoring of treatment is needed as opposed to a 'one size fits all' approach. Further research is needed into the underlying aetiologies and pathophysiology of LGS, together with advancements in treatments that encompass the spectrum of seizures associated with this complex syndrome.