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Jazz Pharmaceuticals
Traitements, essais et publications liés.
Traitements14programmes
Essais7liés
Publications21liées
SourceDBlocale
Traitements
14| Molécule | Indication / population | Phase | Objectif | Pays | Résultat |
|---|---|---|---|---|---|
| CannabidiolThe clinical trial "A Prospective Single-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet syndrome and Lennox-Gastaut Syndrome" is a single-group phase III study done in single tertiary referral center in Seoul, Korea. Chief investigator is Dr. Hoon-Chul Kang of Severance Hospital, Yonsei University College of Medicine. Associate investigators are Dr. Heung Dong Kim, Joon Soo Lee, Se Hee Kim, Han Som Choi, Ji Hoon Na, Dong Hwa Yang, and Hee Jung Kang, of Severance Hospital, Yonsei University College of Medicine. The aim of the study is to evaluate the effect of cannabidiol (CBD-OS®) on cognitive functions in patients aged from 2 to 18 years old diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. The duration of study is planned as one year, after patient recruitment of 6 months. The intervention period in each patient is 24 weeks, with 2 weeks of medication titration, stabilization period of 10 weeks, and maintenance period of 12 weeks. The recruitment goal of patient number is 104, considering the study power of 90 percent. Primary outcomes are improvement of cognitive and development and improvement of seizure outcome. Secondary outcomes are improvement in behavior and quality of life. Safety monitoring criteria are adverse event profiles and physician's and caregiver's global assessment. Statistical analysis of outcomes is subject only to the patients who completed the 24-week medication and 2 times of tests before and after treatment of cannabidiol. Evaluation of seizure outcomes would include all patients who completed the 24-week medication and those who dropped out of the study, either by follow-up loss or discontinuation of medication due to incomplete seizure control or adverse effect of the medication. To evaluate safety, the investigators would measure adverse events and dropout rates by percentage. The investigators would analyze overall evaluation of the caregivers and investigator. Serious adverse events would be noted after causality evaluation. | Épilepsie | Phase 4 | À vérifier | United States | À vérifier |
| Cannabidiol Oral SolutionThis is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults. | Épilepsie | Phase 4 | À vérifier | United States | À vérifier |
| CBD-OSThe efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE). | Épilepsie | Phase 3 | À vérifier | À vérifier | |
| GemcitabineThe goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment). | Cancer, Parkinson | Phase 3 | À vérifier | United States, Argentina, Belgium, Brazil, Canada, Chile, China, Czechia, … | À vérifier |
| JZP926 capsuleThis study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME). | Épilepsie | Phase 2/3 | À vérifier | United States | À vérifier |
| ONC201This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials. | Cancer | À vérifier | À vérifier | United States | À vérifier |
| ZanidatamabThe purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. | Cancer | Phase 3 | À vérifier | United States, Argentina, Belgium, Brazil, Canada, Chile, China, Czechia, … | À vérifier |
| ONC201This is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials. | Cancer | À vérifier | À vérifier | United States | À vérifier |
| CannabidiolThe clinical trial "A Prospective Single-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet syndrome and Lennox-Gastaut Syndrome" is a single-group phase III study done in single tertiary referral center in Seoul, Korea. Chief investigator is Dr. Hoon-Chul Kang of Severance Hospital, Yonsei University College of Medicine. Associate investigators are Dr. Heung Dong Kim, Joon Soo Lee, Se Hee Kim, Han Som Choi, Ji Hoon Na, Dong Hwa Yang, and Hee Jung Kang, of Severance Hospital, Yonsei University College of Medicine. The aim of the study is to evaluate the effect of cannabidiol (CBD-OS®) on cognitive functions in patients aged from 2 to 18 years old diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. The duration of study is planned as one year, after patient recruitment of 6 months. The intervention period in each patient is 24 weeks, with 2 weeks of medication titration, stabilization period of 10 weeks, and maintenance period of 12 weeks. The recruitment goal of patient number is 104, considering the study power of 90 percent. Primary outcomes are improvement of cognitive and development and improvement of seizure outcome. Secondary outcomes are improvement in behavior and quality of life. Safety monitoring criteria are adverse event profiles and physician's and caregiver's global assessment. Statistical analysis of outcomes is subject only to the patients who completed the 24-week medication and 2 times of tests before and after treatment of cannabidiol. Evaluation of seizure outcomes would include all patients who completed the 24-week medication and those who dropped out of the study, either by follow-up loss or discontinuation of medication due to incomplete seizure control or adverse effect of the medication. To evaluate safety, the investigators would measure adverse events and dropout rates by percentage. The investigators would analyze overall evaluation of the caregivers and investigator. Serious adverse events would be noted after causality evaluation. | Épilepsie | Phase 3 | À vérifier | South Korea | À vérifier |
| CannabidiolThe clinical trial "A Prospective Single-Center Single-Arm Clinical Trial on Cognitive Effect of Cannabidiol (CBD-OS®) on Dravet syndrome and Lennox-Gastaut Syndrome" is a single-group phase III study done in single tertiary referral center in Seoul, Korea. Chief investigator is Dr. Hoon-Chul Kang of Severance Hospital, Yonsei University College of Medicine. Associate investigators are Dr. Heung Dong Kim, Joon Soo Lee, Se Hee Kim, Han Som Choi, Ji Hoon Na, Dong Hwa Yang, and Hee Jung Kang, of Severance Hospital, Yonsei University College of Medicine. The aim of the study is to evaluate the effect of cannabidiol (CBD-OS®) on cognitive functions in patients aged from 2 to 18 years old diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. The duration of study is planned as one year, after patient recruitment of 6 months. The intervention period in each patient is 24 weeks, with 2 weeks of medication titration, stabilization period of 10 weeks, and maintenance period of 12 weeks. The recruitment goal of patient number is 104, considering the study power of 90 percent. Primary outcomes are improvement of cognitive and development and improvement of seizure outcome. Secondary outcomes are improvement in behavior and quality of life. Safety monitoring criteria are adverse event profiles and physician's and caregiver's global assessment. Statistical analysis of outcomes is subject only to the patients who completed the 24-week medication and 2 times of tests before and after treatment of cannabidiol. Evaluation of seizure outcomes would include all patients who completed the 24-week medication and those who dropped out of the study, either by follow-up loss or discontinuation of medication due to incomplete seizure control or adverse effect of the medication. To evaluate safety, the investigators would measure adverse events and dropout rates by percentage. The investigators would analyze overall evaluation of the caregivers and investigator. Serious adverse events would be noted after causality evaluation. | Épilepsie | Phase 4 | À vérifier | United States | À vérifier |
| Cannabidiol Oral SolutionThis is a Phase 3b/Phase 4 study. The purpose of this study is to learn more about the efficacy of using CBD-OS as an add-on therapy for the treatment of LGS in adults. | Épilepsie | Phase 4 | À vérifier | United States | À vérifier |
| CBD-OSThe efficacy, safety, and tolerability of CBD-OS have been evaluated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and Tuberous sclerosis complex (TSC). The current JZP926-303 study is being conducted to evaluate the safety and efficacy of CBD-OS in participants with Developmental and Epileptic Encephalopathy (DEE). | Épilepsie | Phase 3 | À vérifier | À vérifier | |
| JZP926 capsuleThis study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME). | Épilepsie | Phase 2/3 | À vérifier | United States | À vérifier |
| ZanidatamabThe purpose of this study is to evaluate the efficacy and safety of Zanidatamab plus CisGem (Cisplatin and Gemcitabine) with or without the addition of a programmed death protein 1/ligand-1 (PD-1/L1) inhibitor (physician's choice of either Durvalumab or Pembrolizumab, where approved under local regulations) as first line of treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive biliary tract cancer. | Cancer | Phase 3 | À vérifier | United States, Argentina, Belgium, Brazil, Canada, Chile, China, Czechia, Finland, France, Germany, India, Israel, Italy, Japan, Portugal, Puerto Rico, Romania, Serbia, South Korea, … | À vérifier |
Essais cliniques
7| Molécule | Indication / population | Phase | NCT | Titre | Statut |
|---|---|---|---|---|---|
| Zanidatamab | Cancer | Phase 3 | NCT06282575 | Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer | RECRUITING |
| JZP926 capsule | Épilepsie | Phase 2/3 | NCT07723963 | A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy | NOT_YET_RECRUITING |
| CBD-OS | Épilepsie | Phase 3 | NCT07723976 | A Study to Evaluate the Safety and Efficacy of CBD-OS in Participants With DEE | NOT_YET_RECRUITING |
| Cannabidiol Oral Solution | Épilepsie | Phase 4 | NCT07728097 | EpiGOAL — A Study to Investigate the Effect of Gradual Titration to Optimize Cannabidiol Treatment in Adults With LGS | NOT_YET_RECRUITING |
| Cannabidiol | Épilepsie | Phase 4 | NCT05044819 | Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution | ACTIVE_NOT_RECRUITING |
| Cannabidiol | Épilepsie | Phase 3 | NCT04611438 | Research on Cognitive Effect of Cannabidiol on Dravet Syndrome and Lennox-Gastaut SyndromeGastaut Syndrome | UNKNOWN |
| ONC201 | Cancer | À vérifier | NCT05392374 | Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas | NO_LONGER_AVAILABLE |
Publications
21| Molécule | Indication / population | Titre | Journal | Date |
|---|---|---|---|---|
| JZP926 capsule | Open-Source Artificial Intelligence in Small-Bowel Capsule Endoscopy-Visual Assistance is Promising, But Not Yet a Standard of Care. | DEN open | ||
| JZP926 capsule | Non-visualized Ultrasonography Should Remain Indeterminate in Patency Capsule Localization. | DEN open | ||
| JZP926 capsule | Risk Stratification for Rebleeding in Obscure Gastrointestinal Bleeding After Comprehensive Gastrointestinal Evaluation. | DEN open | ||
| CBD-OS | Differential Pulse Voltammetric Analysis of Cannabidiol on Fluorine-Doped Tin Oxide (FTO) Electrode Interface: Quantification in Pharmaceutical Oil with Assessment of Electrode Surface Stability. | Sensors (Basel, Switzerland) | ||
| Cannabidiol Oral Solution | Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. | The New England journal of medicine | ||
| Cannabidiol Oral Solution | Effect of Cannabidiol on Drop Seizures in the Lennox-Gastaut Syndrome. | The New England journal of medicine | ||
| Cannabidiol | Investigation into the oral toxicity profile of TruCBN™. | Toxicology reports | ||
| Cannabidiol | Biosensing technologies for cannabinoid monitoring in pain management: Current methods, clinical needs, and translational challenges. | Journal of pharmaceutical and biomedical analysis | ||
| ONC201 | Point/Counterpoint: Dordaviprone for diffuse midline glioma - A landmark approval or a premature step? | Neuro-oncology | ||
| Gemcitabine | Stress-specific 14-3-3-client modules in digestive cancers: an evidence-graded review of adaptive survival and therapy resistance. | Cancer biology & therapy | ||
| ONC201 | Molecular Tumor Board: H3K27M Diffuse Midline Glioma Diagnosed During Pregnancy by Cerebrospinal Fluid Next-Generation Sequencing. | The oncologist | ||
| ONC201 | Interplay of Epigenetic Reprogramming, Mitochondrial Metabolism, and Dopamine Signalling Pathways Uncovers Metabolic Vulnerabilities in Diffuse Midline Glioma. | Cancers | ||
| Gemcitabine | Cost-effectiveness analysis of liposomal Irinotecan in combination with oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) for the first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas in Greece. | Expert review of pharmacoeconomics & outcomes research | ||
| Gemcitabine | Rosmarinic Acid Sensitizes Ovarian Cancer Cells to Gemcitabine Through Oxidative Stress-Associated Apoptotic and Antiproliferative Responses. | International journal of molecular sciences | ||
| Cannabidiol | Artificial Intelligence-enhanced Cannabidiol (CBD) Drug Delivery Systems: Integrating Machine Learning and Nanotechnology for Precision Therapeutic Optimization. | Mini reviews in medicinal chemistry | ||
| Cannabidiol | Synergistic effects of hydropriming and differential gamma radiation on the physiomorphic attributes of L. | International journal of radiation biology | ||
| ONC201 | Early increase in apparent diffusion coefficient predicts favorable response to Dordaviprone (ONC201) therapy in H3K27M-mutant diffuse midline glioma. | Neuro-oncology | ||
| ONC201 | Targeting mitochondrial protease in diffuse gliomas. | Molecular cancer therapeutics | ||
| ONC201 | Dysregulation of Human ClpP Using Small Molecules with Piperazine-Based Scaffold for Diffuse Intrinsic Pontine Glioma Therapy Validated by Patient-Derived Tumor Organoids. | Journal of medicinal chemistry | ||
| ONC201 | H3K27M-mutant diffuse midline glioma pharmacotherapy: Clinical evidence and practice implications of dordaviprone. | Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners | ||
| ONC201 | Small molecule activators of the mitochondrial protease ClpP induce senescence in triple-negative breast cancer cells and sensitize cells to the Bcl-2 inhibitor venetoclax. | Cell death & disease |