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1. 发明申请

WO2022125408A1 USE OF GANAXOLONE IN TREATING AN EPILEPSY DISORDER 审中-公开
公开(公告)号：WO2022125408A1
公开(公告)日：2022-06-16
申请号：PCT/US2021/061937
申请日：2021-12-06
申请人： MARINUS PHARMACEUTICALS, INC [US]/[US]
发明人： AIMETTI, Alex , HULIHAN, Joseph
IPC分类号： A61K31/565 , A61K47/12 , A61K47/24
摘要： The disclosure to methods for treating seizure or an epilepsy disorder comprising administering to a subject in need thereof a therapeutically effective amount of ganaxolone or a pharmaceutically acceptable salt thereof.

2. 发明申请

WO2020118142A1 GANAXOLONE FOR USE IN PROPHYLAXIS AND TREATMENT OF POSPARTUM DEPRESSION 审中-公开
公开(公告)号：WO2020118142A1
公开(公告)日：2020-06-11
申请号：PCT/US2019/064850
申请日：2019-12-06
申请人： MARINUS PHARMACEUTICALS, INC.
发明人： AIMETTI, Alex , CASHMAN, Christopher , MASUOKA, Lorianne , LAPPALAINEN, Jaakko
IPC分类号： A61K31/573 , C07J7/00 , A61K31/56
摘要： Uses of ganaxolone in prophylaxis and treatment of postpartum depression are described. A dose of ganaxolone is administered to a female suffering from postpartum depression or at risk of developing postpartum depression in an amount and at a rate sufficient to alleviate at least one symptom of postpartum depression in the female.

3. 发明申请

WO2019094724A8 GANAXOLONE FOR USE IN TREATING GENETIC EPILEPTIC DISORDERS 审中-公开
公开(公告)号：WO2019094724A8
公开(公告)日：2019-05-16
申请号：PCT/US2018/060037
申请日：2018-11-09
申请人： MARINUS PHARMACEUTICALS, INC.
发明人： MASUOKA, Lorianne, K. , LAPPALAINEN, Jaakko
IPC分类号： A61K31/57 , C12Q1/68 , A61K31/565 , A61K47/12 , A61K47/24 , A61K47/26 , A61K47/34 , A61K47/38 , A61K9/0019 , A61K9/0095 , A61K9/08 , A61K9/485 , A61K9/4858 , A61K9/4866 , A61P25/08
摘要： The disclosure provides a method of treating a mammal having a genetic epileptic disorder, comprising chronically administering a pharmaceutically acceptable pregnenolone neurosteroid to a mammal having a genetic epileptic disorder in an amount effective to reduce the seizure frequency in the mammal. In certain preferred embodiments, the mammal is a human patient who has a CDKL5 genetic mutation. In certain preferred embodiments, the patient has a low endogenous level of a neurosteroid(s). In certain preferred embodiments, the pregnenolone neurosteroid is ganaxolone.

4. 发明申请

WO2016127170A1 INTRAVENOUS GANAXOLONE FORMULATIONS AND THEIR USE IN TREATING STATUS EPILEPTICUS AND OTHER SEIZURE DISORDERS 审中-公开
标题翻译：内分泌松桃酮制剂及其在治疗状态性癫痫和其他癫痫病症中的应用
公开(公告)号：WO2016127170A1
公开(公告)日：2016-08-11
申请号：PCT/US2016/016977
申请日：2016-02-08
申请人： MARINUS PHARMACEUTICALS, INC.
发明人： ZHANG, Mingbao , GLOWAKY, Raymond C.
IPC分类号： A61K47/48 , A61K31/57 , A61K9/00 , A61P25/08
CPC分类号： A61K31/573 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K31/57 , A61K45/06 , A61K47/40 , A61K47/6951
摘要： The disclosure provides an injectable ganaxolone formulation comprising ganaxolone, sulfobutyl ether-β-cyclodextrin; and water. The injectable ganaxolone formulation optionally includes a surfactant and a pH modifier. The ganaxolone and sulfobutyl ether-β-cyclodextrin may be in an inclusion complex. The disclosure also provides a lyophilized powder of the ganaxolone/ sulfobutyl ether-β-cyclodextrin formulation that may be reconstituted in water for injection. The disclosure provides a method of treating a patient having a seizure disorder, stroke, or traumatic brain injury, comprising administering an effective amount of the injectable ganaxolone formulation comprising ganaxolone, sulfobutyl ether-β-cyclodextrin; and water. The disclosure also provides combination methods in which the injectable ganaxolone/ sulfobutyl ether-β-cyclodextrin formulation is administered in combination with at least one additional active agent.
摘要翻译：本公开提供了一种可注射的加纳西酮制剂，其包含加诺沙酮，磺丁基醚-β-环糊精; 和水。可注射的加纳西酮制剂任选地包括表面活性剂和pH调节剂。甘诺沙酮和磺丁基醚-β-环糊精可以是包合物。本公开还提供了可以在注射用水中重构的甘诺沙酮/磺丁基醚-β-环糊精制剂的冻干粉末。本公开提供了治疗患有癫痫发作障碍，卒中或创伤性脑损伤的患者的方法，其包括给予有效量的可注射的加纳西酮制剂，所述制剂包含加诺沙酮，磺丁基醚-β-环糊精; 和水。本公开还提供了组合方法，其中将可注射的加纳西酮/磺丁基醚-β-环糊精制剂与至少一种另外的活性剂组合施用。

5. 发明申请

WO2022109440A1 GANAXOLONE FOR USE IN TREATMENT OF SUPER REFRACTORY STATUS EPILEPTICUS 审中-公开
公开(公告)号：WO2022109440A1
公开(公告)日：2022-05-27
申请号：PCT/US2021/060459
申请日：2021-11-23
申请人： MARINUS PHARMACEUTICALS, INC.
发明人： VAITKEVICIUS, Henrikas , GASIOR, Maciej , HULIHAN, Joseph
IPC分类号： A61K31/565 , A61K47/12 , A61K47/24
摘要： This invention relates to methods for treating super refractory status epilepticus by rapidly weaning the subject in need thereof off an anesthetic agent prior to initiation of administering to the subject in need thereof of ganaxolone at a high infusion dose. The method provides SE suppression and continued suppression of SE.

6. 发明申请

WO2018195186A1 SUSTAINED RELEASE INJECTABLE NEUROSTEROID FORMULATIONS 审中-公开
公开(公告)号：WO2018195186A1
公开(公告)日：2018-10-25
申请号：PCT/US2018/028151
申请日：2018-04-18
申请人： MARINUS PHARMACEUTICALS, INC
发明人： SAPORITO, Michael , ZHANG, Mingbao , GLOWAKY, Raymond C. , CZEKAI, David
IPC分类号： A61K31/57 , A61K9/00 , A61K47/10 , A61K47/36 , A61K9/10 , A61K9/14 , A61P25/24 , A61P25/14 , A61P25/22 , A61P25/18
摘要： The disclosure provides a sustained release injectable neurosteroid formulation comprising neurosteroid particles having a D50 of less than 10 microns, the neurosteroid particles comprising a neurosteroid of Formula I: Formula I or a pharmaceutically acceptable salt thereof, wherein: is a double or single bond and the variables, e.g., R1,R2, R3, R4, R4a, R5, R6, R7, R8, R9, R10, and R10a are described herein. The formulation comprises neurosteroid particles comprising the neurosteroid and a polymeric surface stabilizer and provides an effective plasma concentration of the neurosteroid at steady state for at least 48 hours, and in some embodiments for at least 4 weeks. The sustained release injectable neurosteroid formulation can formulated for intramuscular or subcutaneous administration. The disclosure provides a method of treating a patient having seizures, anxiety, agitation, depression (including post-partum depression), schizophrenia, post-traumatic stress disorder, or tremors by administering the sustained release neurosteroid formulation to the patient. In certain embodiments the neurosteroid is ganaxolone.

7. 发明申请

WO2011019821A2 METHOD FOR MAKING 3a-HYDROXY, 3ß- METHYL-5a-PREGNAN-20-ONE (GANAXOLONE) 审中-公开
标题翻译：制备3α-羟基-3β-甲基-5α-孕烷-20-酮（甘露松酮）的方法
公开(公告)号：WO2011019821A2
公开(公告)日：2011-02-17
申请号：PCT/US2010045176
申请日：2010-08-11
申请人： MARINUS PHARMACEUTICALS INC , SHAW KENNETH , HUTCHISON ALAN
发明人： SHAW KENNETH , HUTCHISON ALAN
IPC分类号： C07J5/00 , A61K31/57 , A61K31/575 , A61P25/28 , C07J9/00
CPC分类号： A61K31/57 , A61K31/575 , C07J7/002 , C07J7/0045 , C07J9/00
摘要： Applicants have discovered a method for the stereoselective and regioselective synthesis of 3a-hydroxy, 3ß-methyl-5a- pregnan-20-one (ganaxolone) comprising reacting 5a-pregnane-3,20-dione; with an organometallic methylating agent in an inert solvent to provide a compound of the formula.
摘要翻译：申请人已经发现了用于3a-羟基-3β-甲基-5α-孕烷-20-酮（加奈索酮）的立体选择性和区域选择性合成的方法，其包括使5a-孕甾-3,20-二酮; 与有机金属甲基化试剂在惰性溶剂中反应以提供下式的化合物。

8. 发明申请

WO2023060067A1 AMORPHOUS SOLID DISPERSION GANAXOLONE FORMULATION 审中-公开
公开(公告)号：WO2023060067A1
公开(公告)日：2023-04-13
申请号：PCT/US2022/077514
申请日：2022-10-04
申请人： MARINUS PHARMACEUTICALS, INC.
发明人： CZEKAI, David , TULIANI, Vinod , SAPORITO, Michael
IPC分类号： A61K31/57 , A61K9/00 , A61K9/14 , A61P25/00 , A61P25/08 , A61P25/22 , A61P25/24 , A61K9/0095 , A61K9/146
摘要： This disclosure relates to a solid pharmaceutical formulation comprising an amorphous neurosteroid dispersed in a polymer matrix that is suitable for oral administration. The disclosure also relates to methods for effectively treating an epileptic disorder, central nervous system disorder, or a neurological disorder. The methods disclosed herein comprise orally administering to a subject in need thereof a therapeutically effective amount of the solid pharmaceutical formulation disclosed herein comprising an amorphous neurosteroid, preferably ganaxolone dispersed in a polymer matrix.

9. 发明申请

WO2011019821A3 METHOD FOR MAKING 3α-HYDROXY, 3β- METHYL-5α-PREGNAN-20-ONE (GANAXOLONE) 审中-公开
公开(公告)号：WO2011019821A3
公开(公告)日：2011-02-17
申请号：PCT/US2010/045176
申请日：2010-08-11
申请人： MARINUS PHARMACEUTICALS, INC. , SHAW, Kenneth , HUTCHISON, Alan
发明人： SHAW, Kenneth , HUTCHISON, Alan
IPC分类号： C07J5/00 , C07J9/00 , A61K31/57 , A61K31/575 , A61P25/28
摘要： Applicants have discovered a method for the stereoselective and regioselective synthesis of 3α-hydroxy, 3β-methyl-5α- pregnan-20-one (ganaxolone) comprising reacting 5α-pregnane-3,20-dione; with an organometallic methylating agent in an inert solvent to provide a compound of the formula.

10. 发明申请

WO2008016596A2 PSEUDOBASE BENZO [C] PHENANTHRIDINES WITH IMPROVED EFFICACY, STABILITY, AND SAFETY 审中-公开
标题翻译： PSEUDOBASE BENZO [C]具有改善效率，稳定性和安全性的苯并噻嗪
公开(公告)号：WO2008016596A2
公开(公告)日：2008-02-07
申请号：PCT/US2007/017095
申请日：2007-07-31
申请人： MARINUS PHARMACEUTICALS, INC. , SHAW, Kenneth, R. , ZHANG, Mingbao
发明人： SHAW, Kenneth, R. , ZHANG, Mingbao
IPC分类号： C07D405/12 , C07D317/70 , A61K31/357
CPC分类号： C07D491/04
摘要： Pseudobase benzo[c]ρhenanthridines and the pharmaceutically acceptable salts thereof of Formula I (i) are provided herein. The variables R, Rj, R2, R3, and R4 are defined herein. Certain pseudobase benzo[c]phenanthridines provided herein act as prodrugs, targeting the parent benzo[c]phenanthridinium alkaloid to hydrophilic or hydrophobic regions in the body. Pharmaceutical compositions comprising a pseudobase benzo[c]phenanthridine and a carrier, excipient, or diluent are provided herein. Methods of treating or preventing microbial, fungal and or viral infections and methods of treating diseases and disorders responsive to protein kinase C modulation, topoisomerase I, and/or topoisomerase II modulation are also provided.
摘要翻译：本文提供了式I（i）的假碱性苯并[c]吗啡啉及其药学上可接受的盐。变量R，Rj，R2，R3和R4在本文中定义。本文提供的某些假碱性苯并[c]菲啶用作前药，将母体苯并[c]菲啶生物碱靶向体内的亲水或疏水区域。本文提供了包含假碱性苯并[c]菲啶和载体，赋形剂或稀释剂的药物组合物。还提供了治疗或预防微生物，真菌和/或病毒感染的方法以及治疗对蛋白激酶C调节，拓扑异构酶I和/或拓扑异构酶II调节的疾病和病症的方法。

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