JP2019511488A5 - - Google Patents
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- JP2019511488A5 JP2019511488A5 JP2018546817A JP2018546817A JP2019511488A5 JP 2019511488 A5 JP2019511488 A5 JP 2019511488A5 JP 2018546817 A JP2018546817 A JP 2018546817A JP 2018546817 A JP2018546817 A JP 2018546817A JP 2019511488 A5 JP2019511488 A5 JP 2019511488A5
- Authority
- JP
- Japan
- Prior art keywords
- item
- aqueous solution
- allopregnanolone
- hours
- subject
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
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- 238000000034 method Methods 0.000 claims description 73
- AURFZBICLPNKBZ-UHFFFAOYSA-N Pregnanolone Natural products C1CC2CC(O)CCC2(C)C2C1C1CCC(C(=O)C)C1(C)CC2 AURFZBICLPNKBZ-UHFFFAOYSA-N 0.000 claims description 16
- 238000011282 treatment Methods 0.000 claims description 9
- 201000009916 Postpartum depression Diseases 0.000 claims description 6
- 239000007864 aqueous solution Substances 0.000 claims 13
- AURFZBICLPNKBZ-FZCSVUEKSA-N 3beta-hydroxy-5alpha-pregnan-20-one Chemical compound C([C@@H]1CC2)[C@@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H](C(=O)C)[C@@]2(C)CC1 AURFZBICLPNKBZ-FZCSVUEKSA-N 0.000 claims 12
- 239000000203 mixture Substances 0.000 claims 12
- 229940097346 sulfobutylether-beta-cyclodextrin Drugs 0.000 claims 5
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims 3
- 238000001802 infusion Methods 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 description 8
- 150000003431 steroids Chemical class 0.000 description 8
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 7
- 239000003814 drug Substances 0.000 description 7
- 229940124597 therapeutic agent Drugs 0.000 description 7
- 150000003839 salts Chemical class 0.000 description 6
- AURFZBICLPNKBZ-YZRLXODZSA-N 3alpha-hydroxy-5beta-pregnan-20-one Chemical compound C([C@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H](C(=O)C)[C@@]2(C)CC1 AURFZBICLPNKBZ-YZRLXODZSA-N 0.000 description 5
- 239000008194 pharmaceutical composition Substances 0.000 description 5
- 208000019901 Anxiety disease Diseases 0.000 description 4
- 208000024714 major depressive disease Diseases 0.000 description 4
- 201000010099 disease Diseases 0.000 description 3
- 208000035475 disorder Diseases 0.000 description 3
- 208000024732 dysthymic disease Diseases 0.000 description 3
- 230000000069 prophylactic effect Effects 0.000 description 3
- 208000024891 symptom Diseases 0.000 description 3
- DUHUCHOQIDJXAT-OLVMNOGESA-N 3-hydroxy-(3-α,5-α)-Pregnane-11,20-dione Chemical compound C([C@@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H](C(=O)C)[C@@]2(C)CC1=O DUHUCHOQIDJXAT-OLVMNOGESA-N 0.000 description 2
- 208000020925 Bipolar disease Diseases 0.000 description 2
- PGTVWKLGGCQMBR-FLBATMFCSA-N Ganaxolone Chemical compound C([C@@H]1CC2)[C@](C)(O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H](C(=O)C)[C@@]2(C)CC1 PGTVWKLGGCQMBR-FLBATMFCSA-N 0.000 description 2
- 208000002787 Pregnancy Complications Diseases 0.000 description 2
- 206010042458 Suicidal ideation Diseases 0.000 description 2
- 208000028552 Treatment-Resistant Depressive disease Diseases 0.000 description 2
- 206010047700 Vomiting Diseases 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- -1 alfadarone Chemical compound 0.000 description 2
- 229960003305 alfaxalone Drugs 0.000 description 2
- AURFZBICLPNKBZ-SYBPFIFISA-N brexanolone Chemical compound C([C@@H]1CC2)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H](C(=O)C)[C@@]2(C)CC1 AURFZBICLPNKBZ-SYBPFIFISA-N 0.000 description 2
- 229950009652 brexanolone Drugs 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000035606 childbirth Effects 0.000 description 2
- 229950007402 eltanolone Drugs 0.000 description 2
- 229950006567 ganaxolone Drugs 0.000 description 2
- 230000000155 isotopic effect Effects 0.000 description 2
- 230000032696 parturition Effects 0.000 description 2
- 230000035935 pregnancy Effects 0.000 description 2
- 238000011321 prophylaxis Methods 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 208000012672 seasonal affective disease Diseases 0.000 description 2
- 230000001568 sexual effect Effects 0.000 description 2
- 241000894007 species Species 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- VOXZDWNPVJITMN-ZBRFXRBCSA-N 17β-estradiol Chemical compound OC1=CC=C2[C@H]3CC[C@](C)([C@H](CC4)O)[C@@H]4[C@@H]3CCC2=C1 VOXZDWNPVJITMN-ZBRFXRBCSA-N 0.000 description 1
- KJMHZGDVKPSVNK-LUOXOLFZSA-N CC(C)OC[C@](CC1)([C@H](CC2)C[C@@H]1O)[C@@H](CC1)[C@@H]2[C@H](CC2)[C@@]1(C)[C@H]2C(C[n]1nncn1)=O Chemical compound CC(C)OC[C@](CC1)([C@H](CC2)C[C@@H]1O)[C@@H](CC1)[C@@H]2[C@H](CC2)[C@@]1(C)[C@H]2C(C[n]1nncn1)=O KJMHZGDVKPSVNK-LUOXOLFZSA-N 0.000 description 1
- NKIYALPHXLYICR-HVOJCETBSA-N C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@H](CC1)[C@@H]3C[C@]1(C)O)[C@H]2C(C[n]1nncn1)=O Chemical compound C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@H](CC1)[C@@H]3C[C@]1(C)O)[C@H]2C(C[n]1nncn1)=O NKIYALPHXLYICR-HVOJCETBSA-N 0.000 description 1
- RTZMJBOJCUNCCF-UZNJFETESA-N C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@H](CC1)[C@H]3C[C@]1(C)O)[C@H]2C(C[n]1ncc(F)c1)=O Chemical compound C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@H](CC1)[C@H]3C[C@]1(C)O)[C@H]2C(C[n]1ncc(F)c1)=O RTZMJBOJCUNCCF-UZNJFETESA-N 0.000 description 1
- GVDKNWHDTOEIQM-LPHGGTRGSA-N C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@H](CC1)[C@H]3C[C@]1(C)O)[C@H]2c1n[o]c(CO)c1 Chemical compound C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@H](CC1)[C@H]3C[C@]1(C)O)[C@H]2c1n[o]c(CO)c1 GVDKNWHDTOEIQM-LPHGGTRGSA-N 0.000 description 1
- WQANJTALVHXWJH-SFXVUFDXSA-N C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@](C)(CC1)[C@@H]3C[C@]1(C)O)[C@H]2c1n[o]c(CO)c1 Chemical compound C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@](C)(CC1)[C@@H]3C[C@]1(C)O)[C@H]2c1n[o]c(CO)c1 WQANJTALVHXWJH-SFXVUFDXSA-N 0.000 description 1
- KOXFAJCPBYWCJO-BDVAEDQCSA-N C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@](COC)(CC1)[C@H]3C[C@]1(C)O)[C@H]2C(C[n](nc1cc2)nc1c(F)c2F)=O Chemical compound C[C@](CC1)([C@@H](CC2)[C@H](CC3)[C@H]1[C@@](COC)(CC1)[C@H]3C[C@]1(C)O)[C@H]2C(C[n](nc1cc2)nc1c(F)c2F)=O KOXFAJCPBYWCJO-BDVAEDQCSA-N 0.000 description 1
- 208000020401 Depressive disease Diseases 0.000 description 1
- 206010065604 Suicidal behaviour Diseases 0.000 description 1
- 208000025748 atypical depressive disease Diseases 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 238000011418 maintenance treatment Methods 0.000 description 1
- 201000003995 melancholia Diseases 0.000 description 1
- 208000028173 post-traumatic stress disease Diseases 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
Applications Claiming Priority (11)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662305279P | 2016-03-08 | 2016-03-08 | |
| US62/305,279 | 2016-03-08 | ||
| US201662355174P | 2016-06-27 | 2016-06-27 | |
| US62/355,174 | 2016-06-27 | ||
| US201662355669P | 2016-06-28 | 2016-06-28 | |
| US62/355,669 | 2016-06-28 | ||
| US201662360762P | 2016-07-11 | 2016-07-11 | |
| US201662360758P | 2016-07-11 | 2016-07-11 | |
| US62/360,762 | 2016-07-11 | ||
| US62/360,758 | 2016-07-11 | ||
| PCT/US2017/021325 WO2017156103A1 (en) | 2016-03-08 | 2017-03-08 | Neuroactive steroids, compositions, and uses thereof |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021019539A Division JP2021073309A (ja) | 2016-03-08 | 2021-02-10 | 神経刺激性ステロイド、組成物、およびその使用 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2019511488A JP2019511488A (ja) | 2019-04-25 |
| JP2019511488A5 true JP2019511488A5 (enExample) | 2021-02-04 |
| JP6838074B2 JP6838074B2 (ja) | 2021-03-03 |
Family
ID=59789807
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2018546817A Active JP6838074B2 (ja) | 2016-03-08 | 2017-03-08 | 神経刺激性ステロイド、組成物、およびその使用 |
| JP2021019539A Pending JP2021073309A (ja) | 2016-03-08 | 2021-02-10 | 神経刺激性ステロイド、組成物、およびその使用 |
| JP2023074398A Pending JP2023093723A (ja) | 2016-03-08 | 2023-04-28 | 神経刺激性ステロイド、組成物、およびその使用 |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2021019539A Pending JP2021073309A (ja) | 2016-03-08 | 2021-02-10 | 神経刺激性ステロイド、組成物、およびその使用 |
| JP2023074398A Pending JP2023093723A (ja) | 2016-03-08 | 2023-04-28 | 神経刺激性ステロイド、組成物、およびその使用 |
Country Status (20)
| Country | Link |
|---|---|
| US (4) | US20200306265A1 (enExample) |
| EP (1) | EP3426257A4 (enExample) |
| JP (3) | JP6838074B2 (enExample) |
| KR (3) | KR102408399B1 (enExample) |
| CN (2) | CN113616661A (enExample) |
| AU (2) | AU2017229656B2 (enExample) |
| BR (1) | BR112018067998A2 (enExample) |
| CA (2) | CA3158448A1 (enExample) |
| HK (1) | HK1258616A1 (enExample) |
| IL (2) | IL261658B2 (enExample) |
| JO (1) | JOP20170059B1 (enExample) |
| MA (1) | MA43815A (enExample) |
| MX (2) | MX391122B (enExample) |
| NZ (1) | NZ785712A (enExample) |
| PH (2) | PH12022551313A1 (enExample) |
| RU (2) | RU2022102537A (enExample) |
| SG (1) | SG11201807785VA (enExample) |
| TW (2) | TW202400182A (enExample) |
| WO (1) | WO2017156103A1 (enExample) |
| ZA (1) | ZA201805905B (enExample) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113234114A (zh) | 2011-10-14 | 2021-08-10 | 萨奇治疗股份有限公司 | 3,3-二取代的19-去甲孕甾烷化合物、组合物、及其用途 |
| CA2862076C (en) | 2012-01-23 | 2020-04-21 | Sage Therapeutics, Inc. | Neuroactive steroid formulations and methods of treating cns disorders |
| PL2887944T3 (pl) | 2012-08-21 | 2022-02-21 | Sage Therapeutics, Inc. | Allopregnanolon do leczenia lekoopornego stanu padaczkowego |
| JP2016501876A (ja) | 2012-11-30 | 2016-01-21 | ザ リージェンツ オブ ザ ユニバーシティ オブ カリフォルニア | ステロイドの抗痙攣活性 |
| MX362543B (es) | 2013-04-17 | 2019-01-24 | Sage Therapeutics Inc | Esteroides c21-n-pirazolilo 19-nor c3,3- disustituidos y metodos de uso de los mismos. |
| WO2014169831A1 (en) | 2013-04-17 | 2014-10-23 | Sage Therapeutics, Inc. | 19-nor c3,3-disubstituted c21-c-bound heteroaryl steroids and methods of use thereof |
| WO2014169836A1 (en) | 2013-04-17 | 2014-10-23 | Sage Therapeutics, Inc. | 19-nor neuroactive steroids and methods of use thereof |
| WO2014169832A1 (en) | 2013-04-17 | 2014-10-23 | Sage Therapeutics, Inc. | 19-nor neuroactive steroids and methods of use thereof |
| HRP20210610T1 (hr) | 2013-07-19 | 2021-05-28 | Sage Therapeutics, Inc. | Neuroaktivni steroidi, pripravci i njihove uporabe |
| PT3035940T (pt) | 2013-08-23 | 2019-01-28 | Sage Therapeutics Inc | Esteroides neuroativos, composições e seus usos |
| WO2015195962A1 (en) | 2014-06-18 | 2015-12-23 | Sage Therapeutics, Inc. | Neuroactive steroids, compositions, and uses thereof |
| JOP20200195A1 (ar) | 2014-09-08 | 2017-06-16 | Sage Therapeutics Inc | سترويدات وتركيبات نشطة عصبياً، واستخداماتها |
| EP3885352B1 (en) | 2014-10-16 | 2024-11-27 | Sage Therapeutics, Inc. | A compound, compositions thereof and this compound for use in methods of treating cns disorders |
| EP4275748A3 (en) | 2014-10-16 | 2024-01-03 | Sage Therapeutics, Inc. | Compositions and methods for treating cns disorders |
| RS60343B1 (sr) | 2014-11-27 | 2020-07-31 | Sage Therapeutics Inc | Kompozicije i postupci za lečenje poremećaja cns-a |
| SMT202100113T1 (it) | 2015-01-26 | 2021-05-07 | Sage Therapeutics Inc | Composizioni e metodi per trattare disturbi del snc |
| EP3258939B1 (en) | 2015-02-20 | 2022-09-07 | Sage Therapeutics, Inc. | Neuroactive steroids, compositions, and uses thereof |
| CN113616661A (zh) | 2016-03-08 | 2021-11-09 | 萨奇治疗股份有限公司 | 神经活性类固醇、其组合物及用途 |
| AU2017296295B2 (en) | 2016-07-11 | 2022-02-24 | Sage Therapeutics, Inc. | C7, C12, and C16 substituted neuroactive steroids and their methods of use |
| MA45599A (fr) | 2016-07-11 | 2019-05-15 | Sage Therapeutics Inc | Stéroïdes neuroactifs substitués en c17, c20 et c21 et leurs procédés d'utilisation |
| JOP20190022B1 (ar) | 2016-08-23 | 2023-03-28 | Sage Therapeutics Inc | ستيرويد 19- نور c3، 3- به استبدال ثنائي لـ c21-n بيرازوليل بلوري |
| WO2018147791A1 (en) | 2017-02-10 | 2018-08-16 | Asarina Pharma Ab | 3-beta-hydroxy-5-alpha-pregnan-20-one for use in treatment of essential tremor |
| EP3678670A1 (en) * | 2017-09-07 | 2020-07-15 | Sage Therapeutics, Inc. | Neuroactive steroids and their methods of use |
| WO2019075362A1 (en) * | 2017-10-12 | 2019-04-18 | Sage Therapeutics, Inc. | METHOD OF TREATING CENTRAL NERVOUS SYSTEM DISORDERS WITH NEUROSTEROIDS AND GABAERGIC COMPOUNDS |
| WO2019094724A1 (en) * | 2017-11-10 | 2019-05-16 | Marinus Pharmaceuticals, Inc. | Ganaxolone for use in treating genetic epileptic disoders |
| US20200291059A1 (en) | 2017-12-08 | 2020-09-17 | Sage Therapeutics, Inc. | Compositions and methods for treating cns disorders |
| CN114085260B (zh) * | 2018-02-11 | 2023-10-20 | 江苏豪森药业集团有限公司 | 甾族类衍生物调节剂、其制备方法和应用 |
| CN117959309A (zh) * | 2018-06-12 | 2024-05-03 | 萨奇治疗股份有限公司 | 19-去甲基c3,3-二取代的c21-n-吡唑基类固醇及其使用方法 |
| WO2020097045A1 (en) * | 2018-11-05 | 2020-05-14 | Ovid Therapeutics Inc. | Use of gaboxadol, ganaxolone and allopregnanolone to treat movement disorders |
| CN109503694A (zh) * | 2018-11-21 | 2019-03-22 | 苏州闻天医药科技有限公司 | 一种新型gabaa受体调节剂及其用途 |
| WO2020118142A1 (en) * | 2018-12-07 | 2020-06-11 | Marinus Pharmaceuticals, Inc. | Ganaxolone for use in prophylaxis and treatment of pospartum depression |
| CA3124703C (en) * | 2019-01-14 | 2023-10-17 | Beijing Xuanyi Pharmasciences Co., Ltd. | Tetrazolone substituted steroids and use thereof |
| US11497754B2 (en) | 2019-02-05 | 2022-11-15 | Washington University | Neurosteroids and enantiomers thereof for the prevention and treatment of neurodegenerative conditions |
| EP3934655A4 (en) * | 2019-03-04 | 2022-12-21 | Praxis Precision Medicines, Inc. | PERIMENOPAUSE AND MENOPAUSE TREATMENT METHODS |
| SG11202112111WA (en) | 2019-05-10 | 2021-11-29 | Brii Biosciences Inc | Pharmaceutical composition containing brexanolone, ganaxolone, or zuranolone, and use thereof |
| AR119047A1 (es) | 2019-05-31 | 2021-11-17 | Sage Therapeutics Inc | Esteroides neuroactivos como moduladores de gabaa y su uso en el tratamiento de trastornos del snc |
| CA3145923A1 (en) | 2019-08-05 | 2021-02-11 | David Czekai | Ganaxolone for use in treatment of status epilepticus |
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| IL293525A (en) * | 2019-12-06 | 2022-08-01 | Marinus Pharmaceuticals Inc | Ganaxolone for use in the treatment of multiple sclerosis complex |
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| EP4255438A4 (en) * | 2020-12-07 | 2024-10-16 | Marinus Pharmaceuticals, Inc. | USE OF GANAXOLONE IN THE TREATMENT OF AN EPILEPTIC DISORDER |
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| WO2022165017A1 (en) * | 2021-01-28 | 2022-08-04 | Sage Therapeutics, Inc. | Use of neuroactive steroids for treatment of sexual dysfunction |
| AU2022258203A1 (en) * | 2021-04-12 | 2023-10-26 | Sage Therapeutics, Inc. | Treatment of essential tremor |
| US11969434B1 (en) | 2022-08-29 | 2024-04-30 | Lipocine Inc. | Oral allopregnanolone compositions and methods of use |
| US12208103B1 (en) | 2021-05-07 | 2025-01-28 | Lipocine Inc. | Compositions and methods for treating CNS disorders |
| US11337987B1 (en) * | 2021-05-07 | 2022-05-24 | Lipocine Inc. | Compositions and methods for treating central nervous system disorders |
| EP4377327A1 (en) | 2021-07-28 | 2024-06-05 | Sage Therapeutics, Inc. | Crystalline forms of a neuroactive steroid |
| JP2025504069A (ja) * | 2022-01-27 | 2025-02-06 | ベルナップ ファーマシューティカルズ， エルエルシー | オキシトシンを使用した治療方法 |
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| US20250345345A1 (en) * | 2022-04-26 | 2025-11-13 | Praxis Precision Medicines, Inc. | Methods for the treatment of neurological disorders |
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| CN115957332B (zh) * | 2022-11-01 | 2023-10-10 | 北京华睿鼎信科技有限公司 | 透明质酸酶稳定的布瑞诺龙纳米晶及其制备方法与应用 |
| TWI897404B (zh) * | 2023-05-11 | 2025-09-11 | 大陸商上海樞境生物科技有限公司 | 甾體類化合物、製備方法及其用途 |
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