AU2019287491B2 - A 19-nor C3,3-disubstituted C21 -N-pyrazolyl steroid and methods of use thereof - Google Patents

A 19-nor C3,3-disubstituted C21 -N-pyrazolyl steroid and methods of use thereof Download PDF

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Publication number
AU2019287491B2
AU2019287491B2 AU2019287491A AU2019287491A AU2019287491B2 AU 2019287491 B2 AU2019287491 B2 AU 2019287491B2 AU 2019287491 A AU2019287491 A AU 2019287491A AU 2019287491 A AU2019287491 A AU 2019287491A AU 2019287491 B2 AU2019287491 B2 AU 2019287491B2
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compound
day
weeks
depression
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AU2019287491A1 (en
Inventor
James J. Doherty
Handan GUNDUZ-BRUCE
Jeffrey M. Jonas
Stephen Jay Kanes
Robert Alfonso LASSER
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Sage Therapeutics LLC
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Sage Therapeutics LLC
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Priority to AU2025217363A priority Critical patent/AU2025217363A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

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  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Hospice & Palliative Care (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2019287491A 2018-06-12 2019-06-12 A 19-nor C3,3-disubstituted C21 -N-pyrazolyl steroid and methods of use thereof Active AU2019287491B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025217363A AU2025217363A1 (en) 2018-06-12 2025-08-15 A 19-nor C3,3-disubstituted C21 -N-pyrazolyl steroid and methods of use thereof

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201862684155P 2018-06-12 2018-06-12
US62/684,155 2018-06-12
US201962789329P 2019-01-07 2019-01-07
US62/789,329 2019-01-07
US201962841645P 2019-05-01 2019-05-01
US62/841,645 2019-05-01
PCT/US2019/036848 WO2019241442A1 (en) 2018-06-12 2019-06-12 A 19-nor c3,3-disubstituted c21 -n-pyrazolyl steroid and methods of use thereof

Related Child Applications (1)

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AU2025217363A Division AU2025217363A1 (en) 2018-06-12 2025-08-15 A 19-nor C3,3-disubstituted C21 -N-pyrazolyl steroid and methods of use thereof

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AU2019287491A1 AU2019287491A1 (en) 2021-01-07
AU2019287491B2 true AU2019287491B2 (en) 2025-05-15

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AU2019287491A Active AU2019287491B2 (en) 2018-06-12 2019-06-12 A 19-nor C3,3-disubstituted C21 -N-pyrazolyl steroid and methods of use thereof
AU2025217363A Pending AU2025217363A1 (en) 2018-06-12 2025-08-15 A 19-nor C3,3-disubstituted C21 -N-pyrazolyl steroid and methods of use thereof

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AU2025217363A Pending AU2025217363A1 (en) 2018-06-12 2025-08-15 A 19-nor C3,3-disubstituted C21 -N-pyrazolyl steroid and methods of use thereof

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Country Link
US (4) US20210338692A1 (https=)
EP (1) EP3806863A1 (https=)
JP (3) JP2021527092A (https=)
KR (1) KR20210021005A (https=)
CN (2) CN112533611A (https=)
AU (2) AU2019287491B2 (https=)
CA (1) CA3103421A1 (https=)
IL (1) IL279315A (https=)
MA (1) MA52894A (https=)
MX (2) MX2020013557A (https=)
SG (1) SG11202012344RA (https=)
WO (1) WO2019241442A1 (https=)

Families Citing this family (17)

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EP2806877B2 (en) 2012-01-23 2025-01-29 Sage Therapeutics, Inc. Neuroactive steroid formulations comprising a complex of allopregnanolone and sulfobutyl ether beta-cyclodextrin
CA2882708A1 (en) 2012-08-21 2014-02-27 Sage Therapeutics, Inc. Methods of treating epilepsy or status epilepticus
KR102396328B1 (ko) 2013-04-17 2022-05-10 세이지 테라퓨틱스, 인크. 19-노르 c3,3-이치환된 c21-n-피라졸릴 스테로이드 및 그의 사용 방법
US10246482B2 (en) 2014-06-18 2019-04-02 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
WO2016082789A1 (en) 2014-11-27 2016-06-02 Sage Therapeutics, Inc. Compositions and methods for treating cns disorders
EP3504189A1 (en) 2016-08-23 2019-07-03 Sage Therapeutics, Inc. A crystalline 19-nor c3, 3-disubstituted c21-n-pyrazolyl steroid
MA51046A (fr) 2017-12-08 2021-03-17 Sage Therapeutics Inc Dérivés de 21-[4-cyano-pyrazol-1-yl]-19-nor-pregan-3. alpha-ol-20-one deutérés pour le traitement de troubles du snc
KR20220112803A (ko) * 2019-12-05 2022-08-11 세이지 테라퓨틱스, 인크. 19-nor c3,3-이치환된 c21-n-피라졸릴 스테로이드 및 그의 사용 방법
EP4125921A1 (en) 2020-03-25 2023-02-08 Sage Therapeutics, Inc. Use of agents for treatment of respiratory conditions
KR20230041049A (ko) * 2020-07-20 2023-03-23 세이지 테라퓨틱스, 인크. 19-노르 c3,3-이치환된 c21-n-피라졸릴 스테로이드의 제형 및 이의 사용 방법
KR20230136599A (ko) * 2021-01-28 2023-09-26 세이지 테라퓨틱스, 인크. 성 기능장애의 치료를 위한 신경활성 스테로이드의용도
US20240245711A1 (en) * 2021-03-17 2024-07-25 Sage Therapeutics, Inc. A 19-nor c3,3-disubstituted c21-n-pyrazolyl steroid for the treatment of major depressive disorder
WO2022232504A1 (en) * 2021-04-29 2022-11-03 Sage Therapeutics, Inc. 19-nor c3,3-disubstituted c21 -n-pyrazolyl steroid for use in treating major depressive disorder and postpartum depression
EP4329769A1 (en) * 2021-04-29 2024-03-06 Sage Therapeutics, Inc. Neuroactive steroid for use in treating major depressive disorder and postpartum depression in a lactating female
IL315023A (en) * 2022-02-16 2024-10-01 Sage Therapeutics Inc Neuroactive steroids for treatment of cns-related disorders
WO2025175214A1 (en) * 2024-02-16 2025-08-21 Engrail Therapeutics, Inc. Methods of treating generalized anxiety disorder

Citations (3)

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WO2014169833A1 (en) * 2013-04-17 2014-10-23 Sage Therapeutics, Inc. 19-nor c3,3-disubstituted c21-n-pyrazolyl steroids and methods of use thereof
WO2018039378A1 (en) * 2016-08-23 2018-03-01 Sage Therapeutics, Inc. A crystalline 19-nor c3, 3-disubstituted c21-n-pyrazolyl steroid
WO2019051264A1 (en) * 2017-09-07 2019-03-14 Sage Therapeutics, Inc. NEUROACTIVE STEROIDS AND METHODS OF USE

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JOP20200195A1 (ar) * 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
ME03809B (me) * 2014-10-16 2021-04-20 Sage Therapeutics Inc KOMPOZICIJE I POSTUPCI ZA LEČENJE POREMEĆAJA CNS-a
KR20240157128A (ko) * 2016-03-08 2024-10-31 세이지 테라퓨틱스, 인크. 신경활성 스테로이드, 조성물, 및 그의 용도

Patent Citations (3)

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WO2014169833A1 (en) * 2013-04-17 2014-10-23 Sage Therapeutics, Inc. 19-nor c3,3-disubstituted c21-n-pyrazolyl steroids and methods of use thereof
WO2018039378A1 (en) * 2016-08-23 2018-03-01 Sage Therapeutics, Inc. A crystalline 19-nor c3, 3-disubstituted c21-n-pyrazolyl steroid
WO2019051264A1 (en) * 2017-09-07 2019-03-14 Sage Therapeutics, Inc. NEUROACTIVE STEROIDS AND METHODS OF USE

Non-Patent Citations (5)

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Clinical Trials.Gov NCT02978326 "A Study to Evaluate SAGE-217 in Participants With Severe Postpartum Depression" *
GABRIEL MARTINEZ BOTELLA et al. JOURNAL OF MEDICINAL CHEMISTRY, vol. 60, no. 18, 17 August 2017, pages 7810-7819 *
GUNDUZ-BRUCE, H. et al. "SAGE-217 in subjects with major depressive disorder: efficacy and safety results from open-label Part A of a phase 2A study" 5 September 2017 *
GUNDUZ-BRUCE, H. et al. "SAGE-217 in subjects with major depressive disorder: efficacy and safety results from open-label Part A of a phase 2A study" EUROPEAN NEUROPSYCHOPHARMACOLOGY, vol. 27, no. Suppl. 4, 2 September 2017, pages s856-s857 *
NCT03000530 "A Study to Evaluate SAGE-217 in Participants With Moderate to Severe Major Depressive Disorder" Version 9, 11 December 2017 https://clinicaltrials.gov/study/NCT03000530?intr=sage-217&rank=9&tab=history&a=9#version-content-panel *

Also Published As

Publication number Publication date
CN112533611A (zh) 2021-03-19
JP2024028849A (ja) 2024-03-05
CN117959309A (zh) 2024-05-03
JP2025108553A (ja) 2025-07-23
MX2025000166A (es) 2025-03-07
IL279315A (en) 2021-01-31
US20210338692A1 (en) 2021-11-04
KR20210021005A (ko) 2021-02-24
US20250339447A1 (en) 2025-11-06
WO2019241442A1 (en) 2019-12-19
MA52894A (fr) 2021-04-21
JP2021527092A (ja) 2021-10-11
TW202005653A (zh) 2020-02-01
EP3806863A1 (en) 2021-04-21
SG11202012344RA (en) 2021-01-28
CA3103421A1 (en) 2019-12-19
US20200113917A1 (en) 2020-04-16
AU2025217363A1 (en) 2025-09-04
MX2020013557A (es) 2021-05-27
AU2019287491A1 (en) 2021-01-07
US20220323462A1 (en) 2022-10-13

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Owner name: SAGE THERAPEUTICS, LLC

Free format text: FORMER NAME(S): SAGE THERAPEUTICS, INC.