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

Info

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
Authority
AU
Australia
Prior art keywords
subject
compound
day
weeks
depression
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.)
Active
Application number
AU2019287491A
Other languages
English (en)
Other versions
AU2019287491A1 (en
Inventor
James J. Doherty
Handan GUNDUZ-BRUCE
Jeffrey M. Jonas
Stephen Jay Kanes
Robert Alfonso LASSER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sage Therapeutics LLC
Original Assignee
Sage Therapeutics LLC
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Sage Therapeutics LLC filed Critical Sage Therapeutics LLC
Publication of AU2019287491A1 publication Critical patent/AU2019287491A1/en
Application granted granted Critical
Publication of AU2019287491B2 publication Critical patent/AU2019287491B2/en
Priority to AU2025217363A priority Critical patent/AU2025217363A1/en
Assigned to Sage Therapeutics, LLC reassignment Sage Therapeutics, LLC Request to Amend Deed and Register Assignors: SAGE THERAPEUTICS, INC.
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • 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)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)

Application Number Title Priority Date Filing Date
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

Publications (2)

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

Family

ID=67211854

Family Applications (2)

Application Number Title Priority Date Filing Date
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

Family Applications After (1)

Application Number Title Priority Date Filing Date
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

Country Status (13)

Country Link
US (4) US20210338692A1 (enExample)
EP (1) EP3806863A1 (enExample)
JP (3) JP2021527092A (enExample)
KR (1) KR20210021005A (enExample)
CN (2) CN117959309A (enExample)
AU (2) AU2019287491B2 (enExample)
CA (1) CA3103421A1 (enExample)
IL (1) IL279315A (enExample)
MA (1) MA52894A (enExample)
MX (2) MX2020013557A (enExample)
SG (1) SG11202012344RA (enExample)
TW (1) TWI923545B (enExample)
WO (1) WO2019241442A1 (enExample)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10201606063RA (en) 2012-01-23 2016-09-29 Sage Therapeutics Inc Neuroactive steroid formulations and methods of treating cns disorders
RS62761B1 (sr) 2012-08-21 2022-01-31 Sage Therapeutics Inc Alopregnanolon za lečenje refraktornog epileptičkog statusa
SMT202100509T1 (it) 2013-04-17 2021-11-12 Sage Therapeutics Inc Steroide di c21-n-pirazolile 19-nor c3,3-disostituito per l'uso in terapia
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
WO2018013613A1 (en) 2016-07-11 2018-01-18 Sage Therapeutics, Inc. C17, c20, and c21 substituted neuroactive steroids and their methods of use
TW202604538A (zh) 2016-08-23 2026-02-01 美商賽吉醫療公司 結晶19-去甲c3,3-二取代之c21-n-吡唑類固醇
US20200291059A1 (en) 2017-12-08 2020-09-17 Sage Therapeutics, Inc. Compositions and methods for treating cns disorders
US20230018765A1 (en) * 2019-12-05 2023-01-19 Sage Therapeutics, Inc. A 19-nor c3,3-disubstituted c21-n-pyrazolyl steroid and methods of use thereof
CN115551514A (zh) 2020-03-25 2022-12-30 萨奇治疗股份有限公司 用于治疗呼吸系统病症的药物的用途
CA3187178A1 (en) * 2020-07-20 2022-01-27 Sage Therapeutics, Inc. Formulations of 19-nor c3,3- disubstituted c21-n-pyrazolyl steroid and methods of use thereof
WO2022165017A1 (en) * 2021-01-28 2022-08-04 Sage Therapeutics, Inc. Use of neuroactive steroids for treatment of sexual dysfunction
JP2024510436A (ja) * 2021-03-17 2024-03-07 セージ セラピューティクス， インコーポレイテッド 大うつ病性障害の処置のための１９－ノルｃ３，３－２置換ｃ２１－ｎ－ピラゾリルステロイド
MX2023012728A (es) * 2021-04-29 2023-11-08 Sage Therapeutics Inc Esteroide neuroactivo para el tratamiento del trastorno depresivo mayor y la depresion posparto en una mujer lactante.
MX2023012727A (es) * 2021-04-29 2023-11-08 Sage Therapeutics Inc Esteroide c21 -n-pirazolilo disubstituido 19-nor c3,3 para uso en el tratamiento de principales trastorno depresivo y depresion posparto.
JP2025508406A (ja) * 2022-02-16 2025-03-26 セージ セラピューティクス， インコーポレイテッド Ｃｎｓ関連障害を処置するための神経活性ステロイド
WO2025175214A1 (en) * 2024-02-16 2025-08-21 Engrail Therapeutics, Inc. Methods of treating generalized anxiety disorder

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JOP20200195A1 (ar) * 2014-09-08 2017-06-16 Sage Therapeutics Inc سترويدات وتركيبات نشطة عصبياً، واستخداماتها
US20170233433A1 (en) * 2014-10-16 2017-08-17 Sage Therapeutics, Inc. Compositions and methods for treating cns disorders
PH12018501923B1 (en) * 2016-03-08 2024-06-28 Sage Therapeutics Inc Neuroactive steroids, compositions, and uses thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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)

* Cited by examiner, † Cited by third party
Title
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
US20200113917A1 (en) 2020-04-16
CN112533611A (zh) 2021-03-19
US20210338692A1 (en) 2021-11-04
JP2025108553A (ja) 2025-07-23
MX2020013557A (es) 2021-05-27
TW202005653A (zh) 2020-02-01
SG11202012344RA (en) 2021-01-28
US20220323462A1 (en) 2022-10-13
EP3806863A1 (en) 2021-04-21
JP2021527092A (ja) 2021-10-11
MA52894A (fr) 2021-04-21
AU2025217363A1 (en) 2025-09-04
CA3103421A1 (en) 2019-12-19
US20250339447A1 (en) 2025-11-06
MX2025000166A (es) 2025-03-07
TWI923545B (zh) 2026-05-01
CN117959309A (zh) 2024-05-03
KR20210021005A (ko) 2021-02-24
JP2024028849A (ja) 2024-03-05
AU2019287491A1 (en) 2021-01-07
WO2019241442A1 (en) 2019-12-19
IL279315A (en) 2021-01-31

Similar Documents

Publication Publication Date Title
US20250339447A1 (en) 19-nor c3,3-disubstituted c21-n-pyrazolyl steroid and methods of use thereof
US20230018765A1 (en) A 19-nor c3,3-disubstituted c21-n-pyrazolyl steroid and methods of use thereof
US20240216395A1 (en) 19-nor c3,3-disubstituted c21 -n-pyrazolyl steroid for use in treating major depressive disorder and postpartum depression
US20250295674A1 (en) Neuroactive steroids for treatment of cns-related disorders
CA2899602A1 (en) Pharmaceutical uses of inorganic nitrites
JP2026505367A (ja) 高タンパク尿慢性腎疾患の治療のためのジボテンタン及びダパグリフロジンの合剤
RU2851101C2 (ru) 19-nor с3,3-замещенный с21-n-пиразолилстероид и способы его применения
US20240238290A1 (en) Use of complement factor d inhibitor for treatment of generalized myasthenia gravis
WO2023159035A1 (en) Neuroactive steroids for treatment of cns-related disorders
WO2024196957A1 (en) Method for treating l-dopa-induced dyskinesia using befiradol
CN117580581A (zh) 用于治疗重度抑郁障碍和产后抑郁症的19-去甲c3,3-二取代的c21-n-吡唑基类固醇
Baker New Drugs Approved by the FDA; New Dosage Forms and Indications Approved by the FDA; Agents Pending FDA Approval; New Drug Applications Filed by Manufacturer; Supplemental Applications Filed by Manufacturer; Significant Labeling Changes or “Dear Health Care Professional” Letters Related to Safety

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
HB Alteration of name in register

Owner name: SAGE THERAPEUTICS, LLC

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