CA3103421A1 - 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
CA3103421A1
CA3103421A1 CA3103421A CA3103421A CA3103421A1 CA 3103421 A1 CA3103421 A1 CA 3103421A1 CA 3103421 A CA3103421 A CA 3103421A CA 3103421 A CA3103421 A CA 3103421A CA 3103421 A1 CA3103421 A1 CA 3103421A1
Authority
CA
Canada
Prior art keywords
subject
compound
weeks
dosing regimen
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.)
Pending
Application number
CA3103421A
Other languages
English (en)
French (fr)
Inventor
Stephen Jay Kanes
James J. Doherty
Handan GUNDUZ-BRUCE
Jeffrey M. Jonas
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 Inc
Original Assignee
Sage Therapeutics Inc
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 Inc filed Critical Sage Therapeutics Inc
Publication of CA3103421A1 publication Critical patent/CA3103421A1/en
Pending legal-status Critical Current

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)
CA3103421A 2018-06-12 2019-06-12 A 19-nor c3,3-disubstituted c21 -n-pyrazolyl steroid and methods of use thereof Pending CA3103421A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3103421A1 true CA3103421A1 (en) 2019-12-19

Family

ID=67211854

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3103421A Pending CA3103421A1 (en) 2018-06-12 2019-06-12 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

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
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
EP3678670A1 (en) * 2017-09-07 2020-07-15 Sage Therapeutics, Inc. Neuroactive steroids and their methods of use

Also Published As

Publication number Publication date
US20200113917A1 (en) 2020-04-16
AU2019287491B2 (en) 2025-05-15
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
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
RU2851101C2 (ru) 19-nor с3,3-замещенный с21-n-пиразолилстероид и способы его применения
EP3952993B1 (en) Method of treating fumaric acid ester-resistant plaque psoriasis
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
Cappello Medication-Assisted Treatment (MAT) in the Emergency Department
WO2023159035A1 (en) Neuroactive steroids for treatment of cns-related disorders
CA3218384A1 (en) Use of complement factor d inhibitor for treatment of generalized myasthenia gravis
Harsh New drugs
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
Mancano New drugs of 2012, part 2
Ferreira 1.5 CEUs

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20240612

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 6TH ANNIV.) - STANDARD

Year of fee payment: 6

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20250523

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: A-2-2-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20250523

D15 Examination report completed

Free format text: ST27 STATUS EVENT CODE: A-2-2-D10-D15-D126 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXAMINER'S REPORT

Effective date: 20250710

T11 Administrative time limit extension requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-T10-T11-T100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXTENSION OF TIME FOR TAKING ACTION REQUEST RECEIVED

Effective date: 20251107

T13 Administrative time limit extension granted

Free format text: ST27 STATUS EVENT CODE: A-2-2-T10-T13-T101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: EXTENSION OF TIME FOR TAKING ACTION REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260105

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260105

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260105

B12 Application deemed to be withdrawn, abandoned or lapsed

Free format text: ST27 STATUS EVENT CODE: N-2-6-B10-B12-B303 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: DEEMED ABANDONED - FAILURE TO RESPOND TO AN EXAMINER'S REQUISITION

Effective date: 20260112

R11 Change to the name of applicant or owner or transfer of ownership requested

Free format text: ST27 STATUS EVENT CODE: A-2-2-R10-R11-R103 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CHANGE OF NAME REQUEST RECEIVED

Effective date: 20260203

R13 Change to the name of applicant or owner recorded

Free format text: ST27 STATUS EVENT CODE: A-2-2-R10-R13-R104 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CHANGE OF NAME REQUIREMENTS DETERMINED COMPLIANT

Effective date: 20260223

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: A-2-2-W10-W00-W111 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: CORRESPONDENT DETERMINED COMPLIANT

Effective date: 20260223

MFA Maintenance fee for application paid

Free format text: FEE DESCRIPTION TEXT: MF (APPLICATION, 7TH ANNIV.) - STANDARD

Year of fee payment: 7

U00 Fee paid

Free format text: ST27 STATUS EVENT CODE: N-6-6-U10-U00-U101 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE REQUEST RECEIVED

Effective date: 20260409

U11 Full renewal or maintenance fee paid

Free format text: ST27 STATUS EVENT CODE: N-6-6-U10-U11-U102 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: MAINTENANCE FEE PAYMENT PAID IN FULL

Effective date: 20260409

W00 Other event occurred

Free format text: ST27 STATUS EVENT CODE: N-6-6-W10-W00-W100 (AS PROVIDED BY THE NATIONAL OFFICE); EVENT TEXT: LETTER SENT

Effective date: 20260514