JP7181318B2 - テベレリクス－ｔｆａ組成物 - Google Patents

テベレリクス－ｔｆａ組成物 Download PDF

Info

Publication number
JP7181318B2
JP7181318B2 JP2020570554A JP2020570554A JP7181318B2 JP 7181318 B2 JP7181318 B2 JP 7181318B2 JP 2020570554 A JP2020570554 A JP 2020570554A JP 2020570554 A JP2020570554 A JP 2020570554A JP 7181318 B2 JP7181318 B2 JP 7181318B2
Authority
JP
Japan
Prior art keywords
teverelix
tfa
composition
trifluoroacetate
molar ratio
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
JP2020570554A
Other languages
English (en)
Japanese (ja)
Other versions
JP2021529165A5 (https=
JP2021529165A (ja
Inventor
ガイ ポーランド，
フランソワ ブティニョン，
Original Assignee
アンテヴ リミテッド
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 アンテヴ リミテッド filed Critical アンテヴ リミテッド
Publication of JP2021529165A publication Critical patent/JP2021529165A/ja
Publication of JP2021529165A5 publication Critical patent/JP2021529165A5/ja
Priority to JP2022183797A priority Critical patent/JP2023027082A/ja
Application granted granted Critical
Publication of JP7181318B2 publication Critical patent/JP7181318B2/ja
Priority to JP2024159884A priority patent/JP2025004006A/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/08—Solutions
    • 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
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/08—Drugs for disorders of the urinary system of the prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/02—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • A61P5/04—Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin for decreasing, blocking or antagonising the activity of the hypothalamic hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/10—Antioedematous agents; Diuretics

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Urology & Nephrology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Dispersion Chemistry (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
JP2020570554A 2018-07-05 2019-07-02 テベレリクス－ｔｆａ組成物 Active JP7181318B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2022183797A JP2023027082A (ja) 2018-07-05 2022-11-17 テベレリクス－ｔｆａ組成物
JP2024159884A JP2025004006A (ja) 2018-07-05 2024-09-17 テベレリクス－ｔｆａ組成物

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP18181945.9A EP3590525A1 (en) 2018-07-05 2018-07-05 Teverelix-tfa composition
EP18181945.9 2018-07-05
PCT/EP2019/067728 WO2020007857A1 (en) 2018-07-05 2019-07-02 Teverelix-tfa composition

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2022183797A Division JP2023027082A (ja) 2018-07-05 2022-11-17 テベレリクス－ｔｆａ組成物

Publications (3)

Publication Number Publication Date
JP2021529165A JP2021529165A (ja) 2021-10-28
JP2021529165A5 JP2021529165A5 (https=) 2022-06-14
JP7181318B2 true JP7181318B2 (ja) 2022-11-30

Family

ID=62874669

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2020570554A Active JP7181318B2 (ja) 2018-07-05 2019-07-02 テベレリクス－ｔｆａ組成物
JP2022183797A Withdrawn JP2023027082A (ja) 2018-07-05 2022-11-17 テベレリクス－ｔｆａ組成物
JP2024159884A Pending JP2025004006A (ja) 2018-07-05 2024-09-17 テベレリクス－ｔｆａ組成物

Family Applications After (2)

Application Number Title Priority Date Filing Date
JP2022183797A Withdrawn JP2023027082A (ja) 2018-07-05 2022-11-17 テベレリクス－ｔｆａ組成物
JP2024159884A Pending JP2025004006A (ja) 2018-07-05 2024-09-17 テベレリクス－ｔｆａ組成物

Country Status (6)

Country Link
US (2) US11357818B2 (https=)
EP (3) EP3590525A1 (https=)
JP (3) JP7181318B2 (https=)
CN (2) CN118161591A (https=)
CA (1) CA3141519A1 (https=)
WO (1) WO2020007857A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3560555A1 (en) * 2018-04-26 2019-10-30 LifeArc A composition for treating one or more estrogen related diseases
EP4541365A1 (en) 2023-10-18 2025-04-23 Antev Limited Teverelix-tfa in a dosage regime for use in the treatment of prostate cancer
EP4643869A1 (en) 2024-05-03 2025-11-05 Antev Limited Use of gnrh antagonists such as teverelix to treat acute urinary retention

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005504787A (ja) 2001-09-06 2005-02-17 ツェンタリス ゲゼルシャフト ミット ベシュレンクテル ハフツング 微晶質ペプチド懸濁液の徐放性

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3985723A (en) * 1971-09-07 1976-10-12 The University Of Mississippi Trifluoroacetylation process
EP1674082A1 (de) * 2004-12-22 2006-06-28 Zentaris GmbH Verfahren zur Herstellung von sterilen Suspensionen oder Lyophilisaten schwerlöslicher basischer Peptidkomplexe, diese enthaltende pharmazeutische Formulierungen sowie ihre Verwendung als Arzneimittel
WO2008071984A1 (en) * 2006-12-13 2008-06-19 Ardana Bioscience Limited Administration of the gonadotropin-releasing hormone antagonist teverelix
CN105693844A (zh) * 2016-03-10 2016-06-22 泰州施美康多肽药物技术有限公司 一种促性腺激素释放激素类似物醋酸盐的制备方法
EP3560555A1 (en) * 2018-04-26 2019-10-30 LifeArc A composition for treating one or more estrogen related diseases

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2005504787A (ja) 2001-09-06 2005-02-17 ツェンタリス ゲゼルシャフト ミット ベシュレンクテル ハフツング 微晶質ペプチド懸濁液の徐放性

Also Published As

Publication number Publication date
US20220273758A1 (en) 2022-09-01
EP3817758B1 (en) 2022-01-05
EP4011373B1 (en) 2026-04-29
CN112423775B (zh) 2024-03-15
CN118161591A (zh) 2024-06-11
US12070484B2 (en) 2024-08-27
JP2025004006A (ja) 2025-01-14
CN112423775A (zh) 2021-02-26
JP2023027082A (ja) 2023-03-01
EP3817758A1 (en) 2021-05-12
WO2020007857A1 (en) 2020-01-09
EP4011373A1 (en) 2022-06-15
EP3590525A1 (en) 2020-01-08
JP2021529165A (ja) 2021-10-28
CA3141519A1 (en) 2020-01-09
US11357818B2 (en) 2022-06-14
US20210236588A1 (en) 2021-08-05

Similar Documents

Publication Publication Date Title
JP2023027082A (ja) テベレリクス－ｔｆａ組成物
RU2201248C2 (ru) Стабильный водный пептидный препарат, способ его получения и способ лечения гормонзависимого заболевания у субъекта
KR101795643B1 (ko) 전립선암 치료용 조성물
JP4845166B2 (ja) ゲルを形成する濃度の性腺刺激ホルモン放出ホルモン拮抗物質
JP2001504802A (ja) 非水性プロトン性ペプチド配合物
JP7177859B2 (ja) 凍結乾燥方法およびこれによって得られるテベレリクス－ｔｆａ凍結乾燥物
KR100633280B1 (ko) 약제학적 활성 펩티드의 서방형 투여 형태 및 이의 제조 방법
US20230285503A1 (en) Reconstitutable teverelix-tfa composition
CN110248679A (zh) 包含至少一种GnRH拮抗剂的组合物
KR20250142363A (ko) 데가렐릭스 유기 용매 제형
WO2025229186A1 (en) Composition for use in reducing the risk of recurrent acute urinary retention

Legal Events

Date Code Title Description
A529 Written submission of copy of amendment under article 34 pct

Free format text: JAPANESE INTERMEDIATE CODE: A529

Effective date: 20210212

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220606

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220606

A871 Explanation of circumstances concerning accelerated examination

Free format text: JAPANESE INTERMEDIATE CODE: A871

Effective date: 20220606

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20220628

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220928

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20221018

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20221117

R150 Certificate of patent or registration of utility model

Ref document number: 7181318

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250