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EP4164653A4 - MORPHIC FORMS OF TRILACICLIB AND METHODS OF MANUFACTURING THEM - Google Patents
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EP4164653A4 - MORPHIC FORMS OF TRILACICLIB AND METHODS OF MANUFACTURING THEM - Google Patents

MORPHIC FORMS OF TRILACICLIB AND METHODS OF MANUFACTURING THEM Download PDF

Info

Publication number
EP4164653A4
EP4164653A4 EP21826036.2A EP21826036A EP4164653A4 EP 4164653 A4 EP4164653 A4 EP 4164653A4 EP 21826036 A EP21826036 A EP 21826036A EP 4164653 A4 EP4164653 A4 EP 4164653A4
Authority
EP
European Patent Office
Prior art keywords
trilaciclib
manufacturing
methods
morphic forms
morphic
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
EP21826036.2A
Other languages
German (de)
French (fr)
Other versions
EP4164653A1 (en
Inventor
Stephen Schneider
Alexander Smith
Hannah S. WHITE
Jay Copeland Strum
Jaroslaw Mazurek
Sara WU
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.)
Pharmacosmos Holding AS
Original Assignee
G1 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
Priority claimed from US17/097,854 external-priority patent/US10988479B1/en
Application filed by G1 Therapeutics Inc filed Critical G1 Therapeutics Inc
Publication of EP4164653A1 publication Critical patent/EP4164653A1/en
Publication of EP4164653A4 publication Critical patent/EP4164653A4/en
Pending legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/22—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains four or more hetero rings
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/12—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains three hetero rings
    • C07D487/20—Spiro-condensed systems
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/527—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim spiro-condensed
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00—Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13—Crystalline forms, e.g. polymorphs

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
EP21826036.2A 2020-06-15 2021-06-15 MORPHIC FORMS OF TRILACICLIB AND METHODS OF MANUFACTURING THEM Pending EP4164653A4 (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202063039372P 2020-06-15 2020-06-15
US17/097,854 US10988479B1 (en) 2020-06-15 2020-11-13 Morphic forms of trilaciclib and methods of manufacture thereof
US202163180578P 2021-04-27 2021-04-27
PCT/US2021/037462 WO2021257587A1 (en) 2020-06-15 2021-06-15 Morphic forms of trilaciclib and methods of manufacture thereof

Publications (2)

Publication Number Publication Date
EP4164653A1 EP4164653A1 (en) 2023-04-19
EP4164653A4 true EP4164653A4 (en) 2024-06-19

Family

ID=80326310

Family Applications (1)

Application Number Title Priority Date Filing Date
EP21826036.2A Pending EP4164653A4 (en) 2020-06-15 2021-06-15 MORPHIC FORMS OF TRILACICLIB AND METHODS OF MANUFACTURING THEM

Country Status (4)

Country Link
EP (1) EP4164653A4 (en)
CN (2) CN120398896A (en)
TW (1) TWI906312B (en)
WO (1) WO2021257587A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230374028A1 (en) * 2020-10-08 2023-11-23 Teva Pharmaceuticals International Gmbh Solid state forms of trilaciclib and of trilaciclib salts
US20250136610A1 (en) 2022-02-28 2025-05-01 Teva Pharmaceuticals International Gmbh Crystalline forms of trilaciclib and trilaciclib salts
WO2024009319A1 (en) * 2022-07-02 2024-01-11 Dr. Reddy's Laboratories Limited Liquid injectable compositions of trilaciclib
IT202300010182A1 (en) * 2023-05-19 2024-11-19 Olon Spa SOLVATED FORM OF TRILACYCLIB DI-HYDROCHLORIDE.
IT202300010824A1 (en) * 2023-05-29 2024-11-29 Olon Spa SOLVATED FORM OF TRILACYCLIB DI-HYDROCHLORIDE.
WO2025134057A1 (en) 2023-12-20 2025-06-26 Assia Chemical Industries Ltd. Solid state forms of trilaciclib citrate salt

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8598186B2 (en) * 2010-10-25 2013-12-03 G1 Therapeutics, Inc. CDK inhibitors
US20160220569A1 (en) * 2015-02-03 2016-08-04 G1 Therapeutics, Inc. CDK4/6 Inhibitor Dosage Formulations For The Protection Of Hematopoietic Stem And Progenitor Cells During Chemotherapy
WO2018005865A1 (en) * 2016-07-01 2018-01-04 G1 Therapeutics, Inc. Synthesis of n-(heteroaryl)-pyrrolo[3,2-d]pyrimidin-2-amines

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ME03557B (en) * 2013-03-15 2020-07-20 G1 Therapeutics Inc PROVISIONAL PROTECTION OF NORMAL CELLS DURING CHEMOTHERAPY
KR20190092478A (en) * 2016-12-05 2019-08-07 쥐원 쎄라퓨틱스, 인크. Preservation of Immune Response During Chemotherapy Regimen
WO2019006393A1 (en) * 2017-06-29 2019-01-03 G1 Therapeutics, Inc. MORPHIC FORMS OF GIT38 AND METHODS OF MAKING SAME
US10988479B1 (en) * 2020-06-15 2021-04-27 G1 Therapeutics, Inc. Morphic forms of trilaciclib and methods of manufacture thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8598186B2 (en) * 2010-10-25 2013-12-03 G1 Therapeutics, Inc. CDK inhibitors
US20160220569A1 (en) * 2015-02-03 2016-08-04 G1 Therapeutics, Inc. CDK4/6 Inhibitor Dosage Formulations For The Protection Of Hematopoietic Stem And Progenitor Cells During Chemotherapy
WO2018005865A1 (en) * 2016-07-01 2018-01-04 G1 Therapeutics, Inc. Synthesis of n-(heteroaryl)-pyrrolo[3,2-d]pyrimidin-2-amines

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2021257587A1 *

Also Published As

Publication number Publication date
TWI906312B (en) 2025-12-01
CN120398896A (en) 2025-08-01
EP4164653A1 (en) 2023-04-19
CN116157403B (en) 2025-04-25
WO2021257587A1 (en) 2021-12-23
TW202214650A (en) 2022-04-16
CN116157403A (en) 2023-05-23

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