AU2022320615B2 - 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer - Google Patents

1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer

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Publication number
AU2022320615B2
AU2022320615B2 AU2022320615A AU2022320615A AU2022320615B2 AU 2022320615 B2 AU2022320615 B2 AU 2022320615B2 AU 2022320615 A AU2022320615 A AU 2022320615A AU 2022320615 A AU2022320615 A AU 2022320615A AU 2022320615 B2 AU2022320615 B2 AU 2022320615B2
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Australia
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administration
gedatolisib
period
inhibitor
cycles
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AU2022320615A
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AU2022320615A1 (en
Inventor
Lance Gavin LAING
Brian Francis Sullivan
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Celcuity Inc
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Celcuity Inc
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Priority to AU2025223785A priority Critical patent/AU2025223785A1/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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • 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
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/537—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/566—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol having an oxo group in position 17, e.g. estrone
    • 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
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2022320615A 2021-07-26 2022-07-25 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer Active AU2022320615B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025223785A AU2025223785A1 (en) 2021-07-26 2025-08-27 1-(4-{[4-(Dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163225707P 2021-07-26 2021-07-26
US63/225,707 2021-07-26
US202163285327P 2021-12-02 2021-12-02
US63/285,327 2021-12-02
PCT/US2022/038188 WO2023009438A1 (en) 2021-07-26 2022-07-25 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025223785A Division AU2025223785A1 (en) 2021-07-26 2025-08-27 1-(4-{[4-(Dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer

Publications (2)

Publication Number Publication Date
AU2022320615A1 AU2022320615A1 (en) 2024-03-14
AU2022320615B2 true AU2022320615B2 (en) 2025-08-21

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AU2022320615A Active AU2022320615B2 (en) 2021-07-26 2022-07-25 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer
AU2025223785A Pending AU2025223785A1 (en) 2021-07-26 2025-08-27 1-(4-{[4-(Dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer

Family Applications After (1)

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AU2025223785A Pending AU2025223785A1 (en) 2021-07-26 2025-08-27 1-(4-{[4-(Dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea (gedatolisib) and its combinations for use in the treatment of cancer

Country Status (11)

Country Link
US (2) US12350276B2 (https=)
EP (1) EP4376848A1 (https=)
JP (1) JP2024529430A (https=)
KR (1) KR20240040768A (https=)
AU (2) AU2022320615B2 (https=)
CA (1) CA3227191A1 (https=)
CL (1) CL2024000208A1 (https=)
IL (1) IL310243A (https=)
MX (1) MX2024001266A (https=)
TW (1) TW202320795A (https=)
WO (1) WO2023009438A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025049962A1 (en) * 2023-08-31 2025-03-06 Aadi Bioscience, Inc. Combination cancer treatments with a composition comprising an mtor pathway inhibitor
US20260053814A1 (en) * 2024-08-21 2026-02-26 Celcuity Inc. Treatment regimens for gedatolisib in hormonally-driven disorders

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US5998402A (en) 1996-04-19 1999-12-07 American Home Products Corporation 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indoles as estrogenic agents
GB9718913D0 (en) 1997-09-05 1997-11-12 Glaxo Group Ltd Substituted oxindole derivatives
MXPA04005939A (es) 2002-01-22 2005-01-25 Warner Lambert Co 2-(piridin-2-ilamino)-pirido[2,3-d]pirimidin-7-onas.
GB0327380D0 (en) 2003-11-25 2003-12-31 Cyclacel Ltd Method
EP1846408B1 (en) 2005-01-14 2013-03-20 Janssen Pharmaceutica NV 5-membered annelated heterocyclic pyrimidines as kinase inhibitors
LT2294072T (lt) 2008-05-23 2017-06-12 Wyeth Llc Triazino junginiai, kaip p13 kinazės ir mtor inhibitoriai
US10022381B2 (en) 2008-05-23 2018-07-17 Pfizer Inc. Triazine compounds as PI3 kinase and mTOR inhibitors
ES2522346T3 (es) 2008-08-22 2014-11-14 Novartis Ag Compuestos de pirrolopirimidina como inhibidores de CDK
UY33227A (es) 2010-02-19 2011-09-30 Novartis Ag Compuestos de pirrolopirimidina como inhibidores de la cdk4/6
MX338327B (es) 2010-10-25 2016-04-12 G1 Therapeutics Inc Inhibidores de cdk.
WO2013090829A1 (en) 2011-12-14 2013-06-20 Aragon Pharmaceuticals, Inc. Estrogen receptor modulators and uses thereof
CA2868966C (en) 2012-03-29 2021-01-26 Francis Xavier Tavares Lactam kinase inhibitors
CA2915534A1 (en) 2013-06-19 2014-12-24 Seragon Pharmaceuticals, Inc. Azetidine estrogen receptor modulators and uses thereof
PE20170312A1 (es) 2014-03-14 2017-03-30 Pfizer Nanoparticulas terapeuticas que comprenden un agente terapeutico, y metodos para su elaboracion y uso
ES2881214T3 (es) 2014-12-17 2021-11-29 Pfizer Formulaciones de un inhibidor de PI3K/mTOR para la administración intravenosa
SI3672571T1 (sl) 2017-08-25 2022-01-31 Pfizer Inc. Farmacevtska vodna raztopina, ki vsebuje 1-(4-((4-(dimetilamino) piperdin-1-il)karbonil)fenil)-3-(4-(4,6-dimorfolin-4-il-1,3, 5-triazin-2-il)fenil)sečnino
EP4249069B1 (en) 2018-06-07 2025-11-19 Pfizer Inc. Aqueous formulation comprising 1-(4-{[4-(dimethylamino)piperidin-1-yl]carbonyl}phenyl)-3-[4-(4,6-dimorpholin-4-yl-1,3,5-triazin-2-yl)phenyl]urea
EP3863618A1 (en) * 2018-10-08 2021-08-18 F. Hoffmann-La Roche AG Methods of treating cancer with pi3k alpha inhibitors and metformin

Non-Patent Citations (2)

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Title
FORERO A ET AL: "Phase Ib study to assess the safety, tolerability, and clinical activity of gedatolisib in combination with palbociclib and either letrozole or fulvestrant...", CANCER RESEARCH, vol. 78, no. 4, Supplement 1, 1 February 2018 *
FORERO-TORRES A ET AL: "Phase Ib study of gedatolisib in combination with palbociclib and endocrine therapy (ET) in women with ER+ metastatic breast cancer (MBC)", JOURNAL OF CLINICAL ONCOLOGY, vol. 36, no. 15, Supplement 1, 1 May 2018 *

Also Published As

Publication number Publication date
JP2024529430A (ja) 2024-08-06
AU2025223785A1 (en) 2025-09-18
EP4376848A1 (en) 2024-06-05
US12350276B2 (en) 2025-07-08
TW202320795A (zh) 2023-06-01
US20230022525A1 (en) 2023-01-26
IL310243A (en) 2024-03-01
WO2023009438A1 (en) 2023-02-02
US20250345342A1 (en) 2025-11-13
CA3227191A1 (en) 2023-02-02
MX2024001266A (es) 2024-04-16
KR20240040768A (ko) 2024-03-28
AU2022320615A1 (en) 2024-03-14
CL2024000208A1 (es) 2024-07-19

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