JP2022554276A - Ｍｔｏｒｃ１モジュレーターを使用する処置方法 - Google Patents

Ｍｔｏｒｃ１モジュレーターを使用する処置方法 Download PDF

Info

Publication number
JP2022554276A
JP2022554276A JP2022525289A JP2022525289A JP2022554276A JP 2022554276 A JP2022554276 A JP 2022554276A JP 2022525289 A JP2022525289 A JP 2022525289A JP 2022525289 A JP2022525289 A JP 2022525289A JP 2022554276 A JP2022554276 A JP 2022554276A
Authority
JP
Japan
Prior art keywords
compound
dose
patient
study
pharmaceutically acceptable
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
JP2022525289A
Other languages
English (en)
Japanese (ja)
Other versions
JP2022554276A5 (https=
Inventor
スティーブン レベンター，
スティーブン ディー． タルグム，
Original Assignee
ナビター ファーマシューティカルズ， インコーポレイテッド
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 ナビター ファーマシューティカルズ， インコーポレイテッド filed Critical ナビター ファーマシューティカルズ， インコーポレイテッド
Publication of JP2022554276A publication Critical patent/JP2022554276A/ja
Publication of JP2022554276A5 publication Critical patent/JP2022554276A5/ja
Priority to JP2025108138A priority Critical patent/JP2025129244A/ja
Pending legal-status Critical Current

Links

Images

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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • 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
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Psychiatry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2022525289A 2019-11-01 2020-11-02 Ｍｔｏｒｃ１モジュレーターを使用する処置方法 Pending JP2022554276A (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025108138A JP2025129244A (ja) 2019-11-01 2025-06-26 Ｍｔｏｒｃ１モジュレーターを使用する処置方法

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201962929449P 2019-11-01 2019-11-01
US62/929,449 2019-11-01
PCT/US2020/058475 WO2021087432A1 (en) 2019-11-01 2020-11-02 Methods of treatment using an mtorc1 modulator

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2025108138A Division JP2025129244A (ja) 2019-11-01 2025-06-26 Ｍｔｏｒｃ１モジュレーターを使用する処置方法

Publications (2)

Publication Number Publication Date
JP2022554276A true JP2022554276A (ja) 2022-12-28
JP2022554276A5 JP2022554276A5 (https=) 2023-09-20

Family

ID=75716349

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2022525289A Pending JP2022554276A (ja) 2019-11-01 2020-11-02 Ｍｔｏｒｃ１モジュレーターを使用する処置方法
JP2025108138A Pending JP2025129244A (ja) 2019-11-01 2025-06-26 Ｍｔｏｒｃ１モジュレーターを使用する処置方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025108138A Pending JP2025129244A (ja) 2019-11-01 2025-06-26 Ｍｔｏｒｃ１モジュレーターを使用する処置方法

Country Status (11)

Country Link
US (2) US11723890B2 (https=)
EP (1) EP4051259A4 (https=)
JP (2) JP2022554276A (https=)
CN (1) CN114786660A (https=)
AU (1) AU2020376950A1 (https=)
BR (1) BR112022008287A2 (https=)
CA (1) CA3156436A1 (https=)
IL (1) IL292612A (https=)
MX (1) MX2022005215A (https=)
TW (1) TWI870497B (https=)
WO (1) WO2021087432A1 (https=)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2016342027B2 (en) 2015-10-23 2021-05-13 Navitor Pharmaceuticals, Inc. Modulators of Sestrin-GATOR2 interaction and uses thereof
PL3615019T3 (pl) 2017-04-26 2026-01-19 Navitor Pharmaceuticals, Inc. Modulator interakcji sestryna-gator2 do zastosowania w leczeniu depresji opornej na leczenie
EP3870158A4 (en) 2018-10-24 2022-08-10 Navitor Pharmaceuticals, Inc. Polymorphic compounds and uses thereof
US11723890B2 (en) 2019-11-01 2023-08-15 Navitor Pharmaceuticals, Inc. Methods of treatment using an mTORC1 modulator
AU2023374029A1 (en) * 2022-11-01 2025-05-08 Navitor Pharmaceuticals, Inc. MODULATORS OF mTORC1 ACTIVITY AND USES THEREOF
WO2026085331A1 (en) 2024-10-16 2026-04-23 Navitor Pharmaceuticals, Inc. Mefluleucin for use in the treatment of suicidal ideations associated with depression

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180333381A1 (en) * 2017-04-26 2018-11-22 Navitor Pharmaceuticals, Inc. Modulators of sestrin-gator2 interaction and uses thereof
JP2018538248A (ja) * 2015-10-23 2018-12-27 ナビター ファーマシューティカルズ， インコーポレイテッド セストリン−ｇａｔｏｒ２相互作用のモジュレーターおよびその使用

Family Cites Families (73)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4110368A (en) 1972-07-24 1978-08-29 American Cyanamid Company Hydro substituted prostanoic acids and esters
US4346110A (en) 1981-06-01 1982-08-24 Merrell Toraude Et Compagnie Method for treating depression
JPS61149964A (ja) 1984-12-25 1986-07-08 Canon Inc 電子写真感光体
US4670196A (en) 1985-09-05 1987-06-02 Norton Company Tower packing element
DE3765646D1 (de) 1986-01-24 1990-11-29 Toray Industries 2,5,6,7-tetranor-4,8-inter-m-phenylen-pgi2-derivate.
GB8827885D0 (en) 1988-11-30 1989-01-05 Wellcome Found Novel heterocyclic pesticidal compounds
US5639600A (en) 1994-08-05 1997-06-17 The Regents Of The University Of California Diagnosis and treatment of cell proliferative disease having clonal macrophage involvement
DE19623142A1 (de) 1996-06-10 1997-12-11 Huels Chemische Werke Ag Enantiomerenangereicherte, durch einen tertiären Kohlenwasserstoffrest substituierte Malonsäuremonoester sowie deren Herstellung
BR9713182A (pt) 1996-08-28 1999-11-03 Procter & Gamble Amidas de ácido fosfìnico como inibidores de metalo protease de matriz
US7087648B1 (en) 1997-10-27 2006-08-08 The Regents Of The University Of California Methods for modulating macrophage proliferation using polyamine analogs
US6458781B1 (en) 1998-04-27 2002-10-01 David Thomas Connor Substituted diarylalkyl amides as calcium channel antagonists
AU6342099A (en) 1998-11-04 2000-05-22 Montell Technology Company B.V. Components and catalysts for the polymerization of olefins
US6329546B1 (en) 1999-01-12 2001-12-11 Laboratory Of Molecular Biophotonics Caged amino acids
US20030203900A1 (en) 1999-05-18 2003-10-30 Martin Quibell Cysteine protease inhibitors
RS50352B (sr) 1999-06-10 2009-11-10 Warner-Lambert Company Llc., Monosupstituisane 3-propil gama-aminobuterne kiseline
DE60217322T2 (de) 2001-04-27 2007-10-04 Zenyaku Kogyo K.K. Heterocyclische verbindung und antitumormittel, das diese als wirkstoff enthält
TWI329105B (en) 2002-02-01 2010-08-21 Rigel Pharmaceuticals Inc 2,4-pyrimidinediamine compounds and their uses
PT1536827E (pt) 2002-08-14 2009-03-20 Silence Therapeutics Ag Utilização de proteína cinase n beta
US6787664B2 (en) 2002-09-17 2004-09-07 Warner-Lambert Company Llc Process for preparing single enantiomers of 5,5,5,5′,5′,5′-hexafluoroleucine and protected analogs
AU2002953255A0 (en) 2002-12-11 2003-01-02 Cytopia Research Pty Ltd Protein kinase inhibitors
AU2004228668B2 (en) 2003-04-03 2011-10-27 Park Funding, Llc PI-3 kinase inhibitor prodrugs
ES2382377T3 (es) 2003-05-30 2012-06-07 Gemin X Pharmaceuticals Canada Inc. Compuestos triheterocíclicos, composiciones, y métodos para tratar cáncer
EP1692153A4 (en) 2003-07-03 2007-03-21 Univ Pennsylvania INHIBITION OF EXPRESSION OF SYK-KINASE
WO2005113556A1 (en) 2004-05-13 2005-12-01 Icos Corporation Quinazolinones as inhibitors of human phosphatidylinositol 3-kinase delta
US20070212428A1 (en) 2004-06-04 2007-09-13 Mood Management Sciences, Inc. Methods and compositions for treating mood disorder
DE102004053407A1 (de) 2004-11-05 2006-05-11 Bayer Healthcare Ag Acylierte Nonadepsipeptide II
AU2006206458B2 (en) 2005-01-19 2012-10-25 Rigel Pharmaceuticals, Inc. Prodrugs of 2,4-pyrimidinediamine compounds and their uses
EP1853552A2 (en) 2005-02-18 2007-11-14 Innodia Inc. Diastereoisomers of 4-hydroxyisoleucine and uses thereof
PL1888550T3 (pl) 2005-05-12 2014-12-31 Abbvie Bahamas Ltd Promotory apoptozy
GB0510390D0 (en) 2005-05-20 2005-06-29 Novartis Ag Organic compounds
US7402325B2 (en) 2005-07-28 2008-07-22 Phoenix Biotechnology, Inc. Supercritical carbon dioxide extract of pharmacologically active components from Nerium oleander
US7989622B2 (en) 2005-10-07 2011-08-02 Exelixis, Inc. Phosphatidylinositol 3-kinase inhibitors and methods of their use
JP5191391B2 (ja) 2005-11-01 2013-05-08 ターゲジェン インコーポレーティッド キナーゼのビ−アリールメタ−ピリミジン阻害剤
SG10202003901UA (en) 2005-12-13 2020-05-28 Incyte Holdings Corp Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors
JO2660B1 (en) 2006-01-20 2012-06-17 نوفارتيس ايه جي Pi-3 inhibitors and methods of use
WO2007129161A2 (en) 2006-04-26 2007-11-15 F. Hoffmann-La Roche Ag Thieno [3, 2-d] pyrimidine derivative useful as pi3k inhibitor
JP2010501566A (ja) 2006-08-21 2010-01-21 プレクサ ファーマシューティカルズ， インコーポレイテッド 中枢神経系障害の治療において使用するための多伝達物質トランスポータ阻害剤
DK2526933T3 (en) 2006-09-22 2015-05-18 Pharmacyclics Inc Inhibitors of Bruton's tyrosine kinase
EP2069339B1 (en) 2006-09-25 2011-05-18 Wockhardt Research Centre Substituted piperidinophenyl oxazolidinones
TWI397418B (zh) 2006-10-10 2013-06-01 Otsuka Pharma Co Ltd 抗憂鬱劑
CA2666310C (en) 2006-10-20 2012-07-31 Merck & Co., Inc. Substituted imidazoles as bombesin receptor subtype-3 modulators
KR101566840B1 (ko) 2007-03-12 2015-11-06 와이엠 바이오사이언시즈 오스트레일리아 피티와이 엘티디 페닐 아미노 피리미딘 화합물 및 이의 용도
WO2008118802A1 (en) 2007-03-23 2008-10-02 Regents Of The University Of Minnesota Therapeutic compounds
TW200902019A (en) 2007-04-26 2009-01-16 Ono Pharmaceutical Co Dicyclic heterocyclic compound
PE20090717A1 (es) 2007-05-18 2009-07-18 Smithkline Beecham Corp Derivados de quinolina como inhibidores de la pi3 quinasa
US8431608B2 (en) 2007-08-17 2013-04-30 Icagen Inc. Heterocycles as potassium channel modulators
CN101903349B (zh) 2007-08-27 2014-01-08 Abbvie德国有限责任两合公司 4-(4-吡啶基)-苯甲酰胺及其作为rock活性调节剂的应用
HUE029767T2 (en) 2008-03-11 2017-04-28 Incyte Holdings Corp JAK inhibitor azetidine and cyclobutane derivatives
WO2010005726A2 (en) 2008-06-16 2010-01-14 Bind Biosciences Inc. Therapeutic polymeric nanoparticles with mtor inhibitors and methods of making and using same
EP2350053B1 (en) 2008-10-17 2013-12-11 Whitehead Institute For Biomedical Research Modulators of MTOR Complexes
EP2443128B1 (en) 2009-06-19 2017-12-20 LEK Pharmaceuticals d.d. New synthetic route for the preparation of alpha-amino boronic esters
WO2011012283A1 (en) 2009-07-30 2011-02-03 University Of Zurich Injectable formulation for treatment and protection of patients having an inflammatory reaction or an ischemia-reperfusion event
PH12012501535A1 (en) 2010-01-29 2012-10-22 Boehringer Ingelheim Int Substituted naphthyridines and their use as syk kinase inhibitors
ES2689103T3 (es) 2010-06-30 2018-11-08 Fujifilm Corporation Nuevo derivado de nicotinamida o sal del mismo
CN102464701B (zh) 2010-11-08 2015-10-21 上海医药工业研究院 一类新型化合物、其制备方法及用途
WO2012076063A1 (en) 2010-12-10 2012-06-14 Rottapharm S.P.A. Pyridine amide derivatives as ep4 receptor antagonists
WO2012113847A1 (en) 2011-02-25 2012-08-30 Lonza Ltd Branched linker for protein drug conjugates
US9321727B2 (en) 2011-06-10 2016-04-26 Hoffmann-La Roche Inc. Pyridine derivatives as agonists of the CB2 receptor
EP2763975B1 (en) 2011-10-05 2016-04-06 Merck Sharp & Dohme Corp. 3-pyridyl carboxamide-containing spleen tyrosine kinase (syk) inhibitors
EP2589383A1 (en) 2011-11-06 2013-05-08 Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. Berlin FKBP subtype-specific rapamycin analogue for use in treatment of diseases
WO2013142229A1 (en) 2012-03-19 2013-09-26 President And Fellows Of Harvard College Designing novel peptides for inducing fibronectin matrix assembly
EP2880014B1 (en) * 2012-08-06 2017-05-17 Pitney Pharmaceuticals Pty Limited Compounds for the treatment of mtor pathway related diseases
WO2014127052A1 (en) 2013-02-13 2014-08-21 Zondlo Neal Perfluoro-tert-butyl hydroxyproline
WO2014145852A2 (en) 2013-03-15 2014-09-18 Knopp Biosciences Llc Imidazo(4,5-b) pyridin-2-yl amides as kv7 channel activators
US20160129030A1 (en) 2013-06-14 2016-05-12 The Brigham And Women's Hospital, Inc. Treatment of mtor hyperactive related diseases and disorders
EP3191116B1 (en) 2014-09-12 2020-11-25 The Whitehead Institute for Biomedical Research Methods of identifying modulators of sestrin-gator2 interaction and use of same to modulate mtorc1
US20180327364A1 (en) 2015-11-13 2018-11-15 Brandeis University Mtor inhibitors and methods of use thereof
EP3445451B1 (en) 2016-04-21 2021-08-18 Baylor College of Medicine Compositions and methods for the treatment of lysosomal storage disorders and disorders characterized by lysosomal dysfunction
KR20250167147A (ko) * 2018-02-08 2025-11-28 오비드 테라퓨틱스 인크. 이명, 급성 감각신경성 난청, 메니에르병, 투렛 증후군, 주의력 결핍 과잉행동 장애 및 중독의 치료에 있어서 (1s,3s)-3-아미노-4-(디플루오로메틸리덴) 시클로펜탄-1-카르복시산 및 (s)-3-아미노-4-(디플루오로메틸리덴)시클로펜트-1-엔-1-카르복시산의 용도
EP3870158A4 (en) * 2018-10-24 2022-08-10 Navitor Pharmaceuticals, Inc. Polymorphic compounds and uses thereof
US10926803B2 (en) 2019-07-17 2021-02-23 GM Global Technology Operations LLC Four rail front crush structure with load dissemination into eight element support structure
JP6689441B1 (ja) 2019-11-01 2020-04-28 エヌ・ティ・ティ・コミュニケーションズ株式会社 電子マネー管理システムおよび電子マネー管理方法
US11723890B2 (en) 2019-11-01 2023-08-15 Navitor Pharmaceuticals, Inc. Methods of treatment using an mTORC1 modulator

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2018538248A (ja) * 2015-10-23 2018-12-27 ナビター ファーマシューティカルズ， インコーポレイテッド セストリン−ｇａｔｏｒ２相互作用のモジュレーターおよびその使用
US20180333381A1 (en) * 2017-04-26 2018-11-22 Navitor Pharmaceuticals, Inc. Modulators of sestrin-gator2 interaction and uses thereof

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
"Safety, Tolerability, PK and Efficacy of Single Doses of NV-5138 in Healthy Volunteers and Subjects", CLINICALTRIALS.GOV, vol. [online], [2024年8月9日検索］, JPN6024032616, 9 July 2019 (2019-07-09), ISSN: 0005393392 *
"Sestrin modulator NV-5138 produces rapid antidepressant effects via direct mTORC1 activation", THE JOURNAL OF CLINICAL INVESTIGATION, vol. 129, no. 6, JPN6024032615, 20 May 2019 (2019-05-20), pages 2542 - 2554, ISSN: 0005692614 *
NAVITOR PHARMACEUTICALS, NEWS (PRESS RELEASE), vol. [online], [2024年8月9日検索］, JPN6024032617, 12 September 2019 (2019-09-12), ISSN: 0005536696 *

Also Published As

Publication number Publication date
US11723890B2 (en) 2023-08-15
EP4051259A1 (en) 2022-09-07
CA3156436A1 (en) 2021-05-06
US12465583B2 (en) 2025-11-11
AU2020376950A1 (en) 2022-06-09
IL292612A (en) 2022-07-01
TW202131910A (zh) 2021-09-01
MX2022005215A (es) 2022-06-08
EP4051259A4 (en) 2023-11-22
US20240041811A1 (en) 2024-02-08
BR112022008287A2 (pt) 2022-07-26
TWI870497B (zh) 2025-01-21
CN114786660A (zh) 2022-07-22
US20210169835A1 (en) 2021-06-10
WO2021087432A1 (en) 2021-05-06
JP2025129244A (ja) 2025-09-04

Similar Documents

Publication Publication Date Title
AU2017229656B2 (en) Neuroactive steroids, compositions, and uses thereof
US12465583B2 (en) Methods of treatment using an mTORC1 modulator
Svigos et al. A practical approach to the diagnosis and management of classic lichen planopilaris
TWI784261B (zh) 神經活性類固醇，其組合物及其用途
RU2463054C2 (ru) Применение тестостерона и агониста 5-нт1a для лечения сексуальной дисфункции
US20240366582A1 (en) Treatment of raynaud's disease
US20240148709A1 (en) Methods of treating eye pain and eye disorders
WO2026085331A1 (en) Mefluleucin for use in the treatment of suicidal ideations associated with depression

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230911

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20230911

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20240816

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20240821

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20241118

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20241230

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20250226

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250626