AU2019277382B2 - Methods for increasing sepiapterin plasma exposure - Google Patents

Methods for increasing sepiapterin plasma exposure Download PDF

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Publication number
AU2019277382B2
AU2019277382B2 AU2019277382A AU2019277382A AU2019277382B2 AU 2019277382 B2 AU2019277382 B2 AU 2019277382B2 AU 2019277382 A AU2019277382 A AU 2019277382A AU 2019277382 A AU2019277382 A AU 2019277382A AU 2019277382 B2 AU2019277382 B2 AU 2019277382B2
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Australia
Prior art keywords
sepiapterin
administration
food
subject
pharmaceutically acceptable
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AU2019277382A
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English (en)
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AU2019277382A1 (en
Inventor
Jonathan Reis
Neil Smith
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PTC Therapeutics MP Inc
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PTC Therapeutics MP Inc
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Publication of AU2019277382A1 publication Critical patent/AU2019277382A1/en
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Publication of AU2019277382B2 publication Critical patent/AU2019277382B2/en
Priority to AU2025200814A priority Critical patent/AU2025200814A1/en
Active legal-status Critical Current
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Obesity (AREA)
  • Neurology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Diabetes (AREA)
  • Neurosurgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)
AU2019277382A 2018-05-30 2019-05-30 Methods for increasing sepiapterin plasma exposure Active AU2019277382B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2025200814A AU2025200814A1 (en) 2018-05-30 2025-02-06 Methods for increasing sepiapterin plasma exposure

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
US201862677943P 2018-05-30 2018-05-30
US62/677,943 2018-05-30
US201862771398P 2018-11-26 2018-11-26
US62/771,398 2018-11-26
US201962822376P 2019-03-22 2019-03-22
US62/822,376 2019-03-22
GC2019/37663 2019-05-28
GC201937663 2019-05-28
PCT/US2019/034523 WO2019232130A1 (en) 2018-05-30 2019-05-30 Methods for increasing sepiapterin plasma exposure

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2025200814A Division AU2025200814A1 (en) 2018-05-30 2025-02-06 Methods for increasing sepiapterin plasma exposure

Publications (2)

Publication Number Publication Date
AU2019277382A1 AU2019277382A1 (en) 2021-01-21
AU2019277382B2 true AU2019277382B2 (en) 2025-01-09

Family

ID=68699037

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2019277382A Active AU2019277382B2 (en) 2018-05-30 2019-05-30 Methods for increasing sepiapterin plasma exposure
AU2025200814A Pending AU2025200814A1 (en) 2018-05-30 2025-02-06 Methods for increasing sepiapterin plasma exposure

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2025200814A Pending AU2025200814A1 (en) 2018-05-30 2025-02-06 Methods for increasing sepiapterin plasma exposure

Country Status (20)

Country Link
US (3) US11617752B2 (https=)
EP (2) EP3801536B1 (https=)
JP (2) JP7502197B2 (https=)
CN (1) CN112703002A (https=)
AU (2) AU2019277382B2 (https=)
CA (1) CA3102106A1 (https=)
DK (1) DK3801536T3 (https=)
ES (1) ES2986920T3 (https=)
FI (1) FI3801536T3 (https=)
HR (1) HRP20241213T1 (https=)
HU (1) HUE068589T2 (https=)
LT (1) LT3801536T (https=)
MD (1) MD3801536T2 (https=)
MX (2) MX2020012979A (https=)
PL (1) PL3801536T3 (https=)
PT (1) PT3801536T (https=)
RS (1) RS65874B1 (https=)
SI (1) SI3801536T1 (https=)
SM (1) SMT202400430T1 (https=)
WO (1) WO2019232130A1 (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11072614B2 (en) 2016-11-29 2021-07-27 Ptc Therapeutics Mp, Inc. Polymorphs of sepiapterin and salts thereof
US11130760B2 (en) 2016-11-29 2021-09-28 Ptc Therapeutics Mp, Inc. Polymorphic form of sepiapterin
JP7811085B2 (ja) 2017-09-01 2026-02-04 ピーティーシー セラピューティクス エムピー,インコーポレイテッド セピアプテリンを含む医薬組成物及びその使用
EP3801536B1 (en) 2018-05-30 2024-07-17 PTC Therapeutics MP, Inc. Administration of sepiapterin without food for use in a method for increasing sepiapterin plasma exposure
CN112654356A (zh) 2018-05-30 2021-04-13 Ptc医疗Mp公司 增加四氢生物蝶呤血浆暴露的组合物和方法
CA3165636A1 (en) * 2020-01-24 2021-07-29 Neil Smith Methods for treating parkinson's disease with sepiapterin
US20230077104A1 (en) * 2020-02-19 2023-03-09 The United States Government As Represented By The Department Of Veteran Affairs L-sepiapterin and methods of use for treating diseases and disorders
JP2024506336A (ja) * 2021-02-09 2024-02-13 ピーティーシー セラピューティクス エムピー,インコーポレイテッド 膠芽腫の治療方法
EP4291196A1 (en) * 2021-02-09 2023-12-20 PTC Therapeutics MP, Inc. Methods for treating covid-19 with sepiapterin
CN120732846A (zh) * 2025-04-09 2025-10-03 中南大学湘雅医院 吲哚乙酸在制备预防或治疗高血压产品中的用途

Citations (3)

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Publication number Priority date Publication date Assignee Title
WO2008128049A2 (en) * 2007-04-11 2008-10-23 Biomarin Pharmaceutical Inc. Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
US20130197000A1 (en) * 2010-04-22 2013-08-01 Nihon University Drug and food/drink for preventing or improving cerebral dysfunction
WO2019232126A1 (en) * 2018-05-30 2019-12-05 Censa Pharmaceuticals Inc. Compositions and methods for increasing tetrahydrobiopterin plasma exposure

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JPS5925323A (ja) * 1982-03-03 1984-02-09 鐘淵化学工業株式会社 プテリン誘導体からなる脳内神経伝達物質の関わる疾病の治療剤
US5910304A (en) 1982-12-13 1999-06-08 Texas A&M University System Low-dose oral administration of interferons
CA1320905C (en) 1986-11-06 1993-08-03 Joseph M. Cummins Treatment of immuno-resistant disease
CA2228970A1 (en) 1995-08-18 1997-02-27 Donald W. Landry Detection of organic compounds through regulation of antibody-catalyzed reactions
US6036949A (en) 1998-03-05 2000-03-14 Amarillo Biosciences, Inc. Treatment of fibromyalgia with low doses of interferon
US8188043B2 (en) 1999-07-28 2012-05-29 The Board Of Trustees Of The Leland Stanford Jr. University Nicotine in therapeutic angiogenesis and vasculogenesis
FR2859996B1 (fr) 2003-09-19 2006-02-03 Aventis Pharma Sa Solvat acetonique du dimethoxy docetaxel et son procede de preparation
EP1696877A4 (en) * 2003-11-13 2010-06-09 Gen Hospital Corp PROCESS FOR PAIN TREATMENT
US7732599B2 (en) 2003-11-17 2010-06-08 Biomarin Pharmaceutical Inc. Process for preparing tetrahydrobiopterin and analogs of tetrahydrobiopterin
KR20070005550A (ko) 2003-11-17 2007-01-10 바이오마린 파머수티컬 인크. 대사 장애 치료를 위한 조성물 및 방법
CA2678125C (en) 2003-11-17 2014-10-14 Merck Eprova Ag Crystalline forms of (6r)-l-erythro-tetrahydrobiopterin dihydrochloride
WO2006055511A2 (en) 2004-11-17 2006-05-26 Biomarin Pharmaceutical Inc. Stable tablet formulation of tetrahydrobiopterin
CA2588994A1 (en) 2004-12-08 2006-06-15 Biomarin Pharmaceutical Inc. Methods and compositions for the treatment of pulmonary hypertension of the newborn
US7582799B2 (en) 2005-04-28 2009-09-01 Shiratori Pharmaceutical Co., Ltd. Method for producing hydrazone derivatives
US20080075666A1 (en) 2006-08-25 2008-03-27 Dudley Samuel C Jr Methods and compositions for treating diastolic dysfunction
US20110144117A1 (en) 2008-08-12 2011-06-16 Orpha Swiss Gmbh Pharmaceutical Dosage Form Containing Tetrahydrobiopterin
US9884909B2 (en) 2010-12-01 2018-02-06 Alderbio Holdings Llc Anti-NGF compositions and use thereof
CA2828685C (en) 2011-03-01 2018-05-29 Rubicon Research Private Limited Stable compositions of tetrahydrobiopterin
US9216178B2 (en) 2011-11-02 2015-12-22 Biomarin Pharmaceutical Inc. Dry blend formulation of tetrahydrobiopterin
IN2014DN09053A (https=) 2012-05-07 2015-05-22 Shiratori Pharm
US10365267B2 (en) 2014-10-31 2019-07-30 Children's Medical Center Corporation Methods and assays relating to sepiapterin reductase inhibition
US11130760B2 (en) 2016-11-29 2021-09-28 Ptc Therapeutics Mp, Inc. Polymorphic form of sepiapterin
US11072614B2 (en) 2016-11-29 2021-07-27 Ptc Therapeutics Mp, Inc. Polymorphs of sepiapterin and salts thereof
JP7811085B2 (ja) 2017-09-01 2026-02-04 ピーティーシー セラピューティクス エムピー,インコーポレイテッド セピアプテリンを含む医薬組成物及びその使用
KR102895167B1 (ko) * 2017-11-23 2025-12-04 가부시키가이샤 한도오따이 에네루기 켄큐쇼 표시 장치 및 전자 기기
AU2019277372B2 (en) 2018-05-30 2024-12-19 Ptc Therapeutics Mp, Inc. Pharmaceutically acceptable salts of sepiapterin
EP3801536B1 (en) 2018-05-30 2024-07-17 PTC Therapeutics MP, Inc. Administration of sepiapterin without food for use in a method for increasing sepiapterin plasma exposure
IL290321B1 (en) 2019-08-05 2026-04-01 Ptc Therapeutics Inc Use of spiapterin and its metabolites for radiation exposure treatment
IL291565B1 (en) 2019-09-25 2026-04-01 Ptc Therapeutics Inc Method for treating phenylalanine irregularity

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008128049A2 (en) * 2007-04-11 2008-10-23 Biomarin Pharmaceutical Inc. Methods of administering tetrahydrobiopterin, associated compositions, and methods of measuring
US20130197000A1 (en) * 2010-04-22 2013-08-01 Nihon University Drug and food/drink for preventing or improving cerebral dysfunction
WO2019232126A1 (en) * 2018-05-30 2019-12-05 Censa Pharmaceuticals Inc. Compositions and methods for increasing tetrahydrobiopterin plasma exposure

Also Published As

Publication number Publication date
CN112703002A (zh) 2021-04-23
EP3801536A1 (en) 2021-04-14
EP4454704A3 (en) 2025-01-01
US12329757B2 (en) 2025-06-17
MX2020012979A (es) 2021-04-29
EP3801536B1 (en) 2024-07-17
JP2024069192A (ja) 2024-05-21
ES2986920T3 (es) 2024-11-13
LT3801536T (lt) 2024-09-25
HUE068589T2 (hu) 2025-01-28
SMT202400430T1 (it) 2024-11-15
US11617752B2 (en) 2023-04-04
EP3801536A4 (en) 2022-03-23
US20230381181A1 (en) 2023-11-30
EP4454704A2 (en) 2024-10-30
SI3801536T1 (sl) 2024-12-31
MD3801536T2 (ro) 2024-11-30
PL3801536T3 (pl) 2025-02-03
HRP20241213T1 (hr) 2024-11-22
PT3801536T (pt) 2024-09-19
RS65874B1 (sr) 2024-09-30
US20210220363A1 (en) 2021-07-22
FI3801536T3 (fi) 2024-08-29
AU2025200814A1 (en) 2025-02-27
DK3801536T3 (da) 2024-08-19
JP7502197B2 (ja) 2024-06-18
WO2019232130A1 (en) 2019-12-05
MX2024005935A (es) 2024-06-04
JP2021525729A (ja) 2021-09-27
AU2019277382A1 (en) 2021-01-21
CA3102106A1 (en) 2019-12-05
JP7841005B2 (ja) 2026-04-06
US20260091037A1 (en) 2026-04-02

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