CA2791081C - Treatment for pulmonary hypertension - Google Patents

Treatment for pulmonary hypertension Download PDF

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Publication number
CA2791081C
CA2791081C CA2791081A CA2791081A CA2791081C CA 2791081 C CA2791081 C CA 2791081C CA 2791081 A CA2791081 A CA 2791081A CA 2791081 A CA2791081 A CA 2791081A CA 2791081 C CA2791081 C CA 2791081C
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CA
Canada
Prior art keywords
treprostinil
oral
therapeutic agent
pulmonary hypertension
inhaled
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
CA2791081A
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English (en)
French (fr)
Other versions
CA2791081A1 (en
Inventor
Martine A. Rothblatt
Lewis J. Rubin
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.)
United Therapeutics Corp
Original Assignee
United Therapeutics Corp
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 United Therapeutics Corp filed Critical United Therapeutics Corp
Priority to CA2892104A priority Critical patent/CA2892104C/en
Publication of CA2791081A1 publication Critical patent/CA2791081A1/en
Application granted granted Critical
Publication of CA2791081C publication Critical patent/CA2791081C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • A61K31/558Eicosanoids, e.g. leukotrienes or prostaglandins having heterocyclic rings containing oxygen as the only ring hetero atom, e.g. thromboxanes
    • A61K31/5585Eicosanoids, e.g. leukotrienes or prostaglandins having heterocyclic rings containing oxygen as the only ring hetero atom, e.g. thromboxanes having five-membered rings containing oxygen as the only ring hetero atom, e.g. prostacyclin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/191Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
    • 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
    • A61K31/513Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • A61K31/5575Eicosanoids, e.g. leukotrienes or prostaglandins having a cyclopentane, e.g. prostaglandin E2, prostaglandin F2-alpha
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/557Eicosanoids, e.g. leukotrienes or prostaglandins
    • A61K31/5578Eicosanoids, e.g. leukotrienes or prostaglandins having a pentalene ring system, e.g. carbacyclin, iloprost
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/08Vasodilators for multiple indications
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pulmonology (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Otolaryngology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
CA2791081A 2010-03-15 2011-03-14 Treatment for pulmonary hypertension Active CA2791081C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2892104A CA2892104C (en) 2010-03-15 2011-03-14 Treatment for pulmonary hypertension

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US28265910P 2010-03-15 2010-03-15
US61/282,659 2010-03-15
PCT/US2011/028390 WO2011115922A1 (en) 2010-03-15 2011-03-14 Treatment for pulmonary hypertension

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2892104A Division CA2892104C (en) 2010-03-15 2011-03-14 Treatment for pulmonary hypertension

Publications (2)

Publication Number Publication Date
CA2791081A1 CA2791081A1 (en) 2011-09-22
CA2791081C true CA2791081C (en) 2015-08-25

Family

ID=43858371

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2791081A Active CA2791081C (en) 2010-03-15 2011-03-14 Treatment for pulmonary hypertension
CA2892104A Active CA2892104C (en) 2010-03-15 2011-03-14 Treatment for pulmonary hypertension

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA2892104A Active CA2892104C (en) 2010-03-15 2011-03-14 Treatment for pulmonary hypertension

Country Status (8)

Country Link
US (2) US8609728B2 (enExample)
EP (2) EP2547341B1 (enExample)
JP (4) JP5681276B2 (enExample)
KR (3) KR20160132501A (enExample)
CN (1) CN102883722B (enExample)
CA (2) CA2791081C (enExample)
ES (2) ES2611187T3 (enExample)
WO (1) WO2011115922A1 (enExample)

Families Citing this family (29)

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EP2252570B1 (en) 2007-12-17 2017-04-05 United Therapeutics Corporation An improved process to prepare treprostinil, the active ingredient in remodulin ®
EP2547341B1 (en) 2010-03-15 2016-09-14 United Therapeutics Corporation Treatment for pulmonary hypertension
JP6046034B2 (ja) 2010-06-03 2016-12-14 ユナイテッド セラピューティクス コーポレイション トレプロスチニルの製造
EP2681204B1 (en) 2011-03-02 2016-04-27 United Therapeutics Corporation Synthesis of intermediate for treprostinil production
US9387214B2 (en) 2012-01-13 2016-07-12 United Therapeutics Corporation Method of identifying therapies for pulmonary hypertension
KR102347340B1 (ko) 2013-03-14 2022-01-06 유나이티드 세러퓨틱스 코오포레이션 트레프로스티닐의 고체 형태
US20140275616A1 (en) 2013-03-15 2014-09-18 United Therapeutics Corporation Salts of treprostinil
WO2014160638A1 (en) 2013-03-25 2014-10-02 United Therapeutics Corporation Process of making prostacyclin compounds with linker thiol and pegylated forms
CN108947843A (zh) 2013-10-25 2018-12-07 英斯梅德股份有限公司 前列环素化合物、其组合物及使用方法
EP3082428A4 (en) 2013-12-09 2017-08-02 Respira Therapeutics, Inc. Pde5 inhibitor powder formulations and methods relating thereto
ES2908142T3 (es) 2014-06-13 2022-04-27 United Therapeutics Corp Formulaciones de treprostinil
KR101890080B1 (ko) 2014-10-20 2018-09-20 유나이티드 쎄러퓨틱스 코포레이션 프로스타시클린 유도체 제조를 위한 중간체의 합성
US10343979B2 (en) 2014-11-18 2019-07-09 Insmed Incorporated Methods of manufacturing treprostinil and treprostinil derivative prodrugs
MD3496739T2 (ro) 2016-07-15 2021-09-30 Acceleron Pharma Inc Compoziții care cuprind polipeptide actriia pentru utilizarea în tratarea hipertensiunii pulmonare
CN110678174A (zh) 2016-09-26 2020-01-10 联合治疗学有限公司 曲前列环素的前药
CN110381951A (zh) 2016-12-14 2019-10-25 瑞必治公司 用于治疗肺性高血压和其他肺病症的方法及组合物
KR20190030805A (ko) * 2017-09-14 2019-03-25 경상대학교산학협력단 폐고혈압 예방 또는 치료용 흡입제, 및 이의 투여방법
HU231296B1 (hu) * 2018-03-09 2022-09-28 Chinoin Zrt Eljárás treprostinil-dietanol-amin só B polimorf formájának előállítására
BR112021002200B1 (pt) 2018-09-18 2024-03-12 Eli Lilly And Company Sal erbumina de trepostinila
US11458098B2 (en) 2019-04-29 2022-10-04 Insmed Incorporated Dry powder compositions of treprostinil prodrugs and methods of use thereof
BR112021021875A2 (pt) 2019-05-14 2021-12-28 Pharmosa Biopharm Inc Composição farmacêutica e método de tratamento de hipertensão pulmonar
JP2022546314A (ja) 2019-08-23 2022-11-04 ユナイテッド セラピューティクス コーポレイション トレプロスチニルプロドラッグ
WO2021211916A1 (en) 2020-04-17 2021-10-21 United Therapeutics Corporation Treprostinil for use in the treatment of intersitial lung disease
CN116113415A (zh) 2020-06-09 2023-05-12 联合治疗公司 曲前列尼尔的富马酰基二酮哌啶前药
IL303668A (en) 2020-12-14 2023-08-01 United Therapeutics Corp Stable treprostinil prodrugs and their uses for the treatment of diseases
EP4301372A1 (en) 2021-03-03 2024-01-10 United Therapeutics Corporation A dry powder composition of trestinil and its prodrug thereof and further comprising comprising (e)-3,6-bis[4-(n-carbonyl-2-propenyl)amidobutyl]-2,5-diketopiperazine (fdkp)
EP4475819A1 (en) 2022-02-08 2024-12-18 United Therapeutics Corporation Treprostinil iloprost combination therapy
EP4516297A1 (en) 2022-04-29 2025-03-05 Zhaoke Pharmaceutical (Guangzhou) Co., Ltd Treprostinil soft mist inhalant
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CN101647792B (zh) 2003-12-16 2012-11-28 联合治疗公司 曲前列环素在制备治疗和预防缺血性损害的药物中的用途
US7879909B2 (en) 2004-04-12 2011-02-01 United Therapeutics Corporation Use of Treprostinil to treat neuropathic diabetic foot ulcers
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WO2012006273A1 (en) 2010-07-09 2012-01-12 United Therapeutics Corporation Combination therapies with cox-2 inhibitors and treprostinil

Also Published As

Publication number Publication date
WO2011115922A1 (en) 2011-09-22
EP3108888A1 (en) 2016-12-28
CN102883722B (zh) 2014-11-05
JP2013522303A (ja) 2013-06-13
US8969409B2 (en) 2015-03-03
KR20150027846A (ko) 2015-03-12
KR101508047B1 (ko) 2015-04-06
KR20130038835A (ko) 2013-04-18
JP2015129129A (ja) 2015-07-16
JP2016153413A (ja) 2016-08-25
CA2791081A1 (en) 2011-09-22
JP5681276B2 (ja) 2015-03-04
US20130253049A1 (en) 2013-09-26
CN102883722A (zh) 2013-01-16
ES2611187T3 (es) 2017-05-05
EP2547341A1 (en) 2013-01-23
US8609728B2 (en) 2013-12-17
ES2790859T3 (es) 2020-10-29
US20110224236A1 (en) 2011-09-15
CA2892104C (en) 2016-08-30
JP2018135383A (ja) 2018-08-30
EP3108888B1 (en) 2020-02-12
KR20160132501A (ko) 2016-11-18
EP2547341B1 (en) 2016-09-14
CA2892104A1 (en) 2011-09-22

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