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    Also known as: 441798-33-0, Opsumit, Act-064992, Act 064992, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide, Act064992
    Molecular Formula
    C19H20Br2N6O4S
    Molecular Weight
    588.3  g/mol
    InChI Key
    JGCMEBMXRHSZKX-UHFFFAOYSA-N
    FDA UNII
    Z9K9Y9WMVL
    Macitentan
    Macitentan is an orally available dual endothelin receptor (ETR) antagonist with potential antihypertensive and antineoplastic activity. Upon administration, macitentan and its metabolites block the binding of endothelin isoform 1 (ET-1) to type-A and type-B ETR on both the tumor cells and the endothelial cells in the tumor vasculature. This prevents ET-1 mediated signaling transduction which may decrease tumor cell proliferation, progression, and angiogenesis in tumor tissue. ET-1, a potent vasoconstrictor that plays an important role in inflammation and tissue repair, is, together with its receptors, overexpressed varyingly in many tumor cell types.
    Macitentan is an Endothelin Receptor Antagonist. The mechanism of action of macitentan is as an Endothelin Receptor Antagonist.
    1 2D Structure

    Macitentan

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-N-(propylsulfamoyl)pyrimidin-4-amine
    2.1.2 InChI
    InChI=1S/C19H20Br2N6O4S/c1-2-7-26-32(28,29)27-17-16(13-3-5-14(20)6-4-13)18(25-12-24-17)30-8-9-31-19-22-10-15(21)11-23-19/h3-6,10-12,26H,2,7-9H2,1H3,(H,24,25,27)
    2.1.3 InChI Key
    JGCMEBMXRHSZKX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCCNS(=O)(=O)NC1=C(C(=NC=N1)OCCOC2=NC=C(C=N2)Br)C3=CC=C(C=C3)Br
    2.2 Other Identifiers
    2.2.1 UNII
    Z9K9Y9WMVL
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Act 064992

    2. Act-064992

    3. Act064992

    4. Actelion-1

    5. N-(5-(4-bromophenyl)-6-(2-(5-bromopyrimidin-2-yloxy)ethoxy)pyrimidin-4-yl)-n'-propylaminosulfonamide

    6. Opsumit

    2.3.2 Depositor-Supplied Synonyms

    1. 441798-33-0

    2. Opsumit

    3. Act-064992

    4. Act 064992

    5. N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide

    6. Act064992

    7. Z9k9y9wmvl

    8. 5-(4-bromophenyl)-6-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-n-(propylsulfamoyl)pyrimidin-4-amine

    9. N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-n'-propylsulfamide

    10. Chebi:76607

    11. Actelion-1

    12. Macitentan [inn]

    13. N-(5-(4-bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxy)ethoxy)pyrimidin-4-yl)-n'-propylsulfamide

    14. N-[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-n'- Propylsulfamide

    15. Macitentan [usan:inn]

    16. Unii-z9k9y9wmvl

    17. Macitentanum

    18. Sulfamide, N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-n'-propyl-

    19. Sulfamide, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propyl-

    20. Macitentan- Bio-x

    21. Opsumit (tn)

    22. Macitentan [mi]

    23. Macitentan [jan]

    24. Macitentan (jan/usan)

    25. Macitentan [usan]

    26. Macitentan [vandf]

    27. (non-labelled)macitentan-d7

    28. Macitentan [who-dd]

    29. Mls006011174

    30. Gtpl7352

    31. Schembl1445625

    32. Chembl2103873

    33. Macitentan [orange Book]

    34. Dtxsid50196063

    35. Ex-a544

    36. Hms3653n06

    37. Hms3747e09

    38. Cas:441798-33-0;macitentan

    39. Bcp05309

    40. Bdbm50395626

    41. Mfcd17167076

    42. S8051

    43. Zinc43202140

    44. Akos024463406

    45. Am81244

    46. Ccg-270155

    47. Cs-0686

    48. Db08932

    49. Sb14841

    50. Macitentan (actelion-1,act-064992)

    51. Ncgc00346456-01

    52. Ncgc00346456-05

    53. Ac-30102

    54. As-74590

    55. Bm162771

    56. Hy-14184

    57. N-(5-(4-bromophenyl)-6-(2-(5-bromopyrimidin-2-yloxy)ethoxy)pyrimidin-4-yl)-n'-propylaminosulfonamide

    58. Smr004702943

    59. Db-070519

    60. Ft-0696675

    61. Sw219473-1

    62. Act 064992; Act-064992

    63. D10135

    64. Q6724151

    65. {[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]sulfamoyl}(propyl)amine

    66. N-(5-(4-bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxi)ethoxy)pyrimidin-4-yl)-n'-propylsulfuric Diamide

    67. N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)-oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide

    68. N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propyl-sulfamide

    69. N-[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]-n'-propylsulfuric Diamide

    2.4 Create Date
    2007-04-02
    3 Chemical and Physical Properties
    Molecular Weight 588.3 g/mol
    Molecular Formula C19H20Br2N6O4S
    XLogP33.7
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count11
    Exact Mass587.96130 g/mol
    Monoisotopic Mass585.96335 g/mol
    Topological Polar Surface Area137 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity642
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameOpsumit
    PubMed HealthMacitentan (By mouth)
    Drug ClassesAntihypertensive
    Drug LabelOPSUMIT (macitentan) is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecula
    Active IngredientMacitentan
    Dosage FormTablet
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyActelion Pharms

    2 of 2  
    Drug NameOpsumit
    PubMed HealthMacitentan (By mouth)
    Drug ClassesAntihypertensive
    Drug LabelOPSUMIT (macitentan) is an endothelin receptor antagonist. The chemical name of macitentan is N-[5-(4-Bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'-propylsulfamide. It has a molecular formula of C19H20Br2N6O4S and a molecula
    Active IngredientMacitentan
    Dosage FormTablet
    RouteOral
    Strength10mg
    Market StatusPrescription
    CompanyActelion Pharms

    4.2 Drug Indication

    Investigated for use/treatment in cardiovascular disorders, hypertension, and pulmonary hypertension.

    Macitentan is indicated for the treatment of WHO group 1 pulmonary arterial hypertension (PAH) both alone and in combination with tadalafil.

    FDA Label

    Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.

    Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

    Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)

    Treatment of idiopathic pulmonary fibrosis, Treatment of pulmonary arterial hypertension, Treatment of systemic sclerosis

    Treatment of functional single ventricle heart disease with total cavo-pulmonary connection

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Macitentan acts primarily by reducing vasoconstriction and cell proliferation due to endothelin overexpression.

    5.2 MeSH Pharmacological Classification

    Endothelin A Receptor Antagonists

    Compounds and drugs that bind to and inhibit or block the activation of ENDOTHELIN A RECECPTORS. (See all compounds classified as Endothelin A Receptor Antagonists.)

    Endothelin B Receptor Antagonists

    Compounds and drugs that bind to and inhibit or block the activation of ENDOTHELIN B RECEPTORS. (See all compounds classified as Endothelin B Receptor Antagonists.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    MACITENTAN
    5.3.2 FDA UNII
    Z9K9Y9WMVL
    5.3.3 Pharmacological Classes
    Endothelin Receptor Antagonists [MoA]; Endothelin Receptor Antagonist [EPC]
    5.4 ATC Code

    C02KX04

    C02KX04

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    C - Cardiovascular system

    C02 - Antihypertensives

    C02K - Other antihypertensives

    C02KX - Antihypertensives for pulmonary arterial hypertension

    C02KX04 - Macitentan

    5.5 Absorption, Distribution and Excretion

    Absorption

    Macitentan has a median Tmax of 8h although some studies have found up to 30h at higher doses. Although the bioavailability has not been experimentally determined, pharmacokinetic modeling has estimated it at 74%. Food has not been found to have a significant effect on absorption.

    Route of Elimination

    Eliminated 50% through urine and 24% through feces. Of the 50% excreted through the urine, none of the recovered dose was in the form of the parent drug nor the active metabolite.

    Volume of Distribution

    Macitentan has an apparent volume of distribution of 40-50L.

    Clearance

    Clearance data was not found.

    5.6 Metabolism/Metabolites

    Macitentan undergoes oxidative depropylation of the sulfonamide moiety via CYP3A4, 2C8, 2C9, and 2C19 to form the active metabolite M6. The ethylene glycol moiety undergoes oxidative cleavage via CYP2C9 to the alcohol metabolite M4. M4 is oxidized to its corresponding acid, M5, then hydrolyzed to the metabolite termed m/z 324. Oxidative depropylation of a distal carbon atom via CYP2C8, 2C9, and 2C19 forms M7. Hydrolysis of both macitentan and M5 produces M3. Finally M5 may be further metabolized via hydrolysis and hydroxylation to M2 or via glucuronidation to a glucuronide metabolite, M1.

    5.7 Biological Half-Life

    The half-life of elimination of macitentan is 16 hours. The half-life of elimination of the active metabolite is 40-66h

    5.8 Mechanism of Action

    Through complete blockade of tissular endothelin, Actelion-1 is expected to protect tissue from the damaging effect of elevated endothelin, specifically in the cardiovascular system. In pre-clinical studies, Actelion-1 also exhibited effects suggesting that it maintains the integrity of the vascular wall and improves long-term outcome. Accordingly, Actelion-1 may provide therapeutic benefit in a wide range of cardiovascular indications.

    Macitentan is an antagonist which binds to the endothelin A and B receptors (EA and EB) and blocks signaling from endothelin-1 and -2. Pulmonary arterial hypertension has many different mechanisms which contribute to the development of endothelial dysfunction including elevated cytosolic calcium, genetic factors, epigenetic changes, and mitochondrial dysfunction. The focus of macitentan's mechanism relates to the role of overexpressed endothelin from the vascular endothelium. Endothelins are released in both a constitutive fashion from secretory vesicles and in response to stimuli via Weibel-Palade storage granules. Endothelins bind to the EA and EB receptors, with endothelins -1 and -2 having more affinity than endothelin-3. Binding to the Gq coupled EA receptor triggers Ca2+ release from the sarcoplasmic reticulum of smooth muscle cells via the phospholipase C (PLC) pathway. Downstream protein kinase C activation may also contribute to increased Ca2+ sensitivity of the contractile apparatus. EA receptor activation is also known to contribute to pulmonary artery smooth muscle cell proliferation. The binding of endothelins to the EB receptors acts in opposition to EA signaling by activating the same PLC cascade in endothelial cells to activate endothelial nitric oxide synthase. The subsequent release of nitric oxide produces vasodilation through the cyclic guanosine monophosphate cascade. Despite the greater presence of EB receptors on endothelial cells, they are still present on smooth muscle cells and may contribute to cell proliferation through the same mechanisms as EA receptors. Macitentan is thought to provide its therapeutic effect primarily via blocking signaling through EA which produces both decreased vasoconstriction via reduced smooth muscle cell contractility and attenuation of the hyperproliferation of smooth muscle cells found in PAH. Blockade of EB is less likely to contribute to a therapeutic effect as this signaling is responsible for the counter-regulatory vasodilatory signal.

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    Masitentan

    Registration Number : 307MF10112

    Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Ch...

    Initial Date of Registration : 2025-09-03

    Latest Date of Registration : 2025-09-03

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    04

    Zhejiang Huayi Pharmaceutical Co. ,...

    China
    AACR Annual meeting
    Not Confirmed
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    Zhejiang Huayi Pharmaceutical Co. ,...

    China
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    Masitentan

    Registration Number : 307MF10144

    Registrant's Address : No. 15 Shuangfeng Road, Fotang, Yiwu, Zhejiang 322002, China

    Initial Date of Registration : 2025-11-26

    Latest Date of Registration : 2025-11-26

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    Drugs in Development

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    Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

    Details:

    Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I).


    Lead Product(s): Macitentan,Inapplicable

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Opsumit-Generic

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 19, 2025

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    01

    Alembic Pharmaceuticals Limited

    India
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    AACR Annual meeting
    Not Confirmed

    Alembic Pharmaceuticals Limited

    India
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    AACR Annual meeting
    Not Confirmed
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    Lead Product(s) : Macitentan,Inapplicable

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

    Details : Macitentan is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I).

    Product Name : Opsumit-Generic

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 19, 2025

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    European Commission Approves Yuvanci® for Patients with Pulmonary Arterial Hypertension

    Details:

    Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Opsynvi

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 30, 2024

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    02

    Johnson & Johnson Innovative Medicine

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson Innovative Medicine

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    European Commission Approves Yuvanci® for Patients with Pulmonary Arterial Hypertension

    Details : Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.

    Product Name : Opsynvi

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 30, 2024

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    EU Approves Yuvanci for Pulmonary Arterial Hypertension Treatment

    Details:

    Yuvanci (macitentan) is a ETA/ETB inhibitor small molecule drug candidate, which is indicated in combination with tadalafil for the treatment of pulmonary arterial hypertension in adult.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Yuvanci

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 30, 2024

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    03

    Johnson & Johnson

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson

    U.S.A
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    EU Approves Yuvanci for Pulmonary Arterial Hypertension Treatment

    Details : Yuvanci (macitentan) is a ETA/ETB inhibitor small molecule drug candidate, which is indicated in combination with tadalafil for the treatment of pulmonary arterial hypertension in adult.

    Product Name : Yuvanci

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 30, 2024

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    Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg

    Details:

    Macitentan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pulmonary Arterial Hypertension.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 14, 2024

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    04

    Humanis

    Turkey
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    Not Confirmed

    Humanis

    Turkey
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadala...

    Details : Macitentan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pulmonary Arterial Hypertension.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 14, 2024

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    Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/...

    Details:

    Macitentan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pulmonary Arterial Hypertension.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 14, 2024

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    05

    Humanis

    Turkey
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    Not Confirmed

    Humanis

    Turkey
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynviÂÂ...

    Details : Macitentan is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Pulmonary Arterial Hypertension.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 14, 2024

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    J&J Receives Positive CHMP Opinion for Yuvanci® in Pulmonary Arterial Hypertension

    Details:

    Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 26, 2024

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    06

    Johnson & Johnson

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    J&J Receives Positive CHMP Opinion for Yuvanci® in Pulmonary Arterial Hypertension

    Details : Yuvanci (macitentan, tadalafil) is an FDC available as a film coated tablet, for the treatment of pulmonary arterial hypertension in adults, works by inhibiting endothelin receptor & PDE5 inhibitor.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 26, 2024

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    FDA Approves OPSYNVI® As First Once-Daily Combination Therapy for PAH

    Details:

    Opsynvi is a combination of macitentan (an endothelin receptor antagonist) and tadalafil (a phosphodiesterase 5 inhibitor), approved for adults with pulmonary arterial hypertension.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Opsynvi

    Study Phase: Approved FDFProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 22, 2024

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    07

    Johnson & Johnson Innovative Medicine

    U.S.A
    arrow
    AACR Annual meeting
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    Johnson & Johnson Innovative Medicine

    U.S.A
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    FDA Approves OPSYNVI® As First Once-Daily Combination Therapy for PAH

    Details : Opsynvi is a combination of macitentan (an endothelin receptor antagonist) and tadalafil (a phosphodiesterase 5 inhibitor), approved for adults with pulmonary arterial hypertension.

    Product Name : Opsynvi

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 22, 2024

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    Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I Patients

    Details:

    Treprostinil Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pulmonary Arterial Hypertension.


    Lead Product(s): Treprostinil Sodium,Tadalafil,Sildenafil Citrate,Ambrisentan,Bosentan Hydrate,Macitentan

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: ANOVA CRO | PharmaLex | Aixial s.r.o. | GCP-Service International

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 19, 2024

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    08

    AOP Orphan

    Austria
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    Not Confirmed

    AOP Orphan

    Austria
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    Lead Product(s) : Treprostinil Sodium, Tadalafil, Sildenafil Citrate, Ambrisentan, Bosentan Hydrate

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : ANOVA CRO | PharmaLex | Aixial s.r.o. | GCP-Service International

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Gro...

    Details : Treprostinil Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Pulmonary Arterial Hypertension.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 19, 2024

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    Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) ...

    Details:

    ACT-064992D (macitentan/tadalafil ) Tablet act Endothelin A receptor antagonists, macitentan, and the PDE5 inhibitor, tadalafil, used for long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 26, 2023

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    09

    Johnson & Johnson

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson

    U.S.A
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking...

    Details : ACT-064992D (macitentan/tadalafil ) Tablet act Endothelin A receptor antagonists, macitentan, and the PDE5 inhibitor, tadalafil, used for long-term treatment of PAH in adult patients of WHO Functional Class (FC) II to III.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 26, 2023

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    Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil for T...

    Details:

    The investigational single tablet combination therapy of ACT-064992D (macitentan) Endothelin A receptor 10mg and tadalafil PDE5 inhibitor 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension.


    Lead Product(s): Macitentan,Tadalafil

    Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 30, 2023

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    Johnson & Johnson

    U.S.A
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    AACR Annual meeting
    Not Confirmed

    Johnson & Johnson

    U.S.A
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    Lead Product(s) : Macitentan,Tadalafil

    Therapeutic Area : Cardiology/Vascular Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Janssen Submits New Drug Application to U.S. FDA Seeking Approval of Investigational Single Tablet...

    Details : The investigational single tablet combination therapy of ACT-064992D (macitentan) Endothelin A receptor 10mg and tadalafil PDE5 inhibitor 40mg (M/T STCT) for the long-term treatment of pulmonary arterial hypertension.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 30, 2023

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    INTERMEDIATE SUPPLIERS

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    01

    ApiSyn

    India
    CPhI Japan
    Attending
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    Virtual BoothApiSyn: From early-phase research and process development to reliable cGMP manufacturing worldwide.

    5-(4-bromophenyl)-4,6-dichloropyrimidine

    CAS Number : 146533-41-7

    End Use API : Macitentan

    About The Company : Operational since 2024, ApiSyn Healthcare Pvt. Ltd. is a rapidly growing cGMP manufacturer and CDMO specializing in APIs, intermediates, peptides, and amino aci...

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    02

    Ami Organics Private Limited

    India
    AACR Annual meeting
    Not Confirmed
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    Ami Organics Private Limited

    India
    AACR Annual meeting
    Not Confirmed
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    5-(4-BROMOPHENYL)-4,6-DICHLOROPYRIMIDINE

    CAS Number : 146533-41-7

    End Use API : Macitentan

    About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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    03

    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    5-(4-bromophenyl)-4,6-dichloropyrimidine

    CAS Number : 146533-41-7

    End Use API : Macitentan

    About The Company : Beijing Cooperate Pharmaceutical Co.,Ltd is a high-tech company specializing in pharmaceutical and advanced material, involving API,pharmaceutical intermediates...

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    04

    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    2-(4-Bromophenyl)-propanedioic acid, 1,3-mdiethyl ...

    CAS Number : 149506-35-4

    End Use API : Macitentan

    About The Company : Beijing Cooperate Pharmaceutical Co.,Ltd is a high-tech company specializing in pharmaceutical and advanced material, involving API,pharmaceutical intermediates...

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    05

    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    Beijing Cooperate Pharmaceutical Co...

    China
    AACR Annual meeting
    Not Confirmed
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    • fda
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    5-(4-Bromophenyl)pyrimidine-4,6-diol

    CAS Number : 706811-25-8

    End Use API : Macitentan

    About The Company : Beijing Cooperate Pharmaceutical Co.,Ltd is a high-tech company specializing in pharmaceutical and advanced material, involving API,pharmaceutical intermediates...

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    Beijing Cooperate Pharmaceutical Co...

    China
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    PropylsulfaMide

    CAS Number : 147962-41-2

    End Use API : Macitentan

    About The Company : Beijing Cooperate Pharmaceutical Co.,Ltd is a high-tech company specializing in pharmaceutical and advanced material, involving API,pharmaceutical intermediates...

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    Blue Circle

    India
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    Propyl sulfamide

    CAS Number : 147962-41-2

    End Use API : Macitentan

    About The Company : Our journey began in 1969, with our first manufacturing facility Jet Chemicals Pvt. Ltd (JCPL), a pioneer in manufacturing Pharmaceutical Excipients (Saccharin ...

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    Blue Jet Healthcare

    India
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    Blue Jet Healthcare

    India
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    n-Propyl sulfamide

    CAS Number : 147962-41-2

    End Use API : Macitentan

    About The Company : Blue Jet Healthcare is a global, science-driven pharmaceutical company specializing in collaboration, development, and manufacturing of advanced pharmaceutical ...

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    Glenfin Chemicals

    India
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    Glenfin Chemicals

    India
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    5-(4-Bromophenyl)-4,6-dichloropyrimidine

    CAS Number : 146533-41-7

    End Use API : Macitentan

    About The Company : Glenfin Chemicals, a trusted provider of high-quality chemical solutions tailored to meet the diverse needs of industries worldwide. Based in the heart of inno...

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    Hangzhou Longshine Bio-Tech Co.,LTD

    China
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    Hangzhou Longshine Bio-Tech Co.,LTD

    China
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    5-4-bromophenyl-4,6-dichloropyrimidine

    CAS Number : 146533-41-7

    End Use API : Macitentan

    About The Company : Established in 2011 and situated in Hangzhou, Zhejiang, China, Hangzhou Longshine Bio-Tech CO., Ltd is dedicated to providing services for pharmaceutical and ch...

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    ABOUT THIS PAGE

    Looking for 441798-33-0 / Macitentan API manufacturers, exporters & distributors?

    Macitentan manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Macitentan API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Macitentan manufacturer or Macitentan supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Macitentan manufacturer or Macitentan supplier.

    API | Excipient name

    Macitentan

    Synonyms

    441798-33-0, Opsumit, Act-064992, Act 064992, N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-n'-propylsulfamide, Act064992

    Cas Number

    441798-33-0

    Unique Ingredient Identifier (UNII)

    Z9K9Y9WMVL

    About Macitentan

    Macitentan is an orally available dual endothelin receptor (ETR) antagonist with potential antihypertensive and antineoplastic activity. Upon administration, macitentan and its metabolites block the binding of endothelin isoform 1 (ET-1) to type-A and type-B ETR on both the tumor cells and the endothelial cells in the tumor vasculature. This prevents ET-1 mediated signaling transduction which may decrease tumor cell proliferation, progression, and angiogenesis in tumor tissue. ET-1, a potent vasoconstrictor that plays an important role in inflammation and tissue repair, is, together with its receptors, overexpressed varyingly in many tumor cell types.

    Macitentan Manufacturers

    A Macitentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Macitentan, including repackagers and relabelers. The FDA regulates Macitentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Macitentan API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Macitentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

    Macitentan Suppliers

    A Macitentan supplier is an individual or a company that provides Macitentan active pharmaceutical ingredient (API) or Macitentan finished formulations upon request. The Macitentan suppliers may include Macitentan API manufacturers, exporters, distributors and traders.

    click here to find a list of Macitentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

    Macitentan USDMF

    A Macitentan DMF (Drug Master File) is a document detailing the whole manufacturing process of Macitentan active pharmaceutical ingredient (API) in detail. Different forms of Macitentan DMFs exist exist since differing nations have different regulations, such as Macitentan USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Macitentan DMF submitted to regulatory agencies in the US is known as a USDMF. Macitentan USDMF includes data on Macitentan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Macitentan USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Macitentan suppliers with USDMF on PharmaCompass.

    Macitentan JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Macitentan Drug Master File in Japan (Macitentan JDMF) empowers Macitentan API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Macitentan JDMF during the approval evaluation for pharmaceutical products. At the time of Macitentan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Macitentan suppliers with JDMF on PharmaCompass.

    Macitentan KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Macitentan Drug Master File in Korea (Macitentan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Macitentan. The MFDS reviews the Macitentan KDMF as part of the drug registration process and uses the information provided in the Macitentan KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Macitentan KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Macitentan API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Macitentan suppliers with KDMF on PharmaCompass.

    Macitentan WC

    A Macitentan written confirmation (Macitentan WC) is an official document issued by a regulatory agency to a Macitentan manufacturer, verifying that the manufacturing facility of a Macitentan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Macitentan APIs or Macitentan finished pharmaceutical products to another nation, regulatory agencies frequently require a Macitentan WC (written confirmation) as part of the regulatory process.

    click here to find a list of Macitentan suppliers with Written Confirmation (WC) on PharmaCompass.

    Macitentan NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Macitentan as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Macitentan API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Macitentan as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Macitentan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Macitentan NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Macitentan suppliers with NDC on PharmaCompass.

    Macitentan GMP

    Macitentan Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Macitentan GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Macitentan GMP manufacturer or Macitentan GMP API supplier for your needs.

    Macitentan CoA

    A Macitentan CoA (Certificate of Analysis) is a formal document that attests to Macitentan's compliance with Macitentan specifications and serves as a tool for batch-level quality control.

    Macitentan CoA mostly includes findings from lab analyses of a specific batch. For each Macitentan CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Macitentan may be tested according to a variety of international standards, such as European Pharmacopoeia (Macitentan EP), Macitentan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Macitentan USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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