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Chemistry

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Also known as: 1103522-45-7, Act-132577, Aprocitentan [usan], Macitentan metabolite m6, Mzi81hv01p, 5-(4-bromophenyl)-4-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-6-(sulfamoylamino)pyrimidine
Molecular Formula
C16H14Br2N6O4S
Molecular Weight
546.2  g/mol
InChI Key
DKULOVKANLVDEA-UHFFFAOYSA-N
FDA UNII
MZI81HV01P

Aprocitentan
Aprocitentan is under investigation in clinical trial NCT03541174 (A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety).
1 2D Structure

Aprocitentan

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
5-(4-bromophenyl)-4-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-6-(sulfamoylamino)pyrimidine
2.1.2 InChI
InChI=1S/C16H14Br2N6O4S/c17-11-3-1-10(2-4-11)13-14(24-29(19,25)26)22-9-23-15(13)27-5-6-28-16-20-7-12(18)8-21-16/h1-4,7-9H,5-6H2,(H2,19,25,26)(H,22,23,24)
2.1.3 InChI Key
DKULOVKANLVDEA-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC(=CC=C1C2=C(N=CN=C2OCCOC3=NC=C(C=N3)Br)NS(=O)(=O)N)Br
2.2 Other Identifiers
2.2.1 UNII
MZI81HV01P
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Act-132577

2. N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)sulfuric Diamide

3. Sulfamide, N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-

2.3.2 Depositor-Supplied Synonyms

1. 1103522-45-7

2. Act-132577

3. Aprocitentan [usan]

4. Macitentan Metabolite M6

5. Mzi81hv01p

6. 5-(4-bromophenyl)-4-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-6-(sulfamoylamino)pyrimidine

7. Chembl2165326

8. Chebi:76609

9. N-[5-(4-bromophenyl)-6-{2-[(5-bromopyrimidin-2-yl)oxy]ethoxy}pyrimidin-4-yl]sulfuric Diamide

10. N-[5-(4-bromophenyl)-6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]sulfamide

11. Sulfamide, N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-

12. Despropyl Macitentan

13. N-despropyl-macitentan

14. Unii-mzi81hv01p

15. N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)sulfamide

16. N-(5-(4-bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxy)ethoxy)pyrimidin-4-yl)sulfuric Diamide

17. Act 132577

18. Aprocitentan (usan/inn)

19. Aprocitentan [inn]

20. Schembl3646065

21. Aprocitentan (act-132577)

22. Gtpl10070

23. Amy39078

24. Bcp28125

25. Ex-a4419

26. Bdbm50395672

27. Who 10552

28. Zinc95553608

29. Db15059

30. Ncgc00378592-01

31. Ac-36529

32. As-82256

33. Hy-15895

34. Db-130379

35. D11441

36. D87138

37. A922313

38. Q27146161

39. Act-132577; Act 132577; Act132577

40. 5-(4-bromophenyl)-4-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-6-(sulfamoylamino)pyrimidine.

41. N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)-sulfamide

42. N-(5-(4-bromophenyl)-6-(2-((5-bromo-2-pyrimidinyl)oxy)ethoxy)-4-pyrimidinyl)sulfuric Diamide

43. N-(5-(4-bromophenyl)-6-(2-((5-bromopyrimidin-2-yl)oxy)ethoxy)pyrimidin-4-yl)sulfamide

2.4 Create Date
2008-12-15
3 Chemical and Physical Properties
Molecular Weight 546.2 g/mol
Molecular Formula C16H14Br2N6O4S
XLogP32.4
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count10
Rotatable Bond Count8
Exact Mass545.91435 g/mol
Monoisotopic Mass543.91640 g/mol
Topological Polar Surface Area151 Ų
Heavy Atom Count29
Formal Charge0
Complexity597
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 Indication

Treatment of hypertension


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Metrochem API Private Limited

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Drugs in Development

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Details:

Tryvio (aprocitentan) is a first and only endothelin receptor antagonist, which is indicated for the treatment of hypertension.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tryvio

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 09, 2025

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01

SCI Medicinal Chemistry
Not Confirmed
SCI Medicinal Chemistry
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Details : Tryvio (aprocitentan) is a first and only endothelin receptor antagonist, which is indicated for the treatment of hypertension.

Product Name : Tryvio

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 09, 2025

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02

SCI Medicinal Chemistry
Not Confirmed
SCI Medicinal Chemistry
Not Confirmed

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 29, 2025

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Details:

Tryvio (aprocitentan) is a first and only endothelin receptor antagonist, which is indicated for the treatment of hypertension in adult patients, in combination with other antihypertensive drugs.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tryvio

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 15, 2024

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03

SCI Medicinal Chemistry
Not Confirmed
SCI Medicinal Chemistry
Not Confirmed

Details : Tryvio (aprocitentan) is a first and only endothelin receptor antagonist, which is indicated for the treatment of hypertension in adult patients, in combination with other antihypertensive drugs.

Product Name : Tryvio

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 15, 2024

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Details:

Jeraygo (aprocitentan), the first endothelin receptor antagonist, treats hypertension in adults by combining it with other antihypertensives to reduce blood pressure.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Jeraygo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 26, 2024

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SCI Medicinal Chemistry
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SCI Medicinal Chemistry
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Details : Jeraygo (aprocitentan), the first endothelin receptor antagonist, treats hypertension in adults by combining it with other antihypertensives to reduce blood pressure.

Product Name : Jeraygo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

April 26, 2024

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Details:

Tryvio (aprocitentan), an endothelin receptor antagonist, is indicated for treating hypertension when combined with other antihypertensives to lower blood pressure in adults.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tryvio

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 20, 2024

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05

SCI Medicinal Chemistry
Not Confirmed
SCI Medicinal Chemistry
Not Confirmed

Details : Tryvio (aprocitentan), an endothelin receptor antagonist, is indicated for treating hypertension when combined with other antihypertensives to lower blood pressure in adults.

Product Name : Tryvio

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 20, 2024

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Details:

Idorsia will reacquire the development and commercialization rights for aprocitentan, a potential novel, effective, once-daily, orally active, dual endothelin A and B receptor antagonist and well-tolerated treatment for resistant hypertension, from Janssen.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Idorsia Pharmaceuticals

Deal Size: $343.0 million Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 09, 2023

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SCI Medicinal Chemistry
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SCI Medicinal Chemistry
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Details : Idorsia will reacquire the development and commercialization rights for aprocitentan, a potential novel, effective, once-daily, orally active, dual endothelin A and B receptor antagonist and well-tolerated treatment for resistant hypertension, from Janss...

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

May 09, 2023

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Details:

ACT-132577 (aprocitentan) is a dual endothelin receptor antagonist, which potently inhibits the binding of ET-1 to ETA and ETB receptors. It has a mechanism of action that is ideally suited for the pathophysiology of resistant hypertension.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tryvio

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: JANSSEN BIOTECH

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 31, 2023

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07

SCI Medicinal Chemistry
Not Confirmed
SCI Medicinal Chemistry
Not Confirmed

Details : ACT-132577 (aprocitentan) is a dual endothelin receptor antagonist, which potently inhibits the binding of ET-1 to ETA and ETB receptors. It has a mechanism of action that is ideally suited for the pathophysiology of resistant hypertension.

Product Name : Tryvio

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

January 31, 2023

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Details:

ACT-132577 (aprocitentan), is an investigational, novel, oral, dual endothelin receptor antagonist (ERA), which potently inhibits the binding of ET-1 to ETA and ETB receptors.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tryvio

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 20, 2022

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08

SCI Medicinal Chemistry
Not Confirmed
SCI Medicinal Chemistry
Not Confirmed

Details : ACT-132577 (aprocitentan), is an investigational, novel, oral, dual endothelin receptor antagonist (ERA), which potently inhibits the binding of ET-1 to ETA and ETB receptors.

Product Name : Tryvio

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 20, 2022

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Details:

Aprocitentan (ACT-132577), a novel, dual ERA, which potently inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan has a low potential for drug-drug interaction and a mechanism of action that is intended to address the pathophysiology of difficult-to-control HTN.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Idorsia Pharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 11, 2022

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09

SCI Medicinal Chemistry
Not Confirmed
SCI Medicinal Chemistry
Not Confirmed

Details : Aprocitentan (ACT-132577), a novel, dual ERA, which potently inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan has a low potential for drug-drug interaction and a mechanism of action that is intended to address the pathophysiology of di...

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 11, 2022

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Details:

ACT-132577 (aprocitentan) reduces blood pressure compared to placebo by week 4 of treatment, the effect is maintained and confirmed over a period of 48 weeks, and is generally well tolerated with no major safety concerns.


Lead Product(s): Aprocitentan,Inapplicable

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Tryvio

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 23, 2022

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10

SCI Medicinal Chemistry
Not Confirmed
SCI Medicinal Chemistry
Not Confirmed

Details : ACT-132577 (aprocitentan) reduces blood pressure compared to placebo by week 4 of treatment, the effect is maintained and confirmed over a period of 48 weeks, and is generally well tolerated with no major safety concerns.

Product Name : Tryvio

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 23, 2022

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INTERMEDIATE SUPPLIERS

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CAS Number : 146533-41-7

End Use API : Aprocitentan

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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APROCITENTAN

Brand Name : TRYVIO

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Packaging :

Approval Date : 2024-03-19

Application Number : 217686

Regulatory Info : RX

Registration Country : USA

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IDORSIA

Switzerland
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IDORSIA

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APROCITENTAN

Brand Name : TRYVIO

Dosage Form : TABLET;ORAL

Dosage Strength : 12.5MG

Approval Date : 2024-03-19

Application Number : 217686

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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STOCK RECAP #PipelineProspector

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Pipeline Prospector March 2024: FDA approves pathbreaking NASH drug from Madrigal, two meds for PAH
March was clearly a month of drug approvals, as the US Food and Drug Administration (FDA) went on an overdrive, green-lighting several therapies before the close of the first quarter (Q1 2024). Amongst them was the first drug to treat non-alcoholic steatohepatitis (NASH) and a breakthrough therapy that treats pulmonary arterial hypertension (PAH).However, the buoyancy in drug approvals didn’t play out in the stock markets and most pharma indices witnessed a marginal dip. The Nasdaq Biotechnology index (NBI) fell marginally (-0.43 percent) to 4,429.97 from 4,449. The SPDR S&P Biotech ETF index (XBI) dropped 4.6 percent to 94.89 after ending February at 99.44. And the S&P Biotechnology Select Industry index (SPSIBI) was down by 3.4 percent from 7,662.14 to 7,402.47 in March.In deals, AstraZeneca bought two companies, shoring up its cancer and rare disease pipelines. The Anglo-Swedish drugmaker first bought France’s Amolyt, which focuses on rare endocrine diseases, for a total of US$ 1.05 billion and then acquired next-generation cancer drugmaker Fusion Pharmaceuticals for around US$ 2 billion. AstraZeneca’s stock was up 4.6 percent in March. Novo Nordisk (stock up 4.8 percent) agreed to acquire Cardior Pharmaceuticals for up to US$ 1.1 billion in order to boost its pipeline for cardiovascular diseases.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel)FDA okays first drug for NASH; Wegovy approved as med to reduce heart risksFor quite some time, the drug development field for the liver condition non-alcoholic steatohepatitis (NASH) has been a graveyard for failed programs. In March, the field celebrated a hurrah moment when Madrigal Pharmaceuticals (stock up 6 percent) won the race to have the first NASH treatment approved by the FDA. Madrigal’s oral drug Rezdiffra (resmetirom) treats adults with NASH, a disease that causes histologic liver damage and occurs in patients who are not alcoholics and are often obese or have type 2 diabetes. The approval has opened a multi-billion dollar opportunity for Madrigal.The GLP-1 agonist drugs that are used to treat diabetes and obesity have shown heart-related benefits too in clinical trials. Last month, FDA approved Novo Nordisk’s Wegovy (semaglutide) to reduce the risk of cardiovascular death, heart attack, and stroke in obese or overweight adults with cardiovascular disease (CVD). The move makes Wegovy the first weight-loss medication that is also approved to help prevent life-threatening cardiovascular events. The approval was hailed as a major advancement in public health.Another significant FDA approval was granted to Akebia’s anemia drug, vadadustat. After being turned down in March 2022, Akebia has now been approved to treat anemia caused by chronic kidney disease (CKD) in dialysis patients.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) FDA okays two meds for PAH; Italfarmaco’s Duvyzat approved for DMDFDA approved a breakthrough therapy from Merck, known as Winrevair (sotatercept-csrk), to treat adults with hypertension that is caused by constriction of the arteries in the lungs, known as pulmonary arterial hypertension (PAH). The agency also approved Johnson & Johnson’s Opsynvi – a single-tablet combination of macitentan and tadalafil – for the chronic treatment of adults with PAH. With this approval, Opsynvi became the only once-daily combination therapy for PAH.Apart from PAH, there was another significant approval for hypertension. FDA okayed Idorsia’s once-daily treatment Tryvio (aprocitentan) in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not able to adequately control their BP on other drugs. Idorsia’s stock was up 50 percent in March. Tryvio is the first oral anti-hypertensive therapy, which works via a new therapeutic pathway, to be approved in almost 40 years.The US agency also approved Italfarmaco Group’s oral medication Duvyzat (givinostat) for the treatment of Duchenne muscular dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all variants of DMD, a genetic disorder characterized by progressive muscle degeneration.Orchard Therapeutics’ Lenmeldy was also greenlit by the FDA as the first gene therapy in the US for a debilitating and rare pediatric disorder, known as metachromatic leukodystrophy (MLD).Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) Breyanzi okayed for complex leukemia; Tevimbra approved for esophageal cancerAmong cancer treatments, FDA granted an accelerated approval to BMS’ Breyanzi, making it the first and only CAR-T cell therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BMS’ stock was up 6 percent in March.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) finally got the go ahead from the FDA as a treatment for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.FDA also granted accelerated approval to Takeda’s Iclusig (ponatinib) to be used with chemotherapy for newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a type of blood cancer of the bone marrow and blood.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) Pfizer-Takeda’s Adcetris posts trial win in DLBCL; FDA defers donanemab approvalIn clinical trials, there was some positive news from a phase 3 trial on Pfizer and Takeda’s drug Adcetris, which is known as a standard of care in classical Hodgkin lymphoma. The med has now shown to be efficacious in diffuse large B-cell lymphoma (DLBCL), a common type of non-Hodgkin lymphoma, when used in combination with two other drugs — lenalidomide and rituximab.In a late-stage trial, Novo Nordisk’s broadly used blockbuster diabetes drug Ozempic (semaglutide) slashed the risk of kidney disease progression and death from cardiovascular or kidney complications by 24 percent in diabetic patients with CKD. In negative news from the trials, the much anticipated approval of Eli Lilly’s donanemab scheduled for March was deferred as FDA opted to convene a panel of independent experts to assess the drug’s safety and efficacy. Similarly, Amylyx’s Relyvrio (sodium phenylbutyrate and taurursodiol), a promising investigational treatment for amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, failed to demonstrate it works better than a placebo in a 48-week long trial. ALS is a fatal motor neuron disease characterized by progressive degeneration of nerve cells.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) Our viewWith so many drug approvals, March was a good month for the biopharma industry. While it may look like the markets didn’t cheer the approvals, all the three indices — the NBI, XBI, and SPSIBI — ended the quarter in the green, growing 2.1 percent, 7.3 percent, and 6.4 percent, respectively, between January 2 and March 28. As we enter the second quarter of 2024, we hope the buoyancy in drug approvals and the indices is maintained.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) 

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NEWS #PharmaBuzz

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Patents & EXCLUSIVITIES

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US Patents

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APROCITENTAN

US Patent Number : 11787782

Drug Substance Claim :

Drug Product Claim :

Application Number : 217686

Patent Use Code : U-3877

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-03-02

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APROCITENTAN

US Patent Number : 11680058

Drug Substance Claim :

Drug Product Claim :

Application Number : 217686

Patent Use Code : U-3878

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-07-26

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APROCITENTAN

US Patent Number : 11174247

Drug Substance Claim :

Drug Product Claim :

Application Number : 217686

Patent Use Code : U-3879

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2037-11-06

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IDORSIA

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APROCITENTAN

US Patent Number : 8324232

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217686

Patent Use Code : U-3878

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-09-21

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IDORSIA

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APROCITENTAN

US Patent Number : 12297189

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217686

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-02-26

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IDORSIA

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APROCITENTAN

US Patent Number : 10919881

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217686

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2038-02-26

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ABOUT THIS PAGE

Looking for 1103522-45-7 / Aprocitentan API manufacturers, exporters & distributors?

Aprocitentan manufacturers, exporters & distributors 1

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

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

PharmaCompass also assists you with knowing the Aprocitentan API Price utilized in the formulation of products. Aprocitentan API Price is not always fixed or binding as the Aprocitentan Price is obtained through a variety of data sources. The Aprocitentan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Aprocitentan

Synonyms

1103522-45-7, Act-132577, Aprocitentan [usan], Macitentan metabolite m6, Mzi81hv01p, 5-(4-bromophenyl)-4-[2-(5-bromopyrimidin-2-yl)oxyethoxy]-6-(sulfamoylamino)pyrimidine

Cas Number

1103522-45-7

Unique Ingredient Identifier (UNII)

MZI81HV01P

About Aprocitentan

Aprocitentan is under investigation in clinical trial NCT03541174 (A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety).

Aprocitentan Manufacturers

A Aprocitentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aprocitentan, including repackagers and relabelers. The FDA regulates Aprocitentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aprocitentan 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 Aprocitentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Aprocitentan Suppliers

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

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

Aprocitentan GMP

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

Aprocitentan CoA

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

Aprocitentan CoA mostly includes findings from lab analyses of a specific batch. For each Aprocitentan 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.

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