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1. (4r,5r)-5-(4-((4-(4-aza-1-azoniabicyclo(2.2.2)octan-1-ylmethyl)phenyl)methoxy)phenyl)-3,3-dibutyl-7-(dimethylamino)-1,1-dioxo-4,5-dihydro-2h-16-benzothiepin-4-ol
2. Livmarli
3. Maralixibat
1. Lopixibat Chloride
2. 228113-66-4
3. Lum-001
4. Maralixibat Chloride [usan]
5. Lum001
6. Maralixibat (chloride)
7. V78m04f0xc
8. 228113-66-4 (chloride)
9. Livmarli
10. Lum 001
11. 4-aza-1-azoniabicyclo(2.2.2)octane, 1-((4-((4-((4r,5r)-3,3-dibutyl-7-(dimethylamino)-2,3,4,5-tetrahydro-4-hydroxy-1,1-dioxido-1-benzothiepin-5-yl)phenoxy)methyl)phenyl)methyl)-, Chloride (1:1)
12. Chembl17879
13. (4r,5r)-5-[4-[[4-(4-aza-1-azoniabicyclo[2.2.2]octan-1-ylmethyl)phenyl]methoxy]phenyl]-3,3-dibutyl-7-(dimethylamino)-1,1-dioxo-4,5-dihydro-2h-1lambda6-benzothiepin-4-ol;chloride
14. 1-(4-((4-((4r,5r)-3,3-dibutyl-7-(dimethylamino)-4-hydroxy-1,1-dioxido-2,3,4,5-tetrahydrobenzo[b]thiepin-5-yl)phenoxy)methyl)benzyl)-1,4-diazabicyclo[2.2.2]octan-1-ium Chloride
15. Lopixibat Chloride [inn]
16. Unii-v78m04f0xc
17. Shp 625
18. Schembl6336189
19. Shp625
20. Maralixibat Chloride (usan/inn)
21. Dtxsid701337104
22. Maralixibat Chloride [inn]
23. Maralixibat Chloride [who-dd]
24. Hy-16747
25. Maralixibat Chloride [orange Book]
26. Cs-0012347
27. D10952
28. Q27291628
Molecular Weight | 710.4 g/mol |
---|---|
Molecular Formula | C40H56ClN3O4S |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 13 |
Exact Mass | 709.3680061 g/mol |
Monoisotopic Mass | 709.3680061 g/mol |
Topological Polar Surface Area | 78.5 Ų |
Heavy Atom Count | 49 |
Formal Charge | 0 |
Complexity | 1080 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Treatment of Progressive Familial Intrahepatic Cholestasis
Treatment of Alagille syndrome
Treatment of biliary atresia
A - Alimentary tract and metabolism
A05 - Bile and liver therapy
A05A - Bile therapy
A05AX - Other drugs for bile therapy
A05AX04 - Maralixibat chloride
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41496
Submission : 2025-03-27
Status : Active
Type : II
NDC Package Code : 76397-040
Start Marketing Date : 2025-03-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Founded in 1997, Lee Pharma Limited has transformed from a small venture into a global leader in the pharmaceutical industry. Our journey began with a commitment to providing affor...
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Details:
Livmarli (maralixibat chloride) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome 3 month of age and older.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 14, 2025
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mirum's LIVMARLI Now FDA Approved in Tablet Formulation
Details : Livmarli (maralixibat chloride) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome 3 month of age and older.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 14, 2025
Details:
Livmarli (maralixibat chloride) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome 1 year of age and older.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2025
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
LIVMARLI now Approved in Japan for ALGS and PFIC
Details : Livmarli (maralixibat chloride) is an ileal bile acid transporter (IBAT) inhibitor indicated for the treatment of cholestatic pruritus in patients with Alagille syndrome 1 year of age and older.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 27, 2025
Details:
Under the agreement, Mirum has appointed Abacus to exclusively promote, market, sell, distribute, and commercialize LIVMARLI in the territory of Denmark, Finland, Iceland, Norway, and Sweden.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Abacus Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 09, 2024
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Abacus Medicine
Deal Size : Undisclosed
Deal Type : Agreement
Abacus & Mirum Partner for the Commercialization of LIVMARLI in Nordic Markets
Details : Under the agreement, Mirum has appointed Abacus to exclusively promote, market, sell, distribute, and commercialize LIVMARLI in the territory of Denmark, Finland, Iceland, Norway, and Sweden.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
September 09, 2024
Details:
LIVMARLI® (maralixibat) oral solution is a minimally absorbed IBAT inhibitor, approved for treating of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2024
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mirum Pharmaceuticals’ LIVMARLI Approved in the European Union for Patients with PFIC
Details : LIVMARLI® (maralixibat) oral solution is a minimally absorbed IBAT inhibitor, approved for treating of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 07, 2024
Details:
Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, approved for PFIC patients 12 months and older in higher concentrations.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 25, 2024
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mirum’s LIVMARLI Now Approved for PFIC in Patients 12 Months and Older
Details : Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, approved for PFIC patients 12 months and older in higher concentrations.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 25, 2024
Details:
Livmarli (maralixibat) is an oral IBAT inhibitor, which is under clinical development for the treatment of Progressive Familial Intrahepatic Cholestasis.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 31, 2024
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mirum Announces Positive CHMP Opinion for LIVMARLI Oral Solution for PFIC
Details : Livmarli (maralixibat) is an oral IBAT inhibitor, which is under clinical development for the treatment of Progressive Familial Intrahepatic Cholestasis.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 31, 2024
Details:
LIVMARLI® (maralixibat), an IBAT inhibitor, has FDA approval for cholestatic pruritus in progressive familial intrahepatic cholestasis.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 13, 2024
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mirum's LIVMARLI Receives FDA Approval for Cholestatic Pruritus Treatment
Details : LIVMARLI® (maralixibat), an IBAT inhibitor, has FDA approval for cholestatic pruritus in progressive familial intrahepatic cholestasis.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 13, 2024
Details:
Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, which is under phase 2 clinical development for the treatment of Biliary Atresia.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 18, 2023
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mirum Pharmaceuticals Announces Data from EMBARK Phase 2b Study for Biliary Atresia
Details : Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, which is under phase 2 clinical development for the treatment of Biliary Atresia.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 18, 2023
Details:
Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of biliary atresia in infant who have previously undergone a hepatoportoenterostomy.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 05, 2023
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Mirum Pharmaceuticals Announces Enrollment Completion in Phase 2b EMBARK Biliary Atresia Study
Details : Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of biliary atresia in infant who have previously undergone a hepatoportoenterostomy.
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 05, 2023
Details:
Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and NMPA has accepted the New Drug Application for the treatment of Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis.
Lead Product(s): Maralixibat Chloride
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 17, 2023
Lead Product(s) : Maralixibat Chloride
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and NMPA has accepted the New Drug Application for the treatment of Cholestatic Pruritus in Progressive Familial Intrahepatic Cholest...
Product Name : Livmarli
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 17, 2023
Regulatory Info : RX
Registration Country : USA
Brand Name : LIVMARLI
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 9.5MG BASE/ML
Packaging :
Approval Date : 2021-09-29
Application Number : 214662
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LIVMARLI
Dosage Form : SOLUTION;ORAL
Dosage Strength : EQ 19MG BASE/ML
Packaging :
Approval Date : 2024-07-24
Application Number : 214662
Regulatory Info : RX
Registration Country : USA
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PharmaCompass offers a list of Maralixibat Chloride 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 Maralixibat Chloride manufacturer or Maralixibat Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Maralixibat Chloride manufacturer or Maralixibat Chloride supplier.
PharmaCompass also assists you with knowing the Maralixibat Chloride API Price utilized in the formulation of products. Maralixibat Chloride API Price is not always fixed or binding as the Maralixibat Chloride Price is obtained through a variety of data sources. The Maralixibat Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Maralixibat Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maralixibat Chloride, including repackagers and relabelers. The FDA regulates Maralixibat Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maralixibat Chloride 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 Maralixibat Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maralixibat Chloride supplier is an individual or a company that provides Maralixibat Chloride active pharmaceutical ingredient (API) or Maralixibat Chloride finished formulations upon request. The Maralixibat Chloride suppliers may include Maralixibat Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Maralixibat Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Maralixibat Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Maralixibat Chloride active pharmaceutical ingredient (API) in detail. Different forms of Maralixibat Chloride DMFs exist exist since differing nations have different regulations, such as Maralixibat Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maralixibat Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Maralixibat Chloride USDMF includes data on Maralixibat Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maralixibat Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maralixibat Chloride suppliers with USDMF on PharmaCompass.
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 Maralixibat Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Maralixibat Chloride API and other APIs are published in this directory by the FDA.
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 Maralixibat Chloride 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.
The NDC directory also contains data on finished compounded human drug products that contain Maralixibat Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Maralixibat Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Maralixibat Chloride suppliers with NDC on PharmaCompass.
Maralixibat Chloride 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 Maralixibat Chloride 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 Maralixibat Chloride GMP manufacturer or Maralixibat Chloride GMP API supplier for your needs.
A Maralixibat Chloride CoA (Certificate of Analysis) is a formal document that attests to Maralixibat Chloride's compliance with Maralixibat Chloride specifications and serves as a tool for batch-level quality control.
Maralixibat Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Maralixibat Chloride 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.
Maralixibat Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Maralixibat Chloride EP), Maralixibat Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Maralixibat Chloride USP).