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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
1. Lopixibat
2. Maralixibat [usan]
3. 716313-53-0
4. Maralixibat Cation
5. Livmarli
6. Uyb6uof69l
7. Lum001 Cation
8. Lum-001 Cation
9. Chembl363392
10. Maralixibat (usan)
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)-
12. Lopixibat Cation
13. Chembl17879
14. Lum 001
15. 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
16. Unii-uyb6uof69l
17. Lopixibat (deleted Inn)
18. Maralixibat [who-dd]
19. Schembl10013954
20. Gtpl11708
21. Dtxsid001337103
22. Bdbm50140282
23. Compound 74 [pmid: 16134951]
24. D10951
25. Q27291331
26. (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
27. 1-{4-[4-((4r,5r)-3,3-dibutyl-7-dimethylamino-4-hydroxy-1,1-dioxo-2,3,4,5-tetrahydro-1h-1lambda*6*-benzo[b]thiepin-5-yl)-phenoxymethyl]-benzyl}-4-aza-1-azonia-bicyclo[2.2.2]octane; Chloride
| Molecular Weight | 675.0 g/mol |
|---|---|
| Molecular Formula | C40H56N3O4S+ |
| XLogP3 | 7.1 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 13 |
| Exact Mass | 674.39915345 g/mol |
| Monoisotopic Mass | 674.39915345 g/mol |
| Topological Polar Surface Area | 78.5 Ų |
| Heavy Atom Count | 48 |
| Formal Charge | 1 |
| 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 | 1 |
Maralixibat is indicated in the treatment of cholestatic pruritus in patients with Alagille syndrome who are at least 1 year old.
Maralixibat is indicated in the treatment of cholestatic pruritus in patients with Alagille syndrome who are at least 1 year old. It has a moderate duration of action as it is given once daily, and a wide therapeutic index as patients have safely tolerated single doses up to 18 times the normal dose. Patients should be counselled regarding the risks of liver test abnormalities, gastrointestinal adverse reactions, and fat-soluble vitamin deficiencies.
Absorption
Maralixibat is not extensively absorbed. A single 30 mg dose of maralixibat given under fasted conditions reached a median Tmax of 0.75 hours, with a mean Cmax of 1.65 1.10 ng/mL, and a mean AUClast of 3.43 2.13 h\*ng/mL. In pediatric patients given a dose of 380 g/kg, the highest serum concentration was 5.93 ng/mL, but was <0.25 ng/mL in the majority of patients.
Route of Elimination
A 5 mg radiolabelled dose of maralixibat is 73% eliminated in feces and 0.066% eliminated in urine. 94% of the dose recovered in the feces was as the unmetabolized parent compound. <3% of the total dose is metabolized.
Maralixibat metabolites have not been identified in plasma, however 3 minor metabolites have been recovered in the feces. The structure of these metabolites have not been defined in the literature.
The mean half life of maralixibat is 1.6 hours.
Patients with Alagille syndrome experience potentially debilitating pruritus. The exact mechanism of cholestatic pruritus in Alagille syndrome is not well defined, however it is correlated with elevated total serum bile acid concentrations. Enterohepatic circulation involves the synthesis of bile acid from cholesterol in the liver, conjugation with glycine or taurine, excretion into the duodenum, 95% resorption in the distal ileum through the ileal bile acid transporter (IBAT), return to the liver via the portal vein, and uptake into the liver by the sodium-dependent taurocholate co-transporting peptide (NTCP). It is important to note that unconjugated bile acids may freely diffuse across the intestinal mucosa or be transported across by other organic anion transporters. Maralixibat reversibly inhibits IBAT to decrease bile acid resorption in the ileum, leading to decreased resorption of bile acids in the distal ileum, increased elimination of bile acids in the feces, and decreased serum bile acids. The mechanism of action of maralixibat also leads to increased rates of diarrhea in patients. Under normal conditions, bile acids binding to the farnesoid X receptor (FXR) in the liver by via nuclear receptor small heterodimer partner (SHP) or in the ileum via fibroblast growth factor 19 (FGF19), triggers signal cascade that inhibits CYP7A1-mediated bile acid synthesis. Inhibition of IBAT by maralixibat, inhibits these negative feedback loops, leading to increased bile acid synthesis, and a reduction of low density lipoprotein cholesterol. In one clinical trial (NCT02057692), not all dose strengths were associated with a clinically significant difference between maralixibat and placebo.
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Drugs in Development
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
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Abacus Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 09, 2024
Lead Product(s) : Maralixibat
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved
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.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 09, 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
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2024
Lead Product(s) : Maralixibat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 25, 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
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2024
Lead Product(s) : Maralixibat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 08, 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
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2024
Lead Product(s) : Maralixibat
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 31, 2024
Details:
LIVMARLI® (maralixibat), an IBAT inhibitor, has FDA approval for cholestatic pruritus in progressive familial intrahepatic cholestasis.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2024
Lead Product(s) : Maralixibat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
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
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Lead Product(s) : Maralixibat
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 18, 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
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2023
Lead Product(s) : Maralixibat
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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...
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 17, 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
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livmarli
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2023
Lead Product(s) : Maralixibat
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 11, 2023
Details:
Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. FDA for the treatment of cholestatic pruritus in patients with alagille syndrome one year of age and older.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2023
Lead Product(s) : Maralixibat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Mirum Submits for European Approval of LIVMARLI in Progressive Familial Intrahepatic Cholestasis
Details : Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. FDA for the treatment of cholestatic pruritus in patients with alagille syndrome one year of age and older.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
April 05, 2023
Details:
Livmarli™ (maralixibat) is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Brand Name: Livmarli
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2023
Lead Product(s) : Maralixibat
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Livmarli™ (maralixibat) is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum.
Brand Name : Livmarli
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 14, 2023
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ABOUT THIS PAGE
A Maralixibat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maralixibat, including repackagers and relabelers. The FDA regulates Maralixibat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maralixibat 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maralixibat supplier is an individual or a company that provides Maralixibat active pharmaceutical ingredient (API) or Maralixibat finished formulations upon request. The Maralixibat suppliers may include Maralixibat API manufacturers, exporters, distributors and traders.
click here to find a list of Maralixibat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Maralixibat 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Maralixibat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Maralixibat suppliers with NDC on PharmaCompass.
Maralixibat 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 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 GMP manufacturer or Maralixibat GMP API supplier for your needs.
A Maralixibat CoA (Certificate of Analysis) is a formal document that attests to Maralixibat's compliance with Maralixibat specifications and serves as a tool for batch-level quality control.
Maralixibat CoA mostly includes findings from lab analyses of a specific batch. For each Maralixibat 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Maralixibat EP), Maralixibat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Maralixibat USP).
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