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Chemistry

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Also known as: Lopixibat chloride, 228113-66-4, Lum-001, Maralixibat chloride [usan], Lum001, Maralixibat (chloride)
Molecular Formula
C40H56ClN3O4S
Molecular Weight
710.4  g/mol
InChI Key
POMVPJBWDDJCMP-RUKDTIIFSA-M
FDA UNII
V78M04F0XC

Maralixibat Chloride
1 2D Structure

Maralixibat Chloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(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;chloride
2.1.2 InChI
InChI=1S/C40H56N3O4S.ClH/c1-5-7-19-40(20-8-6-2)30-48(45,46)37-18-15-34(41(3)4)27-36(37)38(39(40)44)33-13-16-35(17-14-33)47-29-32-11-9-31(10-12-32)28-43-24-21-42(22-25-43)23-26-43;/h9-18,27,38-39,44H,5-8,19-26,28-30H2,1-4H3;1H/q+1;/p-1/t38-,39-;/m1./s1
2.1.3 InChI Key
POMVPJBWDDJCMP-RUKDTIIFSA-M
2.1.4 Canonical SMILES
CCCCC1(CS(=O)(=O)C2=C(C=C(C=C2)N(C)C)C(C1O)C3=CC=C(C=C3)OCC4=CC=C(C=C4)C[N+]56CCN(CC5)CC6)CCCC.[Cl-]
2.1.5 Isomeric SMILES
CCCCC1(CS(=O)(=O)C2=C(C=C(C=C2)N(C)C)[C@H]([C@H]1O)C3=CC=C(C=C3)OCC4=CC=C(C=C4)C[N+]56CCN(CC5)CC6)CCCC.[Cl-]
2.2 Other Identifiers
2.2.1 UNII
V78M04F0XC
2.3 Synonyms
2.3.1 MeSH Synonyms

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

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 710.4 g/mol
Molecular Formula C40H56ClN3O4S
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count7
Rotatable Bond Count13
Exact Mass709.3680061 g/mol
Monoisotopic Mass709.3680061 g/mol
Topological Polar Surface Area78.5 Ų
Heavy Atom Count49
Formal Charge0
Complexity1080
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Treatment of Progressive Familial Intrahepatic Cholestasis


Treatment of Alagille syndrome


Treatment of biliary atresia


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Ileal Bile Acid Transporter Inhibitors [MoA]; Organic Anion Transporting Polypeptide 2B1 Inhibitors [MoA]; Ileal Bile Acid Transporter Inhibitor [EPC]
5.2 ATC Code

A - Alimentary tract and metabolism

A05 - Bile and liver therapy

A05A - Bile therapy

A05AX - Other drugs for bile therapy

A05AX04 - Maralixibat chloride


Drugs in Development

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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: 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 October 16, 2023

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01

American Pharma Summit
Not Confirmed
American Pharma Summit
Not Confirmed

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 16, 2023

blank

Details:

Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and received Marketing Approval for the treatment of Cholestatic Pruritus in Patients with Alagille Syndrome.


Lead Product(s): Maralixibat Chloride

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 October 09, 2023

blank

02

American Pharma Summit
Not Confirmed
American Pharma Summit
Not Confirmed

Details : Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and received Marketing Approval for the treatment of Cholestatic Pruritus in Patients with Alagille Syndrome.

Brand Name : Livmarli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 09, 2023

blank

Details:

Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and received Marketing Approval for the treatment of Cholestatic Pruritus in Patients with Alagille Syndrome.


Lead Product(s): Maralixibat Chloride

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 October 08, 2023

blank

03

American Pharma Summit
Not Confirmed
American Pharma Summit
Not Confirmed

Details : Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and received Marketing Approval for the treatment of Cholestatic Pruritus in Patients with Alagille Syndrome.

Brand Name : Livmarli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 08, 2023

blank

Details:

Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and received Marketing Approval for the treatment of Cholestatic Pruritus in Patients with Alagille Syndrome.


Lead Product(s): Maralixibat Chloride

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 June 02, 2023

blank

04

American Pharma Summit
Not Confirmed
American Pharma Summit
Not Confirmed

Details : Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and received Marketing Approval for the treatment of Cholestatic Pruritus in Patients with Alagille Syndrome.

Brand Name : Livmarli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 02, 2023

blank

Details:

LIVMARLI® (maralixibat) oral solution is a minimally absorbed ileal bile acid transporter (IBAT) inhibitor and has also completed enrollment across the other global locations where the trial is open.


Lead Product(s): Maralixibat Chloride

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 30, 2023

blank

05

American Pharma Summit
Not Confirmed
American Pharma Summit
Not Confirmed

Details : LIVMARLI® (maralixibat) oral solution is a minimally absorbed ileal bile acid transporter (IBAT) inhibitor and has also completed enrollment across the other global locations where the trial is open.

Brand Name : Livmarli

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 30, 2023

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FDF Dossiers

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euroPLX 86 Munich
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MARALIXIBAT CHLORIDE

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

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euroPLX 86 Munich
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euroPLX 86 Munich
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MARALIXIBAT CHLORIDE

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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Patents & EXCLUSIVITIES

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US Patents

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MIRUM

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MARALIXIBAT CHLORIDE

US Patent Number : 11497745

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3974

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-02-12

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MIRUM

U.S.A
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MARALIXIBAT CHLORIDE

US Patent Number : 11376251

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3290

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-26

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MIRUM

U.S.A
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MARALIXIBAT CHLORIDE

US Patent Number : 11260053

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3290

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-05-26

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MIRUM

U.S.A
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MARALIXIBAT CHLORIDE

US Patent Number : 11229647

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3290

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-02-12

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MIRUM

U.S.A
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Compamed
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MARALIXIBAT CHLORIDE

US Patent Number : 11229661

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3973

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-26

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06

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MIRUM

U.S.A
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Compamed
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MARALIXIBAT CHLORIDE

US Patent Number : 11497745

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3290

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-02-12

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MIRUM

U.S.A
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MARALIXIBAT CHLORIDE

US Patent Number : 10512657

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3973

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-26

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08

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MIRUM

U.S.A
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Compamed
Not Confirmed

MARALIXIBAT CHLORIDE

US Patent Number : 11229647

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3974

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-02-12

blank

09

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Compamed
Not Confirmed

MIRUM

U.S.A
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Compamed
Not Confirmed

MARALIXIBAT CHLORIDE

US Patent Number : 11376251

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3974

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2032-10-26

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10

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MIRUM

U.S.A
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Compamed
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MARALIXIBAT CHLORIDE

US Patent Number : 11918578

Drug Substance Claim :

Drug Product Claim :

Application Number : 214662

Patent Use Code : U-3974

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2040-02-12

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