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Also known as: Mgl-3196, 920509-32-6, Via-3196, Mgl 3196, 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile, Resmetirom [usan]
Molecular Formula
C17H12Cl2N6O4
Molecular Weight
435.2  g/mol
InChI Key
FDBYIYFVSAHJLY-UHFFFAOYSA-N
FDA UNII
RE0V0T1ES0

Resmetirom
MGL-3196 has been used in trials studying the treatment of Non-alcoholic steatohepatitis and Heterozygous Familial Hypercholesterolemia.
1 2D Structure

Resmetirom

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[3,5-dichloro-4-[(6-oxo-5-propan-2-yl-1H-pyridazin-3-yl)oxy]phenyl]-3,5-dioxo-1,2,4-triazine-6-carbonitrile
2.1.2 InChI
InChI=1S/C17H12Cl2N6O4/c1-7(2)9-5-13(22-23-15(9)26)29-14-10(18)3-8(4-11(14)19)25-17(28)21-16(27)12(6-20)24-25/h3-5,7H,1-2H3,(H,23,26)(H,21,27,28)
2.1.3 InChI Key
FDBYIYFVSAHJLY-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C)C1=CC(=NNC1=O)OC2=C(C=C(C=C2Cl)N3C(=O)NC(=O)C(=N3)C#N)Cl
2.2 Other Identifiers
2.2.1 UNII
RE0V0T1ES0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-(3,5-dichloro-4-(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yloxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro(1,2,4)triazine-6-carbonitrile

2. Mgl-3196

2.3.2 Depositor-Supplied Synonyms

1. Mgl-3196

2. 920509-32-6

3. Via-3196

4. Mgl 3196

5. 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile

6. Resmetirom [usan]

7. Mgl3196

8. Re0v0t1es0

9. Chembl3261331

10. 1,2,4-triazine-6-carbonitrile, 2-(3,5-dichloro-4-((1,6-dihydro-5-(1-methylethyl)-6-oxo-3-pyridazinyl)oxy)phenyl)-2,3,4,5-tetrahydro-3,5-dioxo-

11. 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-(1,2,4)triazine-6-carbonitrile

12. 2-[3,5-dichloro-4-[(6-oxo-5-propan-2-yl-1h-pyridazin-3-yl)oxy]phenyl]-3,5-dioxo-1,2,4-triazine-6-carbonitrile

13. 2-[3,5-dichloro-4-[(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy]phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile

14. Unii-re0v0t1es0

15. Resmetirom [inn]

16. Resmetirom (usan/inn)

17. Resmetirom (mgl-3196)

18. Schembl2927241

19. Gtpl12026

20. Via3196

21. Hms3746a03

22. Amy16881

23. Bcp24624

24. Ex-a2477

25. Vlb50932

26. Bdbm50012905

27. Mfcd26142653

28. S6663

29. Who 10850

30. Zinc34842512

31. Akos032945066

32. Cs-6179

33. Db12914

34. Sb16825

35. Compound 53 [pmid: 24712661]

36. Ac-31458

37. Bs-17855

38. Hy-12216

39. Sy289460

40. Db-127167

41. C77150

42. D11602

43. Q27288071

44. 2-(3,5-dichloro-4-(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yloxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro(1,2,4)triazine-6-carbonitrile

45. 2-(3,5-dichloro-4-(5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yloxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile

46. 2-(4-(1,6-dihydro-5-isopropyl-6-oxopyridazin-3-yloxy)-3,5-dichlorophenyl)-2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazine-6-carbonitrile

47. 2-[3,5-dichloro-4-(5-isopropyl-6-oxo-1,6-dihydro-pyridazin-3-yloxy)-phenyl]-3,5-dioxo-2,3,4,5-tetrahydro-[1,2,4]triazine-6-carbonitrile

2.4 Create Date
2007-03-19
3 Chemical and Physical Properties
Molecular Weight 435.2 g/mol
Molecular Formula C17H12Cl2N6O4
XLogP32.7
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count4
Exact Mass434.0297083 g/mol
Monoisotopic Mass434.0297083 g/mol
Topological Polar Surface Area136 Ų
Heavy Atom Count29
Formal Charge0
Complexity878
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

USDMF

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DMF Number : 40972

Submission : 2025-02-28

Status : Active

Type : II

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Lee Pharma Ltd

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DMF Number : 39990

Submission : 2024-05-27

Status : Active

Type : II

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Lee Pharma

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Lee Pharma

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Resmetirom IH

Date of Issue : 2022-06-15

Valid Till : 2025-07-28

Written Confirmation Number : WC-0186

Address of the Firm : Sy No.10/G-1, Gaddapotharam (V), Jinnaram (M), Sangareddy District, Pincode 5023...

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19-May-2025
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Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 26, 2025

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01

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 26, 2025

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Details:

Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 21, 2024

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02

IFT FIRST
Not Confirmed
IFT FIRST
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Details : Rezdiffra (resmetirom) is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. It is being studied in compensated patients with NASH cirrhosis.

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

October 21, 2024

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Details:

PRO-140 (leronlimab) a monocloncal antibody works by blocking the activity of CCR5 receptor. It is currently in preclinical in combination with Resmetirom for the treatment of liver fibrosis.


Lead Product(s): Leronlimab,Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Vyrologix

Study Phase: PreclinicalProduct Type: Antibody

Sponsor: SMC Laboratories

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 27, 2024

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CytoDyn

U.S.A
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IFT FIRST
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CytoDyn

U.S.A
arrow
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Not Confirmed

Details : PRO-140 (leronlimab) a monocloncal antibody works by blocking the activity of CCR5 receptor. It is currently in preclinical in combination with Resmetirom for the treatment of liver fibrosis.

Product Name : Vyrologix

Product Type : Antibody

Upfront Cash : Inapplicable

June 27, 2024

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Details:

MGL-3196 (Resmetirom) is a once-daily, oral, liver-directed THR-β agonist , which is being evaluated for the treatment of NASH/MASH with Liver Fibrosis.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 03, 2024

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IFT FIRST
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IFT FIRST
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Details : MGL-3196 (Resmetirom) is a once-daily, oral, liver-directed THR-β agonist , which is being evaluated for the treatment of NASH/MASH with Liver Fibrosis.

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 03, 2024

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Details:

Madrigal plans to use net proceeds for commercial activities related to launching Rezdiffra (resmetirom), a liver-directed THR-β agonist for treating NASH in the U.S.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Goldman Sachs & Co

Deal Size: $600.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 18, 2024

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IFT FIRST
Not Confirmed
IFT FIRST
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Details : Madrigal plans to use net proceeds for commercial activities related to launching Rezdiffra (resmetirom), a liver-directed THR-β agonist for treating NASH in the U.S.

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

March 18, 2024

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Details:

Rezdiffra (resmetirom) is a once-daily oral THR-β agonist approved for treating noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 14, 2024

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IFT FIRST
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IFT FIRST
Not Confirmed

Details : Rezdiffra (resmetirom) is a once-daily oral THR-β agonist approved for treating noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis.

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 14, 2024

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Details:

Madrigal will use the proceeds for its clinical and commercial activities in preparation for a potential launch of MGL-3196 (resmetirom), a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH in the liver.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Goldman Sachs & Co

Deal Size: $500.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering September 28, 2023

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07

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : Madrigal will use the proceeds for its clinical and commercial activities in preparation for a potential launch of MGL-3196 (resmetirom), a once daily, oral, thyroid hormone receptor-beta selective agonist designed to target key underlying causes of NASH...

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

September 28, 2023

blank

Details:

MGL-3196 (resmetirom) is a once daily, oral, thyroid hormone receptor (THR)-beta selective agonist designed to target key underlying causes of NASH in the liver.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 13, 2023

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08

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : MGL-3196 (resmetirom) is a once daily, oral, thyroid hormone receptor (THR)-beta selective agonist designed to target key underlying causes of NASH in the liver.

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

September 13, 2023

blank

Details:

MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 17, 2023

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09

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 17, 2023

blank

Details:

MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.


Lead Product(s): Resmetirom

Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Rezdiffra

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 01, 2023

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10

IFT FIRST
Not Confirmed
IFT FIRST
Not Confirmed

Details : MGL-3196 (resmetirom), is a once daily, oral, liver-directed selective thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.

Product Name : Rezdiffra

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

June 01, 2023

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FDA Orange Book

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MADRIGAL

U.S.A
IFT FIRST
Not Confirmed
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MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

Brand Name : REZDIFFRA

Dosage Form : TABLET;ORAL

Dosage Strength : 60MG

Approval Date : 2024-03-14

Application Number : 217785

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

MADRIGAL

U.S.A
IFT FIRST
Not Confirmed
arrow

MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

Brand Name : REZDIFFRA

Dosage Form : TABLET;ORAL

Dosage Strength : 80MG

Approval Date : 2024-03-14

Application Number : 217785

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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03

MADRIGAL

U.S.A
IFT FIRST
Not Confirmed
arrow

MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

Brand Name : REZDIFFRA

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2024-03-14

Application Number : 217785

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

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01

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IFT FIRST
Not Confirmed

MADRIGAL

U.S.A
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IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 7452882

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217785

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2026-09-12

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IFT FIRST
Not Confirmed

MADRIGAL

U.S.A
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IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 9266861

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217785

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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MADRIGAL

U.S.A
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IFT FIRST
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RESMETIROM

US Patent Number : 10376517

Drug Substance Claim :

Drug Product Claim :

Application Number : 217785

Patent Use Code : U-3861

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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MADRIGAL

U.S.A
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IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 10376517

Drug Substance Claim :

Drug Product Claim :

Application Number : 217785

Patent Use Code : U-3861

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 10376517

Drug Substance Claim :

Drug Product Claim :

Application Number : 217785

Patent Use Code : U-3861

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 11564926

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217785

Patent Use Code : U-3861

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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IFT FIRST
Not Confirmed

MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 11564926

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217785

Patent Use Code : U-3861

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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08

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IFT FIRST
Not Confirmed

MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 11564926

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 217785

Patent Use Code : U-3861

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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09

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IFT FIRST
Not Confirmed

MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 11986481

Drug Substance Claim :

Drug Product Claim :

Application Number : 217785

Patent Use Code : U-3861

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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10

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Not Confirmed

MADRIGAL

U.S.A
arrow
IFT FIRST
Not Confirmed

RESMETIROM

US Patent Number : 11986481

Drug Substance Claim :

Drug Product Claim :

Application Number : 217785

Patent Use Code : U-3861

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-09-17

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ABOUT THIS PAGE

Looking for 920509-32-6 / Resmetirom API manufacturers, exporters & distributors?

Resmetirom manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Resmetirom 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 Resmetirom manufacturer or Resmetirom supplier for your needs.

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

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

API | Excipient name

Resmetirom

Synonyms

Mgl-3196, 920509-32-6, Via-3196, Mgl 3196, 2-(3,5-dichloro-4-((5-isopropyl-6-oxo-1,6-dihydropyridazin-3-yl)oxy)phenyl)-3,5-dioxo-2,3,4,5-tetrahydro-1,2,4-triazine-6-carbonitrile, Resmetirom [usan]

Cas Number

920509-32-6

Unique Ingredient Identifier (UNII)

RE0V0T1ES0

About Resmetirom

MGL-3196 has been used in trials studying the treatment of Non-alcoholic steatohepatitis and Heterozygous Familial Hypercholesterolemia.

Resmetirom Manufacturers

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

Resmetirom Suppliers

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

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

Resmetirom USDMF

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

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

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

Resmetirom WC

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

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

Resmetirom 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 Resmetirom as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Resmetirom 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 Resmetirom 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 Resmetirom and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Resmetirom NDC to their finished compounded human drug products, they may choose to do so.

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

Resmetirom GMP

Resmetirom 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 Resmetirom 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 Resmetirom GMP manufacturer or Resmetirom GMP API supplier for your needs.

Resmetirom CoA

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

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

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