Synopsis
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1. Mbx-8025 Lysine
2. Seladelpar Lysine Dihydrate
3. Mbx-8025 Lysine Dihydrate
4. 928821-40-3
5. Seladelpar Lysine [usan]
6. Mbx-8025 Lysine Salt, Dihydrate
7. N1429130kr
8. Seladelpar (lysine Dihydrate)
9. Unii-n1429130kr
10. Seladelpar Lysine (usan)
11. Chembl3989960
12. Wtkswpygzdcunq-jzxfcxspsa-n
13. Hy-19522c
14. Akos040747473
15. Cs-1068545
16. D11257
17. Q27284370
18. (2s)-2,6-diaminohexanoic Acid;2-[4-[(2r)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]sulfanyl-2-methylphenoxy]acetic Acid;dihydrate
19. (r)-2-(4-((2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetic Acid Compound With (s)-2,6-diaminohexanoic Acid Dihydrate
20. L-lysine (4-(((2r)-2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)sulfanyl)-2-methylphenoxy)acetate Dihydrate
21. L-lysine, 2-(4-(((2r)-2-ethoxy-3-(4-(trifluoromethyl)phenoxy)propyl)thio)-2-methylphenoxy)acetate, Hydrate (1:1:2)
1. 851528-79-5
2. Mbx-8025
3. Mbx-8025 (seladelpar)
4. Seladelpar
Molecular Weight | 626.7 g/mol |
---|---|
Molecular Formula | C27H41F3N2O9S |
Hydrogen Bond Donor Count | 6 |
Hydrogen Bond Acceptor Count | 15 |
Rotatable Bond Count | 16 |
Exact Mass | g/mol |
Monoisotopic Mass | g/mol |
Topological Polar Surface Area | 182 |
Heavy Atom Count | 42 |
Formal Charge | 0 |
Complexity | 617 |
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 | 4 |
NDC Package Code : 48957-0106
Start Marketing Date : 2024-08-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 48957-0106
Start Marketing Date : 2024-08-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Details:
Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 20, 2025
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Gilead’s Seladelpar Gets Conditional Approval for Primary Biliary Cholangitis
Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Product Name : Livdelzi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 20, 2025
Details:
Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 13, 2024
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Gilead’s Seladelpar Receives Positive CHMP Opinion for Primary Biliary Cholangitis
Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Product Name : Livdelzi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 13, 2024
Details:
Gilead expands its liver portfolio with CymaBay’s MBX-8025 (seladelpar), a PPARδ agonist for primary biliary cholangitis.
Lead Product(s): Seladelpar Lysine
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: MBX-8025
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Gilead Sciences
Deal Size: $4,300.0 million Upfront Cash: $4,300.0 million
Deal Type: Acquisition December 02, 2024
Lead Product(s) : Seladelpar Lysine
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Gilead Sciences
Deal Size : $4,300.0 million
Deal Type : Acquisition
Gilead Sciences Expands Liver Portfolio with Acquisition of CymaBay Therapeutics
Details : Gilead expands its liver portfolio with CymaBay’s MBX-8025 (seladelpar), a PPARδ agonist for primary biliary cholangitis.
Product Name : MBX-8025
Product Type : Other Small Molecule
Upfront Cash : $4,300.0 million
December 02, 2024
Details:
MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for Primary Biliary Cholangitis.
Lead Product(s): Seladelpar Lysine
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: MBX-8025
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 02, 2024
Lead Product(s) : Seladelpar Lysine
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CymaBay’s Seladelpar NDA for Primary Biliary Cholangitis Accepted By FDA
Details : MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for Primary Biliary Cholangitis.
Product Name : MBX-8025
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 02, 2024
Details:
The partnership aims for the distribution of a novel selective, first-in-class, PPAR delta agonist, Livdelzi (seladelpar), to treat adults with primary biliary cholangitis (PBC).
Lead Product(s): Seladelpar Lysine
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Gilead Sciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 16, 2024
Lead Product(s) : Seladelpar Lysine
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Gilead Sciences
Deal Size : Undisclosed
Deal Type : Partnership
PANTHERx® Rare Partnering with Gilead Sciences, Inc. for the Distribution of LIVDELZI®
Details : The partnership aims for the distribution of a novel selective, first-in-class, PPAR delta agonist, Livdelzi (seladelpar), to treat adults with primary biliary cholangitis (PBC).
Product Name : Livdelzi
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 16, 2024
Details:
Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 15, 2024
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
With FDA Approval of Livdelzi, Gilead Launches an Inflammatory Drug for The First Time
Details : Livdelzi (seladelpar) is a novel selective, first-in-class, PPAR delta agonist, indicated to treat adults with primary biliary cholangitis (PBC).
Product Name : Livdelzi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
August 15, 2024
Details:
Gilead will buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug Livdelzi (seladelpar lysine), a peroxisome proliferator-activated receptor (PPAR)-delta agonist.
Lead Product(s): Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Gilead Sciences
Deal Size: $320.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 08, 2024
Lead Product(s) : Seladelpar Lysine,Ursodeoxycholic Acid
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Gilead Sciences
Deal Size : $320.0 million
Deal Type : Licensing Agreement
Gilead shells out $320M to J&J to buy out rare liver disease drug royalties
Details : Gilead will buy out Johnson & Johnson’s global royalties for primary biliary cholangitis drug Livdelzi (seladelpar lysine), a peroxisome proliferator-activated receptor (PPAR)-delta agonist.
Product Name : Livdelzi
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 08, 2024
Details:
MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor delta agonist being evaluated for treating primary biliary cholangitis.
Lead Product(s): Seladelpar Lysine
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 18, 2024
Lead Product(s) : Seladelpar Lysine
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Seladelpar Shows Liver, Itch Improvements in PBC
Details : MBX-8025 (seladelpar) is a first-in-class oral, selective peroxisome proliferator-activated receptor delta agonist being evaluated for treating primary biliary cholangitis.
Product Name : Livdelzi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 18, 2024
Details:
MBX-8025 (seladelpar) is an investigational first-in-class oral, selective PPAR delta agonist which is being evaluated for the treatment of Primary Biliary Cholangitis.
Lead Product(s): Seladelpar Lysine
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Livdelzi
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 06, 2024
Lead Product(s) : Seladelpar Lysine
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Gilead’s Seladelpar Shows Sustained Efficacy and Safety Profile in PBC
Details : MBX-8025 (seladelpar) is an investigational first-in-class oral, selective PPAR delta agonist which is being evaluated for the treatment of Primary Biliary Cholangitis.
Product Name : Livdelzi
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 06, 2024
Details:
MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for Primary Biliary Cholangitis.
Lead Product(s): Seladelpar Lysine
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: MBX-8025
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 03, 2024
Lead Product(s) : Seladelpar Lysine
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
CymaBay's Seladelpar MAA Accepted by EMA for Primary Biliary Cholangitis
Details : MBX-8025 (seladelpar) is an investigational first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist which is being evaluated for Primary Biliary Cholangitis.
Product Name : MBX-8025
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 03, 2024
RLD : Yes
TE Code :
Brand Name : LIVDELZI
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 10MG BASE
Approval Date : 2024-08-14
Application Number : 217899
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
07 May 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250506771103/en/Gileads-Livdelzi-Seladelpar-Demonstrated-Consistent-Efficacy-and-Safety-Regardless-of-Prior-Treatment-History-in-New-Data-Presented-at-EASL-2025
17 Apr 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/ipsens-liver-disease-drug-iqirvo-promising-launch-battle-gileads-livdelzi
20 Feb 2025
// BUSINESSWIRE
13 Dec 2024
// BUSINESSWIRE
15 Nov 2024
// BUSINESSWIRE
16 Aug 2024
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/fda-approval-livdelzi-gilead-launches-inflammatory-drug-first-time
Market Place
Patents & EXCLUSIVITIES
Patent Expiration Date : 2025-08-02
US Patent Number : 7301050
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217899
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2025-08-02
Patent Expiration Date : 2035-03-19
US Patent Number : 11596614
Drug Substance Claim :
Drug Product Claim :
Application Number : 217899
Patent Use Code : U-1854
Delist Requested :
Patent Use Description : TREATMENT OF PRIMARY B...
Patent Expiration Date : 2035-03-19
Patent Expiration Date : 2035-03-19
US Patent Number : 11406611
Drug Substance Claim :
Drug Product Claim :
Application Number : 217899
Patent Use Code : U-1854
Delist Requested :
Patent Use Description : TREATMENT OF PRIMARY B...
Patent Expiration Date : 2035-03-19
Patent Expiration Date : 2035-03-19
US Patent Number : 10272058
Drug Substance Claim :
Drug Product Claim :
Application Number : 217899
Patent Use Code : U-1854
Delist Requested :
Patent Use Description : TREATMENT OF PRIMARY B...
Patent Expiration Date : 2035-03-19
Patent Expiration Date : 2035-03-19
US Patent Number : 9486428
Drug Substance Claim :
Drug Product Claim :
Application Number : 217899
Patent Use Code : U-1854
Delist Requested :
Patent Use Description : TREATMENT OF PRIMARY B...
Patent Expiration Date : 2035-03-19
Patent Expiration Date : 2026-09-13
US Patent Number : 7709682
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 217899
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-09-13
Exclusivity Code : NCE
Exclusivity Expiration Date : 2029-08-14
Application Number : 217899
Product Number : 1
Exclusivity Details :
Exclusivity Code : ODE-486
Exclusivity Expiration Date : 2031-08-14
Application Number : 217899
Product Number : 1
Exclusivity Details :
ABOUT THIS PAGE
69
PharmaCompass offers a list of Seladelpar Lysine 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 Seladelpar Lysine manufacturer or Seladelpar Lysine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Seladelpar Lysine manufacturer or Seladelpar Lysine supplier.
PharmaCompass also assists you with knowing the Seladelpar Lysine API Price utilized in the formulation of products. Seladelpar Lysine API Price is not always fixed or binding as the Seladelpar Lysine Price is obtained through a variety of data sources. The Seladelpar Lysine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Seladelpar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Seladelpar, including repackagers and relabelers. The FDA regulates Seladelpar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Seladelpar 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 Seladelpar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Seladelpar supplier is an individual or a company that provides Seladelpar active pharmaceutical ingredient (API) or Seladelpar finished formulations upon request. The Seladelpar suppliers may include Seladelpar API manufacturers, exporters, distributors and traders.
click here to find a list of Seladelpar 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 Seladelpar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Seladelpar 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 Seladelpar 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 Seladelpar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Seladelpar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Seladelpar suppliers with NDC on PharmaCompass.
Seladelpar 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 Seladelpar 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 Seladelpar GMP manufacturer or Seladelpar GMP API supplier for your needs.
A Seladelpar CoA (Certificate of Analysis) is a formal document that attests to Seladelpar's compliance with Seladelpar specifications and serves as a tool for batch-level quality control.
Seladelpar CoA mostly includes findings from lab analyses of a specific batch. For each Seladelpar 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.
Seladelpar may be tested according to a variety of international standards, such as European Pharmacopoeia (Seladelpar EP), Seladelpar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Seladelpar USP).