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Chemistry

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Also known as: Mbx-8025 lysine, Seladelpar lysine dihydrate, Mbx-8025 lysine dihydrate, 928821-40-3, Seladelpar lysine [usan], Mbx-8025 lysine salt, dihydrate
Molecular Formula
C27H41F3N2O9S
Molecular Weight
626.7  g/mol
InChI Key
WTKSWPYGZDCUNQ-JZXFCXSPSA-N
FDA UNII
N1429130KR

Seladelpar Lysine
1 2D Structure

Seladelpar Lysine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2,6-diaminohexanoic acid;2-[4-[(2R)-2-ethoxy-3-[4-(trifluoromethyl)phenoxy]propyl]sulfanyl-2-methylphenoxy]acetic acid;dihydrate
2.1.2 InChI
InChI=1S/C21H23F3O5S.C6H14N2O2.2H2O/c1-3-27-17(11-28-16-6-4-15(5-7-16)21(22,23)24)13-30-18-8-9-19(14(2)10-18)29-12-20(25)26;7-4-2-1-3-5(8)6(9)10;;/h4-10,17H,3,11-13H2,1-2H3,(H,25,26);5H,1-4,7-8H2,(H,9,10);2*1H2/t17-;5-;;/m10../s1
2.1.3 InChI Key
WTKSWPYGZDCUNQ-JZXFCXSPSA-N
2.1.4 Canonical SMILES
CCOC(COC1=CC=C(C=C1)C(F)(F)F)CSC2=CC(=C(C=C2)OCC(=O)O)C.C(CCN)CC(C(=O)O)N.O.O
2.1.5 Isomeric SMILES
CCO[C@H](COC1=CC=C(C=C1)C(F)(F)F)CSC2=CC(=C(C=C2)OCC(=O)O)C.C(CCN)C[C@@H](C(=O)O)N.O.O
2.2 Other Identifiers
2.2.1 UNII
N1429130KR
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

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)

2.3.2 Other Synonyms

1. 851528-79-5

2. Mbx-8025

3. Mbx-8025 (seladelpar)

4. Seladelpar

2.4 Create Date
2015-06-01
3 Chemical and Physical Properties
Molecular Weight 626.7 g/mol
Molecular Formula C27H41F3N2O9S
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count15
Rotatable Bond Count16
Exact Mass g/mol
Monoisotopic Mass g/mol
Topological Polar Surface Area182
Heavy Atom Count42
Formal Charge0
Complexity617
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count4

API SUPPLIERS

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NDC API

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SELADELPAR LYSINE

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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Listed Suppliers

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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Digital Content Digital Content

Seladelpar Lysine

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
HRV Global Life Sciences

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Seladelpar

About the Company : Hefei Home Sunshine Pharmaceutical Technology Co., Ltd.is a high-tech enterprise, which is an integration of R & D, producing and custom synthesis. The products quality is assured ...

Hefei Home Sunshine Pharmaceutical Technology Co., Ltd.is a high-tech enterprise, which is an integration of R & D, producing and custom synthesis. The products quality is assured because of our continuously-optimizing management and technology innovation, complete QA system, advanced testing methods and equipments. We have won the trust of a wide range of customers/partners in the industry. Our Products include active pharmaceutical ingredients (API), pharmaceutical and agrochemical intermediates and chiral compounds.
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Seladelpar Lysine

About the Company : Viyash, true to its name, literally represents honesty and leadership in every sense. We are an integrated pharmaceutical company with a strong portfolio of niche formulations, ...

Viyash, true to its name, literally represents honesty and leadership in every sense. We are an integrated pharmaceutical company with a strong portfolio of niche formulations, APIs and advanced intermediates Viyash and its subsidiaries operate 10 API / Intermediate facilities with a combined capacity ~2000 KL and diversified capabilities in every aspect - small / large volume, potent / non-potent, regulated / semi-regulated markets. In addition, we also operate one formulation manufacturing facility in New Jersey, USA with a capacity of ~ 1.2 Bn units.
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Seladelpar Lysine

About the Company : Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states...

Zydus is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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Drugs in Development

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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

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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).

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 20, 2025

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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 December 13, 2024

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AGGSpend
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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).

Product Name : Livdelzi

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 13, 2024

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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

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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

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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

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AGGSpend
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AGGSpend
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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

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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

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AGGSpend
Not Confirmed
AGGSpend
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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

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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 August 15, 2024

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AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

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

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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

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07

AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

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

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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

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08

AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

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

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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

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09

AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

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

blank

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

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10

AGGSpend
Not Confirmed
AGGSpend
Not Confirmed

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

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FDF Dossiers

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SELADELPAR LYSINE

Brand Name : LIVDELZI

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 10MG BASE

Packaging :

Approval Date : 2024-08-14

Application Number : 217899

Regulatory Info : RX

Registration Country : USA

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FDA Orange Book

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SELADELPAR LYSINE

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 :

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DATA COMPILATION #PharmaFlow

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FDA okays 50 new drugs in 2024; BMS’ Cobenfy, Lilly’s Kisunla lead pack of breakthrough therapies
In 2024, the biopharma industry continued to advance on its robust trajectory of innovation. Though the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) approved fewer drugs, there was a significant increase in medical breakthroughs.While the CDER approved 50 new drugs in 2024, as compared to 55 in 2023, the CBER granted 14 biologics approvals in 2024, down from 20 in 2023.The European Medicines Agency (EMA) approved 34 new therapies, up from 32 in 2023, while Health Canada granted 28 approvals, down from 38 in 2023.The year saw long-awaited treatments being approved in areas such as schizophrenia and Alzheimer’s disease in the second half (H2) of 2024. In H1 2024, drugs to treat metabolic dysfunction-associated steatohepatitis (MASH) and chronic obstructive pulmonary disease (COPD) had been granted FDA approvals.As the year drew to a close, FDA began approving drugs at a feverish pace, with 29 of the CDER’s 50 approvals coming in H2.Like most years, the landscape of drug approvals was dominated by oncology, with 15 of the 50 drugs (30 percent) approved targeting various forms of cancer. This was followed by dermatology and non-malignant hematology, each accounting for 12 percent of approvals. Notably, small molecules continued to dominate the market, making up for 64 percent of the new drug approvals, while 32 percent were proteins, including monoclonal and bi-specific antibodies. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available)Karuna-BMS’ schizophrenia drug, Lilly’s Alzheimer’s med, Neurocrine’s Crenessity dominate list of pathbreaking approvals in H2Out of the 50 new drugs approved in 2024, CDER identified 24 (48 percent) as first-in-class, showcasing novel mechanisms of action. The most anticipated approval of 2024 was Karuna and Bristol Myers Squibb’s Cobenfy, a groundbreaking treatment for schizophrenia. This fixed-dose combination of xanomeline and trospium chloride represents the first novel mechanism of action in decades for this debilitating psychiatric condition. Analysts forecast peak annual sales of over US$ 3.3 billion for Cobenfy. Eli Lilly’s Alzheimer’s drug Kisunla (donanemab) became the third amyloid-targeting antibody to gain FDA approval. Unlike its predecessors, Kisunla offers a unique limited-duration treatment regimen, allowing patients to discontinue therapy once amyloid levels in the brain drop below a certain threshold. Priced at approximately US$ 32,000 per year, it is positioned as a cost-effective alternative to existing treatments. Analysts estimate peak sales of US$ 2.4 billion for Kisunla.Crenessity (crinecerfont), developed by Neurocrine Biosciences, became the first FDA-approved treatment in decades for classic congenital adrenal hyperplasia (genetic conditions that affect the adrenal glands). Similarly, Vertex’s triple combination therapy of deutivacaftor, tezacaftor & vanzacaftor (Alyftrek) for cystic fibrosis represents a significant advancement in genetic disease treatment. Analysts forecast peak sales exceeding US$ 8.3 billion, underscoring the therapy’s potential to transform patient care.Meanwhile, Bridgebio’s Attruby (acoramidis hydrochloride) emerged as a promising treatment for cardiac amyloidosis, a life-threatening condition. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Roche’s Itovebi, Checkpoint’s Unloxcyt clinch FDA approvals in H2 2024; forecast to achieve blockbuster statusThe dominance of cancer drug approvals reflects the ongoing focus on targeted therapies, immuno-oncology, and precision medicine to improve outcomes for patients with hard-to-treat cancers.Among the year’s notable FDA approvals was Genentech’s Itovebi (inavolisib), another targeted therapy that treats hormone receptor-positive (HR+), HER2-negative breast cancer. Itovebi is a PI3Kα inhibitor designed specifically for patients with PIK3CA mutations, a common driver of resistance to endocrine therapy in breast cancer. It demonstrated a more tolerable safety profile. Roche projects Itovebi’s peak (annual) sales to reach CHF 2 billion (US$ 2.3 billion).Checkpoint Therapeutics’ Unloxcyt (cosibelimab) joined the crowded checkpoint inhibitor market as the eleventh PD-1/PD-L1-targeting monoclonal antibody approved by the FDA. It was granted approval for cutaneous squamous cell carcinoma (cSCC), an aggressive form of skin cancer with high recurrence rates. As compared to other checkpoint inhibitors, like Keytruda (pembrolizumab) and Opdivo (nivolumab), Unloxcyt is likely to offer an advantage in immune activation.FDA also approved Astellas’ Vyloy (zolbetuximab), a first-in-class monoclonal antibody for metastatic gastric and gastroesophageal junction (GEJ) adenocarcinoma. Analysts forecast peak sales of approximately US$ 850 million for Vyloy.Syndax Pharmaceuticals’ Revuforj (revumenib) was approved by FDA to treat a type of acute leukemia in both adults and children. This approval introduces a novel class of medications known as menin inhibitors. These agents are currently in clinical development for the treatment of genetically defined subsets of acute leukemia. These inhibitors function by preventing the activation of cancer growth-related proteins. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Potential blockbusters Lilly’s Ebglyss, Galderma’s Nemluvio lead advances in dermatologyEli Lilly’s Ebglyss (lebrikizumab) garnered significant attention. Approved by FDA for moderate-to-severe atopic dermatitis, this monoclonal antibody introduces a less burdensome dosing regimen compared to its competitors, with maintenance therapy required only once a month. This feature positions it as a potential contender to Dupixent (dupilumab), a market leader in atopic dermatitis. Ebglyss sales are forecast to reach US$ 1.9 billion by 2030.Galderma’s Nemluvio (nemolizumab) secured FDA approval for two indications in 2024 — prurigo nodularis (a chronic disorder of the skin) and moderate-to-severe atopic dermatitis in patients aged 12 years and older. As the first humanized IgG2 monoclonal antibody targeting the IL-31 receptor, Nemluvio directly inhibits the key driver of itch and inflammation in both these conditions. With its unique mechanism and broad dermatology potential, analysts forecast peak sales of approximately US$ 1.66 billion. Ebglyss and Nemluvio underscore the growing importance of biologics in dermatological care.Botanix Pharmaceuticals also made strides in dermatology by clinching an FDA approval for Sofdra (sofpironium) in June. The drug has been okayed for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive sweating.Ascendis Pharma’s Yorvipath (palopegteriparatide), a therapy approved by FDA to treat hypoparathyroidism, is forecast to achieve blockbuster sales of US$ 1.8 billion by 2030, highlighting its potential to transform endocrine care. View New Drug Approvals in 2024 with Estimated Sales (Free Excel Available) Our viewOverall, 2024 was defined by its breakthrough drug approvals. The year also saw significant reduction in complete response letters (CRLs) — they dropped from 43 in 2023 to just 29 in 2024. This suggests improved industry preparedness and alignment with regulatory expectations.The new year began with the approval of Datroway (datopotamab deruxtecan) from AstraZeneca and Daiichi Sankyo, marking a significant advancement in oncology. Several other promising new drugs are coming up for FDA approval this year, such as J&J’s nipocalimab, Vertex Pharmaceuticals’ suzetrigine, Elevar Therapeutics’ rivoceranib/camrelizumab, Sanofi’s fitusiran and GSK’s gepotidacin. Hopefully, the momentum of breakthrough approvals will continue through 2025, political headwinds in the US notwithstanding. 

Impressions: 11023

https://www.pharmacompass.com/radio-compass-blog/fda-okays-50-new-drugs-in-2024-bms-cobenfy-lilly-s-kisunla-lead-pack-of-breakthrough-therapies

#PharmaFlow by PHARMACOMPASS
30 Jan 2025

NEWS #PharmaBuzz

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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

BUSINESSWIRE
07 May 2025

https://www.fiercepharma.com/pharma/ipsens-liver-disease-drug-iqirvo-promising-launch-battle-gileads-livdelzi

FIERCE PHARMA
17 Apr 2025

https://www.businesswire.com/news/home/20250213709259/en

BUSINESSWIRE
20 Feb 2025

https://www.businesswire.com/news/home/20241212516221/en

BUSINESSWIRE
13 Dec 2024

https://www.businesswire.com/news/home/20241114931214/en

BUSINESSWIRE
15 Nov 2024

https://www.fiercepharma.com/pharma/fda-approval-livdelzi-gilead-launches-inflammatory-drug-first-time

FIERCE PHARMA
16 Aug 2024

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US Patents

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SELADELPAR LYSINE

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

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SELADELPAR LYSINE

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

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SELADELPAR LYSINE

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

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SELADELPAR LYSINE

US Patent Number : 11406611

Drug Substance Claim :

Drug Product Claim :

Application Number : 217899

Patent Use Code : U-1854

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Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2035-03-19

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SELADELPAR LYSINE

US Patent Number : 10272058

Drug Substance Claim :

Drug Product Claim :

Application Number : 217899

Patent Use Code : U-1854

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Patent Use Description : TREATMENT OF PRIMARY B...

Patent Expiration Date : 2035-03-19

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SELADELPAR LYSINE

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

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US Exclusivities

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SELADELPAR LYSINE

Exclusivity Code : NCE

Exclusivity Expiration Date : 2029-08-14

Application Number : 217899

Product Number : 1

Exclusivity Details :

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SELADELPAR LYSINE

Exclusivity Code : ODE-486

Exclusivity Expiration Date : 2031-08-14

Application Number : 217899

Product Number : 1

Exclusivity Details :

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ABOUT THIS PAGE

Looking for 928821-40-3 / Seladelpar Lysine API manufacturers, exporters & distributors?

Seladelpar Lysine manufacturers, exporters & distributors 1

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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.

API | Excipient name

Seladelpar Lysine

Synonyms

Mbx-8025 lysine, Seladelpar lysine dihydrate, Mbx-8025 lysine dihydrate, 928821-40-3, Seladelpar lysine [usan], Mbx-8025 lysine salt, dihydrate

Cas Number

928821-40-3

Unique Ingredient Identifier (UNII)

N1429130KR

Seladelpar Lysine Manufacturers

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

Seladelpar Lysine Suppliers

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

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

Seladelpar Lysine 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 Seladelpar Lysine as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Seladelpar Lysine GMP

Seladelpar Lysine 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 Lysine 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 Lysine GMP manufacturer or Seladelpar Lysine GMP API supplier for your needs.

Seladelpar Lysine CoA

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

Seladelpar Lysine CoA mostly includes findings from lab analyses of a specific batch. For each Seladelpar Lysine 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 Lysine may be tested according to a variety of international standards, such as European Pharmacopoeia (Seladelpar Lysine EP), Seladelpar Lysine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Seladelpar Lysine 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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