IP Library Granted Patent US 12,201,609
Granted Patent B2
US 12,201,609 · App. 17/414,733 · Granted Jan 21, 2025

Saroglitazar for the treatment of hepatocellular carcinoma

Inventors: Mukul R. Jain (Gujarat, IN); Suresh Giri (Gujarat, IN)
Assignee: ZYDUS LIFESCIENCES LIMITED
A61K31/40A61P35/00
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Quick Facts
Patent No.
US 12,201,609
App. No.
17/414,733
Granted
Jan 21, 2025
Kind
B2
Abstract

The present invention relates to pharmaceutical compositions containing the formula (I) for the prevention, delay of progression, or treatment of a disease or condition from hepatocellular carcinoma. The present invention further provides the composition of formula (I) useful in the prevention and treatment of hepatocellular carcinoma.

Claims (8)

1. A method of treating Hepatocellular Carcinoma, comprising administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable salt of

wherein R is —S-methyl, to treat the Hepatocellular Carcinoma.

2. The method of claim 1 , wherein the pharmaceutically acceptable salt is a metal cation salt.

3. The method of claim 1 , wherein the pharmaceutically acceptable salt is a metal cation salt selected from the group consisting of a sodium salt, potassium salt, calcium salt, and magnesium salt.

4. The method of claim 1 , wherein the pharmaceutically acceptable salt is a magnesium salt.

5. A method of treating Hepatocellular Carcinoma, comprising administering to a patient in need thereof a therapeutically effective amount of a pharmaceutical composition comprising a pharmaceutically acceptable excipient and compound of Formula (I)

wherein R is —S-methyl and M + is a metal cation, to treat the Hepatocellular Carcinoma.

6. The method of claim 5 , wherein M + is Mg 2+ .

Assignments (2)
CHANGE OF NAME Recorded Aug 12, 2024
From: CADILA HEALTHCARE LIMITED
To: ZYDUS LIFESCIENCES LIMITED
Reel/Frame 068549/0374 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 17, 2021
From: JAIN, MUKUL R.; GIRI, SURESH
To: CADILA HEALTHCARE LIMITED
Reel/Frame 056613/0106 →
Priority Claims (1)
IN 201821047938 · Dec 18, 2018 · national
Continuity (1)
Related Publication 20220071954A1 · Mar 10, 2022
References Cited (23)
US 9814697B2 · Patel et al. · 2017 [cited by examiner]
WO 2003009841A1 · 2003 [cited by applicant]
WO 2012104869A1 · 2012 [cited by applicant]
WO 2014174524A1 · 2014 [cited by applicant]
WO WO2014174524 · 2014 [cited by examiner]
WO 2016181409A1 · 2016 [cited by applicant]
WO 2017089979A1 · 2017 [cited by applicant]
WO 2017089980A1 · 2017 [cited by applicant]
Shen et al., (British Journal of Cancer (2012) 106, 1486-1494., PPAR gamma inhibits hepatocellular carcinoma metastases in vitro and in mice); (Year: 2012). [cited by examiner]
Yu J, et al., Inhibitory role of peroxisome proliferator-activated receptor gamma in hepatocarcinogenesis in mice and in vitro; Hepatology (2010), 51: 2008-2019 (Year: 2010). [cited by examiner]
Grommes et al., (Antineoplastic effects of peroxisome proliferator-activated receptor gamma agonists. Lancet Oncol. (2004), 5: 419-429 (Year: 2004). [cited by examiner]
Yu J et al., (Troglitazone inhibits tumor growth in hepatocellular carcinoma in vitro and in vivo. Hepatology (2006), 43: 134-143 (Year: 2006). [cited by examiner]
Yang et al (Molecular Carcinogenesis 54:1584-1595 (2015) (Year: 2015). [cited by examiner]
Jain et al., (Liver International. 2018; 38:1084-1094., Dual PPARα/γ agonist Saroglitazar improves liver histopathology and biochemistry in experimental NASH models (Year: 2018). [cited by examiner]
Bottoni et al., “A Two-Dimensional Electrophoresis Preliminary Approach to Human Hepatocarcinoma Differentiation Induced by PPAR-Agonists,” Journal of Cellular and Molecular Medicine, vol. 9, No. 2, (2005), pp. 462-467,… [cited by applicant]
International Search Report for Application No. PCT/IB2019/060898; International Filing Date—Dec. 17, 2019; Date of Mailing—May 4, 2020; 4 pages. [cited by applicant]
Lindblom et al., “Tesaglitazar, A Dual PPAR-[alpha]/[gamma] Agonist, Hamster Carcinogenicity, Investigative Animal and Clinical Studies,” Toxicologic Pathology, vol. 40, No. 1, (2011), pp. 18-32. [cited by applicant]
Tacke et al., “An Update on the Recent Advances in Antifibrotic Therapy,” Expert Review of Gastroenterology and Hepatology, vol. 12, No. 11, (2018), pp. 1143-1152. [cited by applicant]
Written Opinion for Application No. PCT/IB2019/060898; International Filing Date—Dec. 17, 2019; Date of Mailing—May 4, 2020; 8 pages. [cited by applicant]
Yu et al., “Hepatobiliary Malignancies—Inhibitory Role of Peroxisome Proliferator-Activated Receptor Gamma in Hepatocarcinogenesis in Mice and InVitro,” Hepatology, vol. 51, No. 6, (2010), pp. 2008-2019,. [cited by applicant]
Zydus Discovery: “Lipaglyn-Saroglitazar. Novel. Superior Dual Acting Product information,” (2013), pp. 1-12, XP055685771, [retrieved on Apr. 15, 2020]. [cited by applicant]
Kimura, O. et al.; “PPAR Could Contribute to the Pathogenesis of Hepatocellular Carcinoma”; PPAR Research, Vo. 2012, Article ID 574180; 5 pages; DOI: 10.1155/2012/574180 (2012). [cited by applicant]
Shen, Y-C. et al.; “Lack of efficacy of troglitazone at clinically achievable concentrations, with or without 9-cis retinoic acid or cytotoxic agents, for hepatocellular carcinoma cell lines”; British Journal of Cancer,… [cited by applicant]