Open-Label Extension Study of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis

Inclusion Criteria:

1. Must provide written informed consent and agree to comply with the trial protocol

2. Participated and completed SARO.21.001, the double-blind treatment phase study

Exclusion Criteria:

1. Consumption of 2 standard drinks per day if male and 1 standard drink per day iffemale for 3 consecutive months (12 consecutive weeks) throughout double-blind phasetill screening.

2. Participants with MELD 3.0 score of 15 or greater

3. History or presence of other concomitant liver diseases at screening:

4. Chronic hepatitis B or C virus (HBV, HCV) infection

5. Primary sclerosing cholangitis (PSC)

6. Alcoholic liver disease

7. Autoimmune hepatitis (AIH)-PBC overlap syndrome

8. Hemochromatosis

9. Non-alcoholic steatohepatitis (NASH) on historical biopsy

10. Cirrhosis with complications, including history or presence of: spontaneousbacterial peritonitis, hepatocellular carcinoma, uncontrolled ascites,encephalopathy, history of variceal bleeding or history of hepatorenal syndrome atscreening.

11. Use of Thiazolidinediones or Fibrates (within 12 weeks prior to screening)

12. Use of other PPAR agonists (i.e., Elafibranor, Seladelpar), Obeticholic acid (OCA),methotrexate, budesonide and other systemic corticosteroids (Prednisone dose morethan 10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproicacid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening)

13. History of bowel surgery (gastrointestinal [bariatric] surgery in the preceding 1year or undergoing evaluation for gastrointestinal surgery (bariatric surgery forobesity, extensive small-bowel resection) or orthotopic liver transplant (OLT) orlisted for OLT

14. Unstable cardiovascular disease, including:

15. Unstable angina, (i.e., new or worsening symptoms of coronary heart disease inthe 12 weeks before screening and throughout the screening period), acutecoronary syndrome in the 24 weeks before screening and throughout the screeningperiod, acute myocardial infarction in the 12 weeks before screening andthroughout the screening period or heart failure of New York Heart Associationclass (III - IV) or worsening congestive heart failure, or coronary arteryintervention, in the 24 weeks before screening and throughout the screeningperiod

16. History/current unstable cardiac dysrhythmias

17. Uncontrolled hypertension at screening

18. Stroke or transient ischemic attack in the 24 weeks before screening

19. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder,and coagulation disorders

20. An uncontrolled thyroid disorder

21. Uncontrolled hyperthyroidism: defined as any history of hyperthyroidism thathas either not been treated with either radioactive iodine and/or surgery orthat has been treated with radioactive iodine and/or surgery, but has requiredongoing continuous or intermittent use of thyroid hormone synthesis inhibitors (i.e., methimazole or propylthiouracil) in the 24 weeks before screening

22. Uncontrolled hypothyroidism: defined as initiation of thyroid hormonereplacement therapy or dose adjustment of replacement therapy in the 12 weeksbefore screening

23. History of myopathies or evidence of active muscle disease demonstrated by CPK ≥ 5 ×ULN at screening

24. Any of the following laboratory values:

25. Total bilirubin > 3 x ULN

26. Platelets < 50 × 103/mL

27. Albumin < 2.8 g/dL

28. eGFR < 45 mL/min/1.73 m2

29. ALT or AST > 250 U/L

30. ALP > 10 × ULN

31. Participation in another interventional clinical study and receipt of any otherinvestigational medication or medical device within 30 days or within 5 half-lives,whatever is longer, prior to screening

32. History of malignancy in the past 5 years and/or active neoplasm which may diminishlife expectancy (except resolved superficial non-melanoma skin cancer, carcinomas insitu or other stable, relatively benign conditions if appropriately treated prior toscreening)

33. Known allergy, sensitivity or intolerance to the study medication or formulationingredients

34. Pregnancy-related exclusions, including:

35. Pregnant/lactating female (including positive pregnancy test at screening)

36. Participants agree to avoid pregnancy either by true abstinence or the use ofan acceptable effective contraceptive measures for the duration of the studyand for at least 1 month after the end of the study medication. Refer Appendix 9 Contraceptive Guidance.

37. History or other evidence of severe illness or any other conditions that would makethe participant, in the opinion of the investigator, unsuitable for the study (suchas poorly controlled psychiatric disease, HIV, coronary artery disease or activegastrointestinal conditions that might interfere with drug absorption)

38. Cirrhosis with Child-Pugh-Turcotte (CPT) class B or C having score of 7 or above atscreening (Refer Appendix 11