NSEPress Release3d ago · 6 Nov 2026, 07:01 pm
Press Release
Zydus Lifesciences Limited · ZYDUSLIFE
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Zydus Lifesciences Limited announced positive results from a Phase 2b clinical trial of saroglitazar in adults with metabolic dysfunction-associated steatohepatitis (MASH) and stage F2–F3 fibrosis. The trial showed that saroglitazar achieved resolution of steatohepatitis without worsening of fibrosis in 39.1% of patients receiving 4 mg and 32.4% receiving 2 mg, compared to 13.7% receiving placebo. The results will be presented at The Liver Meeting 2026.
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Zydus Lifesciences Limited has informed the Exchange regarding a press release dated November 06, 2026, titled "Press Release".
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November 6, 2026
BSE Limited Code: 532321
P J Towers,
Dalal Street,
Mumbai-400001
National Stock Exchange of India Limited Code: Zyduslife
Exchange Plaza,
C/1, Block G,
Bandra-Kurla Complex, Bandra (East),
Mumbai-400051
Re.: Press Release
Dear Sir / Madam,
Please find enclosed a copy of press release dated November 6, 2026, titled “Zydus
Therapeutics Presents Phase 2b Data at AASLD 2026 Showing Greater Resolution of
Steatohepatitis Without Worsening of Fibrosis With Investigational Saroglitazar Compared
to Placebo in Adults With MASH and Fibrosis”.
The contents of the press release give full details.
Please bring the aforesaid news to the notice of the members of the exchange and the
investors’ at large.
Yours faithfully,
For, Zydus Lifesciences Limited
Dhaval N. Soni
Company Secretary and Compliance Officer
Membership No. FCS7063
Encl.: As above
Zydus Therapeutics Presents Phase 2b Data at AASLD 2026 Showing Greater
Resolution of Steatohepatitis Without Worsening of Fibrosis With Investigational
Saroglitazar Compared to Placebo in Adults With MASH and Fibrosis
Resolution of steatohepatitis without worsening of fibrosis was achieved by 39.1% of patients
receiving saroglitazar magnesium 4 mg and 32.4% receiving 2 mg, compared with 13.7% receiving
placebo, after 52 weeks of treatment in adults with metabolic dysfunction-associated steatohepatitis
(MASH) and stage F2–F3 fibrosis
Saroglitazar was generally well tolerated, without significant weight gain or a drug-induced liver
injury signal
Ahmedabad, India and Pennington, N.J. November 6, 2026
Zydus Therapeutics Inc. (“Zydus Therapeutics”), a wholly owned subsidiary of Zydus Lifesciences Limited,
a global innovation-led healthcare company, today announced results from a Phase 2b randomized, double-
blind, placebo-controlled clinical trial of saroglitazar in adults with biopsy-confirmed MASH and stage F2–
F3 fibrosis. The results will be presented as a late-breaking oral presentation at The Liver Meeting® 2026,
the annual meeting of the American Association for the Study of Liver Diseases (AASLD).
The presentation, titled “Saroglitazar Magnesium Achieves Resolution of Steatohepatitis Without Worsening
Fibrosis in Patients with MASH: Results of a Randomized, Placebo-Controlled Phase 2b Trial (EVIDENCES
X)”, will be delivered by Naga Chalasani, MD, FAASLD, David W. Crabb Professor of Gastroenterology
and Hepatology, Co Editor-in-Chief, HEPATOLOGY. The study evaluated the efficacy and safety of
saroglitazar magnesium 2 mg and 4 mg compared with placebo, administered once daily for 52 weeks, in
189 adults with biopsy-confirmed MASH and stage F2–F3 fibrosis at sites in Argentina, Turkey, and the
United States. The primary endpoint was resolution of steatohepatitis without worsening of fibrosis.
In the primary analysis, resolution of steatohepatitis without worsening of fibrosis was achieved by 39.1%
of patients treated with saroglitazar magnesium 4 mg and 32.4% of patients treated with saroglitazar
magnesium 2 mg, compared with 13.7% of patients receiving placebo (treatment differences versus placebo
of 24.9% (95% CI, 9.5–40.3; P=0.002) and 16.5% (95% CI, 1.3–31.6; P=0.033), respectively). Improvement
in fibrosis by at least one stage without worsening of NAFLD Activity Score (NAS), a secondary endpoint,
was numerically higher with 4 mg than with placebo (34.8% vs. 24.6%; treatment difference 10.2%) but did
not reach statistical significance; the response rate with 2 mg was 22.8%. Compared with placebo, 4 mg
demonstrated favorable improvements in non-invasive assessments of liver fibrosis, with treatment
differences of −9.50 ng/mL for Pro-C3 (95% CI, −15.3 to −3.7), −0.35 for APRI (95% CI, −0.5 to −0.2),
−0.30 for FIB-4 (95% CI, −0.5 to −0.1) and −0.53 for ADAPT (95% CI, −1.0 to −0.1).
Treatment was generally well tolerated, without significant weight gain or a drug-induced liver injury signal.
“Many people with MASH and fibrosis also have type 2 diabetes or obesity, so we need options that address
both the liver disease and the metabolic dysfunction that drives it,” said Naga Chalasani. Chalasani continued,
“In this Phase 2b trial, more patients achieved resolution of steatohepatitis without worsening of fibrosis with
saroglitazar than with placebo, along with improvements in lipid and glycemic parameters. These results
support evaluating saroglitazar in larger, longer-term studies.”
Zydus Therapeutics is evaluating saroglitazar as a potential treatment for adults with MASH and fibrosis.
Saroglitazar is an investigational product for MASH, and its safety and effectiveness for this use have not
been established.
Analyses used the intention-to-treat population with missing-at-random methodology and were stratified by
baseline diabetes status.
About Metabolic Dysfunction-Associated Steatohepatitis (MASH):
MASH, formerly known as NASH, is a progressive form of metabolic dysfunction-associated steatotic liver
disease (MASLD) characterized by fat accumulation, inflammation and liver cell injury. MASH can progress
to fibrosis, cirrhosis, hepatocellular carcinoma, liver transplantation and death, creating a substantial clinical
and economic burden worldwide.
About the Phase 2b Trial:
EVIDENCES X (NCT05011305) is a multicenter, randomized, double-blind, placebo-controlled Phase 2b
trial evaluating the efficacy and safety of saroglitazar in adults aged 18–75 years with biopsy-confirmed
MASH (NAS ≥4) and stage F2–F3 fibrosis. A total of 189 participants were randomized 1:1:1 to saroglitazar
magnesium 4 mg (n=64), saroglitazar magnesium 2 mg (n=63) or placebo (n=62) once daily for 52 weeks at
sites in Argentina, Turkey and the United States. The primary endpoint was resolution of steatohepatitis
without worsening of fibrosis.
About Saroglitazar:
Saroglitazar is a novel Peroxisome Proliferator-Activated Receptor (PPAR) α/γ agonist, currently under
investigation as a treatment for patients with MASH and patients with Primary Biliary Cholangitis (PBC).
Its distinct biological profile targets both bile acid toxicity and liver inflammation. Saroglitazar has received
Orphan Drug Designation, Fast Track Designation, and Priority Review from the US Food and Drug
Administration for the treatment of PBC.
About Zydus Therapeutics:
Zydus Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., is a clinical-stage, specialty-
focused biopharmaceutical company dedicated to developing transformative treatments for rare and serious
liver diseases, including PBC and Metabolic Dysfunction-Associated Steatohepatitis (MASH). The company
is headquartered in Pennington, New Jersey. For more information, visit www.zydustx.com.
About Zydus Lifesciences:
Zydus Lifesciences Ltd., with an overarching purpose of empowering people with freedom to live healthier
and more fulfilled lives, is an innovative, global lifesciences company that discovers, develops,
manufactures, and markets a broad range of healthcare therapies. The group employs over 30,000 people
worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new
possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to
transform lives through pathbreaking discoveries. Over the last decade, Zydus has introduced several
innovative, first-in-class products in the market to address unmet healthcare needs with vaccines,
therapeutics, biologicals, and New Chemical Entities. For more details, visit www.zyduslife.com.
Forward-Looking Statements:
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of
1995, as amended, including statements about the clinical development and potential of saroglitazar. These statements
are based on current expectations and are subject to risks and uncertainties. Actual results could differ. Zydus
Therapeutics does not commit to updating any of these statements unless required by law.