Zydus Lifesciences Limited
Drugmaker with rare disease work · based in Ahmedabad, India · ticker ZYDUSLIFE · zyduslife.com
Zydus Lifesciences Limited works on Amyotrophic Lateral Sclerosis and Primary Biliary Cholangitis, 2 of the rare diseases we track. It has 6 active clinical trials, and 5 are looking for volunteers now. It also has 8 FDA-approved rare disease drugs.
Zydus Lifesciences is a global pharmaceutical company based in Ahmedabad, India, that makes medicines, vaccines and biosimilars. Its US subsidiary, Zydus Therapeutics in Pennington, New Jersey, develops treatments for liver diseases, and its saroglitazar is under FDA review for primary biliary cholangitis with Orphan Drug, Fast Track and Priority Review designations, with a decision due November 27, 2026.
Zydus Lifesciences Limited pipeline
Each row lists the diseases Zydus Lifesciences Limited is studying at that stage, from the ones closest to approval down to the earliest work.
Bortezomib (bortezomib) · Cholestyramine (cholestyramine) · Doxorubicin Hydrochloride (doxorubicin hydrochloride) · Eltrombopag (eltrombopag) · Glatiramer Acetate (glatiramer acetate) · Minocycline hydrochloride (minocycline hydrochloride) · Sildenafil Citrate (sildenafil citrate) · Sodium phenylacetate and Sodium benzoate (sodium phenylacetate and sodium benzoate)
Primary Biliary Cholangitis 3 trials recruiting
Amyotrophic Lateral Sclerosis recruiting
Progressive Familial Intrahepatic Cholestasis 2 trials recruiting
Zydus Lifesciences Limited clinical trials
These are Zydus Lifesciences Limited trials for the rare diseases we track, from ClinicalTrials.gov. Statuses there can lag behind company news, so confirm with the study team before you plan around one.
5 trials looking for volunteers now
Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy
Tests Saroglitazar Magnesium 1 mg, Placebo
For Primary Biliary Cholangitis
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
Tests Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg
For Hepatic Impairment, Cirrhosis and Cholestatic Liver Disease
Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease
Tests Saroglitazar Magnesium 1 mg
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
Tests 50 mg Usnoflast, 75 mg Usnoflast, Placebo
For Amyotrophic Lateral Sclerosis (ALS)
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
Tests Saroglitazar magnesium 1 mg, Placebo
For Primary Biliary Cholangitis
1 trial underway, not taking new volunteers
Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis
Tests Saroglitazar Magnesium 1 mg
For Primary Biliary Cholangitis
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FDA-approved drugs from Zydus Lifesciences Limited
From the openFDA database. Tap a drug for side effects, dosing and help paying.
Bortezomib bortezomib
For Multiple Myeloma. Approved Nov 6, 2017. Taken by intravenous, subcutaneous route.
Cholestyramine cholestyramine
For Primary Biliary Cholangitis. Approved May 28, 1998. Taken by mouth.
Doxorubicin Hydrochloride doxorubicin hydrochloride
For Multiple Myeloma. Approved Dec 23, 1987. Taken by intravenous route.
Eltrombopag eltrombopag
For Immune Thrombocytopenia and Aplastic Anemia. Approved Mar 16, 2026. Taken by mouth.
Glatiramer Acetate glatiramer acetate
For Multiple Sclerosis. Approved Oct 3, 2017. Taken by subcutaneous route.
Minocycline hydrochloride minocycline hydrochloride
For Bartonella Infection, Rocky Mountain Spotted Fever and Tularemia. Approved Dec 30, 1991. Taken by mouth.
Sildenafil Citrate sildenafil citrate
For Pulmonary Arterial Hypertension. Approved Nov 9, 2012. Taken by mouth.
Sodium phenylacetate and Sodium benzoate sodium phenylacetate and sodium benzoate
For Urea Cycle Disorders. Approved Feb 24, 2016. Taken by intravenous route.
More about Zydus Lifesciences Limited
Within its broader pharmaceutical portfolio, Zydus Lifesciences Limited has active clinical trial programs and drug development efforts across 2 rare diseases, including Amyotrophic Lateral Sclerosis, Primary Biliary Cholangitis. These programs may span orphan drug designation, novel therapeutic mechanisms, and precision medicine approaches targeting the underlying causes of each disease.
The clinical trials section below shows active and recruiting rare disease studies sponsored by Zydus Lifesciences Limited, sourced live from ClinicalTrials.gov. Each trial includes its current recruitment status, study phase (Phase 1 through Phase 4), conditions under investigation, and the number of active trial sites.
The FDA-approved drugs section lists treatments that have received U.S. Food and Drug Administration approval, with brand names, generic names, approval dates, and matched rare disease indications from the openFDA database.
Zydus Lifesciences Limited is headquartered in Ahmedabad, India, publicly traded under the ticker symbol ZYDUSLIFE. The company maintains a dedicated rare disease division alongside its broader therapeutic portfolio, working to bring innovative treatments to patients with conditions that have historically had limited or no treatment options.
Where Zydus Lifesciences Limited trials take place
The trials above run at 83 study sites in 14 countries. Tap a country to see its states, cities and hospitals.
Rare diseases Zydus Lifesciences Limited works on
Each disease page lists every open trial, not only Zydus Lifesciences Limited's, plus approved treatments.
Amyotrophic lateral sclerosis is a progressive neurodegenerative disease destroying motor neurons in the brain and spinal cord.
How common: About 5,000 new cases per year in the U.S.; CDC's National ALS Registry estimates about 33,000 Americans were living with ALS in 2022, a number projected to pass 36,000 by 2030
Primary Biliary Cholangitis (PBC) is a chronic autoimmune liver disease in which the immune system mistakenly attacks the small bile ducts in the liver, leading to bile duct destruction and...
How common: About 14.6 per 100,000 people worldwide in a 2021 pooled analysis of 47 population studies, highest in North America (21.8 per 100,000) and lowest in the Asia-Pacific region (9.8 per 100,000)
Where to get support
Patient groups can explain a diagnosis, point you to specialists and tell you about trials before they open. Zydus Lifesciences Limited's own site is zyduslife.com, and our help paying for treatment page lists drugmaker programs and charity funds.
- The ALS AssociationAmyotrophic Lateral Sclerosis
- ALS Therapy Development InstituteAmyotrophic Lateral Sclerosis
- American Liver FoundationPrimary Biliary Cholangitis
- National Center for Advancing Translational Sciences (NCATS)Primary Biliary Cholangitis