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ZYDUS LIFESCIENCES LIMITED

🇮🇳India
Ownership
-
Established
1952-01-01
Employees
-
Market Cap
$13.6B
Website
http://cadilapharma.com

Clinical Trials

47

Active:7
Completed:20

Trial Phases

5 Phases

Phase 1:9
Phase 2:14
Phase 3:9
+2 more phases

Drug Approvals

313

FDA:313

Drug Approvals

carbamazepine

Approval Date
Apr 3, 2024
FDA

Sitagliptin and metformin hydrochloride

Approval Date
Mar 23, 2024
FDA

ZITUVIMET

Approval Date
Mar 22, 2024
FDA

ZITUVIO

Approval Date
Mar 22, 2024
FDA

Sitagliptin

Approval Date
Mar 22, 2024
FDA

Chlorpromazine Hydrochloride

Approval Date
Mar 14, 2024
FDA

vigabatrin

Approval Date
Mar 13, 2024
FDA

Mirabegron

Approval Date
Mar 6, 2024
FDA

fluconazole

Approval Date
Mar 4, 2024
FDA

acetazolamide

Approval Date
Feb 22, 2024
FDA
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Clinical Trials

Distribution across different clinical trial phases (47 trials with phase data)• Click on a phase to view related trials

Phase 2
14 (29.8%)
Phase 1
9 (19.1%)
Phase 3
9 (19.1%)
Phase 4
9 (19.1%)
Not Applicable
6 (12.8%)

A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates

Phase 2
Completed
Conditions
Ulcerative Colitis
Interventions
Drug: Arm1
Drug: Arm 2
First Posted Date
2024-05-03
Last Posted Date
2024-12-20
Lead Sponsor
Zydus Lifesciences Limited
Target Recruit Count
24
Registration Number
NCT06398808
Locations
🇮🇳

ICON Hospital, Ahmedabad, Gujarat, India

Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZYIL1 in Patients With Amyotrophic Lateral Sclerosis

Phase 2
Completed
Conditions
Amyotrophic Lateral Sclerosis
Interventions
Drug: ZYIL1 capsules 25 mg and 50 mg Placebo
Drug: ZYIL1 capsules 50 mg and 25 mg Placebo
Drug: ZYIL1 capsules 25 mg and ZYIL1 capsules 50 mg
Drug: Matching placebo 25 mg and Matching placebo 50 mg
First Posted Date
2023-08-08
Last Posted Date
2024-12-19
Lead Sponsor
Zydus Lifesciences Limited
Target Recruit Count
24
Registration Number
NCT05981040
Locations
🇮🇳

Zydus Hospitals & Healthcare Research, Ahmedabad, Gujarat, India

🇮🇳

Rhythm heart institute, Vadodara, Gujarat, India

🇮🇳

BrainS Super Speciality Hospital, Bengaluru, Karnataka, India

and more 4 locations

A Study to Determine Safety, Tolerability, and Pharmacokinetics of Different Orally Administered Regimens of the Combination ZY19489-Ferroquine in Adult Asymptomatic Plasmodium Falciparum Carriers

Phase 1
Recruiting
Conditions
Falciparum Malaria
Asymptomatic Condition
Uncomplicated Malaria
Interventions
First Posted Date
2023-06-22
Last Posted Date
2024-10-01
Lead Sponsor
Zydus Lifesciences Limited
Target Recruit Count
36
Registration Number
NCT05911828
Locations
🇬🇦

Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon

A Study to Evaluate the Safety and Effectiveness of Saroglitazar 4 mg in Patients With NAFLD With Comorbidities

Phase 4
Recruiting
Conditions
NAFLD
Type 2 Diabetes
Obesity
Dyslipidemias
Metabolic Syndrome
Interventions
First Posted Date
2023-05-24
Last Posted Date
2024-02-07
Lead Sponsor
Zydus Lifesciences Limited
Target Recruit Count
1500
Registration Number
NCT05872269
Locations
🇮🇳

Gastroplus Digestive Disease Centre, Ahmedabad, India

🇮🇳

Mission GastroHospital, Ahmedabad, India

🇮🇳

Artemis Hospital, Gurgaon, India

and more 16 locations

A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)

Phase 4
Recruiting
Conditions
Chronic Kidney Diseases
Anemia of Chronic Kidney Disease
Interventions
First Posted Date
2022-08-25
Last Posted Date
2025-01-22
Lead Sponsor
Zydus Lifesciences Limited
Target Recruit Count
1004
Registration Number
NCT05515367
Locations
🇮🇳

Indira Gandhi Institute of Medical Sciences, Sheikhpura, Bihar, India

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News

Sun Pharma Names Kirti Ganorkar as Managing Director in Major Leadership Transition

Kirti Ganorkar, a 29-year Sun Pharma veteran, will become Managing Director on September 1, 2025, succeeding founder Dilip Shanghvi who transitions to Executive Chairman.

Zydus Lifesciences Secures Exclusive Rights to Agenus' BOT/BAL Cancer Immunotherapy for India and Sri Lanka

Zydus Lifesciences has signed an exclusive licensing agreement with US-based Agenus Inc to commercialize the investigational cancer therapy combination of Botensilimab (BOT) and Balstilimab (BAL) in India and Sri Lanka.

Sickle Cell Disease Pipeline Shows Robust Growth with 60+ Therapies in Development Across Multiple Clinical Phases

DelveInsight's 2025 assessment reveals a robust sickle cell disease pipeline with 55+ companies developing 60+ therapeutic candidates across various clinical development stages.

Zydus MedTech Partners with Braile Biomedica to Expand TAVI Technology Across Europe and India

Zydus MedTech has formed a strategic partnership with Brazil-based Braile Biomedica to exclusively commercialize Transcatheter Aortic Valve Implantation (TAVI) technology in Europe, India, and select markets.

NULIBRY Shows Significant Survival Benefits in Ultra-Rare MoCD Type A: Landmark Clinical Evidence Published

Sentynl Therapeutics has published the first comprehensive clinical evidence for NULIBRY (fosdenopterin), showing statistically significant survival benefits in patients with Molybdenum Cofactor Deficiency Type A compared to untreated patients.

Real-World Studies Confirm Bevacizumab Biosimilars Deliver Cost Savings and Equivalent Clinical Outcomes in Metastatic Colorectal Cancer

A Canadian population-based study found bevacizumab biosimilars Mvasi and Zirabev provided $6,379 CAD in annual cost savings per patient compared to originator Avastin while maintaining equivalent survival outcomes in metastatic colorectal cancer.

Zydus Lifesciences Secures USFDA Approval for Generic Ketoconazole Shampoo

Zydus Lifesciences has received final USFDA approval to manufacture Ketoconazole Shampoo 2%, a generic equivalent of Nizoral Shampoo used to treat dandruff and fungal skin infections.

Zydus Launches ANVIMO: Game-Changing CMV Prevention Drug for Transplant Patients at 91% Lower Cost

Zydus Lifesciences introduces ANVIMO (letermovir) in India, offering a breakthrough treatment for preventing Cytomegalovirus infection in stem cell and kidney transplant patients.

Zydus Lifesciences' Topical Manufacturing Facility Achieves Perfect FDA Inspection Amid Strong Q3 Performance

Zydus Lifesciences' Ahmedabad-based topical manufacturing facility successfully passed USFDA inspection with zero observations during a routine surveillance conducted February 10-14, 2025.

Zydus' Usnoflast Receives FDA Orphan Drug Designation and Phase 2b Trial Approval for ALS Treatment

The FDA has granted Orphan Drug Designation to Zydus' Usnoflast for treating amyotrophic lateral sclerosis (ALS), a rare neurodegenerative disease.

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