LUPIN LIMITED
Clinical Trials
33
Trial Phases
5 Phases
Drug Approvals
89
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (30 trials with phase data)• Click on a phase to view related trials
An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR
- Conditions
- Myotonia
- Interventions
- Drug: Granular powder in unit dose foil-lined sachet Mexiletine (PR)Drug: Oral Capsule Mexiletine (IR)
- First Posted Date
- 2025-07-31
- Last Posted Date
- 2025-08-03
- Lead Sponsor
- Lupin Ltd.
- Target Recruit Count
- 24
- Registration Number
- NCT07097701
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 Who Have Completed MEX-DM-302 Study.
- Conditions
- Myotonic Dystrophy
- Interventions
- First Posted Date
- 2024-08-12
- Last Posted Date
- 2025-08-03
- Lead Sponsor
- Lupin Ltd.
- Target Recruit Count
- 176
- Registration Number
- NCT06549400
The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2
- Conditions
- Myotonic Dystrophy
- Interventions
- First Posted Date
- 2024-07-26
- Last Posted Date
- 2024-07-26
- Lead Sponsor
- Lupin Ltd.
- Target Recruit Count
- 176
- Registration Number
- NCT06523400
A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
- Conditions
- NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors
- Interventions
- First Posted Date
- 2022-01-12
- Last Posted Date
- 2023-03-17
- Lead Sponsor
- Lupin Ltd.
- Target Recruit Count
- 15
- Registration Number
- NCT05187858
- Locations
- 🇧🇪
Cliniques universitaires Saint-Luc, Brussels, Belgium
🇳🇱Amsterdam UMC, Amsterdam, Netherlands
🇬🇧Sarah Cannon Research Institute, London, United Kingdom
Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2
- Conditions
- Myotonic Dystrophy Type 1 and Type 2
- Interventions
- Drug: Placebo
- First Posted Date
- 2021-01-07
- Last Posted Date
- 2024-05-06
- Lead Sponsor
- Lupin Ltd.
- Registration Number
- NCT04700046
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News
Major Pharmaceutical Companies Face Surge in Generic Drug Patent Challenges in Early 2025
Major pharmaceutical companies including AstraZeneca, Novartis, and Astellas are defending patents for blockbuster drugs like Lynparza, Entresto, and Xtandi against generic manufacturers in early 2025.
Lupin Partners with Sandoz to Commercialize Ranibizumab Biosimilar Across Multiple Global Markets
Lupin Limited has entered into a strategic partnership with Sandoz Group AG to commercialize its biosimilar ranibizumab across the European Union, Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia.
Lupin Secures $50 Million Licensing Deal with Zentiva for Global Certolizumab Pegol Biosimilar Rollout
Lupin has entered into a strategic licensing and supply agreement with Czech-based Zentiva to commercialize its biosimilar version of Certolizumab Pegol across multiple global markets.
Lupin Partners with Sino Universal Pharmaceuticals to Commercialize Tiotropium DPI for COPD Treatment in China
Lupin has signed a license and supply agreement with Sino Universal Pharmaceuticals for the commercialization of tiotropium dry powder inhaler (18 mcg/capsule) in China for chronic obstructive pulmonary disease treatment.
Harmony Biosciences Secures Patent Protection for WAKIX Through 2030 Settlement with Lupin
Harmony Biosciences reached a settlement agreement with Lupin Limited that prevents generic competition for WAKIX until January 2030, strengthening the company's intellectual property position for its narcolepsy treatment.
US Court Allows Lupin and Zydus to Expand Patent Defense Arguments in Myrbetriq Generic Drug Case
A US court has permitted Lupin Ltd. and Zydus Lifesciences Ltd. to expand their patent argument scope in their defense against Astellas Pharma's Myrbetriq patent litigation.
Lupin's PRMT5 Inhibitor LNP7457 Shows Promising Safety Profile in Phase 1 Solid Tumor Trial
Lupin Limited will present Phase 1a clinical trial data for LNP7457, a novel PRMT5 inhibitor, at ASCO 2025 in Chicago from May 30 to June 3.
Novartis Launches Zero-Interest Payment Plan for High-Cost Cholesterol Drug Inclisiran in India
Novartis has introduced a first-of-its-kind financing scheme with Pine Labs for its cholesterol-lowering drug Sybrava (inclisiran) in India, offering zero-interest EMI options to improve patient access.
Lupin Partners with SteinCares to Commercialize Ranibizumab Biosimilar Across Latin America
Lupin Limited has signed a license and supply agreement with SteinCares for the commercialization of its biosimilar ranibizumab across Latin American markets, excluding Mexico and Argentina.
Lupin Receives FDA Approval for Generic Rivaroxaban Tablets for Thrombosis Prevention
Lupin has received U.S. FDA approval for its generic version of Rivaroxaban Tablets, expanding its cardiovascular portfolio with a key anticoagulant medication.