LUPIN LIMITED
Clinical Trials
34
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
Prospective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders
- First Posted Date
- 2025-09-04
- Last Posted Date
- 2025-09-23
- Lead Sponsor
- Lupin Ltd.
- Target Recruit Count
- 10
- Registration Number
- NCT07154654
- Locations
- 🇫🇷
Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France
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
- 2025-09-25
- Lead Sponsor
- Lupin Ltd.
- Target Recruit Count
- 24
- Registration Number
- NCT07097701
- Locations
- 🇧🇪
Universitair Ziekenhuis Leuven"UZ Leuven Gasthuisberg Campus Herestraat 49 Leuven, 3000", Leuven, Belgium
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
- 2025-08-28
- Lead Sponsor
- Lupin Ltd.
- Target Recruit Count
- 176
- Registration Number
- NCT06523400
- Locations
- 🇧🇪
Laboratory for Muscle Diseases and Neuropathies, Leuven, Belgium
🇩🇰Aarhus University Hospital, Aarhus, Denmark
🇩🇪Ludug-Maximilians University, München, Germany
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
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News
Lupin Manufacturing Solutions Launches Dedicated Oncology Block at Vizag Facility to Expand CDMO Capabilities
Lupin Manufacturing Solutions commissioned a new 4,270 square meter oncology block at its Vizag facility in India, featuring 20 reactors and advanced containment systems to support high potent active pharmaceutical ingredient manufacturing.
Lupin Invests $250 Million in Florida Manufacturing Facility to Strengthen US Respiratory Drug Supply
Lupin announced a $250 million investment over five years to construct a new state-of-the-art pharmaceutical manufacturing facility in Coral Springs, Florida.
Lupin to Present Phase 1a Data on STING Agonist LNP3693 at ESMO 2025
Lupin will present Phase 1a clinical trial data for LNP3693, an investigational STING agonist, at the ESMO Congress 2025 in Berlin from October 17-21, 2025.
Lupin Acquires VISUfarma for €190 Million to Expand European Ophthalmology Portfolio
Lupin's subsidiary Nanomi B.V. has signed a definitive agreement to acquire VISUfarma B.V. from GHO Capital Partners for €190 million enterprise value.
Lupin Receives Tentative FDA Approval for Generic HIV Treatment Targeting $16.2 Billion Market
Lupin Limited has received tentative FDA approval for its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, targeting a significant HIV treatment market.
MacuMira Receives First Health Canada Approval for Non-Invasive Dry AMD Treatment Device
MacuMira Medical Devices has launched the first Health Canada-approved device to improve visual function in patients with dry age-related macular degeneration.
Lupin Receives Four FDA Observations at Pune Biotech Facility Following Pre-Approval Inspection
Lupin's Pune biotech facility received four observations from the US FDA following a product-specific pre-approval inspection conducted from September 8-19, 2024.
Lupin Challenges ARS Pharmaceuticals' Neffy Patents with Generic Application Filing
Lupin filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of neffy, ARS Pharmaceuticals' epinephrine nasal spray, causing ARS stock to drop 9%.
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.