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LUPIN LIMITED

🇮🇳India
Ownership
-
Established
1968-01-01
Employees
-
Market Cap
$11.9B
Website
http://www.lupin.com/

Clinical Trials

33

Active:4
Completed:14

Trial Phases

5 Phases

Phase 1:7
Phase 2:2
Phase 3:10
+2 more phases

Drug Approvals

89

FDA:37
PHILIPPINES:20
CANADA:15
+1 more agencies

Drug Approvals

Ethambutol Hydrocloride

Product Name
盐酸乙胺丁醇
Approval Number
H20150547
Approval Date
Oct 14, 2015
NMPA

Cefaclor

Product Name
头孢克洛
Approval Number
H20140232
Approval Date
Apr 3, 2014
NMPA

Clinical Trials

Distribution across different clinical trial phases (30 trials with phase data)• Click on a phase to view related trials

Phase 3
10 (33.3%)
Phase 1
7 (23.3%)
Phase 4
5 (16.7%)
Not Applicable
4 (13.3%)
Phase 2
2 (6.7%)
phase_2_3
2 (6.7%)

An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR

Not Applicable
Not yet recruiting
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.

Phase 3
Not yet recruiting
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

Phase 3
Not yet recruiting
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

Phase 1
Completed
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

and more 1 locations

Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2

Phase 3
Withdrawn
Conditions
Myotonic Dystrophy Type 1 and Type 2
Interventions
First Posted Date
2021-01-07
Last Posted Date
2024-05-06
Lead Sponsor
Lupin Ltd.
Registration Number
NCT04700046
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News

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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.

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