COMPANY
Lupin
FDA-approved therapeutic company Clinical Phase 3
Timeline
- Trial start —: An Ambispective Natural History Study in Myotonic Dystrophy Patients Linking Retrospective Data Captured From the DM-Scope Registry With a Prospective 24-month Follow-up Period source ↗
- Trial start —: Prospective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders source ↗
- Trial start Phase 3: 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 Stu source ↗
- Trial start Phase 3: An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR source ↗
- Trial start Phase 3: The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 source ↗
- Trial start Not phased (device or behavioral study): Open-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study. source ↗
- Trial start Phase 3: Open Label Study in Adolescents and Children With Myotonic Disorders source ↗
- Trial start Phase 3: Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2 source ↗
- Trial start —: An Observational Study in Adult Patients With Non-dystrophic Myotonic Disorders source ↗
- Trial start Phase 1: A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors source ↗
- Trial start Phase 3: Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD source ↗
- Trial start Phase 4: Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer source ↗
- Trial start Phase 3: Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness source ↗
- Trial start Phase 3: Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma source ↗
- Trial start Phase 1: A Study to Test the Safety/Tolerability of Increasing Doses of LNP1892 Versus Placebo in Healthy Male/Female Subjects source ↗
- Trial start Phase 1: Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fast source ↗
- Trial start Phase 1: Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed source ↗
- Trial start Phase 1: Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets source ↗
Upcoming milestones
- Jan 22, 2027 (ESTIMATED) · Phase 3 · An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR · NCT07097701
- 2027-06 (ESTIMATED) · Phase 3 · The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 · NCT06523400
- Nov 22, 2027 (ESTIMATED) · · Prospective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders · NCT07154654
- May 29, 2028 (ESTIMATED) · Phase 3 · 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. · NCT06549400
- 2029-09 (ESTIMATED) · · An Ambispective Natural History Study in Myotonic Dystrophy Patients Linking Retrospective Data Captured From the DM-Scope Registry With a Prospective 24-month Follow-up Period · NCT07732439
Clinical trials (lead sponsor) 18
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06523400 | The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2 | Phase 3 | Recruiting | Feb 13, 2025 | 2027-06 (estimated) |
| NCT04622553 | Open-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study. | Not phased (device or behavioral study) | Completed | Nov 5, 2021 | Jun 4, 2026 (actual) |
| NCT07732439 | An Ambispective Natural History Study in Myotonic Dystrophy Patients Linking Retrospective Data Captured From the DM-Scope Registry With a Prospective 24-month Follow-up Period | Not listed | Not yet recruiting | Aug 3, 2026 | 2029-09 (estimated) |
| NCT04616807 | An Observational Study in Adult Patients With Non-dystrophic Myotonic Disorders | Not listed | Completed | Dec 17, 2020 | Jan 16, 2026 (actual) |
| NCT04690556 | Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD | Phase 3 | Completed | Sep 14, 2020 | May 31, 2024 (actual) |
| NCT06549400 | 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 | Enrolling by invitation | Sep 12, 2025 | May 29, 2028 (estimated) |
| NCT07097701 | An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR | Phase 3 | Recruiting | Sep 3, 2025 | Jan 22, 2027 (estimated) |
| NCT07154654 | Prospective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders | Not listed | Recruiting | Sep 30, 2025 | Nov 22, 2027 (estimated) |
| NCT04624750 | Open Label Study in Adolescents and Children With Myotonic Disorders | Phase 3 | Completed | Sep 3, 2021 | Jun 14, 2024 (actual) |
| NCT04700046 | Study to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2 | Phase 3 | Withdrawn | Sep 3, 2021 | Jul 1, 2024 (estimated) |
| NCT05187858 | A Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors | Phase 1 | Completed | Sep 22, 2020 | Feb 23, 2022 (actual) |
| NCT03511378 | Immunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer | Phase 4 | Completed | Mar 6, 2018 | Jan 9, 2019 (actual) |
| NCT03137992 | Clinical Endpoint Bioequivalence Study of Test and Reference Inhalation Products in Patients With COPD With Device Robustness | Phase 3 | Completed | Nov 21, 2017 | Jan 31, 2018 (actual) |
| NCT02584257 | Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma | Phase 3 | Completed | 2016-04 | 2016-08 (actual) |
| NCT02174237 | A Study to Test the Safety/Tolerability of Increasing Doses of LNP1892 Versus Placebo in Healthy Male/Female Subjects | Phase 1 | Completed | 2014-05 | 2014-09 (actual) |
| NCT01717235 | Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fasting Conditions | Phase 1 | Completed | 2008-09 | 2008-10 (actual) |
| NCT01714856 | Bioequivalence Study of Ropinirole Hydrochloride CR 2mg Tablets of Lupin Limited, India, With REQUIP XL of GlaxoSmithKline Research Triangle Park, in Healthy, Adult, Male, Subjects Under Fed Conditions | Phase 1 | Completed | 2008-09 | 2008-10 (actual) |
| NCT01712568 | Two Way Cross Over BE Fasting Pilot Study of Ropinirole Hydrochloride CR 2mg Tablets | Phase 1 | Completed | 2008-09 | 2008-09 (actual) |
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