Lupin Ltd.

Other

Pipeline Programs↗

Distinct drugs in development (Preclinical–Phase 3)

Indications↗

Distinct diseases across all programs

Clinical Trials↗

All sponsored trials (all statuses)

Orange Book Patents

Across 1 drug with upcoming expirations

Pipeline

Pipeline Snapshot

By Phase

1 drugs in development

Approved1

Phase 31

Phase 21

Phase 11

By Therapeutic Area

top 3

Neurology

125%

Cardiovascular

125%

Gastroenterology

125%

R&D Momentum

30/100

Pipeline Velocity

15/100

Trial Completion Rate

92/100

Pipeline Concentration

25/100

Pipeline Freshness

83/100

Strategic Signals

↗Active in Neurology but thin pipeline — potential licensing opportunity

Activity

Key Events

Jun 24, 2026TrialAn Observational Study to Describe the Long-term Safety and Effectiveness of Namuscla in the Symptomatic Management of Myotonia in Adult Patients With Non-dystrophic Myotonic Disorders

Sep 30, 2025TrialProspective, Long Term, Observational Study (Patient Registry) of Paediatric Myotonic Disorders

Sep 12, 2025TrialAn 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.

Sep 3, 2025TrialAn Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR

Feb 13, 2025TrialThe Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2

Nov 5, 2021TrialOpen-label Extension Study in Paediatric Patients Who Have Completed the MEX-NM-301 Study.

Sep 3, 2021TrialStudy to Investigate the Efficacy and Safety of Mexiletine in Patients With Myotonic Dystrophy Type 1 and Type 2

Sep 3, 2021TrialOpen Label Study in Adolescents and Children With Myotonic Disorders

4 more events

Nov 5, 2020FDACerebyx — SESQUIENT

Sep 22, 2020TrialA Study of LNP3794 in Subjects With NRAS/KRAS Mutated Advanced or Metastatic Refractory Solid Tumors

Sep 14, 2020TrialStudy to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD

Mar 6, 2018TrialImmunogenicity Assessment of Peg-filgrastim vs. Neulasta® as Adjunct to Chemotherapy in Patients With Breast Cancer

Details

Company Info

Company Overview

—

Mkt Cap

—

Revenue

—

Cash

Patent Expirations

1 patent group across drugs · Source: FDA Orange Book

DrugExpires

Cerebyx2 patentsMar 13, 2029

Pipeline

Drug Pipeline

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Approved

MexitilApproved

Ventricular Tachycardia

MexitilApproved

Gastroenterology

Irritable Bowel Syndrome

MexitilPhase 1

Neurology

Charcot-Marie-Tooth Disease

MexitilApproved

Diabetic Neuropathy

MexitilPhase 3

Focal Dystonia

MexitilPhase 2

Myotonic Dystrophy

MexitilApproved

Myotonic Dystrophy Type 1

MexitilPhase 3

Neuropathy

MexitilApproved

Sporadic Amyotrophic Lateral Sclerosis

MexitilPhase 2

Steinert Myotonic Dystrophy

MexitilApproved

Unknown / Other

Muscle Cramp

MexitilApproved

Tooth Disease

MexitilPhase 2

Regulatory

Regulatory Timeline

19961 event

FDAAug 5

Cerebyx — CEREBYX

Application NDA020450 (NDA)

20061 event

FDAOct 6

Brovana — BROVANA

Application NDA021912 (NDA)

20201 event

FDANov 5

Cerebyx — SESQUIENT

Application NDA210864 (NDA)

Data sources: ClinicalTrials.gov (NIH) · OpenFDA (FDA) · ChEMBL (EMBL-EBI) · Open Targets (EBI/Sanger) · MedlinePlus (NIH) · PubMed (NIH) · SEC EDGAR (SEC)