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Lupin Limited (IN:LUPIN)
:LUPIN
Granular Powder In Unit Dose Foil-Lined Sachet Mexiletine (Pr), Oral Capsule Mexiletine (Ir)
Myotonia
Phase III
Recruiting
An Open-Label, Randomized, Cross-Over Study to Investigate the Efficacy and Safety of Mexiletine PR Compared to Mexiletine IR
Nov 21, 2024
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Mexiletine Granules For Prolonged-Release Oral Suspension
Myotonic Dystrophy
Phase III
Not Yet Recruiting
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.
May 09, 2024
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Mexiletine Granules For Prolonged-Release Oral Suspension
Myotonic Dystrophy
Phase III
Recruiting
The Efficacy and Safety of Once Daily Mexiletine PR in Patients With Myotonic Dystrophy Type 1 and Type 2
May 03, 2024
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Mexiletine
Myotonic Dystrophy
Phase III
Completed
Open Label Study in Adolescents and Children With Myotonic Disorders
Oct 20, 2020
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Lupin Limited (LUPIN) have in its pipeline
LUPIN is currently developing the following drugs: Granular Powder In Unit Dose Foil-Lined Sachet Mexiletine (Pr), Oral Capsule Mexiletine (Ir), Mexiletine Granules For Prolonged-Release Oral Suspension, Mexiletine Granules For Prolonged-Release Oral Suspension. These drug candidates are in various stages of clinical development as the company works toward FDA approval.