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Lexicon Pharmaceuticals (LXRX)
NASDAQ:LXRX
Sotagliflozin
Obstructive Cardiomyopathy, Hypertrophic, Non-Obstructive Hypertrophic Cardiomyopathy
Phase III
Recruiting
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
Jun 25, 2024
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Lx9211 (Blinded)
Diabetic Peripheral Neuropathic Pain
Phase II
Completed
A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Nov 30, 2023
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Lx9211
Postherpetic Neuralgia
Phase II
Completed
Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
Dec 04, 2020
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Lx9211
Diabetes, Diabetic Peripheral Neuropathy
Phase II
Completed
Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain
Jun 29, 2020
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Sotagliflozin
Type 2 Diabetes Mellitus, Heart Failure
Phase III
Terminated
Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)
Apr 30, 2018
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Sotagliflozin
Type 2 Diabetes Mellitus
Phase III
Terminated
Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Dec 21, 2017
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Sotagliflozin, Empagliflozin
Type 2 Diabetes Mellitus
Phase III
Completed
Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin
Nov 20, 2017
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Metformin, Glimepiride, Sotagliflozin (Sar439954)
Type 2 Diabetes Mellitus
Phase III
Completed
Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy
Nov 02, 2017
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Telotristat Ethyl
Hepatic Impairment
Phase I
Completed
Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment
Oct 24, 2017
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Sotagliflozin
Type 2 Diabetes Mellitus, Heart Failure, Chronic Kidney Diseases
Phase III
Terminated
Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Oct 16, 2017
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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 Lexicon Pharmaceuticals (LXRX) have in its pipeline
LXRX is currently developing the following drugs: Sotagliflozin, Lx9211 (Blinded), Lx9211. These drug candidates are in various stages of clinical development as the company works toward FDA approval.