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Poxel SA (GB:0RA2)
:0RA2
Pxl770
Nash - Nonalcoholic Steatohepatitis
Phase I
Completed
Study to Assess the Safety, Tolerability, and Pharmacokinetics of PXL770 in Healthy Subjects.
Jun 22, 2022
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Pxl065
Ald (Adrenoleukodystrophy)
Phase II
Withdrawn
Study to Assess PXL065 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD)
Jan 06, 2022
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Pxl770
Adrenomyeloneuropathy
Phase II
Withdrawn
Study to Assess PXL770 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD)
Nov 16, 2021
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Pxl065
Nash - Nonalcoholic Steatohepatitis
Phase II
Completed
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
Mar 23, 2020
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Pxl770
Nonalcoholic Fatty Liver
Phase I
Completed
A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD
May 13, 2019
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14C Labeled Pxl770
Healthy
Phase I
Completed
Pharmacokinetics and Metabolism of (14C)-Labelled PXL770
Mar 20, 2019
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Imeglimin
Hepatic Impairment
Phase I
Completed
Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
Jan 10, 2019
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Pxl770
Nonalcoholic Fatty Liver
Phase II
Completed
A Study of the Efficacy and Safety of PXL770 Versus Placebo After 12 Weeks of Treatment in Patients With NAFLD
Nov 28, 2018
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Imeglimin, Imeglimin Reference Product
Bioequivalence
Phase I
Completed
Bioequivalence of Imeglimin Tablet Formulations
Aug 23, 2018
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Cimetidine, Imeglimin
Healthy
Phase I
Completed
Effect of Cimetidine on the PK of Imeglimin
Jun 08, 2018
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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 Poxel SA (0RA2) have in its pipeline
0RA2 is currently developing the following drugs: Pxl770, Pxl065, Pxl770. These drug candidates are in various stages of clinical development as the company works toward FDA approval.