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Aldeyra Therapeutics (ALDX)
NASDAQ:ALDX
Vehicle Ophthalmic Solution, Reproxalap Ophthalmic Solution (0.25%)
Dry Eye Disease
Phase III
Completed
A Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
Jul 02, 2024
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Vehicle Ophthalmic Solution, Reproxalap Ophthalmic Solution (0.25%)
Dry Eye Disease
Phase III
Completed
A Clinical Trial to Assess the Safety and Efficacy of Subjects With Dry Eye Disease
May 17, 2024
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Vehicle Ophthalmic Solution, Reproxalap Ophthalmic Solution (0.25%)
Dry Eye Disease
Phase III
Completed
A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease
Apr 25, 2024
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Adx-629 (Open-Label)
Atopic Dermatitis
Phase II
Completed
A Clinical Trial in Subjects With Atopic Dermatitis (Part 1)
Jan 25, 2023
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Adx-629
Ethanol Intoxication
Phase I/II
Completed
A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels
Aug 02, 2022
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Vehicle Ophthalmic Solution, Reproxalap Ophthalmic Solution (0.25%)
Dry Eye Syndromes
Phase II
Completed
A Clinical Trial to Evaluate the Safety and Efficacy of Rreproxalap in Adults With Dry Eye Disease
Jun 15, 2022
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Adx-629
Chronic Cough
Phase II
Completed
A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough
May 05, 2022
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Vehicle Ophthalmic Solution, Reproxalap Ophthalmic Solution (0.25%)
Allergic Conjunctivitis
Phase III
Completed
The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis
Feb 01, 2022
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Reproxalap Ophthalmic Solution (0.25%), Xiidra (5% Lifitegrast Ophthalmic Solution)
Dry Eye
Phase II
Completed
An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber
Oct 18, 2021
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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 Aldeyra Therapeutics (ALDX) have in its pipeline
ALDX is currently developing the following drugs: Adx-629, Vehicle Ophthalmic Solution, Reproxalap Ophthalmic Solution (0.25%), Vehicle Ophthalmic Solution, Reproxalap Ophthalmic Solution (0.25%). These drug candidates are in various stages of clinical development as the company works toward FDA approval.