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VYNE Therapeutics (VYNE)
NASDAQ:VYNE
Vehicle Gel, Vyn201 Gel
Non-segmental Vitiligo
Phase II
Active Not Recruiting
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VYN201 Gel in Subjects With Non-segmental Vitiligo.
Mar 18, 2024
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Vehicle, Fmx114
Atopic Dermatitis
Phase I/II
Completed
Safety, Pharmacokinetics and Efficacy of FMX114 Versus Vehicle in Adults With Atopic Dermatitis
Jun 02, 2021
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Vehicle Foam, Fmx103 Minocycline Foam 1.5%
Facial Papulopustular Rosacea
Phase III
Completed
A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
Oct 20, 2020
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Vehicle Foam, Fcd105, 3% Minocycline Foam, 0.3% Adapalene Foam
Acne Vulgaris
Phase II
Completed
A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.
Sep 24, 2019
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Fmx-101
Healthy
Phase I
Completed
A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design
Aug 08, 2019
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Fmx-101
Healthy
Phase I
Completed
Dermal Cumulative Irritant Patch Study
Aug 08, 2019
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Fmx-101
Healthy
Phase I
Completed
Dermal Photo Allergic Skin Reaction
Aug 08, 2019
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Fmx101
Healthy
Phase I
Completed
Dermal Phototoxicity Study
Aug 08, 2019
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5 Mg Serlopitant Tablets
Pruritus
Phase II
Completed
Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Chronic Pruritus of Unknown Origin
Feb 12, 2019
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Fmx101 Vehicle, Hydro-Alcohol Solution
Acne Vulgaris
Phase I
Completed
A Study Comparing Two Topicals in the Treatment of Acne Vulgaris
Nov 10, 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 VYNE Therapeutics (VYNE) have in its pipeline
VYNE is currently developing the following drugs: Vehicle Gel, Vyn201 Gel, Vehicle, Fmx114, Vehicle Foam, Fmx103 Minocycline Foam 1.5%. These drug candidates are in various stages of clinical development as the company works toward FDA approval.