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Minocycline Hydrochloride Capsules
Rosacea
Phase I
Completed
Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks
Oct 24, 2022
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Dfd-29 (Minocycline) Fasting, Dfd-29 (Minocycline) Fed, Solodyn (Minocycline) Fasting
Pharmacokinetics
Phase I
Completed
A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects
Jun 19, 2022
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Dfd-29, Doxycycline
Papulopustular Rosacea
Phase III
Completed
A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2)
Apr 18, 2022
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Dfd-29, Doxycycline
Papulopustular Rosacea
Phase III
Completed
A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.
Mar 17, 2022
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Vehicle, Glycopyrronium Cloth, 2.4%
Palmar Hyperhidrosis
Phase II
Completed
A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis
Mar 15, 2019
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Glycopyrronium Topical Wipes
Hyperhidrosis
Phase III
Completed
Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis
Sep 15, 2015
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Vehicle, Glycopyrronium Topical Wipes
Hyperhidrosis
Phase III
Completed
Study of Glycopyrronium in Axillary Hyperhydrosis
Aug 19, 2015
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Vehicle, Glycopyrronium Topical Wipes
Hyperhidrosis
Phase III
Completed
Study of Glycopyrronium in Subjects With Axillary Hyperhidrosis
Aug 19, 2015
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Vehicle, Dose 1 Of Glycopyrrolate, 2.0% Qd, Dose 2 Of Glycopyrrolate, 3.0% Qd, Dose 1 Of Glycopyrronium, 2.5% Qd, Dose 2 Of Glycopyrronium, 3.75% Qd
Hyperhidrosis
Phase II
Completed
Comparator Study of the Effect of Glycopyrrolate and Glycopyrronium in Subjects With Axillary Hyperhidrosis
Apr 30, 2014
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Vehicle, Glycopyrrolate, 1.0%, Glycopyrrolate, 2.0%, Glycopyrrolate, 3.0%, Glycopyrrolate, 4.0%
Hyperhidrosis
Phase II
Completed
A Dose-Ranging Study of the Effect of Glycopyrrolate in Subjects With Axillary Hyperhidrosis
Dec 16, 2013
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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 Journey Medical Corp (DERM) have in its pipeline
DERM is currently developing the following drugs: Minocycline Hydrochloride Capsules, Dfd-29 (Minocycline) Fasting, Dfd-29 (Minocycline) Fed, Solodyn (Minocycline) Fasting, Dfd-29, Doxycycline. These drug candidates are in various stages of clinical development as the company works toward FDA approval.