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Organon (OGN)
NYSE:OGN
Vtama (Tapinarof) Cream, 1%
Psoriasis
Phase IV
Completed
A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Region
Mar 14, 2023
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Atozet 10/40 Mg Or 10/80 Mg, Lipitor 40 Mg Or 80 Mg
Atherosclerotic Cardiovascular Disease
Phase IV
Completed
Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients
Feb 27, 2023
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Vtama® (Tapinarof) Cream 1%
Psoriasis
Phase IV
Completed
A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis
Dec 26, 2022
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Og-6219
Endometriosis
Phase II
Completed
A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain
Sep 20, 2022
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Tapinarof Cream, 1%
Atopic Dermatitis
Phase II
Completed
Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
Nov 08, 2021
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Tapinarof Cream, 1%
Atopic Dermatitis
Phase III
Completed
Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis
Oct 29, 2021
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Tapinarof Cream, 1%
Plaque Psoriasis
Phase III
Recruiting
Tapinarof for the Treatment of Plaque Psoriasis in Pediatric Subjects
Oct 28, 2021
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Vehicle Cream, Tapinarof Cream, 1%
Atopic Dermatitis
Phase III
Completed
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults (DMVT-505-3102)
Aug 27, 2021
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Vehicle Cream, Tapinarof Cream, 1%
Atopic Dermatitis
Phase III
Completed
Tapinarof for the Treatment of Atopic Dermatitis in Children and Adults
Aug 16, 2021
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Radiopaque Etonogestrel (Eng) Implant
Contraception
Phase III
Completed
A Study to Assess Contraceptive Efficacy and Safety of Etonogestrel (ENG) Implant Beyond 3 Years of Use (MK-8415-060)
Nov 06, 2020
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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 Organon (OGN) have in its pipeline
OGN is currently developing the following drugs: Vtama (Tapinarof) Cream, 1%, Atozet 10/40 Mg Or 10/80 Mg, Lipitor 40 Mg Or 80 Mg, Vtama® (Tapinarof) Cream 1%. These drug candidates are in various stages of clinical development as the company works toward FDA approval.