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Novan Inc (NOVN)
NASDAQ:NOVN
Vehicle Gel, Sb206 10.3% Berdazimer
Molluscum Contagiosum
Phase III
Completed
A Phase 3 Molluscum Contagiosum Efficacy and Safety Study
Aug 27, 2020
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Sb206 12%
Molluscum Contagiosum
Phase III
Completed
A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1)
Apr 23, 2019
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Sb206 12%
Molluscum Contagiosum
Phase III
Completed
A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC
Apr 23, 2019
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Sb206 12%, Sb206 4%, Sb206 8%
Molluscum Contagiosum
Phase II
Completed
A Study to Evaluate the Safety and Efficacy of SB206 in Subjects With Molluscum Contagiosum
Feb 06, 2018
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Vehicle, Sb414 6%
Psoriasis
Phase I
Completed
A Study Assessing the PK, PD, Safety, and Tolerability of SB414 in Psoriasis
Jan 31, 2018
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Vehicle, Sb414 6%, Sb414 2%
Atopic Dermatitis
Phase I
Completed
A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
Jan 31, 2018
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Vehicle Gel, Sb208 2%, Sb208 4%, Sb208 16%
Tinea Pedis
Phase II
Completed
SB208 for the Treatment of Tinea Pedis
Aug 02, 2016
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Sb204 4%
Acne Vulgaris
Phase I
Completed
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
Jun 09, 2016
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Sb204 4%
Acne Vulgaris
Phase III
Completed
P3 Long Term Safety Study of Once Daily SB204 in Acne
Jun 09, 2016
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Vehicle Gel, Sb204 4%
Acne Vulgaris
Phase III
Completed
P3 Study in Acne Comparing Once Daily SB204 and Vehicle
Feb 01, 2016
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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 Novan Inc (NOVN) have in its pipeline
NOVN is currently developing the following drugs: Vehicle Gel, Sb206 10.3% Berdazimer, Sb206 12%, Sb206 12%. These drug candidates are in various stages of clinical development as the company works toward FDA approval.