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SCYNEXIS (SCYX)
NASDAQ:SCYX
Ibrexafungerp
Vulvovaginal Candidiasis, Vaginal Candidiasis, Candida Infection
Phase I
Completed
Pharmacokinetic Study in Healthy Lactating Women Exposed to Ibrexafungerp
Jan 09, 2024
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Ibrexafungerp
Fungal Disease
Phase I
Completed
ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
Dec 08, 2022
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Ibrexafungerp
Vulvovaginal Candidiasis
Phase III
Completed
Ibrexafungerp for the Treatment of Complicated Vulvovaginal Candidiasis
May 23, 2022
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Fluconazole, Scy-078, Echinocandin
Candidemia, Candidiasis, Invasive
Phase III
Recruiting
A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole
Dec 16, 2021
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[14C]-Ibrexafungerp
Fungal Infection
Phase I
Completed
ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects
Mar 04, 2020
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Pra, Scy-078 Plus Pra
Pharmacokinetics
Phase I
Completed
Study to Evaluate the Effect of SCY-078 (Ibrexafungerp) on the PK of Pravastatin in Healthy Subjects
Sep 10, 2019
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Dab, Scy-078 Plus Dab
Pharmacokinetics
Phase I
Completed
Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects
Sep 03, 2019
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Fluconazole Tablet, Ibrexafungerp
Recurrent Vulvovaginal Candidiasis
Phase III
Completed
Phase 3 Study of Oral Ibrexafungerp (SCY-078) Vs. Placebo in Subjects With Recurrent Vulvovaginal Candidiasis (VVC)
Jul 19, 2019
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Ibrexafungerp
Candida Vulvovaginitis
Phase III
Completed
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis
Jun 12, 2019
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Ibrexafungerp
Candida Vulvovaginitis
Phase III
Completed
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
Oct 30, 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 SCYNEXIS (SCYX) have in its pipeline
SCYX is currently developing the following drugs: Ibrexafungerp, Ibrexafungerp, Ibrexafungerp. These drug candidates are in various stages of clinical development as the company works toward FDA approval.