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PEPTONIC medical AB (DE:28L)
FRANKFURT:28L
Oxytocin 400 Iu Vaginal Gel
Vulvovaginal Atrophy
Phase II
Completed
Study to Evaluate Efficacy of Vagitocin in Postmenopausal Women With Vulvovaginal Atrophy Symptoms
May 08, 2017
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Oxytocin
Atrophy
Phase II
Completed
An Efficacy Study of Vagitocin in Postmenopausal Women With Symptoms of Vaginal Atrophy
Jul 06, 2015
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Oxytocin 100 I.U., Oxytocin 400 I.U.
Vaginal Atrophy
Phase II
Completed
Dose-relationship of Vaginally Administrated Oxytocin in Postmenopausal Women
Nov 13, 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 PEPTONIC medical AB (28L) have in its pipeline
28L is currently developing the following drugs: Oxytocin 400 Iu Vaginal Gel, Oxytocin, Oxytocin 100 I.U., Oxytocin 400 I.U.. These drug candidates are in various stages of clinical development as the company works toward FDA approval.