The vasomotor symptoms of menopause therapeutics have more than 20 drugs. In pipeline analysis, drugs are analyzed on the basis of route of administration and molecule type. The pipeline is also analyzed on the basis of monotherapy and combination therapy, and different clinical phases including Phase III, Phase II, Phase I and Pre-Clinical stage.
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Phase III clinical trial known for the comparison of new treatments with the standard treatment in which safety, efficacy and side effects of new intervention is compared with the already existing treatment. The Phase III clinical trial takes around 2-3 years to complete and the total number of participants vary from 100-1,000. In vasomotor symptoms of menopause, there are 2 drugs in Phase III clinical trial. For instance, (Estradiol + Progesterone) is under development by TherapeuticsMD, Inc. The drug candidate is a fixed dose novel combination of 17ß-estradiol and progesterone, which is developed for the treatment of moderate to severe vasomotor symptoms due to menopause, including hot flashes, night sweats, sleep disturbances, vaginal dryness, and for post-menopausal women with an intact uterus.
ESN-364, is a phase II drug candidate of Ogeda SA being developed for the treatment of vasomotor symptoms of menopause, polycystic ovary syndrome and uterine fibroids. In vasomotor symptoms of menopause, there are 8 drugs in Phase II clinical trial. Phase II clinical trial is the second phase that answer safety, efficacy and dosing of the new intervention. It takes around 2 years to complete and between 100 – 120 patients participate in the Phase II trial.
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FP-101 is under development by Fervent Pharmaceuticals for vasomotor symptoms. FP-101 is an oral formulation of a non-hormonal/non-herbal compound for the treatment of vasomotor symptoms associated with menopause and hot flashes. In vasomotor symptoms of menopause, there are 4 drugs in Phase I clinical trial. In Phase I clinical trial, safety of the new intervention is determined. The trial takes around 1-2 years to complete and the total number of volunteers participating in the trial vary between 15 – 30.