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Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, preclinical, and clinical data. In case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market.
CagriSema entered Phase III clinical trials in 2023. [6] In December 2024, Novo Nordisk announced the results of REDEFINE 1, one of their series of Phase III trials, testing weekly cagrilintide 2.4 mg and semaglutide 2.4 mg individually and together versus placebo in obese or overweight subjects with one or more comorbidities. [7]
A pivotal trial is typically a Phase III clinical trial in the multi-year process of clinical research intended to demonstrate and confirm the safety and efficacy of a treatment – such as a drug candidate, medical device or clinical diagnostic procedure – and to estimate the incidence of common adverse effects. [1]
Buparlisib was under investigation as a treatment for advanced or metastatic HER2-negative breast cancer in several phase III clinical trials: . The phase III trial BELLE-2 compared buparlisib + fulvestrant with fulvestrant alone in patients with advanced or metastatic HER2-negative, hormone receptor-positive (HR+) aromatase inhibitor-resistant breast cancer.
Clinical trial costs vary depending on trial phase, type of trial, and disease studied. A study of clinical trials conducted in the United States from 2004 to 2012 found the average cost of Phase I trials to be between $1.4 million and $6.6 million, depending on the type of disease.
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness.
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