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Mereo Biopharma Group Plc (MREO)
NASDAQ:MREO
Setrusumab
Osteogenesis Imperfecta
Phase II
Terminated
Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta
Mar 28, 2022
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Setrusumab
Osteogenesis Imperfecta
Phase II/III
Active Not Recruiting
Setrusumab vs Placebo for Osteogenesis Imperfecta
Nov 08, 2021
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Nivolumab, Etigilimab
Metastatic Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult
Phase I/II
Completed
A Study of Etigilimab and Nivolumab in Participants With Locally Advanced or Metastatic Tumors
Feb 12, 2021
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Alvelestat Oral Tablet - Dose 1, Alvelestat Oral Tablet - Dose 2
Copd, Emphysema, Alpha 1-Antitrypsin Deficiency
Phase II
Completed
A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.
Jun 20, 2018
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Bct197, Itraconazole 200 Mg
Interaction
Phase I
Completed
The Effect of Itraconazole on BCT197 Exposure in Healthy Male Participants
Apr 06, 2018
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Bps804
Osteogenesis Imperfecta
Phase II
Withdrawn
An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
Jul 12, 2017
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Vitamin D, Calcium, Setrusumab, Zoledronic Acid (Optional)
Osteogenesis Imperfecta, Type I, Osteogenesis Imperfecta Type Iii, Osteogenesis Imperfecta Type Iv
Phase II
Completed
A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Apr 03, 2017
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Bct197, Azithromycin
Interaction
Phase I
Completed
The Effect of Azithromycin on BCT197 Exposure in Healthy Male Volunteers
Sep 28, 2016
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Bgs649
Hypogonadotropic Hypogonadism
Phase II
Completed
A 6 Month Safety Extension Study of MBGS205
Sep 12, 2016
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Bgs649
Hypogonadotropic Hypogonadism
Phase II
Completed
Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism
Mar 17, 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 Mereo Biopharma Group Plc (MREO) have in its pipeline
MREO is currently developing the following drugs: Setrusumab, Setrusumab, Nivolumab, Etigilimab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.