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Mbx 4291
Obesity
Phase I
Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MBX 4291 in Adult Participants With Obesity
Aug 04, 2025
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Mbx 1416 (Inn Imapextide)
Postbariatric Hypoglycemia
Phase II
Recruiting
Study to Evaluate Efficacy and Dose Response of Imapextide (STEADI)
Jun 11, 2025
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400 Μg Of Mbx 2109 Once-Weekly By Subcutaneous Injection, 200-1600 Μg Of Mbx 2109 Once-Weekly By Subcutaneous Injection
Hypoparathyroidism
Phase II
Recruiting
Extension Study to Evaluate the Long-Term Safety and Tolerability of MBX 2109 in Patients With Hypoparathyroidism
Jul 16, 2024
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Mbx 2109
Hypoparathyroidism
Phase II
Active Not Recruiting
Safety, Pharmacokinetics and Efficacy of MBX 2109 in Patients With Hypoparathyroidism
Jun 13, 2024
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Mbx 1416 (Part A), Mbx 1416 (Part B), Mbx 1416 (Part C)
Postbariatric Hypoglycemia
Phase I
Completed
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of MBX 1416 in Healthy Subjects
Aug 28, 2023
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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 MBX Biosciences, Inc. (MBX) have in its pipeline
MBX is currently developing the following drugs: Mbx 4291, Mbx 1416 (Inn Imapextide), 400 Μg Of Mbx 2109 Once-Weekly By Subcutaneous Injection, 200-1600 Μg Of Mbx 2109 Once-Weekly By Subcutaneous Injection. These drug candidates are in various stages of clinical development as the company works toward FDA approval.