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Rhythm Pharmaceuticals Inc (RYTM)
NASDAQ:RYTM
Bivamelagon
Hypothalamic Obesity
Phase II
Not Yet Recruiting
A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO)
Aug 25, 2025
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Setmelanotide
Obesity, Prader-Willi Syndrome, Hyperphagia
Phase II
Recruiting
A Study of Setmelanotide in Patients With Prader-Willi Syndrome
Jan 10, 2025
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Setmelanotide
Hypothalamic Obesity, Multiple Pituitary Hormone Deficiency Genetic Form, Septo-Optic Dysplasia, Optic Nerve Hypoplasia, Childhood-Onset Combined Pituitary Hormone Deficiency, Pituitary Stalk Interruption Syndrome
Phase III
Recruiting
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Dec 31, 2024
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Setmelanotide
Obesity Associated With Defects In Leptin-Melanocortin Pathway
Phase III
Enrolling By Invitation
Open-Label Extension Study of Setmelanotide
Sep 10, 2024
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Part C: Rm-718
Hypothalamic Obesity
Phase I
Recruiting
A Study of RM-718 in Healthy Subjects and in Patients With HO
Jan 25, 2024
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Lb54640
Hypothalamic Obesity
Phase II
Active Not Recruiting
A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity
Sep 14, 2023
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Setmelanotide
Hypothalamic Obesity
Phase III
Active Not Recruiting
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Mar 01, 2023
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Setmelanotide
Obesity, Genetic Obesity
Phase III
Active Not Recruiting
EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway
Sep 30, 2021
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Setmelanotide 2 Mg, Setmelanotide 2.5 Mg, Setmelanotide 3 Mg, Setmelanotide 20 Mg, Setmelanotide 25 Mg, Setmelanotide 30 Mg
Bardet-Biedl Syndrome, Pomc Deficiency
Phase III
Completed
Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway
Jul 27, 2021
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Setmelanotide
Genetic Obesity
Phase II
Completed
DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway
Jun 28, 2021
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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 Rhythm Pharmaceuticals Inc (RYTM) have in its pipeline
RYTM is currently developing the following drugs: Bivamelagon, Setmelanotide, Setmelanotide. These drug candidates are in various stages of clinical development as the company works toward FDA approval.