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