COMPANY
Rhythm Pharmaceuticals
FDA-approved therapeutic company Clinical Phase 3
Rhythm Pharmaceuticals is a biopharmaceutical company focused on rare neuroendocrine diseases. Rhythm Pharmaceuticals' medicine IMCIVREE (setmelanotide), FDA-approved in 2020, is designed to treat severe obesity caused by an impairment of the MC4R pathway in the hypothalamus. From company website Source · Source · checked 2026-10-19
Sources for this description (2)
- Rhythm Pharmaceuticals is a biopharmaceutical company focused on rare neuroendocrine diseases.
- “Rhythm Pharmaceuticals is a global biopharmaceutical company committed to transforming the lives of patients with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.” https://rhythmtx.com/ (2026-10-19)
- Rhythm Pharmaceuticals' medicine IMCIVREE (setmelanotide), FDA-approved in 2020, is designed to treat severe obesity caused by an impairment of the MC4R pathway in the hypothalamus.
- “Our lead asset, IMCIVREE® (setmelanotide), FDA-approved in 2020, is a precision medicine designed to treat severe obesity caused by an impairment of a pathway in the hypothalamus called the MC4R pathway.” https://rhythmtx.com/about/ (2026-10-19)
Hiring
| Title | Location (from posting) | Employer posted | First seen |
|---|---|---|---|
| Associate Director, US Patient Marketing | Boston, MA | Not stated | Oct 17, 2026 |
| Head of Global Strategic Sourcing | Boston, MA | Not stated | Oct 11, 2026 |
| Treasury Manager | Boston, MA | Not stated | Oct 11, 2026 |
| Associate Director, Biostatistics | Boston, MA | Not stated | Oct 11, 2026 |
| Senior Director, Biostatistics | Boston, MA | Not stated | Oct 11, 2026 |
Timeline
- FDA FDA New indication / efficacy supplement: IMCIVREE (setmelanotide acetate) — NDA213793/9, Mar 19, 2026. Applicant at approval: Rhythm Pharmaceuticals, Inc. source ↗
- Trial start Phase 2: A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO) source ↗
- Trial start Phase 3: A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) source ↗
- Raise Follow-on offering: $175M (total, as published), announced Jul 10, 2025. Source: company release on GlobeNewswire. source ↗
- Trial start Phase 2: A Study of Setmelanotide in Patients With Prader-Willi Syndrome source ↗
- FDA FDA New indication / efficacy supplement: IMCIVREE (setmelanotide acetate) — NDA213793/7, Dec 20, 2024. Applicant at approval: Rhythm Pharmaceuticals, Inc. source ↗
- Trial start Phase 3: Open-Label Extension Study of Setmelanotide source ↗
- Trial start Phase 2: A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity source ↗
- Trial start Phase 1/Phase 2: A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment source ↗
- Trial start Phase 3: A Trial of Setmelanotide in Acquired Hypothalamic Obesity source ↗
- Trial start Phase 3: Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity source ↗
- Trial start 3: Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway source ↗
- Trial start Phase 3: EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway source ↗
- Trial start Phase 2: DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway source ↗
- Trial start Phase 4: Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants source ↗
- Trial start Phase 2: Open-Label Study of Setmelanotide in Hypothalamic Obesity source ↗
- Trial start 1: A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment source ↗
- Trial start —: An Observational,Prospective Natural History Study of Early-Onset Extreme Obesity Due to Bi-Allelic Loss-of-Function Mutations in the POMC, PCSK1 or LEPR Genes source ↗
- Trial start Phase 3: Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity source ↗
- Trial start Phase 2/Phase 3: Long Term Extension Trial of Setmelanotide source ↗
- Trial start —: The TEMPO (Tracing the Effect of the MC4 Pathway in Obesity) Registry source ↗
- Trial start Phase 3: Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity source ↗
- Trial start Phase 2: Setmelanotide in a Single Patient With Partial Lipodystrophy source ↗
- Trial start Phase 3: Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity source ↗
- Trial start 2: Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity source ↗
Upcoming milestones
- Oct 31, 2026 (ESTIMATED) · Phase 2 · A Study of Setmelanotide in Patients With Prader-Willi Syndrome · NCT06772597
- Mar 13, 2027 (ESTIMATED) · Phase 3 · A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) · NCT06760546
- May 7, 2027 (ESTIMATED) · Phase 1/Phase 2 · A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment · NCT06239116
- Apr 15, 2028 (ESTIMATED) · Phase 2 · A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO) · NCT07156578
Funding
- Follow-on offering: $175M (total, as published), announced Jul 10, 2025. Source: company release on GlobeNewswire. source ↗
Clinical trials (lead sponsor) 29
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06239116 | A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment | Phase 1/Phase 2 | Active, not recruiting | Mar 5, 2024 | May 7, 2027 (estimated) |
| NCT05774756 | A Trial of Setmelanotide in Acquired Hypothalamic Obesity | Phase 3 | Active, not recruiting | Apr 26, 2023 | Mar 18, 2025 (actual) |
| NCT05093634 | EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway | Phase 3 | Completed | Dec 10, 2021 | Dec 22, 2025 (actual) |
| NCT06596135 | Open-Label Extension Study of Setmelanotide | Phase 3 | Completed | Oct 21, 2024 | Jun 24, 2026 (actual) |
| NCT06046443 | A Study to Assess Efficacy and Safety of LB54640 in Patients With Hypothalamic Obesity | Phase 2 | Completed | Jul 11, 2024 | Feb 9, 2026 (actual) |
| NCT06772597 | A Study of Setmelanotide in Patients With Prader-Willi Syndrome | Phase 2 | Active, not recruiting | Mar 4, 2025 | Oct 31, 2026 (estimated) |
| NCT06760546 | A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756) | Phase 3 | Recruiting | Sep 23, 2025 | Mar 13, 2027 (estimated) |
| NCT07156578 | A Long-Term Study of Bivamelagon in Participants With Hypothalamic Obesity (HO) | Phase 2 | Enrolling by invitation | Nov 10, 2025 | Apr 15, 2028 (estimated) |
| NCT04963231 | DAYBREAK: A Study of Setmelanotide in Participants With Specific Gene Variants in the Melanocortin-4 Receptor (MC4R) Pathway | Phase 2 | Completed | Nov 30, 2021 | Aug 4, 2023 (actual) |
| NCT03651765 | Long Term Extension Trial of Setmelanotide | Phase 2/Phase 3 | Completed | Jul 15, 2018 | Jan 9, 2025 (actual) |
| NCT04725240 | Open-Label Study of Setmelanotide in Hypothalamic Obesity | Phase 2 | Completed | Jun 7, 2021 | Jun 28, 2022 (actual) |
| NCT04966741 | Setmelanotide in Pediatric Participants With Rare Genetic Diseases of Obesity | Phase 3 | Completed | Mar 8, 2022 | Sep 18, 2023 (actual) |
| NCT05194124 | Phase 3 Crossover Trial of Two Formulations of Setmelanotide in Participants With Specific Gene Defects in the MC4R Pathway | 3 | Completed | Dec 21, 2021 | Oct 19, 2023 (actual) |
| NCT05046132 | Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants | Phase 4 | Completed | Aug 5, 2021 | Apr 7, 2022 (actual) |
| NCT03746522 | Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity | Phase 3 | Completed | Nov 23, 2018 | Nov 16, 2020 (actual) |
| NCT02896192 | Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity | Phase 3 | Completed | Feb 14, 2017 | May 25, 2020 (actual) |
| NCT03013543 | Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity | 2 | Completed | Feb 10, 2017 | Mar 1, 2022 (actual) |
| NCT01749137 | Phase 2 Study to Evaluate Safety and Efficacy of RM-493 in Obese Participants | 2 | Completed | Jan 14, 2013 | Sep 28, 2013 (actual) |
| NCT02041195 | Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients | 1 | Completed | 2014-01 | 2014-08 (actual) |
| NCT02311673 | Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome | 2 | Completed | Mar 19, 2015 | Oct 26, 2016 (actual) |
| NCT03287960 | Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity | Phase 3 | Completed | Jan 30, 2018 | Sep 25, 2020 (actual) |
| NCT02849977 | Genetic Testing and Phenotypic Characterization of Severely Obese Pediatric and Adult Volunteers | Not listed | Completed | Sep 28, 2016 | Jun 9, 2020 (actual) |
| NCT05183802 | An Expanded Access Protocol for Setmelanotide for Treatment of Bardet-Biedl Syndrome (BBS) | Not listed | Approved for marketing | Not listed | Not listed |
| NCT03262610 | Setmelanotide in a Single Patient With Partial Lipodystrophy | Phase 2 | Completed | Aug 15, 2017 | Jan 31, 2018 (actual) |
| NCT04348175 | A Phase 1 Study to Evaluate the Pharmacokinetics of Setmelanotide in Subjects With Varying Degrees of Renal Impairment | 1 | Completed | Jul 9, 2020 | Apr 17, 2021 (actual) |
| NCT03621007 | An Observational,Prospective Natural History Study of Early-Onset Extreme Obesity Due to Bi-Allelic Loss-of-Function Mutations in the POMC, PCSK1 or LEPR Genes | Not listed | Completed | Aug 6, 2019 | Jan 22, 2021 (actual) |
| NCT03479437 | The TEMPO (Tracing the Effect of the MC4 Pathway in Obesity) Registry | Not listed | Completed | Apr 15, 2018 | Dec 1, 2020 (actual) |
| NCT01867437 | Effects of RM-493 on Energy Expenditure in Obese Individuals | Phase 1 | Completed | 2013-05 | 2014-03 (actual) |
| NCT02431442 | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers | Phase 1 | Completed | 2012-01 | 2014-01 (actual) |
FDA records (last 2 years)
- FDA New indication / efficacy supplement: IMCIVREE (setmelanotide acetate) — NDA213793/9, Mar 19, 2026. Applicant at approval: Rhythm Pharmaceuticals, Inc. source ↗
- FDA New indication / efficacy supplement: IMCIVREE (setmelanotide acetate) — NDA213793/7, Dec 20, 2024. Applicant at approval: Rhythm Pharmaceuticals, Inc. source ↗
NIH awards 3
- NIH award 5R01FD005094-03 FY2017: $210,406 awarded for that fiscal year; activity R01 (OTHER_NIH); PI GOTTESDIENER, KEITH; recipient as written: RHYTHM PHARMACEUTICALS, INC., BOSTON, MA. Phase II clinical evaluation source ↗
- NIH award 5R01FD005094-02 FY2016: $392,688 awarded for that fiscal year; activity R01 (OTHER_NIH); PI GOTTESDIENER, KEITH; recipient as written: RHYTHM PHARMACEUTICALS, INC., BOSTON, MA. Phase II clinical evaluation source ↗
- NIH award 1R01FD005094-01A1 FY2015: $396,259 awarded for that fiscal year; activity R01 (OTHER_NIH); PI GOTTESDIENER, KEITH; recipient as written: RHYTHM PHARMACEUTICALS, INC., BOSTON, MA. Phase II clinical evaluatio source ↗
Open jobs 56
| Title | Location (from posting, not HQ) | Employer posted | First seen | Level |
|---|---|---|---|---|
| Associate Director, US Patient Marketing | Boston, MA | Not stated | Oct 17, 2026 | Not stated |
| Head of Global Strategic Sourcing | Boston, MA | Not stated | Oct 11, 2026 | Not stated |
| Treasury Manager | Boston, MA | Not stated | Oct 11, 2026 | Not stated |
| Associate Director, Biostatistics | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Senior Director, Biostatistics | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Senior Statistical Programmer | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Director, Field Operations & Effectiveness | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Director, Patient Services Training | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Executive Medical Director | Boston, MA | Not stated | Oct 11, 2026 | Executive |
| Senior Director, Clinical Pharmacology | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Senior Manager, Compensation | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| (Senior) Brand Manager Italy | Milan, Italy | Not stated | Oct 11, 2026 | Senior |
| (Senior) Brand Manager, Iberia | Madrid, Spain | Not stated | Oct 11, 2026 | Mid |
| Director, HR Business Partner, International | Amsterdam, Netherlands | Not stated | Oct 11, 2026 | Senior |
| Federated Registry Data Scientist | Madrid; London; Paris; Amsterdam; Munich, UK, France, Netherlands, Germany, Spain, Italy, France | Not stated | Oct 11, 2026 | Mid |
| Federated Registry Program Coordinator | Remote | Not stated | Oct 11, 2026 | Entry |
| Hospital Affairs Director, Germany | Munich, Germany | Not stated | Oct 11, 2026 | Senior |
| Hospital Affairs Lead - Germany (East) | Berlin, Germany | Not stated | Oct 11, 2026 | Not stated |
| Hospital Affairs Lead - Germany (North) | Hamburg, Germany | Not stated | Oct 11, 2026 | Senior |
| Hospital Affairs Lead - Germany (South) | Munich, Germany | Not stated | Oct 11, 2026 | Not stated |
| Hospital Affairs Lead - UK & Ireland (Midlands East) | Leicester, United Kingdom | Not stated | Oct 11, 2026 | Not stated |
| Hospital Affairs Lead - UK & Ireland (Midlands West) | Birmingham, United Kingdom | Not stated | Oct 11, 2026 | Not stated |
| Hospital Affairs Lead, Austria | Innsbruck or Salzburg or Linz, Western Austria, Austria | Not stated | Oct 11, 2026 | Senior |
| Scientific Affairs Manager - Germany (North East) | Remote | Not stated | Oct 11, 2026 | Mid |
| Scientific Affairs Manager - Italy (South) | Naples Metropolitan Area, Italy | Not stated | Oct 11, 2026 | Senior |
| Scientific Affairs Manager, UK - Manchester | Birmingham, United Kingdom | Not stated | Oct 11, 2026 | Senior |
| Senior Director, International Compliance | Amsterdam, London, Munich, Milan, Madrid, Netherlands | Not stated | Oct 11, 2026 | Senior |
| IT Business Analyst, Clinical & Biostatistics | Boston, MA | Not stated | Oct 11, 2026 | Mid |
| IT Business Analyst, G&A | Boston, MA | Not stated | Oct 11, 2026 | Mid |
| IT Business Analyst, Regulatory | Boston, MA | Not stated | Oct 11, 2026 | Mid |
| Senior Regional Account Manager | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Senior Medical Communications Writer - Medical Affairs, North America | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Director, Program Management | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Associate Director, Medical Writing | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Director, Regulatory CMC | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Director, Nonclinical Development - ADME/DMPK | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Director, Nonclinical Development - Toxicology | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Territory Manager (Eastern Canada) | Montreal, QC, Canada | Not stated | Oct 11, 2026 | Mid |
| Territory Manager, BBS (Northwest - Seattle) | Seattle, WA | Not stated | Oct 11, 2026 | Not stated |
| Territory Manager, BBS (Sierra West) | San Francisco, CA | Not stated | Oct 11, 2026 | Mid |
| Territory Manager, BBS (Southwest) | Los Angeles, CA | Not stated | Oct 11, 2026 | Mid |
| Senior Publications Manager | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Quality Assurance Specialist | Amsterdam, Netherlands | Not stated | Oct 11, 2026 | Mid |
| Senior Director, Analytical Development & Quality Control | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Senior Manager, Analytical Chemistry | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Senior Manager, Drug Substance | Boston, MA | Not stated | Oct 11, 2026 | Senior |
| Senior Manager, Quality Assurance/Qualified Person | Amsterdam, Netherlands | Not stated | Oct 11, 2026 | Senior |
| Senior Manager, Swiss Responsible Person and GDP Quality Assurance | Zug, Switzerland | Not stated | Oct 11, 2026 | Senior |
| Medical Science Liaison (Senior Manager, Field Medical) - New York Metro | New York, NY | Not stated | Oct 11, 2026 | Senior |
| Medical Science Liaison (Senior Manager, Field Medical) - Northwest | Seattle, WA | Not stated | Oct 11, 2026 | Senior |
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