Luspatercept
- Generic Name
- Luspatercept
- Brand Names
- Reblozyl
- Drug Type
- Biotech
- CAS Number
- 1373715-00-4
- Unique Ingredient Identifier
- AQK7UBA1LS
- Background
Luspatercept is a recombinant fusion protein comprised of a modified extracellular domain of activin receptor type IIB fused to the FC domain of human IgG1. It was first approved for use in the United States in November 2019 under the brand name Reblozyl® for the treatment of anemia in patients with beta thalassemia who require regular blood transfusions. Luspatercept is novel in that it ameliorates anemia via action on late-stage erythropoiesis, in contrast to typical erythropoiesis-stimulating agents (ESAs), such as darbepoetin alfa and epoetin alfa, which act only on early-stage erythropoiesis. Luspatercept's novel mechanism of action, then, is uniquely suited for the treatment of conditions in which late-stage erythropoiesis is defective, such as beta thalassemia and other myelodysplastic diseases.
- Indication
Luspatercept is indicated for the treatment of:
- Associated Conditions
- Anemia
An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia
- Conditions
- Erythrocyte TransfusionBeta-Thalassemia
- Interventions
- Other: Placebo
- First Posted Date
- 2015-11-13
- Last Posted Date
- 2023-04-18
- Lead Sponsor
- Celgene
- Target Recruit Count
- 336
- Registration Number
- NCT02604433
- Locations
- 🇺🇸
Children's Hospital of Los Angeles, Los Angeles, California, United States
🇦🇺Royal Adelaide Hospital Institute of Medical and Veterinary Science, Adelaide, South Australia, Australia
🇬🇷Laiko General Hospital of Athens, Ampelokipi - Athens, Greece
Extension Study to Evaluate Long-Term Effects of Luspatercept in Patients With Myelodysplastic Syndromes (MDS) (A536-05/MK-6143-003)
- First Posted Date
- 2014-10-20
- Last Posted Date
- 2024-07-29
- Lead Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Target Recruit Count
- 75
- Registration Number
- NCT02268383
- Locations
- 🇩🇪
Acceleron Investigative Site, Dresden, Germany
Extension Study to Evaluate the Safety and Efficacy of Luspatercept in Participants With β-Thalassemia Previously Enrolled in A536-04 (A536-06/MK-6143-004)
- First Posted Date
- 2014-10-20
- Last Posted Date
- 2024-07-18
- Lead Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Target Recruit Count
- 51
- Registration Number
- NCT02268409
- Locations
- 🇮🇹
Acceleron Investigative Site, Turin, Italy
Study to Evaluate the Safety and Efficacy of Luspatercept (ACE-536) in Participants With Beta-thalassemia (A536-04/MK-6143-002)
- First Posted Date
- 2012-12-13
- Last Posted Date
- 2024-07-18
- Lead Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Target Recruit Count
- 64
- Registration Number
- NCT01749540
- Locations
- 🇮🇹
AORN A. Cardarelli, Napoli, Italy
🇮🇹CEMEF Medicina 2, Modena, Italy
🇮🇹ARNAS Garibaldi - P.O. Garibaldi Centro, Catania, Italy
Study of Luspatercept for the Treatment of Anemia in Patients With Myelodysplastic Syndrome (MDS) (MK-6143-001)
- First Posted Date
- 2012-12-13
- Last Posted Date
- 2024-07-29
- Lead Sponsor
- Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
- Target Recruit Count
- 116
- Registration Number
- NCT01749514
- Locations
- 🇩🇪
Acceleron Investigative Site, Dresden, Germany
Connect® Myeloid Disease Registry
- Conditions
- Primary MyelofibrosisMyelodysplastic SyndromesLeukemia, Myeloid, Acute
- Interventions
- First Posted Date
- 2012-09-19
- Last Posted Date
- 2024-05-02
- Lead Sponsor
- Celgene
- Target Recruit Count
- 2300
- Registration Number
- NCT01688011
- Locations
- 🇺🇸
Local Institution - 1088, Cleveland, Ohio, United States
🇺🇸Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
🇺🇸TriHealth, Good Samaritan Hospital, Cincinnati, Ohio, United States
Drug Development Updates
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