Emapalumab
- Generic Name
- Emapalumab
- Brand Names
- Gamifant
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1709815-23-5
- Unique Ingredient Identifier
- 3S252O2Z4X
- Background
Emapalumab, also known as NI-0501, is a fully human monoclonal antibody that targets interferon gamma. Emapalumab development was sponsored by NovImmune SA, further developed by Sobi and FDA approved on November 20, 2018. The approval of emapalumab was followed by the designation of orphan drug, priority review and breakthrough therapy. As well, emapalumab w...
- Indication
Emapalumab is indicated for the treatment of pediatric and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance to conventional HLH therapy.
...
- Associated Conditions
- Progressive, refractory, primary intolerance with conventional therapy, recurrent Hemophagocytic Lymphohistiocytosis
- Associated Therapies
- -
Emapalumab Prevention of CAR-T Cell Associated Toxicities
- Conditions
- Interventions
- First Posted Date
- 2024-08-12
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Marcela V. Maus, M.D.,Ph.D.
- Target Recruit Count
- 28
- Registration Number
- NCT06550141
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
A Pilot Study of Emapalumab for the Treatment of CAR T-Cell Therapy-Associated Prolonged Cytopenia
- First Posted Date
- 2024-02-29
- Last Posted Date
- 2024-05-06
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 32
- Registration Number
- NCT06285825
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
A Study of Treatment of Inflammation Before Stem Cell Transplant in People With a Primary Immune Regulatory Disorder (PIRD) and/or an Autoinflammatory Condition
- First Posted Date
- 2023-03-28
- Last Posted Date
- 2024-11-20
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Target Recruit Count
- 39
- Registration Number
- NCT05787574
- Locations
- 🇺🇸
University of California, San Francisco (Data collection only), San Francisco, California, United States
🇺🇸Children's Healthcare of Atlanta (Data Collection Only), Atlanta, Georgia, United States
🇺🇸Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
Evaluate Efficacy, Safety and Tolerability, PK and PD of Emapalumab in Children and Adults With MAS in Still's or SLE
- Conditions
- Interventions
- First Posted Date
- 2021-08-12
- Last Posted Date
- 2024-10-15
- Lead Sponsor
- Swedish Orphan Biovitrum
- Target Recruit Count
- 41
- Registration Number
- NCT05001737
- Locations
- 🇧🇪
Universitair Ziekenhuis Leuven, Leuven, Belgium
🇨🇳Children's Hospital of Fudan University, Shanghai, China
🇳🇱UMC Utrecht, Utrecht, Netherlands
Study to Investigate the Pharmacokinetics, Pharmacodynamics and Assess the Efficacy and Safety to Support Dose Selection of Emapalumab in Pre-empting Graft Failure in Patients at High Risk After HSCT.
- First Posted Date
- 2021-01-29
- Last Posted Date
- 2023-12-28
- Lead Sponsor
- Swedish Orphan Biovitrum
- Target Recruit Count
- 2
- Registration Number
- NCT04731298
- Locations
- 🇨🇦
CHU Sainte-Justine, Montréal, Quebec, Canada
🇮🇱The Rambam Academic Hospital, Haifa, Israel
🇮🇱Hadassah Hebrew University, Jerusalem, Israel
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH
- First Posted Date
- 2019-06-13
- Last Posted Date
- 2023-10-06
- Lead Sponsor
- Swedish Orphan Biovitrum
- Target Recruit Count
- 7
- Registration Number
- NCT03985423
- Locations
- 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis
- First Posted Date
- 2017-10-18
- Last Posted Date
- 2024-03-12
- Lead Sponsor
- Swedish Orphan Biovitrum
- Target Recruit Count
- 35
- Registration Number
- NCT03312751
- Locations
- 🇺🇸
Texas Children's Hospital - Feigin Center, Houston, Texas, United States
🇺🇸Cincinnati Children's Hospital, Cincinnati, Ohio, United States
🇺🇸Seattle Children's Hospital, Seattle, Washington, United States
A Study to Investigate the Safety and Efficacy of Emapalumab, an Anti-IFN-gamma mAb in Patients With Systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still's Disease (AOSD) Developing Macrophage Activation Syndrome/Secondary HLH (MAS/sHLH)
- Conditions
- Interventions
- First Posted Date
- 2017-10-17
- Last Posted Date
- 2022-05-17
- Lead Sponsor
- Swedish Orphan Biovitrum
- Target Recruit Count
- 14
- Registration Number
- NCT03311854
- Locations
- 🇮🇹
IRCCS Ospedale Pediatrico, Bambino Gesù, Rome, Italy
🇬🇧Great Ormond Street Hospital for Children, London, United Kingdom
🇪🇸Hospital Sant Joan de Deu, Barcelona, Spain
A Study for Long-term Follow-up of Hemophagocytic Lymphohistiocytosis (HLH) Participants Who Received Treatment With Emapalumab (NI-0501), an Anti-interferon Gamma Monoclonal Antibody
- First Posted Date
- 2014-02-24
- Last Posted Date
- 2022-06-28
- Lead Sponsor
- Swedish Orphan Biovitrum
- Target Recruit Count
- 58
- Registration Number
- NCT02069899
- Locations
- 🇬🇧
Great Ormond Street Hospital - Department of Haematology, London, United Kingdom
🇮🇹Azienda Ospedaliera Padova, Padova, Italy
🇮🇹Ospedale della Donna e del Bambino - U.O.C. Oncoematologia Pediatrica, Verona, Italy
Drug Development Updates
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