Rozanolixizumab
- Generic Name
- Rozanolixizumab
- Brand Names
- Rystiggo
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1584645-37-3
- Unique Ingredient Identifier
- P7186074QC
- Background
Rozanolixizumab is a humanized high-affinity anti-human neonatal Fc receptor (FcRn) monoclonal antibody (IgG4P) targeting the immunoglobulin G (IgG). Rozonolixizumab itself is an IgG4P, an inactive isotype, to reduce the likelihood of unwanted chain exchange. It is investigated for use in autoimmune and alloimmune diseases with pathologic IgG, particularly g...
- Indication
Rozanolixizumab-noli is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
- Associated Conditions
- Generalized Myasthenia Gravis
- Associated Therapies
- -
A Study to Assess the Concentration of Rozanolixizumab in the Breast Milk of Healthy Lactating Women
- First Posted Date
- 2024-12-06
- Last Posted Date
- 2024-12-16
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 20
- Registration Number
- NCT06720714
- Locations
- đşđ¸
UP0141 2, San Antonio, Texas, United States
đşđ¸UP0141 1, Salt Lake City, Utah, United States
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
- First Posted Date
- 2024-08-06
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 12
- Registration Number
- NCT06540144
- Locations
- đ¨đł
Mg0008 20081, Taipei City, Taiwan
đŽđšMg0008 40290, Bologna, Italy
đľđąMg0008 40734, Lodz, Poland
A Study of Rozanolixizumab in Pediatric Study Participants With Moderate to Severe Generalized Myasthenia Gravis
- First Posted Date
- 2023-11-29
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 12
- Registration Number
- NCT06149559
- Locations
- đľđą
Mg0006 40734, Lodz, Poland
đ¨đłMg0006 20081, Taipei City, Taiwan
đŽđšMg0006 40144, Milano, Italy
A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)
- First Posted Date
- 2023-01-12
- Last Posted Date
- 2024-05-23
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 62
- Registration Number
- NCT05681715
- Locations
- đˇđ¸
Mg0020 40729, NIS, Serbia
đşđ¸Mg0020 50099, San Francisco, California, United States
đŽđšMg0020 40150, Roma, Italy
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
- First Posted Date
- 2022-12-09
- Last Posted Date
- 2024-08-09
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 63
- Registration Number
- NCT05643794
- Locations
- đŹđ§
Fm0001 4402, Manchester, United Kingdom
đŹđ§Fm0001 4405, Blackpool, United Kingdom
đŹđ§Fm0001 4406, Cannock, United Kingdom
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOG-AD)
- Conditions
- Interventions
- First Posted Date
- 2021-09-30
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 104
- Registration Number
- NCT05063162
- Locations
- đşđ¸
Mog001 50308, Tampa, Florida, United States
đşđ¸Mog001 50297, Scottsdale, Arizona, United States
đşđ¸Mog001 50450, Palo Alto, California, United States
CIDP07 Rozanolixizumab Post Trial Access Program (the PTA)
- First Posted Date
- 2021-08-20
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- UCB Biopharma SRL
- Registration Number
- NCT05014724
A Study to Test the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis
- Conditions
- Interventions
- First Posted Date
- 2021-05-06
- Last Posted Date
- 2024-06-28
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 12
- Registration Number
- NCT04875975
- Locations
- đşđ¸
Aie001 50342, Jacksonville, Florida, United States
đşđ¸Aie001 50298, New York, New York, United States
đşđ¸Aie001 50090, Winston-Salem, North Carolina, United States
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rozanolixizumab Administered Subcutaneously Via Manual Push Versus Syringe Driver to Healthy Participants
- Conditions
- Interventions
- First Posted Date
- 2021-04-02
- Last Posted Date
- 2024-03-07
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 32
- Registration Number
- NCT04828343
- Locations
- đŹđ§
Up0106 001, London, United Kingdom
A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis
- First Posted Date
- 2020-12-03
- Last Posted Date
- 2024-02-26
- Lead Sponsor
- UCB Biopharma SRL
- Target Recruit Count
- 165
- Registration Number
- NCT04650854
- Locations
- đ¨đł
Mg0007 20086, Taipei City, Taiwan
đşđ¸Mg0007 50073, Tampa, Florida, United States
đşđ¸Mg0007 50122, Miami, Florida, United States
Drug Development Updates
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