Ustekinumab
Withdrawn from marketAlso known as Imuldosa, Otulfi, Pyzchiva, Selarsdi+5 more
Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, Steqeyma, Wezlana, Yesintek.
Recent clinical, regulatory, research and industry developments relating to this drug.
Indication expansion: USTEKINUMAB (BLA761406)
Label change: USTEKINUMAB (BLA125261)
Market withdrawal: Qoyvolma (EMA)
Label change: USTEKINUMAB (BLA125261)
Supplemental approval: USTEKINUMAB (BLA761406)
Label change: USTEKINUMAB (BLA125261)
Label change: USTEKINUMAB (BLA125261)
Approval: USTEKINUMAB (BLA761406)
Label change: USTEKINUMAB (BLA125261)
Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Regulatory timeline
The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.
Indication: Adult Crohn’s Disease Qoyvolma is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with,… Show full indicationShow less
Adult Crohn’s Disease Qoyvolma is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Paediatric Crohn's Disease Qoyvolma is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy. Ulcerative colitis Qoyvolma is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Qoyvolma is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasis Qoyvolma is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Qoyvolma, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
Indication: Crohn’s Disease Usgena is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response… Show full indicationShow less
Crohn’s Disease Usgena is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist. Ulcerative colitis Usgena is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic. Plaque psoriasis Usgena is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1). Paediatric plaque psoriasis Usgena is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1). Psoriatic arthritis (PsA) Usgena, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Indication: Plaque psoriasis Yesintek is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are… Show full indicationShow less
Plaque psoriasis Yesintek is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A). Paediatric plaque psoriasis Yesintek is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Psoriatic arthritis (PsA) Yesintek, alone or in combination with MTX, is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Adult Crohn’s Disease Yesintek is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with lost response to, or were intolerant to either conventional therapy or a TNFα (tumor necrosis factor alpha) antagonist or have medical contraindications to such therapies Paediatric Crohn's Disease (applicable only for vial and PFS presentations) Yesintek is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40 kg, who have had an inadequate response to, or were intolerant to either conventional or biologic therapy.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Journals, researchers & institutions
- BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy1
- Al-Saleh J1
- Balsa A1
- Barile-Fabris L1
- Hawes C1
- Horiuchi T1
- Kola B1
- Lula S1
- Marshall L1
- Collegeville1
- Dubai Hospital1
- Hospital de Especialidades Centro Médico Nacional Siglo XXI1
- Instituto de Investigación Sanitaria del Hospital Universitario La Paz (IdiPAZ)1
- Keio University School of Medicine1
- Kyushu University Beppu Hospital1
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Studied across 6 of the same disease areas as Ustekinumab in the shared literature.
Studied across 6 of the same disease areas as Ustekinumab in the shared literature.
Studied across 6 of the same disease areas as Ustekinumab in the shared literature.
Studied across 6 of the same disease areas as Ustekinumab in the shared literature.
- RxNorm (U.S. National Library of Medicine) — drug identity
- Europe PMC — research literature
- Regulatory event sources are credited in the Regulatory Timeline above.