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Drug

Ustekinumab

Withdrawn from market
ResearchRetrospective safety research
Also known as Imuldosa, Otulfi, Pyzchiva, Selarsdi+5 more

Imuldosa, Otulfi, Pyzchiva, Selarsdi, Starjemza, Stelara, Steqeyma, Wezlana, Yesintek.

RxNorm847083UNIIFU77B4U5Z0
1
Research papers
39
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Market withdrawal: Qoyvolma (EMA)

Regulatory2026-06-12EMA

Approval: Usgena (EMA)

Regulatory2025-11-17EMA

Approval: USTEKINUMAB (BLA761406)

Regulatory2025-04-30FDA

Approval: Yesintek (EMA)

Regulatory2025-02-14EMA

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

Research2017-08-01Strand V · BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ustekinumab
Aliases & brands
ImuldosaOtulfiPyzchivaSelarsdiStarjemzaStelaraSteqeymaWezlanaYesintek
RxNorm CUI
847083
UNII
FU77B4U5Z0
Regulatory jurisdictions
emafda

Regulatory timeline

39 events

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.

Approval / market entry confirmed across FDA and EMA (2009-01-162009-12-30)
Approval / market entry confirmed across FDA and EMA (2024-11-292026-08-14)
Earliest approval
2009-01-16
Latest approval
2026-08-14
Authorities
FDA · EMA
Total events
39
fdaU.S. Food and Drug Administration· 35 events
2026-08-14Indication expansionMulti-authority
Indication expansion: USTEKINUMAB (BLA761406)
Evidence ↗
2026-07-15Label change
Label change: USTEKINUMAB (BLA125261)
Evidence ↗
2026-04-15Label change
Label change: USTEKINUMAB (BLA125261)
Evidence ↗
emaEuropean Medicines Agency· 4 events
2026-06-12Market withdrawalMarket
Market withdrawal: Qoyvolma (EMA)
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 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, 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.

Evidence ↗
2025-11-17ApprovalMulti-authority
Approval: Usgena (EMA)
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 responseShow full 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 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).

Evidence ↗
2025-02-14ApprovalMulti-authority
Approval: Yesintek (EMA)
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 areShow full 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 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.

Evidence ↗

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

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017 · 231 cites
Recent papers

Immunogenicity of Biologics in Chronic Inflammatory Diseases: A Systematic Review.

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2017 · 231 cites
Journals, researchers & institutions
Top journals
  • BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy1
Leading researchers
  • Al-Saleh J1
  • Balsa A1
  • Barile-Fabris L1
  • Hawes C1
  • Horiuchi T1
  • Kola B1
  • Lula S1
  • Marshall L1
Leading institutions
free-text, unnormalised
  • 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

4 matches

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.

6 shared diseases1 shared paper

Studied across 6 of the same disease areas as Ustekinumab in the shared literature.

6 shared diseases1 shared paper

Studied across 6 of the same disease areas as Ustekinumab in the shared literature.

6 shared diseases1 shared paper

Studied across 6 of the same disease areas as Ustekinumab in the shared literature.

6 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • Regulatory event sources are credited in the Regulatory Timeline above.