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    DRUG:

    Uplizna (inebilizumab-cdon)

    i
    Other names: MEDI-551, MEDI 551, 16C4-aFuc, A-fucosylated anti-CD19 antibody, VIB0551, MT-0551, VIB 0551, VIB-0551, MT0551, MT 0551, MEDI551
    Associations

    News

    Trials
    Company:
    Amgen, Jiangsu Hansoh Pharma, Tanabe Pharma
    Drug class:
    CD19 inhibitor
    Related drugs:
    Associations

    News

    Trials
    3d
    MINT: Myasthenia Gravis Inebilizumab Trial (clinicaltrials.gov)
    P3, N=238, Active, not recruiting, Amgen | Trial completion date: Nov 2027 --> Jun 2029
    Trial completion date
    |
    Uplizna (inebilizumab-cdon)
    3d
    A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG) (clinicaltrials.gov)
    P2, N=15, Recruiting, Amgen | Initiation date: Apr 2026 --> Aug 2026
    Trial initiation date
    |
    Uplizna (inebilizumab-cdon)
    11d
    A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (clinicaltrials.gov)
    P2, N=220, Recruiting, Amgen | Trial completion date: Mar 2029 --> Jul 2028 | Trial primary completion date: Jan 2028 --> Jul 2028
    Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    |
    Blincyto (blinatumomab) • Uplizna (inebilizumab-cdon)
    14d
    Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, Amgen | Initiation date: Apr 2026 --> Jul 2026
    Trial initiation date
    |
    Uplizna (inebilizumab-cdon)
    18d
    Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants With IgG4-RD (clinicaltrials.gov)
    P2, N=15, Not yet recruiting, Amgen
    Trial initiation date
    |
    Uplizna (inebilizumab-cdon)
    25d
    Efficacy and Safety of Inebilizumab in the Treatment of Relapsing Neuromyelitis Optica Spectrum Disorder : A Multicenter, Randomized Controlled, Open-Label Study (ChiCTR2600119728)
    P4, N=80, Completed, Affiliated Provincial Hospital of Shandong First Medical University (Shandong Provincial Hospital); Affiliated Provincial Hospital of Shandong First M
    New P4 trial
    |
    Uplizna (inebilizumab-cdon)
    2ms
    BEST-NMOSD: Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (clinicaltrials.gov)
    P4, N=540, Not yet recruiting, Massachusetts General Hospital | N=160 --> 540
    Enrollment change
    |
    Rituxan (rituximab) • Truxima (rituximab-abbs) • Uplizna (inebilizumab-cdon)
    3ms
    20240202: Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Inebilizumab in Pediatric Participants with Immunoglobulin G4-related Disease (IgG4-RD) (2025-520988-41-00)
    P1/2, N=2, Not yet recruiting, Amgen Inc.
    New P1/2 trial
    |
    Uplizna (inebilizumab-cdon)
    3ms
    A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases (clinicaltrials.gov)
    P2, N=220, Recruiting, Amgen | N=98 --> 220 | Trial completion date: Jun 2029 --> Mar 2029 | Trial primary completion date: Sep 2028 --> Jan 2028
    Enrollment change • Trial completion date • Trial primary completion date
    |
    CRP (C-reactive protein)
    |
    Blincyto (blinatumomab) • Uplizna (inebilizumab-cdon)
    3ms
    IgG4-related sclerosing cholangitis: navigating diagnostic dilemmas and the challenge of relapse. (PubMed, Front Med (Lausanne))
    Maintenance therapy with steroid-sparing immunomodulators (e.g., azathioprine, mycophenolate mofetil) or B-cell depleting agents such as rituximab is often required. The anti-CD19 monoclonal antibody inebilizumab has emerged as a potent new option for maintaining remission. Maintaining a high index of clinical suspicion for IgG4-SC is essential in patients with obstructive jaundice and biliary strictures. Future efforts should focus on validating specific biomarkers (e.g., circulating plasmablasts, autoantibody profiles) and developing evidence-based protocols for long-term management to prevent fibrotic complications and reduce the relapse rate.
    Review • Journal
    |
    CD4 (CD4 Molecule) • ANXA1 (Annexin A1) • ANXA11 (Annexin A11)
    |
    Rituxan (rituximab) • Uplizna (inebilizumab-cdon)
    3ms
    20240236: An Open-label Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in children with gMG (2025-520993-20-00)
    P1/2, N=4, Not yet recruiting, Amgen Inc.
    New P1/2 trial
    |
    Uplizna (inebilizumab-cdon)
    3ms
    BEST-NMOSD: Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab, and Eculizumab in NMOSD (clinicaltrials.gov)
    P4, N=160, Not yet recruiting, Massachusetts General Hospital | Initiation date: Nov 2025 --> May 2026 | Trial primary completion date: Feb 2029 --> Jan 2030
    Trial initiation date • Trial primary completion date
    |
    Rituxan (rituximab) • Truxima (rituximab-abbs) • Uplizna (inebilizumab-cdon)